News

PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 ...

Trial shows Vascazen (Pivotal Therapeutics) effective in altering cholesterol levels in patients with CV Risk

A trial has demonstrated that Vascazen (omega-3 oil), from Pivotal Therapeutics, is highly effective in correcting an omega-3 deficiency. The company suggests this could have benefits for people at risk of developing CardioVascular Disease. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA ...

European Commission approves Hexyon/Hexcima (Sanofi Pasteur) Six in One vaccine

Sanofi Pasteur, the vaccines division of Sanofi has announced that the European Commission, on 22 April 2013, approved Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis ...

EU extends Berinert (CSL Behring) indication for pre-procedure prevention of acute HAE episodes

The EU has approved an extended use of Berinert (C1 inhibitor concentrate), from CSL Behring, for pre-procedure prevention (short-term prophylaxis) of acute episodes of Hereditary Angio-Oedema (HAE) in adult and pediatric patients undergoing medical, dental or surgical procedures. Berinert is already indicated in Europe for the treatment of acute attacks of HAE at all body sites in adults and children. ...

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 ...

IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The Institute for Quality and Efficiency in Healthcare (IQWiG)in Germany said that Eliquis (apixaban) from BMS and partner Pfizer Inc.has "significant" additional benefit to prevent Stroke and Systemic Embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors -- an indication approved by the European Commission in November.

IQWiG said Eliquis provides "significant" additional ...

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 ...

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 ...

EU approves Carotid Embolic Protection Stent (InspireMD) for Stroke prevention

InspireMD's Carotid Embolic Protection Stent has received CE mark approval in the EU. It is based on MicroNet mesh technology, designed to provide procedural and post-procedural distal embolic protection in carotid artery stenting procedures to reduce the risk of Stroke. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris ...

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 ...

PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients

New results on the PREVAIL trial, which randomized 407 patients with nonvalvular Atrial Fibrillation to either LAA closure with the Watchman device, from Boston Scientific or warfarin, indicates the study has met 2 of its 3 primary end points. Data shows that the device was implanted more successfully in the trial (95.1%) than in 2 prior Watchman studies: PROTECT AF ...

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 ...

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 ...

NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention

NICE (The National Institute of Health and Clinical Excellence) has recommended the oral anticoagulant Eliquis (apixaban) from BMS and Pfizer, as an option for Prevention of Sroke and Systemic Embolism in people with non-valvular Atrial Fibrillation with one or more risk factors.

The NICE appraisal committee considered that Eliquis was cost effective and more clinically effective for reducing stroke and ...

CE Mark granted to st Jude Medical for Amplatzer LAA Occluder

European CE Mark approval is granted to St. Jude Medical for its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot ...

FEIBA NF success in Phase III trial for Hemophilia A and B

Baxter International Inc. has announced pivotal Phase III study results evaluating the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with Hemophilia A or B and inhibitors

Top-line results from the study showed a reduced median annual bleed rate (ABR) from 28.7 during FEIBA NF ...

FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism

The FDA on 28 December 2012 approved the anti-clotting drug Eliquis (apixaban) from BMS/Pfizer, an oral tablet used to reduce the risk of Stroke and dangerous blood clots (Systemic Embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by ...

FDA approves Gattex (NPS Pharma) for adult patients with Short Bowel Syndrome

The FDA has approved Gattex (teduglutide), from NPS Pharma, for subcutaneous use for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The drug was approved in the EU in September 2012 as Revestine. Gattex will be available in the first quarter of 2013.

The FDA's approval of Gattex was based on an international, ...

Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the ...

FDA Advisory Committee recommends Gattex (NPS Pharma) for Short Bowel Syndrome

The FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex (teduglutide) from NPS Pharma. It voted 12-0 that the drug delivered meaningful benefits as a treatment for Short Bowel Syndrome (SBS) and that the benefits of the drug outweigh its potential risks.The drug was approved in September 2012 in the EU for Nycomed/Takeda as Revestive...

Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk

The reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) from BMS/Pfizer ,compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation. These results of a subanalysis from the ARISTOTLE trial were published today in The Lancet.The subanalysis demonstrated ...

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 ...

CHMP recommends Eliquis (BMS/Pfizer) for Prevention of Stroke and Systemic Embolism in NVAF patients

BMS and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the Prevention of Stroke and Systemic Embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke The positive ...

European approval for Revestive(Takeda) for Short Bowel Syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc. jointly announced that the European Commission (EC) has granted European market authorization for the medicinal product Revestive (teduglutide), known as Gattex in the US, as a once-daily treatment for adult patients with Short Bowel Syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal ...

Two new Phase III studies of Xarelto (Bayer HealthCare) initiated for AF patients scheduled for surgery

Bayer HealthCare has initiated two new studies investigating Xarelto (rivaroxaban) in patients with Atrial Fibrillation who are scheduled for cardioversion or first catheter ablation. X-VeRT is the largest randomised study dedicated to evaluating patients with AF scheduled for cardioversion. It will include approximately 1,500 patients across 17 countries worldwide, including the UK. The study will further examine the efficacy and ...

NICE recommends Xgeva for as a treatment for people with bone metastases from most solid cancer tumours including Breast Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Xgeva(denosumab) from Amgen/GSK as a treatment for people with bone metastases from most solid cancer tumours.It provisionally recommends denosumab for the prevention of skeletal-related events in: •people with bone metastases from breast cancer and •people with bone metastases from solid tumours (other than breast or ...

Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and ...

Selzentry/Celsentri(ViiV) in trial for HIV Prevention

The first clinical trial to test whether drug regimens containing Selzentry/Celsentri (maraviroc) from Viiv HealthCare, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection. The trial involves a strategy known as pre-exposure prophylaxis, or ...

FDA approves Truvada(Gilead Sciences) for HIV Prevention

The FDA has approved Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences, the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices ...

Final results from trial of Truvada (Gilead Sciences) for HIV Prevention

Final results from the FEM-PrEP HIV-prevention trial of Truvada (emtricitabine/tenofovir disoproxil fumarate), from Gilead Sciences, reinforce the key role of adherence in HIV Prevention studies and the need to determine better approaches to support adherence in future pre-exposure prophylaxis (PrEP) programs. Despite targeted counseling and support, adherence to the drug regimen was low, suggesting that women in the clinical trial ...

FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention

The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps ...

CHMP recommends EU approval of Revestive (Nycomed) for treating Short Bowel Syndrome

The CHMP has recommended granting marketing authorisation for Revestive (teduglutide), from Nycomed, as a once-daily treatment for adult patients with Short Bowel Syndrome (SBS). The marketing authorisation application was submitted in March 2011. The CHMP opinion was based upon data from STEPS, the pivotal Phase III study in patients with SBS, who required parenteral nutrition; 43-patients were randomised to a ...

Sub-analysis of RE-LY trial shows Pradaxa (Boehringer) similar to warfarin in Atrial Fibrillation patients undergoing surgery

A new retrospective sub-analysis of the RE-LY trial for Pradaxa (dabigatran etexilate), from Boehringer, vs warfarin suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a Stroke or systemic embolism, in non-valvular Atrial Fibrillation (NVAF) patients undergoing a surgical or invasive procedure. A total of 4,591 out of 18,113 patients in the trial had anti-coagulant therapy interrupted at ...

NICE recomends Xgeva (Amgen) for bone metastases

The latest draft guidance from NICE recommends Xgeva (denosumab)from Amgen: •For adults with bone metastases from breast cancer •For adults with bone metastases from solid tumours other than breast and prostate only if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients....

Prescribing update to Pradaxa (Boehringer) for Stroke Prevention (AF) patients

Prescribing information for Pradaxa (dabigatran etexilate) capsules, from Boehringer, has been updated to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the Clinical Studies section is based on the results of the pivotal RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). In the RE-LY trial, ...

FDA Advisory Committee recommends Truvada(Gilead) for HIV Prophylaxis

The FDA Antiviral Drugs Advisory Committee voted to recommend the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences ,as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults. The panellists voted 19-3 that the application supported a favourable risk-benefit assessment adequate to approve Truvada for PrEP in HIV-uninfected men who have sex with ...

Success For Watchman LAAC device ( Boston Scientific) in Stroke Prevention

Results were announced by Boston Scientic from the ASA Plavix (ASAP) Study, which studied the Watchman Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.The prospective multi-center ASAP Study evaluated 150 patients with contraindications ...

Study shows Stroke risk high when Xarelto (Bayer HealthCare) stopped

Patients with irregular heartbeats who are taken off anti-clotting medication Xarelto (rivaroxaban), from Bayer HealthCare, face a high risk of Stroke within a month. Researchers analyzed data from the Phase III ROCKET AF trial following concerns about possible increased rates of Stroke and blood clots after discontinuing Xarelto. They found strokes and blood clots occurred at similar rates with either ...

FDA Complete Response Letter to Xgeva application to treat high risk Prostate Cancer bone metastases

The FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Xgeva (denosumab) from Amgen to treat men with castration-resistant Prostate Cancer at high risk of developing bone metastases.The Complete Response Letter states that the FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival was of ...

Truvada (Gilead Sciences) given to men at high risk for HIV would be cost-effective prophylaxis

Giving a daily Truvada (emtricitabine/tenofovir disoproxil fumarate) pill to help prevent HIV infection could significantly reduce the spread of AIDS, but only makes economic sense if used in select, high-risk groups, Stanford University researchers conclude. The researchers investigated whether it would be cost-effective to prescribe the pill daily in large populations, a prevention technique known as pre-exposure prophylaxis, or PrEP. ...

NICE recommends Xarelto (Bayer) for Stroke Prevention

NICE (The National Institute for Health and Clinical Excellence) has recommended Xarelto (rivaroxaban) from Bayer Healthcare in a final draft guidance as an option for the Prevention of Stroke and Systemic Embolism in people with atrial fibrillation. NICE revised its original decision not to recommend Xarelto after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the ...

NICE recommends Xgeva (Amgen/GSK) for SRE prevention of Solid Tumors

NICE, The National Institute for Health and Clinical Excellence, has issued draft guidance recommending the use of human monoclonal antibody Xgeva (denosumab) from Amgen/GSK for for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) for those with bone metastasis from breast cancer, patients with painful bone metastasis from hormone-refractory prostate cancer ...

CRTX 080 (Cornerstone) is filed at FDA for Hyponatraemia

FDA has accepted the new drug application for the investigational Hyponatraemia treatment CRTX 080, from Cornerstone Therapeutics CRTX 080 is a highly potent oral non-peptide, which acts on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes. Hyponatremia is a metabolic condition that occurs when there is not enough sodium in ...

Pradaxa(Boehringer) risk of Myocardial Infarction and Acute Coronary Syndrome

Pradaxa/Rendix (dabigatran etexilate), from Boehringer, is associated with an increased risk of Myocardial Infarction (MI) or Acute Coronary Syndrome (ACS) in a broad spectrum of patients when tested against some other medicines, according to a study published by the Archives of Internal Medicine. The meta-analysis of 7 studies, with 30,514 participants, Ken Uchino and Adrian V. Hernandez of the Cleveland ...

FDA to review Xgeva(Amgen) potential to delay bone metastases in non-metastatic Prostate Cancer

The FDA has invited Amgen to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. The review results from clinical studies in support of this new indication, including ...

FDA accepts for review Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The FDA has accepted for review a New Drug Application for Eliquis (apixaban) from BMS/Pfizer,an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 28, 2012. An application ...

Xgeva results of '147' trial prevention of bone metastases in Prostate Cancer is published in The Lancet

The'147' Phase III study of Xgeva (denosumab)from Amgen/GSK ) evaluated Xgeva for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer and is published in The Lancet. The study found Xgeva significantly prolonged bone metastasis-free survival, delayed time to bone metastasis and reduced the risk of symptomatic bone metastases. This study is ...

Xarelto(Bayer/Johnson & Johnson) is FDA approved for Stroke prevention in patients with non valvular atrial fibrillation

The FDA has approved Xarelto (rivaroxaban) from Bayer HealthCare/Johnson & Johnson for prevention of stroke in patients with nonvalvular atrial fibrillation, making it the first oral direct factor Xa inhibitor to secure an indication for stroke prevention.The drug had already been approved for prevention of deep vein thrombosis in patients undergoing joint replacement surgery...

Pro-FEIBA study success in prophylaxis in Haemophlia A patients

An investigator-initiated study (Pro-FEIBA) evaluated the prophylactic use of FEIBA [Anti-inhibitor Coagulant Complex] from Baxter, to ascertain if it can achieve a decrease in the frequency of joint and other bleeding events in patients with severe hemophilia A and inhibitors,compared to on-demand therapy. The study reported that patients with severe hemophilia A treated with FEIBA prophylactically during a six-month period ...

NICE recommends Pradaxa for Stroke Prevention in non vavular atrial fibrillation patients

NICE has made a final appraisal determination that recommends the direct thrombin inhibitor Pradaxa (dabigatran etexilate) from Boehringer as an option for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more of the following risk factors •previous stroke, transient ischaemic attack or systemic embolism; •left ventricular ejection fraction below 40%; •symptomatic heart failure of ...

Xgeva success in Prevention of Bone Metastases in Prostate Cancer

In a phase III study of Zgeva(denosumab), men with castration-resistant prostate cancer and no previous exposure to intravenous bisphosphonate drugs (such as zoledronic acid) were enrolled from 342 centres in 39 countries. Patients were assigned 120 mg subcutaneous denosumab plus intravenous placebo, or 4 mg intravenous zoledronic acid plus subcutaneous placebo, every 4 weeks . Median time to first on-study ...

Xgeva success in Trial "147" for prevention of bone metastases in Prostate Cancer

Amgen reports results of its study "147", which not only confirmed that its 120mg dosage form of denosumab, known as Xgeva, improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer (CRPC) versus placebo – the first time a bone-targeted drug has delayed the spread of prostate cancer to the bones – but new data showed ...

Merck Inc. returns rights to betrixaban to Portola Pharma

Merck will return to Portola Pharma all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio....