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Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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Teva announces favorable court ruling in AZILECT® patent infringement litigation against Mylan
23 September 2013 | By Teva
The Court has upheld the validity of Teva’s patent. Teva anticipates the Court will enter Judgment that prevents Mylan from launching its generic version of Azilect® until Teva’s patent expires in 2017.
Merck receives complete response letter for investigational medicine Sugammadex Sodium Injection
23 September 2013 | By Merck
Merck has received a Complete Response Letter from the FDA for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium...
Roche to share important oncology data at European Cancer Congress (ECC)
23 September 2013 | By Roche
Data for established therapies Avastin, Herceptin, Kadcyla and Zelboraf amongst highlights...
Biogen Idec to present extensive new data from its robust multiple sclerosis portfolio at ECTRIMS
23 September 2013 | By Biogen Idec
More than 55 company-sponsored presentations underscore Biogen Idec’s commitment to treatment advances for people with MS...
Ablynx And AbbVie sign global license agreement for anti-IL-6R nanobody, ALX-0061
23 September 2013 | By Abbvie
Anti-IL-6R Nanobody, ALX-0061, to be developed in rheumatoid arthritis and systemic lupus erythematosus...
Otsuka and Lundbeck receive positive CHMP opinion for Abilify Maintena(r) in schizophrenia
21 September 2013 | By
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilised…
NovoEight® (turoctocog alfa) receives positive opinion from the European regulatory authorities
20 September 2013 | By Novo Nordisk
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on its recombinant factor VIII product turoctocog alfa, with the intended brand name NovoEight®...
GSK and Prosensa announce primary endpoint not met in Phase III study of drisapersen in patients with Duchenne Muscular Dystrophy
20 September 2013 | By GlaxoSmithKline (GSK)
Clinical study of drisapersen did not meet the primary endpoint of a statistically significant improvement in the 6 Minute Walking Distance (6MWD) test compared to placebo...
Fluenz Tetra, four-strain nasal spray vaccine, receives positive opinion in EU from CHMP
20 September 2013 | By AstraZeneca
For the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age...
GSK signs a multi-year agreement with BARDA to supply the US government with anthrax treatment
19 September 2013 | By GSK
The US government is purchasing the medicine as a counter measure against a potential bioterrorist attack...
Ventana to collaborate with Boehringer Ingelheim on the development of companion diagnostic tests
19 September 2013 | By Boehringer Ingelheim
Companies collaborate on the development of companion diagnostic tests for Boehringer Ingelheim Oncology programmes...
Amgen and Onyx Pharmaceuticals announce early termination of HSR waiting period
18 September 2013 | By Amgen
Amgen and Onyx Pharmaceuticals have announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (HSR), in connection with Amgen's proposed acquisition of Onyx, was terminated early on Sept. 18, 2013...
FDA accepts new drug application for investigational compound Epanova
18 September 2013 | By AstraZeneca
Epanova™ is an investigational compound for the treatment of severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL)...
AstraZeneca and Daiichi Sankyo announce iPhone app for reflux esophagitis
18 September 2013 | By
Daiichi Sankyo Co., Ltd. and AstraZeneca K.K. are working to educate the public about reflux esophagitis through a campaign entitled “Do you experience heartburn or acid reflux?”
BioMarin provides highlights ahead of research and development day
17 September 2013 | By
Members of BioMarin's management team and industry experts will provide an update on the company's product portfolio and advancements in the research and development pipeline...
