News

Merck Inc files MK 3641 at FDA for treatment of Ragweed Pollen Allergies

Merck & Co. has announced that the FDA has accepted its biologics license application for MK 3641, a dissolvable tablet to treat Ragweed Pollen Allergies and expects the agency to complete its review in the first half of 2014.

Merck has partnered with ALK-Abello A/S to develop the sublingual allergy immunotherapy tablets for ragweed.

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 ...

Ruconest (Santarus/Pharming) is re-filed with FDA for treatment of Hereditary Angioedema

Santarus, Inc. and Pharming Group NV have announced the submission of a Biologics License Application (BLA) to the FDA to obtain marketing approval for Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). The safety and efficacy of Ruconest for the treatment of HAE attacks ...

Phase II study of Favorite (Activaero) shows superiority over conventional Asthma treatment

Results from a Phase II trial in children with mild to moderate Asthma, conducted with the Favorite Inhalation system (budesonide suspension), from Activaero, shows it is effective and holds the promise to become the preferred treatment option when compared to conventional, general purpose therapy. Activaero's Favorite (Flow and Volume Controlled Inhalation Technology) is a drug-device combination consisting of budesonide in ...

Fostamatinib (AstraZeneca) mixed results in OSKIRA-1 trial for RA

AstraZeneca has announced top-line results of OSKIRA-1, a Phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for Rheumatoid Arthritis (RA).

OSKIRA-1 had two primary endpoints: assessing signs and symptoms of RA as measured by ACR20 response rates, and an X-ray endpoint known as mTSS (modified ...

FDA approves Karbinal ER (Tris Pharma) for Allergic Rhinitis

The FDA has on 3 April 2013 approved a New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, from Tris Pharma, being the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial Allergic Rhinitis in children ages 2 and up.

Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing ...

Merck Inc. files Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet at FDA

Merck Inc., announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the FDA. In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.

The BLA for Merck’s grass pollen AIT is supported by ...

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, ...

Dymista(Meda AB) is EU approved via decentralised procedure for Allergic Rhinitis

Dymista (azelastine hydrochloride and fluticasone propionate)from Meda AB has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial Allergic Rhinitis and is now approved by the MHRA in the UK .

National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior ...

Phase II study of CYT003 (Cytos Biotechnology) for Allergic Asthma meets all end points

Results from a Phase IIa clinical trial with CYT003 (vaccine), from Cytos Biotechnology, show the Allergic Asthma treatment has met all its end points. The study is a randomized, double-blind, placebo-controlled trial in patients requiring long-term treatment with inhaled corticosteroids (ICS). The study recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ...

Takeda files vedolizumab at EMA for Crohns and Ulcerative Colitis

Takeda Pharmaceutical Company Limited has announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn’s disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would ...

NICE now recommends Xolair (Novartis) for Allergic Asthma

NICE,the National Institute for Health and Clinical Excellence said it now recommends Xolair (omalizumab) from Novartis as an option for treating severe, persistent Allergic Asthma in adults, adolescents and children, in a complete change from its earlier intention to exclude it from the NHS.

Phase II trial of ToleroMune (Circassia) shows benefits for Cat Allergy two years after treatment

Results of a Phase II clinical study show that a course of just four doses of ToleroMune Cat Allergy therapy (T cell vaccine), from Circassia Ltd, maintained improvements in patients' symptoms two years after the start of treatment. The study originally measured improvements in nasal and ocular allergy symptoms (Total Rhinoconjunctivitis Symptom Score; TRSS) in 202 patients, following treatment with ...

New Phase III trial results of Xolair (Genentech/Roche/Novartis) for patients with Urticaria

Results from a Phase III trial, ASTERIA II, demonstrate that Xolair (omalizumab), from Genentech/Roche and Novartis, met its primary endpoint in patients with moderate to severe chronic Idiopathic Urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). Three dose groups ...

Analysis of two Phase III studies shows Spiriva (Boehringer) provides benefits for Asthma patients

New data from two UniTinA-asthma studies of Spiriva (tiotropium bromide), from Boehringer, shows that the drug improved lung function and Asthma control in patients with poorly controlled Asthma, irrespective of their allergic status. The two studies were replicate double-blind parallel-group trials involving a total of 912 patients, who were randomized to receive tiotropium 5 mcg or placebo in addition to ...

UCB files Cimzia at FDA and EMA for treatment of axial Spondyloarthritis

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active axial Spondyloarthritis (axSpA)

FDA approves Zortress (Novartis)for prophylaxis of organ rejection in Liver Transplant patients

Novartis announced that the FDA has, on 15 February 2013 ,approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a Liver Transplant.

Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following Liver Transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following ...

NICE does not recommend Krystexxa (Savient Pharma) for treatment of severe Gout

The National Institute for Health and Clinical Excellence (NICE) has opened a consultation on the use of Krystexxa (peglioticase) from Savient Pharma, in treating severe debilitating chronic tophaceous Gout in adults. Draft guidance does not recommend the drug for this use. NICE's independent appraisal committee has decided that the drug effectively lowers the level of uric acid in the ...

Cinryze(ViroPharma) success in paediatric Hereditary Angio-Oedema

New data demonstrates that use of Cinryze (C1 esterase inhibitor [human]), from Viro Pharma, in pediatric patients provided relief from symptoms of Hereditary Angio-Oedema (HAO) attacks and reduced the rate of attacks. In the study, children had a nearly twofold reduction in number of HAE attacks while receiving Cinryze for prophylaxis compared with the time period during which they received ...

FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis

The FDA has approved Uceris (budesonide) extended release tablets, from Santarus, for the induction of remission in patients with active, mild to moderate Ulcerative Colitis. Approval is based on two trials, namely study CB 01-02/02 in Europe and CB 01-02/01 in USA and India, which showed the drug superior to placebo in achieving clinical remission as measured by the Ulcerative ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

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 ...

NICE recommends Revolade (GSK) for ITP

The National Institute for Health and Clinical Excellence(NICE) now recommends the use of Revolade (eltrombopag olamine)for patients with the bleeding disorder Chronic Immune Thrombocytopenic Purpura (ITP). The recommendation is for use of the drug for treating ITP in patients who have had their spleens removed or those refractory to other treatments, or as a second line treatment in those who ...

Phase II study of PCI 32765 (Pharmacyclics Inc) shows some benefits in patients with Mantle Cell Lymphoma

Findings from an ongoing, open-label, Phase II, single-agent study shows that in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), PCI 32765 (ibrutinib), from Pharmacyclics Inc., resulted in an overall response rate of 68 percent, including a complete response of 22 percent and a partial response of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ...

European Commission approves Humira (Abbott Labs) for paediatric Crohn's Disease

The European Commission has approved Humira (adalimumab) from Abbott Labs for the treatment of paediatric patients aged six to 17 years with severe active Crohn’s Disease who have failed conventional therapy, such as maintaining proper nutrition, a corticosteroid and an immunomodulator. With this approval, it becomes the first biologic treatment for these patients in more than five years....

Sobi files Kineret at EMA for CAPS treatment

Sobi (Swedish Orphan Biovitrium)) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of Cryopyrin Associated Periodic Syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe ...

Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence ...

NICE will not recommend Xolair (novartis) on re-appraisal for Allergic Asthma

NICE, the National Institute for Health and Clinical Excellence, has reviewed evidence on Xolair (omalizumab) from Novartis and decided not to recommend the drug as a treatment for severe persistent Allergic Asthma in adults and children. NICE noted that clinical trials submitted included data on people whose asthma was less severe than those currently treated with Xolair and that the ...

Study of Pycnogenol (Horphag Research Ltd) shows positive results in treatment of Asthma

A new study suggests that Pycnogenol (pine bark extract), from Horphag Research Ltd, can help improve control of allergic Asthma, reducing night awakenings caused by asthma symptoms by nearly 50 percent. Asthma patients who used Pycnogenol experienced reduced dependence on inhalation corticosteroid (ICS), which is commonly administered through an inhaler, and required less visits to a doctor due to asthma ...

Positive results from Phase III trial of Ruconest (Santarus) in patients with Hereditary Angioedema

A pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug Ruconest (recombinant human C1 esterase inhibitor), from Santarus, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief. A statistically significant difference in the time to beginning of symptom ...

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 ...

CHMP recommends Humira (Abbott) for paediatric patients with Crohn's Disease

The CHMP has adopted a positive opinion for Humira (adalimumab), from Abbott Labs, for the treatment of paediatric patients aged six to 17 years with severely active Crohn's Disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next few months. ...

CHMP recommends Krystexxa (Savient Pharma) for treatment of Gout

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Krystexxa, 8 mg/ml, concentrate from Savient Pharma, for solution for infusion intended for the treatment of severe debilitating chronic tophaceous Gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric ...

EU approves subcutaneous formulation of Orencia (BMS) for moderate to severe Rheumatoid Arthritis

The European Commission has granted marketing authorization for the subcutaneous formulation of Orencia (abatacept), from BMS, in combination with methotrexate (MTX), for the treatment of adults with moderate to severe active Rheumatoid Arthritis (RA). The drug was previously approved for intravenous delivery so this extends the choice of administration route for patients and doctors. Approval of the subcutaneous formulation of ...

FDA approves Aerospan (Acton Pharma) for Asthma

Acton Pharmaceuticals, Inc. has announced that the FDA has approved the sNDA (Supplemental New Drug Application) for Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of Asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older. With this approval, Acton is now planning ...

FDA approve Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

Belinostat (TopoTarget/Spectrum) success in BELIEF study for PTCL

The pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat from Topo Target A/S for the treatment of patients with relapsed/refractory Peripheral T-Cell Lymphoma (PTCL) met its primary endpoint. A Special Protocol Assessment agreement with the FDA requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data ...

Novartis reports on Phase II study of AIN 457 in Plaque Psoriasis

Novartis announced Phase II data showing AIN 457 (secukinumab) may significantly improve moderate-to-severe Plaque Psoriasis on the hands, feet and nails when used every week for the first month of treatment, compared to placebo. Additional analysis on patients with moderate-to-severe Plaque Psoriasis also showed that AIN 457 may successfully improve quality of life by Week 12 in the study. The ...

Success for SNG 001 (Synairgen) in early Asthma trial

In a mid-stage study of 134 adults who caught a cold, SNG001 from Synairgen, was effective in the most difficult-to-treat patients, preventing asthma symptoms from getting worse during the first week of infection and treatment. There was also a 65 percent reduction in the number of patients who experienced asthma attacks during the treatment period compared with a group on ...

Positive data from Phase III trial of Spiriva (Boehringer) in Asthma patients

Initial data from the Phase III UniTinA-asthma program reveals that Spiriva (tiotropium bromide), from Boehringer, delivered daily via the Respimat inhaler significantly improved lung function and reduced Asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). The two studies were replicate double-blind parallel-group trials including Asthma ...

FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis

The FDA Gastrointestinal Drugs Advisory Panel voted 15-2 to recommend Humira (adalimumab) from Abbott Labs for reducing the signs and symptoms of moderate to severe Ulcerative Colitis in patients who have an inadequate response to conventional therapy.The members of the Panel considered that the benefits outweight the potential risks with the drug. The Panel called for post-approval studies in Ulcerative ...

Bosatria (GSK) study in severe Eosinophilic Asthma

A year-long study involving 621 patients treated with Bosatria (mepolizumab) from Glaxo Smith Kline found that the rate in patients on mepolizumab of clinically significant exacerbations - defined as episodes requiring oral corticosteroids or a hospital visit - was around half that of those on placebo. But while monthly intravenous injections of the drug cut attacks they failed to produce ...

Tofacitinib (Pfizer) success in Phase II study for Ulcerative Colitis

A Phase II trial of tofacitinib from Pfizer shows it has potential as an effective treatment for Ulcerative Colitis. The trial studied the efficacy of tofacitinib in 194 adults with severely active forms of the disease. Patients were randomised for treatment with tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or were given a ...

Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis

Cosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi­ca­ted for the induction of remission in patients with active, mild to moderate Ulce­ra­tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons ...

Positive results for Humira (Abbott) for pediatric patients with Crohn's Disease

Humira (adalimumab), from Abbott, is effective in maintaining remission in pediatric patients with Crohn's disease, according to a new study in the journal Gastroenterology. This study is the largest double-blind study of an anti-TNF agent in children with Crohn's disease.

Researchers studied 192 patients, ages 6 to 17 years, across 45 sites in Canada, Europe and the US between ...

FDA approves generic Singulair for Asthma

The FDA has approved the first generic versions of Singulair (montelukast sodium)from AstraZeneca for use in adults and children to control Asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc., and Torrent Pharmaceuticals have gained FDA approval ...

FDA requires more data for Arcalyst (Regeneron) for Gout Flares treatment

The FDA has again issued a Complete Response Letter for the supplemental Biologics License Application for Arcalyst (rilonacept) from Regeneron for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The agency has requested additional clinical data, as well as additional chemistry, manufacturing and controls information related to a proposed new dosage form....

ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 ...

EU approves Humira (Abbott) for treatment of Axial Spondyloarthritis

Abbott has announced that the European Commission (EC) has approved Humira(adalimumab) for the treatment of adults with severe Axial Spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Humira is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for Humira in the European Union since the product's first approval ...

Study shows Cinryze (Viro Pharma) effective for long-term treatment of Hereditary Angio-oedema

New results demonstrate that routine prophylactic use of Cinryze (C1 esterase inhibitor), from Viro Pharma, provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with Hereditary Angio-oedema. Treated with Cinryze 1000 units every 3 to 7 days, subjects experienced a 93.7 percent reduction in attacks while taking prophylactic Cinryze (median of 0.19 attacks per ...

CHMP refuses recommendation of Istodax( Celgene) for T-cell Lymphoma

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment

Janssen Biotech and Janssen Biologics have requested the FDAand European Medicines Agency to approve Simponi(golimumab) a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy." Simponi ,a once-monthly subcutaneously administered drug , received approvals in the United States, Europe and Canada in 2009 for the treatment of moderately to ...

Fluticasone/vilanterol combination (GSK) is filed in US for COPD and in the EU for Asthma and COPD

GSK and Theravance announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine Relovair( fluticasone furoate /vilanterol).

In the European Union the application is for patients with Chronic Obstructive Pulmonary Disease (COPD) and an application for Asthma. The Marketing Authorisation Application for the European Union for the combination has a new proposed ...

EMA approves Flutiform (Mundipharma) for Asthma treatment

The EMA has approved Flutiform (fluticasone plus formoterol), from Mundipharma, for the maintenance treatment of Asthma. This decision is binding on all 21 Concerned Member States involved in the decentralised procedure and the first national approvals of Flutiform are expected across a number of countries by the end of 2012. It is indicated for the regular treatment of Asthma in ...

Positive data in study of Krystexxa (Savient Pharma) in patients with Gout

New results show that adult patients with refractory chronic Gout (RCG) treated bi-weekly with Krystexxa (pegloticase), from Savient Pharma, experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies. Results at week 25 demonstrated that mean improvements from baseline ...

Positive results in Phase III study of VPRIV (Shire) for Gaucher-related bone disease

New data shows VPRIV (velaglucerase alfa for injection), from Shire, significantly improved selected markers of Gaucher-related bone disease in patients. A head-to-head Phase III study (HGT-GCB-039) of VPRIV and Cerezyme, and follow-on extension trial (HGT-GCB-044) of VPRIV, demonstrate a statistically significant improvement in lumbar spine (LS) bone mineral density in Gaucher patients starting at nine months of treatment with VPRIV, ...

Positive results from Phase IV study of MuGard (Access Pharma) for oral Mucositis

Results from the ongoing Phase IV clinical trial of mouth rinse treatment Mu-Gard, from Access Pharma, for oral Mucositis show that patients undergoing chemoradiation therapy for head and neck cancer and using Mu-Gard experienced a statistically significant reduction in mouth and throat soreness, a statistically significant delay to onset of oral Mucositis as measured in days or cumulative radiation, and ...

CHMP refuses to recommend approval to Uplyso(Pfizer)for Gaucher Disease

The Committee for Medicinal Products for Human Use (CHMP) will not recommend approval to Uplyso (taliglucerase alfa) from Protalix/Pfizer for long-term enzyme replacement therapy for adults with Type 1 Gaucher disease because the drug works in the same way as Vpriv (velaglucerase alfa) from Shire and as Vpriv is an orphan drug it has 10 years exclusivity...

Horizon Pharma licenses Latin American rights to Duexis to Grunenthal

Horizon Pharma has exclusively licensed Duexis (ibuprofen and famotidine) to Grunenthal for commercialisation in Latin America. Duexis is a single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine. It is indicated in the US for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, in ...

FDA grants PermaDerm (Regenicin) for Skin Grafts orphan status

The FDA has granted Orphan Status approval for PermaDerm, from Regenicin, the first tissue-engineered skin prepared from autologous skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients requiring Skin Grafts. The FDA had previously designated PermaDerm to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm is the ...

Stiefel takes world rights to Toctino from Basilea for Chronic Hand Eczema

Stiefel,a unit of GSK, is gaining exclusive worldwide rights to Toctino (alitretinoin.) from Basilea Pharma. Toctino is commercially available in 14 countries (and approved in an additional 15) for severe Chronic Hand Eczema that is refractory to treatment with potent topical corticosteroids. In the USA, oral alitretinoin is in a Phase III trial. Stiefel will assume responsibility for the development ...

Ceptaris Therapeutics receives Complete Response Letter from FDA for mechlorethamine hydrochloride treatment for Mycosis Fungoides

Ceptaris Therapeutics (formerly Yaupon Therapeutics) has received a Complete Response Letter (CRL) from the FDA for mechlorethamine hydrochloride gel as a treatment for early-stage Mycosis Fungoides, the most common type of cutaneous T-Cell lymphoma a rare form of non-Hodgkin's lymphoma. Mechlorethamine hydrochloride is a water-soluble, greaseless topical gel, which could lead to better compliance for patients with Mycosis Fungoides....

Humira (Abbott) benefits in ABILITY-1 study in patients with active non-radiographic Axial Spondyloarthritis

Initial 12-week data from the ABILITY-1 study of Humira (adalimumab)from Abbott showed that a significantly higher proportion of patients receiving Humira (40mg every other week) achieved a 40% or greater improvement from baseline using the ASAS (or Assessment of SpondyloArthritis international Society) response criteria compared with placebo (36% vs 15%, p<0.001). Also, significantly more patients achieved the secondary endpoint of ...

Positive Phase III data for Krystexxa (Savient Pharma) in Gout patients with chronic Kidney Disease

New results show that patients with refractory chronic Gout (RCG) who also suffer from chronic Kidney Disease (CKD) responded to treatment with Krystexxa (pegloticase), from Savient Pharma, regardless of baseline CKD stage. This post-hoc analysis evaluated more than 200 patients with CKD stages one through four who were randomized to receive treatment with Krystexxa 8 mg every other week, 8 ...

Simponi (Janssen Biotech) shows positive results in Phase III trial for Ulcerative Colitis

A study of subcutaneous induction regimens of Simponi (golimumab), from Janssen Biotech/Merck Inc., induced clinical response in a majority of patients with moderately to severely active Ulcerative Colitis who had previously failed or were intolerant to conventional agents. The PURSUIT trial had an adaptive design with Phase II dose ranging followed by a confirmatory Phase III component. All enrolled patients ...

Spiriva (Boehringer) in Phase III for Asthma

Boehringer announced that a comprehensive confirmatory Phase III trial program named UniTinA-asthma is ongoing to fully evaluate the potential of the long-acting bronchodilator, Spiriva(tiotropium bromide)in the treatment of Asthma in pediatric, adolescent and adult patients....

FDA Advisory Committee rejects Arcalyst(Regeneron) for treatment of Gout Flares

The FDA Arthritis Advisory Committee rejected Arcalyst (rilonacept) from Regeneron , voting 11-0 that the data submitted had failed to support the approval of a subcutaneous once weekly dosage of Arcalyst to prevent Gout Flares. The Advisory Committee noted the small numbers of patients in the studies and the absence of long term and safety data which did not exist ...

F 627 (Generon) commences Phase II study for Neutropenia

A Phase II clinical trial for F 627,recombinant G-CSF from Generon(Shanghai)Corporation, has been started after FDA regulatory clearance. The study is a randomized, multicenter, open-label, active-controlled trial of F 627 in women with Breast Cancer receiving myelotoxic chemotherapy. The clinical trial will enroll approximately 200 patients and will be conducted at approximately 35 clinical centers in North America and Europe. ...

FDA aproves Elelyso (Pfizer) for Type 1 Gaucher Disease

The FDA on 1st May 2012 approved Elelyso (taliglucerase alfa) from Pfizer for long-term enzyme replacement therapy to treat a form of Gaucher Disease. Gaucher Disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials (lipids) to collect in the spleen, liver, kidneys, and other organs. Elelyso is an injection ...

NICE rejects Benlysta (GSK) for SLE in final guidance

The health technology appraisal body in England and Wales, NICE, has in its final guidance rejected Benlysta ((belimumab ) from GSK/Human Genoma Sciences for Systemic Lupus Erythematosus (SLE) treatment. The decision was criticised by GSK, which said the UK's failure to adopt innovative medicines is a continuing systemic problem....

CHMP recommends Flutiform (Skye Pharma/MundiPharma) for Asthma

The CHMP of the European Medicines Agency ("EMA") has issued a positive opinion recommending the granting of a marketing authorisation for Flutiform (fluticasone propionate/formoterol fumarate) from Skye Pharma. The decentralised procedure ("DCP")of the marketing authorisation application for Flutiform was referred to the CHMP for arbitration because a concerned member state did not agree with the positive benefit/risk assessment made by ...

Positive results in Phase IIb study of CG100649 (CrystalGenomics) for Osteoarthritis

A Phase IIb study of the CG100649, from CrystalGenomics, shows the candidate drug for Osteoarthritis met its primary and secondary endpoints in an evaluation of the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex (celecoxib) (200 mg per day) over a 4 week treatment period. Anti-arthritic efficacy was evaluated using the ...

Endurant AAA Stent Graft System(Medtronic) two year results

Medtronic Inc.has announced the two-year results from its U.S. clinical study of the Endurant AAA Stent Graft System for Abdominal Aortic Anuerysm. Presented at this year's Charing Cross International Symposium in London, the prospective Endurant U.S. investigational device exemption (IDE) study's complete results at two years continue to demonstrate durable clinical performance with strong safety and efficacy in long-term follow-up. ...

Cimzia success in Phase III trial for Axial Spondyloarthritis

UCB has announced positive top-line results from the phase III study designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases which includes ankylosing spondylitis (AS).In this 24-week, multicenter, double-blind, placebo-controlled phase III study, 325 patients with AxSpA were randomized to receive certolizumab pegol, 200 ...

European Commission approves Humira(Abbott Labs) for Ulcerative Colitis

The European Commission has approved Humira (adalimumab)from Abbott Labs, for the treatment of moderately to severely active Ulcerative Colitis (UC) in adult patients who have had an inadequate response to conventional therapy. With this approval, Humira becomes the first and only self-injectable biologic therapy for the treatment of moderately to severely active Ulcerative Colitis in adults. The approval also marks ...

Toctino(Basilea Pharma) success in Phase III HANDEL study for Chronic Hand Eczema

Topline results were reported from the U.S. Phase III 596 patient HANDEL study of Toctino(alitretinoin) from Basilea Pharma in severe Chronic Hand Eczema refractory to potent topical corticosteroids. Patients with severe Chronic Hand Eczema unresponsive to potent topical corticosteroids were randomized either to a once-daily dose of 30 mg alitretinoin or placebo for a treatment duration of up to six ...

Amylin completes application to FDA for metreleptin for Lipidostrophy

Amylin has completed its biologics license application with the FDA for metreleptin – an analogue of the human hormone leptin, which is under investigation to treat lipodystrophy. Lipidosytophy patients lack the required fat tissue for normal metabolic function. A lack of fat tissue can lead to relative deficiency of leptin, which is needed to help the metabolic system function properly ...

Minophagen extends marketing rights to bexarotene for T-Cell Lymphoma

Minophagen Pharma has acquired further rights to market the synthetic retinoid bexarotene from Eisai. Minophagen has added to its rights to market in Japan the territories of Asia, Oceana, the Middle East and Eastern Europe.The drug is marketed in 20 countries for refractory/recurrent T-Cell Lymphoma and in the USA by Eisai as Targretin....

Actelion discointinues setipiprant in Asthma and Allergic Rhinitis

Actelion is discontinuing development of its orally-active CRTH2 antagonist, setipiprant, in asthma (Phase IIb) and seasonal allergic rhinitis (Phase III profiling), after two recently concluded studies did not confirm efficacy findings made in earlier studies....

Alair Bronchial Thermoplasty System(Boston Scientific) has positive technology assessment

Boston Scientific Corporation announces the first published technology assessment in support of the safety, efficacy and long-term positive health outcomes of bronchial thermoplasty (BT) as delivered by the Alair Bronchial Thermoplasty System, a catheter-based device designed to treat patients 18 years or older with severe persistent asthma. The report was published by the California Technology Assessment Forum (CTAF) and states ...

TC 6987 (Targacept) success in Phase II Asthma study

A Phase II asthma study of TC 6987 from Targacept was a double blind, placebo controlled, parallel group trial conducted at 23 sites in the United States. The study enrolled 93 adult patients with persistent mild to moderate Asthma that were being treated with inhaled corticosteroids, and 90 patients completed the study. The study included a number of different efficacy ...

PA 32540 (Pozen) effective against Gastric Ulcers in Phase III study

Top-line results from Study 303, a Phase III trial tracking the safety of PA 32540, from Pozen Inc.,, in patients at risk for aspirin-associated Gastric Ulcers, shows that adverse events were consistent with those expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the drug's components. PA 32540 is a combination tablet of ...

Wheat bran Brana Vita(Fugeia NV) positive in Gut trial

Brana Vita, a wheat bran, from Fugeia NV, is associated with an increase in gut levels of bifidobacteria according to a placebo controlled trial published in the British Journal of Nutrition.Results showed that 10 grams produced significant changes to levels of bifidobacteria in the faeces and an increase in short chain fatty acids.see British Journal of Nutrition published online ahead ...

Procoralan (Servier) approved by European Commission for Chronic Heart Failure

Procoralan (ivabradine) from Servier Laboratories, the first selective If channel inhibitor, has been approved by the European Commission for the treatment of patients with Chronic Heart Failure. The European Commission´s decision to authorise this new indication for Procoralan followed the review of data from the SHIfT trial, the largest-ever morbi-mortality study of treatments for Chronic Heart Failure involving more than ...

Repligen files Secreflo with EMA for detection of Pancreatic Duct Abnormalities

Repligen has submitted a marketing authorization application (MAA) for SecreFlo (synthetic human secretin) as an agent to improve the detection of pancreatic duct abnormalities in patients with Pancreatitis. SecreFlo stimulates secretion of watery fluid into the pancreatic ducts. When the ducts are filled with water they are more effectively visualised. FDA decision expected on 21 June 2012....

FDA refuses to approve lipid-lowering combination of atorvastatin and ezetimibe (Merck)

The FDA has issued a Complete Response Letter regarding Merck's new drug application ezetimibe and atorvastatin tablets, an investigational combination medicine for Dyslipidaemia. In the letter, the agency advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck plans to discuss next steps with the agency in the near future, including ...

Zelboraf (Roche) for Metastatic Melanoma nearly doubles median survival

A new study shows that Zelboraf (vemurafenib), from Roche, a newly approved drug for patients with Metastatic Melanoma, nearly doubles median survival time. The data comes from an international Phase II study of Zelboraf that included 132 patients followed for at least one year. Patients with this advanced form of Melanoma that has spread to other organs typically survive about ...

Vedolizumab (Takeda) meets endpoints in Phase III Ulcerative Colitis trial

The GEMINI I Phase III trial evaluating vedolizumab, from Takeda, for Ulcerative Colitis has met its endpoints. The study involved 895 patients with moderately to severely active Ulcerative Colitis who have failed at least one conventional therapy, including tumour necrosis factor-alpha antagonists, such as Abbott Laboratories Humira. Patients received a year of vedolizumab, also known as MLN0002, or placebo, starting ...

Zelboraf (Daiichi Sankyo/Roche) is EU approved for BRAFV600 mutation Metastatic Melanoma

Plexxikon Inc., a member of Daiichi Sankyo Group,has announced that the European Commission has approved Zelboraf (vemurafenib) for the monotherapy treatment of adult patients with BRAFV600 mutation-positive unresectable or Metastatic Melanoma. The cobas 4800 BRAF V600 Mutation Test, a companion diagnostic used to identify patients with the BRAF mutation, is CE marked and commercially available in Europe. Zelboraf is designed ...

CHMP recommends Humira(Abbott) for Ulcerative Colitis

The CHMP gives a positive opinion to expand the label on Humira (adalimumab) from Abbott Labs to include the treatment of adults with moderate to severely active Ulcerative Colitis for whom conventional therapies are not suitable. If the European Commission acts on the advice, Humira will be the first self-injectable biologic therapy available for those Ulcerative Colitis patients....

RP-G28 success in Phase II trial fro lactose Intolerance

Ritter Pharma announced results of a Phase II trial for which showed RP-G28 improved digestive symptoms associated with Lactose Intolerance, including abdominal pain, and also reduced breath hydrogen production (a commonly used diagnostic test for lactose maldigestion). An abstract summarising the results is being presented orally at the annual international Digestive Disease Week (DDW) 2012 meeting in San Diego, California ...

CHMP recommends Remicade (Janssen Biologic) for Paediatric Ulcerative Colitis

The CHMP has issued a positive opinion for Remicade (infliximab) from Janssen Biologic for the treatment of severely active Ulcerative Colitis in paediatric patients aged between six to 17 who have had an inadequate response to conventional therapy, or who or intolerant to, or have medical contraindications to these therapies. The recommendation is based on a Phase III randomised, open-label ...

CHMP rejects Folotyn (AllosTherapeutics and Mundipharma) for T-Cell Lymphoma

The CHMP adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Folotyn,(pralatrexate injection), from Allos Therapeutics, intended for the treatment of peripheral T-cell Lymphoma. The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not ...

FDA extends Berinert (CSL Behring) indication to self administration in HAE attacks

The FDA has approved an extended indication to allow self administration of Berinert (C1 inhibitor concentrate), from CSL Behring, in cases of acute abdominal or facial attacks of Hereditary Angioedema (HAE). This means that there is no need with Berinert for a patient to visit a clinic or hospital to receive the drug intravenously and allows the possibility of quicker ...

Flutiform (Skye/Mundipharma) European application referred to arbitration

SkyePharma PLC announced that the decentralised procedure ("DCP") for the regulatory review of Flutiform (fluticasone plus formoterol),which was submitted by its partner MundiPharma International, has been referred to the European Medicines Agency ("EMA") and its Committee for Medicinal Products for Human Use ("CHMP") for arbitration. The arbitration procedure is part of the DCP and is initiated when a unanimous decision ...

FDA extends review date of Uplyso (Pfizer)for Gauchers Disease until 1 May 2012

The FDA has extended its review by three months of the new drug application for Uplyso (taliglucerase alfa) from Pfizer/Protalix Biotherapeutics for the treatment of Gaucher's Disease .The effect delays the Prescription Drug User Fee Act action date until 1 May 2012. No additional data was requested by the FDA....

Arcalyst (Regeneron) is filed at FDA for Gout Flares

The FDA has accepted the supplemental Biologics License Application for Arcalyst (rilonacept) injection from Renereron, for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The FDA plans to review the application on July 30 2012. Arcalyst is already available in the USA and EU for treatmentof rare genetic cryopyrin-associated periodic syndromes (CAPS). Arcalyst is ...

FDA approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts

The FDA has given 510(K) approval for the HeliFX Aortic Securement System, from Aptus Endosystems, the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large Aortic Aneurysm. The HeliFX Aortic Securement System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. ...

FDA approved ABBOTT ESA Chagas diagnostic test for Chagas Disease

The FDA has approved a new Chagas in vitro diagnostic test from Abbott Diagnostics. The ABBOTT ESA Chagas is the first FDA-approved supplemental test that detects antibodies to Trypanosoma cruzi (T. cruzi), a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, also known as a "kissing bug."...

AzaSite and DexaSite (InSite Vision) enter Phase II for Blepharitis

InSite Vision Inc. commences a 900 patient Phase III trial (DOUBle study)for Azasite Plus ( dexamethasone plus azithromycin)-ISV 502 and DexaSite (dexamethasone)-ISV-305 both using its DuraSite drug delivery platform in the treatment of chronic Blepharitis (or lid margin disease). This condition is an inflammation of the eyelid for which there is no FDA approved treatment....

Kalbitor (Dyax/Defiante Farma) is withdrawn from EMA for acute Hereditary Angioedema

Kalbitor from Dyax Corporation and Defiante Farmaceutica S.A. is withdrawn from its application to the EMA for the treatment of acute attacks of Hereditary Angioedema in patients 16 years and older. The CHMP had required further data. The drug is approved for the indication in the USA....

Phase III trial of Humira (Abbott) shows significant benefits for Axial Spondyloarthritis treatment

The Phase III ABILITY-1 study of Humira (adalimumab), from Abbott, in patients with active non-radiographic Axial Spondyloarthritis (axSpA), has reported encouraging results. At week 12, more than twice as many Humira patients compared to those receiving placebo achieved the primary endpoint of 40 percent improvement in the Assessment of SpondyloArthritis international Society criteria (ASAS 40). AxSpA is a debilitating condition ...

FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients

The FDA has approved the Ovation Abdominal Stent Graft System, from Trivascular, which provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening Abdominal Aortic Aneurysms. Such aneurysms can be repaired through open surgery or less invasively using a stent graft. However this treatment depends on the patient’s anatomy. A small number of people ...

Lipitor ineffective for Atherosclerosis in pediatric Lupus

A trial to determine the efficacy and safety of Lipitor (atorvastatin), from Pfizer, in preventing subclinical Atherosclerosis progression in pediatric-onset Systemic Lupus Erythematosus (SLE) found that the therapy was ineffective in reducing Atherosclerosis progression in children and adolescents. However results from the trial showed that the treatment could benefit patients with more severe SLE who were not included in the ...

US CDC recommend HPV vaccine against Human Papalloma Virus for 11 or 12 year old boys

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has approved recommendations for routine vaccination of 11 or 12 years old males using 3-doses of HPV4 vaccine, from Merck, to protect against Human Papalloma Virus. The HPV vaccine will provide protection against certain HPV-related conditions and cancers in males, including genital warts and oral, penile and ...

Luveniq is withdrawn from EMA for chronic non-infectious Uveitis

Lux Biosciences has withdrawn Luveniq (voclosporin oral) from the EMA as a treatment for chronic non-infectious Uveitis following a negative opinion from the CHMP which considered that the benefits of the drug did mnot outweight its risks....

Flutiform delays in EU for treatment approval for Asthma

Mundipharma/Napp filed Flutiform (fluticasone propionate plus formoterol fumarate) for asthma using the decentralised procedure in the EU with the UK as reference state and has now encountered delays in achieving consensus amongst the reference states. A launch in 2011 now looks unlikely although most reference states have found the drug approvable.Skye Pharma is the originator of the drug....

NICE rejects Yervoy for Metastatic Malignant Melanoma

In a provisional draft guidance the National Institute for Health and Clinical Excellence (NICE)will not recommend payment by the UK National Health Service for Yervoy (ipilimumab) from BMS for Metastatic Malignant Melanoma in patients who have received prior chemotherapy. NICE acknowledged that the drug met the criteria for being a life-extending, end-of-life treatment but considers that in quality-adjusted life year ...

Mechlorethamine hydrochloride gel is filed at FDA for Mycosis Fungoides

Yaupon Therapeutics has filed at the FDA an application (NDA) for its gel formulation of mechlorethamine hydrochloride as a topical treatment for early-stage mycosis fungoides, the most common type of cutaneous T-Cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma. Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma, a rare form of non-Hodgkin's lymphoma. The cause of ...

NICE refuses to recommend Benlysta for SLE

In a draft guidance, NICE, the health technology appraisal institute for England and Wales, has provisionally rejected Benlysta (belimumab) from GlaxoSmithKline (GSK) and Human Genome Sciences (HGS), for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy. GSK plans to contest the decision....

Studies show Flutiform benefits for Asthma patients

According to three phase III studies presented at the 2011 European Respiratory Society Congress, the single aerosol inhaler Flutiform (fluticasone plus formoterol) from Napp Pharmaceuticals, offers a safe and efficient treatment for patients with Asthma. These studies support previous data that shows the efficacy and safety of Flutiform in adults and adolescents aged 12 years and above. As measured by ...

Study finds benefits of Xolair for Allergic Asthma treatment

New results from the APEX trial of Xolair (omalizumab), from Novartis, show that the drug considerably reduces patients need for steroid use, while at the same time helping disease control and lowering the amount of Asthma exacerbations. Usual treatment for Allergic Astham is oral steroids, but these are associated with weight gain, hypertension, osteoporosis and depression. The data, presented at ...

FDA approves Remicade for Pediatric Ulcerative Colitis

The FDA has approved Remicade (infliximab), from Janssen Biotech, for the treatment of moderately to severely active Ulcerative Colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. The approval was supported by evidence from studies of Remicade in adults with Ulcerative Colitis plus additional data from a pivotal Phase III trial evaluating the efficacy and ...