News

TaiGen Biotechnology files NDA for antibiotic nemonoxacin in Taiwan and China

TaiGen Biotechnology has submitted an New Drug Application for the oral formulation of nemonoxacin, for Infectious Diseases, with the Taiwan Food and Drug Administration and China Food and Drug Administration. The application is based on a pivotal Phase III trial with 532 patients in community-acquired Pneumonia (CAP).

The trial was conducted in both Taiwan and mainland China (441 patients from ...

FDA issues Complete Response Letters for elvitegravir and cobicistat (Gilead Sciences)

Gilead Sciences, Inc. has announced that the company has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

In its communications,the FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in ...

Phase II data show CEM 101 (Cempra Inc) useful against urogenital Infections and multidrug-resistant pathogens

New Phase II data on CEM 101 (solithromycin), from Cempra Inc, in patients with Infectious Diseases show that patients with gonococcal infections were treated successfully in 100% of cases. Infections were eradicated from all 22 evaluable patients (from an enrollment of 28) including from cervical, urethral, rectal and pharyngeal infection sites. It was well tolerated and was accompanied by only ...

Phase II data shows ABT 450/r, ABT 267, ABT 333 (Abbvie) successful in patients with Hepatitis C

New data from AbbVie's Phase IIb Aviator trial of ABT 450/r (protease inhibitor and ritonavir), ABT 267 (NS5A inhibitor) and ABT 333 (non-nucleoside polymerase inhibitor) for the treatment of Hepatitis C virus (HCV) infection demonstrates sustained viral response rates across multiple patient types with HCV Genotype 1. Data shows that 96 percent of treatment-naive patients and 93 percent of prior ...

Phase III trial of BI 201335 (Boehringer) succesful for Hepatitis C patients

Results from the pivotal Phase III STARTVerso1 trial of BI 201335 (faldaprevir), from Boehringer, in combination with pegylated interferon and ribavirin (PegIFN/RBV) show that untreated patients with genotype-1 Hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure 12 weeks after treatment was completed (SVR12). This is ...

UK and German approvals for FLUARIX TETRA (GSK) influenza vaccine

GSK announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain ...

Miravirsen (Santaris Pharma) Phase II trial for Hepatitis C is reported in NEJM

Santaris Pharma A/S, has announced the publication of study results online in the New England Journal of Medicine (NEJM). The publication highlights the potential benefits of miravirsen, a host-targeted, pan-HCV genotype anti-viral agent and the first microRNA-targeted drug to enter clinical trials for the treatment of Hepatitis C virus (HCV). In the study, miravirsen, given as a four-week monotherapy ...

Janssen R&D files TMC 435 to the FDA for Hepatitis C

Janssen R&D has submitted a New Drug Application (NDA) to the FDA seeking approval for TMC 435 (simeprevir) 150mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adult patients. The submission is supported in part by data from three pivotal Phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in ...

Complete Response Letter from FDA for Q-Pan H5N1 influenza vaccine

GSK has received a Complete Response Letter from the FDA for its pandemic influenza A vaccine, called Q-Pan H5N1. Q-PAN H5N1 is intended for the prevention of Infuenza in adults who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.

In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee ...

Positive Phase III results for tedizolid phosphate (Trius Therapeutics) for ABSSSI

Trius Therapeutics, Inc. has announced top-line results from its ESTABLISH 2 Phase III clinical trial of tedizolid phosphate (TR-701) for the treatment of Acute Bacterial Skin and Skin Dtructure Infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). As in the ESTABLISH 1 study, which tested the oral dosage form of tedizolid, the ESTABLISH 2 intravenous to oral transition study ...

CHMP recommends Stribild (Gilead Sciences) for the treatment of HIV

Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP), has adopted a positive opinion on the company's Marketing Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of ...

HyQvia (Baxter/Halozyme) is CHMP recommended for treatment of Immunodeficiencies

Baxter International and Halozyme Therapeutics, Inc. have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary Immunodeficiencies.

The product is a combination of human normal immunoglobulin (IGSC, ...

Phase IIa trial of AFN 1252 (Affinium Pharma) shows drug is effective and safe against Bacterial Infections

Results from a Phase IIa clinical trial evaluating oral AFN 1252, from Affinium Pharma, in acute Bacterial Skin and Skin Structure Iinfections (ABSSSI), demonstrates the drug offers excellent efficacy and safety. This study involved 103 patients with infections due to Staphylococcus, dosed twice daily for 5-14 days. The results show that Day 3 Improvement was achieved in 94% of patients ...

RTS,S Malaria Vaccine (GSK) disappoints

The effectiveness of a Malaria Vaccine, RTS,S, developed by GlaxoSmithKline wanes over time, with the shot protecting only 16.8 percent of children over four years, according to trial data. The disappointing results for RTS,S - the world's first potential malaria vaccine - raise further questions about whether it can make a difference in the fight against the disease, a major ...

Phase III results using E 5564 (Eisai) show no significant benefit for Sepsis

A Phase III trial to evaluate the safety and efficacy of E 5564 (eritoran), from Eisai, in reducing mortality in patients with severe Sepsis shows the drug failed to demonstrate a significant effect on reducing all-cause 28-day mortality or 1-year mortality, compared with placebo. The randomized, multinational trial was conducted in 197 intensive care units. Patients were enrolled from June ...

Pegasys (Roche) European indication expanded by EMA in Hepatitis C to include to children

Roche has announced that the European Medicines Agency (EMA) has expanded the approval of Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic Hepatitis C virus (HCV). The new label includes children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus. Pegasys in combination with the antiviral ...

Positive topline results from Phase III trial of Enterovirus 71 vaccine (Sinovac Biotech) against Hand, Foot and Mouth Disease

Preliminary top-line data from a Phase III clinical trial assessing the efficacy, immunogenicity and safety of Enterovirus 71 vaccine, from Sinovac Biotech, against Hand, Foot and Mouth Disease, showed that the vaccine was 95.4% efficacious against HFMD. The Phase III trial involving 10,000 healthy infants of 6 to 35 months old showed good immunogenicity and safety.

The overall incidence of ...

Phase III SAILING study of dolutegravir(ViiV) success in HIV-1

ViiV Healthcare has announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor.

At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c/mL) vs. ...

Phase IV study of Livalo (Eli Lilly/Kowa Pharmaceuticals) meets end point in patients with Dyslipidemia

Results of a Phase IV study evaluating the efficacy of Livalo (pitavastatin), from Eli Lilly/Kowa Pharmaceuticals, compared with pravastatin in reducing low-density lipoprotein cholesterol (LDL-C) in HIV-infected adults with Dyslipidemia has met its end point. Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 ...

Positive results from Phase III trial of BI 201335 (Boehringer) for Hepatitis C patients

Interim results from HCVerso, a trial of BI-201335 (faldaprevir), from Boehringer, for Hepatitis C (HCV) showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS), as defined by the study protocol. Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment ...

VOICE study of Truvada gel (Gilead Sciences) unsuccessful in HIV prevention

Anti retroviral therapy was applied in the VOICE study which used a vaginal gel containing tenofovir (Viread as a pill) and tenofovir-emtricitabine (Truvada) from Gilead Sciences. None of the treatments was effective in the VOICE study, mostly because patients failed to use the product daily. 315 out of 5029 women in the study were infected by HIV (5.7%).

Investigators ...

Dalbavancin (Durata Therapeutics) success in Phase III DISCOVER 2 trial for ABSSSI

Durata Therapeutics, Inc. has announced preliminary, top-line results for its DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results ...

Phase III study shows TR 701 (Trius Therapeutics) equivalent to best alternative treatment for ABSSSI

New results from a Phase III study of TR 701 (tedizolid phosphate), from Trius Therapeutics, shows it is as effective as current best treatment for acute bacterial skin and skin structure infections(ABSSSI). The ESTABLISH 1 trial examined the efficacy and safety of 200 mg tedizolid given once a day for six days versus 600 mg linezolid given twice a day ...

FISSION and Neutrino studies success for GS 7977 (Gilead Sciences) for Hepatitis C

Gilead Sciences has announced topline results from two Phase III studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic Hepatitis C virus (HCV) infection.

In the FISSION study, patients with genotype 2 or 3 HCV ...

FDA approves extension of Prevnar 13 vaccine indication

Pfizer Inc. has announced that the FDA has granted approval on 25 January 2013 for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus ...

Soliris (Alexion Pharma) rejected by UK Health Ministers for Haemolytic Uraemic Syndrome

Soliris (eculizumab)from Alexion Pharma was referred in the UK to the Advisory Group for National Specialised Services (AGNSS) instead of NICE and AGNSS recommended the $400 000 per patient, per year, drug for treatment of patients with atypical Haemolytic Uraemic Syndrome (aHUS), a rare, chronic blood disease. The decision of AGNSS was overruled by Health Ministers and the application has ...

CHMP recommends Pegasys(Roche) for paediatric use in Hepatitis C

The CHMP recommends Pegasys (peginterferon alfa-2a) from Roche, in combination with ribavirin, be indicated for the treatment of chronic Hepatitis C in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus (HCV) RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The ...

European Commission approves Bexsero vaccine (Novartis) for Meningococcal Disease

Novartis has announced that the European Commission has approved Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.

MenB disease is a bacterial infection and is the leading cause of meningitis across Europe, particularly in infants. Although ...

EC approve new strength Prezista (J&J Janssen Cilag) for AIDS patients

The European Commission has approved a new Prezista (darunavir) 800mg tablet, from J&J Janssen Cilag, allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated mutations. This new tablet strength has been developed to ...

Preliminary results from Phase IIb study of BI 201335 and BI 207127 (Boehringer) show positive response in Hepatitis C patients

New preliminary results from the SOUND-C3 trial, Boehringer Ingelheim's investigational Interferon-free regimen which combines BI 201335 (faldaprevir) and BI 207127, show that 100 percent (n=20) of patients with Hepatitis C GT-1b achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to ...

FDA approves FluBlok vaccine ( Protein Sciences) for Influenza

The FDA announced on 16 January 2013 that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior ...

The Lancet reports successful Phase III study of Bexsero vaccine (Novartis)against MenB

The Lancet published findings online from a pivotal Phase III clinical trial of Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) from Novartis, involving 3,630 infants from two months of age. The study showed that Bexsero demonstrated a protective immune response and has an acceptable safety profile when administered as a three-dose primary series concomitantly with routine vaccines. The investigators ...

Dalbavancin (Durata Therapeutics) reports on DISCOVER 1 trial for Skin Infections

Durata Therapeutics has announced additional preliminary, top-line results for its DISCOVER 1 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).

As ...

FDA approves Sirturo (Janssen Therapeutics) for multi-drug resistant Tuberculosis

The FDA has granted accelerated approval to Sirturo (bedaquiline), from Janssen Therapeutics, for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The FDA accelerated approval is based on Phase II data from TMC207-C208 Study 1 and Study 2.

The primary endpoint was time to sputum culture conversion: the interval in days between the ...

ViiV healthCare files dolutegravir for HIV treatment in EU, US and Canada

ViiV Healthcare has announced the submission of regulatory applications in the European Union , United States and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically: -A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 ...

FDA approves VariZIG (Cangene Corpn) for Chicken Pox treatment

The FDA on 21 December 2012 approved VariZIG,a varicella zoster immune globulin preparation from Cangene Corporation, for reducing the severity of Chicken Pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. Varicella zoster immune globulin (VZIG) has been shown to lower the risk of severe infections if given soon enough after exposure. An ...

FDA approves Bivigam (Biotest Pharmaceuticals Corporation) for Primary Humoral Immunodeficiency

The FDA has given Biotest Pharmaceuticals Corporation approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency. Approval is based on a pivotal clinical study which successfully achieved its primary endpoints for safety, efficacy and tolerability. The results were recently published in the Journal of Clinical Immunology (Wassermann RL, Church JA, Stein M, et al. "Safety, efficacy and ...

Phase III trials of TMC 435 (Medivir/Tibotec) show positive response in patients with Hepatitis C

Top-line results from three pivotal Phase III trials examining TMC 435 (simeprevir, from Medivir/Tibotec, administered with pegylated interferon and ribavirin found that 80% and 81% of treatment-naive patients with chronic genotype 1 Hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). These results were from QUEST-1 and QUEST-2 ...

FDA approves Fluarix Quadrivalent (GSK) Influenza vaccine

The FDA has approved Fluarix Quadrivalent Influenza Virus Vaccine from Glaxo Smith Kline, for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine. Fluarix Quadrivalent is the first intramuscular vaccine to cover against four influenza strains....

FDA approves raxibacumab (Human Genome Sciences/GSK) to treat Anthrax

The FDA approved raxibacumab injection, from Human Genome Sciences/GSK, on 14 December 2012, to treat inhalational Anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Raxibacumab is the first monoclonal antibody approved under ...

FDA updates prescribing information for Edurant (Tibotec) for AIDS patients

The FDA has approved a prescribing information update for Edurant (rilpivirine) tablets, from Tibotec, to include 96-week pooled data from the Phase III ECHO and THRIVE studies, which evaluated the efficacy and safety of Edurant for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) in antiretroviral treatment-naive adults. In addition to the inclusion of the 96-week data in the ...

FDA Advisory Committee recommends bedaquiline (Janssen)for treatment of Tuberculosis

Janssen Research & Development, LLC (Janssen) has announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a ...

FDA Advisory Committee gives restricted recommendation for Vibativ (Theravance) for Nosocomial Pneumonia

The Advisory Committee (AIDAC) of the FDA has voted 9-6 that data, from Theravance relative to Vibativ (telavancin), failed to provide substantial evidence of the safety and effectiveness of Vibativ in treating Nosocomial Pneumonia (NP) including ventilator-associated pneumonia, caused by the susceptible Gram-positive microorganisms Staphylococcus aureus, including methicillin-resistant isolates (MRSA), and Streptococcus pneumoniae.

However in a 13-2 vote, the ...

Phase III trial of GS 7977 plus RBV (Gilead Sciences) shows positive results in patients with Hepatitis C

Gilead Sciences has announced topline results from the Phase III POSITRON study of GS 7977 (sofosbuvir) plus ribavirin (RBV) in patients with genotype 2 or 3 chronic Hepatitis C who are not candidates to take interferon (IFN). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). SVR12 rates were 93 ...

Succesful trial of Synflorix vaccine (Glaxo Smith Kline) to protect infants against Pneumococcal Disease

New results of a study suggest that a series of three or four shots of Synflorix PCV10 vaccine, from Glaxo Smith Kline, which includes three additional pneumococcal strains, should prevent over 70% of severe Pneumococcal Disease cases in children worldwide. The FinIP trial is the first European randomised study and included nearly 46 000 children younger than 19 months, randomised ...

Lambda plus daclatasvir (BMS) combination success in Phase IIb trial for Hepatitis C

BMS has announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a (Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir (DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment (SVR12) in 93% (13/14) of treatment-naïve, genotype 1b chronic Hepatitis C patients who achieved ...

IDX 184 and IDX 719 safety data presented by Indenix.

Idenix has announced the presentation of safety and antiviral activity results for the Company's clinical-stage Hepatitis C virus (HCV) drug candidates — IDX 719, a next-generation pan-genotypic NS5A inhibitor, and IDX 184, a nucleotide polymerase inhibitor. Idenix presented updated clinical findings from a three-day proof-of-concept study, which demonstrated that IDX 719 was well-tolerated at daily doses up to 100 ...

Positive topline results from study of ABT 450/r, ABT 267, ABT 333 (Abbott) for Hepatitis C

Abbott announced topline results from AVIATOR, a phase IIb study of its ABT 450/r and ABT 267 and ABT 333 regimen for the treatment of Hepatitis C (HCV). The treatment demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR12) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). ...

RTS.S anti malaria vaccine further results in African study

Results from a pivotal, large-scale Phase III trial, published online in the New England Journal of Medicine, show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and ...

FDA Advisory Committee recommends raxibacumab (HGS), for Anthrax

The FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted 16-1, with one abstention, that animal studies conducted by Human Genome Sciences of raxibacumab, an injectable recombinant fully human monoclonal antibody that targets the protective antigen component of the lethal toxin of Bacillus anthracis, provided substantial evidence the drug, with or without antimicrobials, was reasonably likely to produce clinical benefit as ...

NICE does not recommend Colobreathe (Forest Labs) for treatment of Cystic Fibrosis infection

NICE does not recommend Colobreathe (colistimethate dry powder for inhalation)from Forest Labs as a cost effective option for treating chronic pulmonary infection caused by P. aeruginosa in people with Cystic Fibrosis. The Committee noted that there was no economic analysis pitting the product against the nebulised form of colistimethate, while results of its preferred economic analysis showed that Colobreathe was ...

NICE recommends Tobi Podhaler (Novartis) for treatment of Cystic Fibrosis

NICE has recommended the use of Tobi Podhaler (tobramycin inhalation powder) from Novartis for the treatment of pseudomonas lung infection in Cystic Fibrosis patients aged six years and above. Tobi Podhaler may only be used in cases where treatment with the nebulised form of the drug is considered appropriate, i.e. when patients cannot have or do not respond to treatment ...

CHMP recommends extension of Isentress indication for HIV

The CHMP has recommended a change to the indication for Isentress (raltegravir), from Merck., which is now indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years....

Sanofi Pasteur has submitted Hexaxim vaccine to EMA for approval in Europe

The Hexaxim vaccine (DTaP-IPV-Hib-HepB) has been submitted by Sanofi Pasteur MSD to the EMA for approval to licence within the European Union. Upon approval the company says it will commercialise it in its European territories under its own brand name. The new hexavalent vaccine, developed by Sanofi Pasteur, is the only fully liquid, ready to use 6-in-1 vaccine to protect ...

No significant evidence that cranberry juice can prevent UTIs

A Cochrane Library review finds that cranberries may not be effective in treating Urinary Tract Infections. Some evidence shows that cranberry juice may decrease the number of symptomatic UTIs over a 12 month period, particularly for women with recurrent UTIs. However the addition of 14 further studies suggests that cranberry juice is less effective than previously indicated. Although some of ...

FDA approve Aptima HPV Assay (Hologic) for detecting Human Papillomavirus

The FDA has approved the Aptima HPV 16 18/45 Genotype Assay, from Hologic, for use on its Tigris instrument system. It is the first FDA-approved test for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive Cervical Cancers worldwide. The test is specifically approved for use adjunctively with the Aptima HPV ...

ABT 450/r , ABT 267, ABT 333 combination in Hepatitis C

Abbott has announced initial results from "AVIATOR," a phase IIb study of its interferon-free, investigational regimen for the treatment of Hepatitis C (HCV). Initial results show sustained virological response at 12 weeks post treatment (SVR12) in 99 percent of treatment-naïve (n=77) and 93 percent of null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination of ABT-450/r, ...

FDA approves Simplexa Flu A/B & RSV Direct test (Focus Diagnostics) to detect Influenza

The FDA has provided 510(k) clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test, from Focus Diagnostics, on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of Influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. The Simplexa Flu A/B & ...

Aquacell Ag (Convatec) surgical cover success reported in JAMA

A new study looking at infections following joint replacement surgery finds a 78 percent decrease in joint infections when Aquacell Ag SURGICAL cover dressing from ConvaTec was used. The study found that the infection rate for total joint replacement patients dropped to 0.4 percent when Aquacell Ag SURGICAL cover dressing was used as compared to 1.8 percent when gauze ...

Positive results from study of delamanid (Otsuka) for patients with MDR-TB

Results from an observational study evaluating delamanid, from Otsuka, have found that the treatment can improve outcomes and reduce mortality among patients with both multi-drug resistant Tuberculosis MDR-TB and extensively drug-resistant Tuberculosis (XDR-TB). A previous trial had evaluated the effectiveness of 2 months treatment but the new study followed the same patients for a further 24 months of treatment.

The ...

Dalbavancin (Durata Therapeutics) QT study results

Results from a QT study of dalbavancin from Durata Therapeutics were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and showed that in this study dalbavancin had no clinically significant impact on cardiac conduction. The drug is currently under investigation in two ongoing, global, Phase III clinical trials for the treatment of acute bacterial skin and ...

IQWiG finds Incivek/Incivo (J&J Janssen Cilag) offers some advantages for Hepatitis C patients

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether Incivek/Incivo (telaprevir), from J&J Janssen Cilag, offers an added benefit for patients with Hepatitis C compared to conventional therapy. The assessment finds that the drug offers advantages in various groups of patients with chronic Hepatitis C infection of genotype 1. The available studies provide proof, indications ...

FDA votes to support inhaled powder form of tobramycin (Novartis) for patients with Cystic Fibrosis

An FDA drug advisory committee has voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (TIP), from Novartis, for the management of Cystic Fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa). It based its recommendation on three Phase III clinical studies involving more than 650 ...

FDA approves Elecsys HSV Assays (Roche) for detecting Herpes Simplex virus

The FDA has cleared the Elecsys HSV-1 IgG and HSV-2 IgG assays, from Roche, for detecting Herpes Simplex virus (HSV) types 1 and 2. The assays are for use on Roche's cobas modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The ...

Janssen submit MAA to the EMA for TMC 207 as treatment for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a Marketing Authorisation Application to the EMA seeking conditional approval for the use of the investigational drug TMC 207 (bedaquiline) as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. The submission is supported by 24-week data from the Phase II clinical development program, which includes an open-label study ...

EMA 401 has Phase II success for Post Herpetic Neuralgia

There have been positive headline results from the Phase II clinical trial of EMA 401 from Spinifex Pharmaceuticals, in Postherpetic Neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo ...

EU approves Zinforo (AstraZeneca) for cSSTI and CAP infections

AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo(ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). This makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause ...

FDA approves Stribild ( Gilead Sciences) for treatment of HIV-1 Infection

Gilead Sciences,announced that the FDA has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil ...

Development of BMS 986094 (BMS/Inhibitex) for Hepatitis C halted

BMS/Inhibitex have discontinued development of BMS 986094, for Hepatitis C, following the death of a participant in a Phase II trial. A spokesperson stated that the decision "was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients". The trial was voluntarily suspended on 1 August 2012. The company states that while "the ...

FDA approve SurgiClear (Covalon Technologies) for Wound Healing

The FDA has cleared SurgiClear (antimicrobial dressing), from Covalon Technologies, to cover and protect Wound sites and wound closure devices, as well as secure other primary dressings to a patient's skin. SurgiClear is the first clear antimicrobial silicone surgical dressing that combines silver and chlorhexidine to provide broad spectrum antimicrobial activity for 7 days. SurgiClear is the only antimicrobial surgical ...

EMA accepts filing for Heplisav (Dynavax Technologies), a vaccine for Hepatitis B.

The EMA has accepted the filing of the Marketing Authorization Application for Heplisav vaccine, from Dynavax Technologies, pursuing an indication for immunization against infection caused by all known subtypes of Hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to ...

IDX 184 (Idenix)trial for Hepatitis C halted by FDA for suspected cardiotoxicity

IDX 184 is a drug from Idenix Pharmaceuticals for treatment of Hepatitis C. The development of the drug has been placed on partial hold by the FDA as the drug may be linked to serious cardiac related adverse events. Idenix maintains that no evidence of cardiotoxicity has been found in its trials but will perform cardiac tests on its 67 ...

Vacc-4x (Bionor Pharma) in Phase III trial with Revlimid(Celgene)for HIV treatment

Bionor Pharma announced that the clinical trial application for the placebo-controlled study with Vacc-4x in combination with Celgene`s Revlimid has been approved by the German health regulatory authorities. The study will be conducted at four different clinics in Germany, and will include HIV patients who do not recover a normal CD4 T-cell count (measurement of the immune system) despite receiving ...

Sanofi Pasteur Dengue vaccine success in clinical trial

Sanofi Pasteur, the vaccines division of Sanofi announced that its tetravalent Dengue Vaccine candidate demonstrated proof of efficacy against Dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety. The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of ...

Positive results from Phase III study of Isentress (Merck Inc) for HIV-1 patients

Final results from the STARTMRK study, a Phase III trial evaluating Isentress (raltegravir), from Merck Inc, in combination therapy in previously untreated adult HIV-1 patients, indicate that virologic efficacy was better than the efavirenz-based regimen at 240 weeks. In the study, 563 previously untreated HIV-1 infected adult patients with HIV-1 RNA greater than 5000 copies/mL received either 400 mg Isentress ...

Vestiq Pharma licenses Oravig for Oropharyngeal Candidiasis in US from BioAlliance Pharma

BioAlliance Pharma has entered into a licence agreement with Vestiq Pharmaceuticals, under which the latter gains the US commercialisation rights to the antifungal treatment, Oravig (miconazole), for oropharyngeal candidiasis in adults.Following PAR Strativa restructuring and change of its strategy including the acquisition of generic portfolio, BioAlliance Pharma had decided to regain full US commercialisation rights for Oravig in October 2011.In ...

Success in Phase III SINGLE trial of Dolutegravir

Interim results from the Phase III SINGLE study involving dolutegravir from Shionogi-Viiv HealthCare,demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla. At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed (<50 copies/mL) vs. 81% of participants on the single tablet regimen Atripla: The difference in the primary endpoint was statistically significant. ...

Gilead Sciences files cobicistat"booster" for AIDS drugs

Gilead Sciences, announced it has submitted a New Drug Application (NDA) to the FDA for marketing approval of cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. Cobicistat is also a component of the Quad once-daily single tablet regimen for HIV, which is ...

FDA accepts filing of Hepislav ( Dynavax Technologies) vaccine for Hepatitis B

The FDA has accepted for review the biologics license application (BLA) for the Hepatitis B vaccine, Heplisav, from Dynavax Technologies. Hepislav is an immunostimulatory sequence targeting toll-like receptor 9 (TLR9) combined with hepatitis B surface antigen. The FDA set 24 February 2013 as the Prescription Drug User Fee Act action date for Heplisav. The attraction of Hepislav is an easier ...

Elvitegravir (Gilead Sciences) is filed at FDA for HIV-1 Infection in treatment-experienced adults

Elvitegravir,from Gilead Sciences, an integrase inhibitor for treatment for HIV-1 infection in treatment-experienced adults is filed at the FDA. The submission is supported by 96-week data from a pivotal Phase III 145 study, in which the drug dosed once daily at 150mg or 85mg was non-inferior to the integrase inhibitor raltegravir 400mg dosed twice daily – each administered with a ...

New drug application filed with FDA for TMC 207 (Janssen Pharmaceuticals) for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking accelerated approval for the use of TMC 207 (bedaquiline) to be used as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. If approved, it would be the first drug with a new mechanism of action for TB in more than 40 years and the ...

FDA approves Verigene GP Blood Culture Nucleic Acid Test (Nanosphere) for identifying Bacterial Infections

The FDA has allowed marketing of the Verigene GP Blood Culture Nucleic Acid Test (BC-GP), from Nanosphere. This is the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of ...

Study shows Viramune/Viramune XR (Boehringer) halves risk of HIV infection in newborns

Adding the drug Viramune/Viramune XR (nevirapine), from Boehringer, to the regimen given to newborns of women diagnosed with HIV shortly before or during labour halves the newborns’ risk of contracting the virus. Researchers led by Karin Nielsen-Saines of the University of California, Los Angeles, School of Medicine, found that the rate of mother-to-child HIV transmission around the time of delivery ...

CHMP recommends Zinforo(AstraZeneca) for cSSTI or CAP infections

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Zinforo (ceftaroline fosamil) (Teflaro in USA) from AstraZeneca, a new intravenous cephalosporin antibiotic for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP).The CHMP reviewed data from the Phase III clinical trial programmes ...

EMA accepts application for elvitegravir(Gilead Sciences) for HIV-1 treatment

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients,from Gilead Sciences. The filing for elvitegravir was supported by 96-week data from a pivotal Phase III study (Study 145) in which the product (150mg or 85mg) dosed once daily was shown to be non-inferior ...

IDX 184 (Idenix) in Phase II for Hepatitis C

Idenix Pharmaceuticals has reported positive data from both an interim analysis of a Phase II study of its drug candidate for Hepatitis C virus , IDX184. The company plans to begin a combination study of the IDX 184 and IDX 719, which has just completed a proof of concept study, by the end of the year....

Cranberry juice and Urinary Tract Infections study

A new study from Jeffrey Blumberg at Tufts University evaluated the cranberry’s role in promoting urinary tract health through compounds known as proanthocyanidins (PACs). The study confirmed the presence of unmetabolized PACs in the urinary tract after consumption, adding some evidence to ex-vivo research that suggests potential benefits of the compounds found in cranberry juice. In addition, a pilot study ...

FDA approves vaccine Menhibrix (GSK)for bacterial diseases

The FDA on 14 June 2012 approved Menhibrix, from Glaxo Smith Kline, a combined meningococcal disease (serogroups C and Y) and Haemophilus influenzae type b (Hib) conjugated vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b. Diseases caused by the bacteria ...

Delamanid (Otsuka) positive in Phase IIb trial for Tuberculosis

Otsuka Pharmaceutical Co., Ltd. announced clinical trial results on the safety and efficacy of delamanid, the company's investigational compound for the treatment of multidrug-resistant Tuberculosis (MDR-TB).Results from the Phase IIb trial showed a 53% increase in sputum culture conversion (SCC) after two months between study subjects receiving delamanid 100 mg twice-daily (BID) plus a background regimen (BR) consistent with WHO ...

FDA approves Horizant (GlaxoSmithKline/XenoPort) for Postherpetic Neuralgia in adults

The FDA has approved Horizant (gabapentin enacarbil) extended-release tablets, from GlaxoSmithKline / XenoPort, for Postherpetic Neuralgia in adults. Approval is based on a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. Somnolence and dizziness were the most frequently ...

Cobicistat (Gilead Sciences) "booster" for AIDS drugs is filed at EMA

The marketing authorisation application (MAA) for the HIV drug "boosting" agent cobicistat from Gilead Sciences had been validated by the European Medicines Agency (EMA). cobicistat is a pharmaco-enhancing agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir (Bristol-Myers Squibb's Reyataz) and darunavir (Janssen's Prezista), to enable once-daily dosing....

New formulation of Viread (Gilead Sciences) makes gel safer for rectal use against HIV

New results show that a change in the formulation of Viread (tenofovir gel), from Gilead Sciences, developed for vaginal use to protect against HIV may make it safer to use in the rectum. The rectal epithelium is much thinner than the vaginal lining, so the gel may not be safe or effective to use rectally. To make Viread safe and ...

Positive data from Phase III study of Dificid/Dificlir (Optimer Pharma) for patients with CDAD

The results of a retrospective subpopulation analysis of 183 patients with cancer from two large Phase III trials of Dificid/Dificlir (fidaxomicin), from Optimer Pharma, which showed the cancer patients with Clostridium difficile-associated diarrhea (CDAD) who were treated with Dificid/Dificlir tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. Results showed that overall, ...

IMDx GBS (IntelligentMDx) test system for Group B Streptococcus receives CE mark

The IMDx GBS for Abbott m2000, from IntelligentMDx, an automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen, has received CE mark approval. The system utilizes real time PCR, operates on the Abbott m2000 system ...

Viramune (Boehringer) patent expires on 22 May 2012

Zhejiang Huahai Pharmaceutical has agreed with Breckenridge Pharmaceutical to market, in the USA, a generic version of Viramune (nevirapine) currently marketed by Boehringer Ingelheim for HIV treatment. The US patent for Viramune expires on 22 May 2012....

FDFA Advisory Committee recommends QUAD (Gilead) for HIV treatment

The FDA Antiviral Drugs Advisory Committee voted 13-1 that Quad (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) from Gilead Sciences, is a safe and effective drug for HIV patients who have not received prior treatment for the disease.The FDA is expected to take action on the application for Quad by August 27....

Lipoprotein 2086 vaccine (Pfizer) shows promise in protecting against Meningococcal infection

New results show that Lipoprotein 2086, a new vaccine for serogroup B Neisseria meningitidis, from Pfizer, is safe and immunogenic in adolescents, the majority of whom generated bactericidal antibodies that were active against strains that represent 90% of invasive Meningococcus serogroup B strains circulating in the USA and Europe. This Phase II trial enrolled 539 healthy adolescents from 25 sites ...

Positive study of probiotics (Danone) for Antibiotic Associated Diarrhoea

A study from Susan Hempel of RAND Health, Santa Monica, Calif., and researchers shows that eating probiotic foods such as yogurt, reduces the risk of antibiotic-associated diarrhoea, a prevalent side effect of antibiotic use. The team searched databases in order to identify randomized controlled trials (RCTs) involving probiotic use (Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus) for the prevention or ...

FDA approves Panther testing system (Gen-Probe) for Sexually Transmitted Infections

The FDA has cleared the Panther system from Gen-Probe. The Panther is a fully automated and integrated molecular testing platform designed to test for the common Sexually Transmitted Diseases Chlamydia trachomatis and Neisseria gonorrhoeae with the APTIMA Combo 2 assay. The Panther system uses fully integrated "sample-in, results-out" automation and a single operator can process 275 samples in eight hours. ...

Ranbaxy launches Indias first new drug Synriam for Malaria

Ranbaxy Laboratories Limited has launched India’s first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria, in adults.The new drug, has been approved by the Drug Controller General of India (DCGI) for marketing in India and conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. Synriam provides quick relief from most ...

Study shows Zostavax (Merck Inc.) safe for Shingles

A retrospective study of 193,083 adults shows that Zostavax, the vaccine for Herpes Zoster, from Merck Inc., is safe for preventing Shingles. The study was conducted in patients over the age of 50, between 2007 and 2008. The results reveal a small rise in local reactions to the injection which occurred from 1 to 7 days after vaccination. However once ...

FDA halts alisporivir (Novartis) Phase III trial

The FDA has placed a clinical hold on a Phase III trial testing alisporivir (DEB025), from Novartis/Debiopharm, plus pegylated interferon and ribavirin in treatment naive genotype 1 patients with Hepatitis C, after a study participant died potentially of pancreatitis.The death was the first and only fatality in the overall alisporivir clinical study programme involving about 1,800 patients. Results of an ...

EMERGE study of Lambda (BMS) in Hepatitis C genotypes 2 and 3 presented at EASL

EMERGE study findings of Peg-interferon lambda-1a (Lambda) from BMS in Hepatitis C genotype 2 and 3 patients were presented in an oral session at the International Liver Congress ,the 47th annual meeting of the European Association for the Study of the Liver in Barcelona. The Phase IIb EMERGE clinical trial involved 118 treatment-naïve patients chronically infected with genotype 2 or ...

Phase IIa results for Miravirsen (Santaris Pharma) show prolonged antiviral activity in Hepatitis C patients

Data from a Phase IIa trial shows that Miravirsen (SPC3649), from Santaris Pharma, given as a four-week monotherapy treatment for Hepatitis C provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was sustained well beyond the end of therapy. The data showed the drug was safe, well ...

Phase IIb data show SVR12 in Hepatitis C patients treated with BI 201335 (Boehringer Ingelheim)

A sub-analysis from SOUND-C2, a Phase IIb study in patients with Hepatitis C evaluating interferon-free treatment with investigational antiviral compounds BI 201335 and BI 207127, from Boehringer Ingelheim, plus ribavirin (RBV), show that up to 43 percent of genotype-1a (GT1a) and up to 71 percent of GT1b Hepatitis C virus (HCV) patients achieved sustained viral response (SVR12). SVR12 has been ...

FDA clears Rotor-Gene Q MDx Instrument and compatible Influenza A/B assay (Qiagen)

The FDA has approved the Rotor-Gene Q MDx instrument and the artus Infl A/B RG real-time PCR IVD test, from Qiagen, for use in detection and identification of Influenza A and B viral infections in nasopharyngeal swab samples. The Rotor-Gene Q MDx instrument is an automated molecular detection platform based on real-time PCR technology. The artus Infl A/B RG RT-PCR ...

ABT-450.r plus ABT 333 Phase II studies in Hepatitis C announced by Abbott Labs

Abbott Labs will present clinical trial results from two different interferon-free, Phase II studies for the treatment of Hepatitis C (HCV) at the International Liver Congress(TM) 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Abstracts for the meeting were published online today. In the study known ...

Omadacycline (Paratek Pharma)special protocol with FDA is agreed for Phase III study for ABSSSI and CABP

Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the Phase III program design for the Company's lead antibiotic candidate, omadacycline (formerly PTK 0796). Omadacycline is a broad-spectrum, first-in-class aminomethylcycline antibiotic with oral and IV formulations that Paratek is developing to address the leading organisms that cause bacterial infections such as serious ...

CEM-101 (Cempra) effective in Phase II study against N. gonorrhoeae

Cempra Inc. has announced data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrating that CEM-101 (solithromycin) is active against antibiotic-resistant strains of N. gonorrhoeae. The investigators of the study compared the activity of solithromycin to several antibiotics including a number of macrolides and third-generation cephalosporins such as ceftriaxone. By measuring the minimum inhibitory ...

CEM-101 (Cempra) success in Phase II trial for CABP

Cempra Inc. announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase II trial of patients with Community-Acquired Bacterial Infections (CABP). The study also demonstrates solithromycin's favorable safety and tolerability profile compared to levofloxacin.Clinical success ...

Dificlir success in reduction of recurrence in Clostridium difficile

A report in The Lancet Infectious Diseases shows that Dificlir (fidaxomicin) from Optimer Pharma has a similar efficacy and tolerability profile for Clostridium difficile infection (CDI) compared with the current standard therapy oral vancomycin. However, the sustained response of Dificlir is superior with a larger rate of recurrence reduction. Researchers have evaluated the efficacy and tolerability of Dificlir in a ...

PLEX-ID assay from Abbott has CE Mark for detection of Infectious Diseases

CE Marking (Conformite Europeene) in the European Union has been granted to Abbott Labs to market its rapid, high-throughput PLEX-ID(TM) instrument, along with three assays for use on the system: PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum BC and PLEX-ID Flu. PLEX-ID, which is based on molecular diagnostic technologies, addresses a significant unmet need for rapid detection and identification of ...

NICE recommends Incivo (J&J Janssen Cilag) for genotype 1 chronic Hepatitis C patients

NICE has issued final draft guidance recommending Incivo (telaprevir), from J&J Janssen Cilag, in combination with Peg alfa and ribavirin, as an option for the treatment of in adults with compensated Liver Disease. It recommends the drug as an option for the treatment of such patients who are previously untreated or in whom previous treatment with Peg alfa and ribavirin ...

CHMP recommends extended approval for Menveo(Novartis)for Meningococcal Disease

The CHMP recommends approval for an extended indication of Menveo (meningococcal vaccine) from Novartis which protects against Neisseria meningitidis groups A, C, W135 and Y,and will shortly be indicated for use in children aged two years and older, as well as adolescents and adults at risk of exposure to the bacteria, to prevent invasive disease. It is currently approved for ...

Purocin protein technology (AvidBiotics) offers rapid response to E.coli infection

A new study shows that AvidBiotics' antibacterial Purocin protein technology can be used to create a highly targeted bactericidal protein against the life-threatening foodborne E. coli O104 strain by making use of rapidly acquired, published, draft genomic sequence data. This strategy offers a rapid-response platform with the potential to create targeted agents for use against emerging bacterial pathogens within days-to-weeks ...

TMC 435 (Medivir) begins two new Phase III trials for Hepatitis C

Patient dosing and screening has begun in two new Phase III clinical trials testing TMC 435, from Medivir/Tibotec, in Hepatitis C infected patients. Trial HPC3001 is an efficacy, safety and tolerability study comparing TMC 435 against telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in 744 Hepatitis C genotype-1 infected patients. Patients will receive TMC 435 ...

Phase II study underway of Shok-Pak (Inflammagen Therapeutics) for patients with Shock

A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics, as a potential treatment for critically ill patients suffering from Multiple Organ Dysfunction Syndrome (MODS), formally known as multiple organ failure. Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding. ...

TMC 435 (Medivir) begins two new Phase III trials for Hepatitis C

Patient dosing and screening has begun in two new Phase III clinical trials testing TMC 435, from Medivir/Tibotec, in Hepatitis C infected patients. Trial HPC3001 is an efficacy, safety and tolerability study comparing TMC435 against telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in 744 Hepatitis C genotype-1 infected patients. Patients will receive TMC435 150 mg ...

Avastin (Roche) possible new treatment for Haemorrhagic Telangiectasia

A new study suggests that Avastin (bevacizumab), from Roche, may help to improve cardiac function and reduce the number of potentially life-threatening nose bleeds caused by a rare genetic vascular disorder known as Haemorrhagic Telangiectasia. In a Phase II study of 24 patients treated in France, the duration of nosebleeds dropped from a mean of 221 minutes per month to ...

Tentative FDA approval for generic Viagra

The patent for Viagra (sildenafil) from Pfizer expires in March 2012. The FDA on 7 March 2012 has granted tentative approval to Mylan Pharma for a generic sildenafil citrate for Erectile Dysfunction....

Study shows Allergy Immunotherapy Tablet (Merck) reduces Ragweed Allergy symptoms and medication use

Results from a Phase III clinical study of allergy immunotherapy tablet (AIT) for Ragweed pollen showed that the use of Ragweed AIT significantly reduced the total combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo, in Ragweed-Allergic adults with or without Asthma. The study was conducted during peak ragweed pollen season. This ...

EU approves Vepacel(Baxter) vaccine for immunisation against HSN1 Influenza A

The European Commission (EC) has granted marketing authorization for Vepacel from Baxter International in all European Union (EU) Member States, as well as Iceland , Liechtenstein and Norway. Vepacel is a pre-pandemic influenza vaccine indicated for active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known ...

FDA approves Flumist Quadrivalent (Medimmune) for Influenza

The FDA has approved FluMist Quadrivalent,from Medimmune a vaccine to prevent seasonal influenza in people ages 2 years through 49 years. FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains. Like the already approved FluMist (trivalent), the quadrivalent vaccine contains weakened forms of the virus ...

First trial of LEISH - F3 + GLA-SE for Leishmaniasis

The nonprofit Infectious Disease Research Institute has commenced the world's first clinical trial of a vaccine against Leishmaniasis. The vaccine, code-named LEISH–F3 + GLA-SE, includes a recombinant form of two fused Leishmania parasite proteins with an adjuvant to promote the immune response. The first trial, which is taking place in Washington, will include 36 volunteers who will receive the vaccine ...

CHMP positive for Pyramax(Shin Poong Pharma) a new treatment for Malaria

The CHMP has recommended Pyramax, a fixed combination consisting of pyronaridine and artesunate, an artemisinin derivative, from Shin Poong Pharmaceutical Co, for use outside the European Union for Malaria. The CHMP opinion is intended to support registrations in countries outside the EU where there is reported artemisinin resistance. Parasitic resistance to artemisinin as well as partner drugs is on the ...

CHMP recommends Nimenrix vaccine (GSK) for Meningococcal Diseases

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nimenrix, powder and solvent for solution for injection from GSK, intended for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135 and Y....

Vacc-4x(Bionor Pharma) success in Phase IIb trial for HIV/AIDS

Bionor Pharma announced a final review of phase IIb data for its vaccine, Vacc-4x, which confirms a statistically significant 64% reduction of viral load “set point” (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo. The HIV viral load set point in patients given Vacc-4x was ...

Viread(Gilead Sciences) and Kidney Disease risk

Viread (tenofovir) from Gilead Sciences one of the most commonly prescribed antiretroviral medications for HIV/AIDS, is associated with a significant risk of kidney damage and chronic kidney disease that increases over time, according to a study of more than 10,000 patients led by researchers at the San Francisco VA Medical Center (SFVAMC) and the University of California, San Francisco . ...

Alcon acquires North American rights to Finafloxacin for Ear Infections.

Alcon has acquired from Singapore company, MerLion Pharma, exclusive rights in North America to an otic formulation of finafloxacin for use in ear infections, including acute otitis externa (outer ear and ear canal) and acute otitis media (middle ear) infections.Drug is in Phase II....

OraQuick Advance Rapid HIV-112 (OraSure) compares to conventional blood test for HIV

The OraQuick Advance Rapid HIV-112 Antibody Test, from OraSure, is comparable in accuracy to the traditional blood test, according to a new study. The meta-analysis, which compared studies worldwide, showed that the OraQuick test had the same accuracy as the blood test for high-risk populations. The test sensitivity was slightly reduced for low risk populations. The findings showed that the ...

Aganocide (Novabay Pharma) enters Phase IIb trial for Adenoviral Conjunctivitis

NovaBay Pharmaceuticals, Inc. is developing its first-in-class, anti-infective Aganocide compounds for the local non-systemic treatment and prevention of infections.The company has announced that it has selected multiple organizations to manage the Company's Phase IIb clinical study of NVC-422 for the treatment of Adenoviral Conjunctivitis, a form of "pink eye." This global study is anticipated to enroll up to 450 patients ...

Novel antibacterial ozenoxacin (Ferrer) enters Phase III for treatment for Impetigo

Ferrer has received approval to initiate Phase III clinical trials of ozenoxacin as a topical treatment for infectious dermatological conditions such as Impetigo. Ozenoxacin is a novel second generation non-fluorinated quinolone antibacterial agent. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to complete in the first quarter, 2013. The multicentre clinical ...

Positive results for 4CMenB (Novartis) vaccine against group B Meningococcal Disease

Results of a Phase IIb/III placebo-controlled clinical trial of 4CMenB, from Novartis, in which 1631 adolescents received the vaccine, suggest that is is a safe and efficacious vaccine for protection against group B meningococcal disease. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA), an established immunological correlate of protection against meningococcal disease, for three of the antigens ...

Daclatasvir plus asunaprevir(BMS) in Phase II Hepatitis C trial

cThe full results were published in the New England Journal of Medicine, from a Phase II clinical trial in patients with Hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin (‘null responders’1). The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible ...

Isentress (Merck) shows promise in treating young patients with HIV

An update on a Phase II clinical trial of Isentress (raltegravir), from Merck, sponsored by the National Institute of Health’s National Institute of Allergy and Infectious Diseases, shows the drug has an excellent efficacy profile in children with HIV who have failed other regimens. All of the 96 patients enrolled had previously been treated with a regimen of other HIV ...

CHMP recommends Vepacel (Baxter) Influenza vaccine

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vepacel, 7.5 µg Haemagglutinin (HA) antigen per 0.5 ml dose, suspension for injection intended for the prophylaxis of H5N1 subtype of influenza A in either a pre-pandemic or pandemic situation in adults aged 18 years and older. The applicant for this medicinal ...

BI-201335 (Boehringer Ingelheim) Phase III trial completes recruitment

Boehringer Ingelheim has completed recruitment for a late-stage Phase III clinical trial programme for BI-201335, its oral protease inhibitor for the treatment of chronic Hepatitis C virus. The programme, which was awarded a Fast Track designation by the FDA, consists of three studies that will be conducted to evaluate BI-201335 plus the standard treatment, pegylated interferon (pegIFN) and ribavirin (RBV) ...

Patients with Chronic Hepatitis C may benefit from Victrelis (Merck) but extent unclear

Some patients with Chronic Hepatitis C may benefit from Victrelis (boceprevir), from Merck, though the extent of added benefit is still unclear. The information comes from an early benefit assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG). With the available studies on patients without cirrhosis, it is not possible to assess directly whether the combination ...

Dificlir (Astellas/Optimer Pharma) is EU approved for Clostridium difficile

Dificlir (fidaxomicin)from Astellas and Optimer Pharma is EU approved for the treatment of Clostridium difficile infections, which can cause severe diarrhoea. The decision is based on two Phase III trials which compared the drug with oral vancomycin, a common antibiotic used to treat CDI and showed that Dificlir was as effective as vancomycin in treating CDI and had a significantly ...

NVC-422 (NovaBay) shows potential against adenoviral Conjuctivitis

A new study has demonstrated the virucidal activity of NVC-422 (aganocide) against adenovirus type 5 that causes Conjunctivitis. In vitro assays show that NVC-422 has a good therapeutic index and the virucidal activity of NVC-422 is rapid with complete inactivation of Ad5 within 15 min. The virucidal activity of NVC-422 is due to its reacting with key viral proteins. If ...

Cobicistat (Gilead Sciences) success in Study 114 as "booster" in AIDS treatment

Study 114 of Cobicistat from Gilead Sciences reported a primary endpoint analysis that indicated that after 48 weeks of treatment, 85 percent of patients taking a regimen of cobicistat-boosted atazanavir (a protease inhibitor) plus Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) achieved HIV RNA (viral load) of less than 50 copies/mL, compared to 87 percent of patients taking ritonavir-boosted atazanavir plus ...

Daclatasvir (BMS) and TME 435(Tibotec) combination for Phase II for Hepatitis C

BMS will collaborate with Tibotec, a Johnson & Johnson company, to investigate the combination of oral drug daclatasvir, a NS5A replication complex inhibitor, plus TMC435 a once a day oral NS 3/4a protease inhibitor for the treatment of chronic Hepatitis C genotype 1. The combination will enter a Phase II study early next year to investigate the potential for sustained ...

Viread (Gilead Sciences) dropped from HIV prevention trial

Viread gel (tenofovir disoproxil fumarate), from Gilead Sciences, has been dropped from the VOICE trial. The decision to discontinue use of the anti-retroviral (ARV) gel was made after a routine review of study data concluded Viread was not effective in preventing HIV in the women enrolled in the trial. VOICE is evaluating two ARV-based approaches for preventing the sexual transmission ...

FDA approve a labelling update for Reyataz (BMS) for HIV-infected pregnant women

The FDA has approved an update to the labeling for Reyataz (atazanavir sulfate), from BMS, to include dose recommendations in HIV-infected pregnant women. In HIV combination therapy, treatment with the recommended adult dose of Reyataz 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy comparable to that observed ...

Eviplera triple therapy ( Gilead Sciences) is EU approved for HIV-1 infection

The EMA has granted marketing authorisation for the combination drug Eviplera, from Gilead Sciences, for HIV-1 infection.Eviplera is a once-daily single-tablet that combines Truvada (tenofovir/emtricitabine) from Gilead Sciences and Edurant(rilpivirine) from Tibotec, a Johnson & Johnson company.The combination has been approved by the FDA as Complera....

BD MAX Assay (Becton, Dickinson and Company) for MRSA detection is EU approved

The BD MAX MRSA Assay, from BD Diagnostics, a Becton Dickinson company, for rapidly and accurately identifing methicllin-resistant Staphylococcus aureus (MRSA) in patients has received CE mark approval in the EU. The BD MAX is a fully automated, bench-top molecular system designed to perform a broad range of molecular testing. This offers the flexibility and versatility to perform CE/in vitro ...

FDA approves Anti-HBc IgM Assay (Roche) for Hepatitis B testing

The FDA has granted Premarket Approval for the Anti-HBc IgM Assay (IgM antibody to Hepatitis B core antigen Assay), from Roche, for use on its cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series, as a test for Hepatitis B. The test represents the final component of the acute panel within the Hepatitis test menu for ...

EU approves Prevnar 13 for Pneumococcal Disease in adults aged 50 years and older

The European Commission has approved the pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) from Pfizer for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older a time of life when the risk for contracting the disease begins to increase.The vaccine is filed at the FDA ...

Transdermal IQP-0410 patch shows promise for HIV patients

Studies of IQP-0410, from ImQuest Biosciences, a promising HIV therapeutic, demonstrate that it can be applied to the skin of patients with HIV as transdermal patches which are capable of releasing more than 96 percent of the HIV medication over the course of seven days. The results were presented at the 2011 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting ...

Vertex Pharma starts Phase IIIb trial in genoytpe 1 Hepatitis C patients who have 'CC' variation near the IL28B gene

Vertex Pharmaceuticals will initiate a Phase IIIb study called CONCISE that will evaluate the potential for treatment with Incivek (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene. Incivek is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis ...

RTS,S anti malaria vaccine success in large African study

RTS,S, a new experimental vaccine from GlaxoSmithKline, with research funded in part through grants from the Bill & Melinda Gates Foundation, has been shown in interim Phase III results to significantly reduce the incidence of both clinical and severe malaria in African children. In a study of 15 410 children in Africa RTS, S RTS,S reduced the incidence of clinical ...

Why Viread acts against both HIV and HVS

New research published in the journal Cell Host and Microbe reveals why giving anti-HIV drug Viread (tenofovir disoproxil fumarate) from Gilead Sciences, as a gel results in dual protection against both HIV and Herpes Simplex Virus. Infection with HSV is known to facilitate the risk of HIV infection and impacts the clinical course of the disease. It is also known ...

Ceftazidime/avibactam from Forest/AstraZeneca enters Phase III trials

AstraZeneca and Forest Laboratories, Inc. announced that ceftazidime/avibactam (CAZ-AVI) will enter phase III trials to investigate efficacy in treating hospitalised patients with serious Gram-negative bacterial infections including Complicated Intra-Abdominal Infections (cIAI) and Complicated Urinary Tract Infections (cUTI). CAZ-AVI combines a broad-spectrum cephalosporin (ceftazidime) and a novel beta-lactamase inhibitor (avibactam, formerly NXL104) to overcome antibiotic-resistance and treat the increasing number of ...

Raltegravir shows benefits in adult HIV-1 patients

A new analysis reveals that Isentress (raltegravir), from Merck, used in combination therapy shows better efficacy compared to efavirenz-based therapy in previously untreated (treatment-naïve) adult HIV-1-infected patients. The analysis of the STARTMRK Phase III study at 192 weeks of treatment showed that the percentage of patients maintaining undetectable virus levels (less than 50 copies/mL) was 76.2 percent (n=214/281) for Isentress ...

BioAlliance files Sitavir in the EU for Orofacial Herpes

BioAlliance has filed its orofacial herpes drug Sitavir (aciclovir Lauriad) through the decentralised procedure in Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden and the UK, with Sweden acting as the reference member state. Sitavir is a mucoadhesive buccal tablet delivering high concentrations of the active ingredient to the mucosa and lips, the sites of the herpes infection, ...

FDA approves anti-Helicobacter pylori antibody

The FDA has given 510(K) approval to Ventana anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (H. pylori), from Ventana Medical Systems. This antibody is the first H. pylori antibody to receive such clearance and when used in immunohistochemical staining, aids in the detection of Helicobacter pylori, a bacterium linked to Chronic Gastritis, Ulcers and Stomach Cancer. The antibody provides pathologists ...

Surfaxin is re-filed at FDA for Respiratory Distress Syndrome

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature ...

Combination Vfend plus Eraxis fails Phase III trial for Aspergillosis

A Phase III trial has failed to show a statistically significant benefit in combining antifungal medications, Vfend (voriconazole) plus Eraxis/Ecalta (anidulafungin) both drugs from Pfizer compared with using Vfend alone in treating invasive aspergillosis. Vfend now has generic competition in the USA...

FDA approves Soliris for Hemolytic Uremic Syndrome

The FDA has approved Soliris (eculizumab) from Alexion Pharma for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare, chronic blood disease that can lead to kidney failure, stroke, heart attack and death. This is the first treatment for aHUS that has been FDA-approved and the first approval for use of Soliris in children. The decision is ...

Optimer Pharma agrees a licence to Cubist Pharma to market Dificid in USA

Optimer Pharma has agreed with Cubist Pharma for Cubist Pharma to market Dificid(fidaxomicin) in the USA for a two year period. The alliance is expected to help Optimer gain market share in the antibiotic space by using the experienced sales force from Cubist, which markets Cubicin (daptomycin for injection), a therapy for Staphylococcus aureus bacteremia, including right-sided endocarditis, and complicated ...

CHMP recommends Dificlir for Clostrium difficile

The CHMP recommends European marketing authorisation for the first in class antibiotic Dificlir (fidaxomicin, known as Dificid in the USA) from Astellas/Optimer Pharma. The authorisation is for Clostridium difficile. The FDA had approved Dificid for the treatment of C. difficile-associated diarrhoea in May 2011. Astellas have the European rights...

CHMP recommends Edurant for HIV-1 infection

The CHMP has adopted a positive opinion recommending the approval of Edurant (rilpivirine), a 25 mg tablet from Tibotec Pharma, as a once-daily treatment in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load = 100,000 HIV-1 RNA copies/mL. Edurant is a non-nucleoside reverse ...

CHMP recommends Eviplera triple therapy for HIV-1 infection

The CHMP has adopted a positive opinion for the once-daily single-tablet regimen, Eviplera, combining Gilead's Truvada (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine (as hydrochloride)) from Gilead, for the treatment of HIV-1 infection in antiretroviral-naive adults with a viral load less than or equal to 100,000 HIV-1 RNA copies. The combination is ...

Incivo will launch in Germany first for Hepatitis C

Virco-Virology, a Janssen Pharmaceutical subsidiary, will launch Incivo (telaprevir), the treatment for hepatitis C virus in Germany within a next week or so The European Commission gave approval on 20 September 2011....

Viramine XR once a day is EU approved for HIV treatment

Once-daily Viramune (nevirapine) prolonged-release tablet from Boehringer Ingelheim has been approved for use in EU in combination with other antiretroviral medications for the treatment of HIV-1 infection. The EU approval is for the use of one 400mg tablet once daily for adults and adolescents and for 50mg and 100mg strengths for once-daily treatment of children. The Viramune XR single 400mg ...

QUAD HIV drug more effective than other therapies

New results from a pivotal Phase III trial of QUAD (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate), from Gilead Sciences, for HIV-1 infection in treatment-naïve patients, has met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada. The primary endpoint analysis of Study 103 indicated that 90 percent of patients in the QUAD arm ...

Incivek treatment still effective when course is half as long in treatment of Hepatitis C genotype 1

A Phase III study (ADVANCE) of Incivek (telaprevir) tablets in patients with genotype 1 chronic Hepatitis C published in The New England Journal of Medicine (NEJM) reveals that a 24-week treatment course that adds Incivek to peginterferon alfa and ribavirin is just as effective as a 48-week regimen for many patients. Shortening the duration of treatment reduces a patient's exposure ...

Vibativ is EU approved for nosocomial pneumonia caused by MNSA

Astellas and Theravance have received marketing authorisation from the European Commission for Vibativ (telavancin hydrochloride) for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA).Its labelling will include its use in the treatment of adults with nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. In the US and Canada, ...

IlLLUMINATE trial of Incivek is published in NEJM

The New England Journal of Medicine (NEJM) published data from a Phase III study of Incivek(telaprevir) tablets in people with genotype 1 chronic Hepatitis C who were new to treatment. In ILLUMINATE, Incivek was given for the first 12 weeks in combination with pegylated-interferon and ribavirin. Nearly two-thirds of patients responded early to Incivek combination treatment (measured by having undetectable ...

No sex difference in HIV patients with boosted Reyataz

A retrospective study, which included 1,294 antiretroviral (ARV)-experienced patients, demonstrated no difference in time to virologic failure in women compared to men taking Reyataz (atazanavir sulphate), from BMS, (ATV/ritonavir)-based regimens, over a follow-up period of up to five years. The results revealed no gender-based differences in time to virological failure, defined as two consecutive HIV RNA = 50 c/mL or ...

Zyvox (Pfizer)effective for patients with MRSA

Zyvox (linezolid) from Pfizer may be more effective than the antibiotic vancomycin in treating ventilated patients who develop methicillin-resistant Staphylococcus aureus (MRSA) pneumonia as a result of their ventilation, according to a study presented at the American Thoracic Society 2011 Conference in Denver. In the study 286 patients with MRSA ventilator-associated pneumonia (VAP) were randomized to treatment with either vancomycin ...

BI 201335 enters Phase III for Hepatitis C

Boehringer Ingelheim announced that enrollment has commenced at North American sites in its pivotal Phase III clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase III trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, ...

Menactra (Sanofi Pasteur) indication is expanded by FDA

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group announced that the FDA has granted a license to expand the indication for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. ...

Phase II data for BI 201335 for Hepatitis C

New data presented EASL (European Association for Study of the Liver) in Berlin, highlighted the efficacy of Boehringer Ingelheim's once-daily oral protease inhibitor BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus (HCV) infection. Genotype-1 HCV is the most challenging genotype of HCV to treat. Results from SILEN-C1 trial show high rates of sustained viral ...

Phase II b EMERGE study of PEG-interferon lambda in Hepatitis C

The results from the Phase IIb EMERGE clinical trial conducted by BMS showed treatment with the investigational compound PEG-Interferon lambda and ribavirin achieved higher rates of rapid virologic response (RVR) in genotypes 1, 2, 3, and 4, and complete early virologic response (cEVR) in genotypes 1 and 4 than the standard regimen of PEG-Interferon alfa and ribavirin in treatment-naïve patients ...

Novabay introduces a new class of agonacides with NVC422

NovaBay Pharmaceuticals, Inc., based in Emeryville, CA, is innovating a new class of drugs, known as Aganocide compounds, that mimic the body's natural defense against infection. The Aganocides could potentially equal or exceed the utility of antibiotics and address the problem of antibiotic resistance via their novel mechanism. A poster relating to a study of NVC422, was presented at the ...