Merck says US FDA accepts its sBLA for Keytruda
March 8, 2016Manufacturing and Production, Research and Development Merck & Co, US FDA, keytruda, melanoma
US pharma giant Merck & Co said the US Food and Drug Administration (FDA) has accepted for review a new …
GSK says long-term study for Nucala backs safety profile
March 8, 2016Manufacturing and Production, Research and Development GSK, GlaxoSmithKline, Nucala, asthma
UK pharma major GlaxoSmithKline (LSE: GSK) said its asthma drug, Nucala (mepolizumab) showed a similar safety profile in a long-term …
EMA launches PRIME scheme
March 8, 2016Manufacturing and Production, Research and Development EMA, Guido Rasi, PRIME
The European Medicines Agency (EMA) has launched its new PRIME (priority medicines) scheme, which aims to strengthen support to medicines …
AstraZeneca’s Faslodex gets US FDA nod in combination treatment for breast cancer
March 8, 2016Manufacturing and Production, Research and Development AstraZeneca, Faslodex, US FDA, palbociclib
UK drug-maker AstraZeneca said the US Food and Drug Administration (FDA) has approved a new indication expanding the use of …
BMS criticises Scottish regulator over Opdivo skin cancer ‘no’
March 7, 2016Medical Communications, Research and Development Bristol-Myers Sqibb, NICE, SMC, melanoma, opdivo
Bristol-Myers Squibb says the Scottish Medicines Consortium’s (SMC) decision not to recommend its immunotherapy Opdivo (nivolumab) as a monotherapy for …
AbbVie’s Imbruvica gets US FDA okay as first-line treatment for CLL
March 7, 2016Sales and Marketing AbbVie, Janssen, Janssen Biotech, US FDA, imbruvica
Drug maker AbbVie said the US Food and Drug Administration (FDA) has approved its Imbruvica (ibrutinib) as a first-line treatment …
Eli Lilly’s plaque psoriasis treatment impresses in Phase III trials
March 7, 2016Research and Development, Sales and Marketing Eli Lilly, Enbrel, ixekizumab, psoriasis
Eli Lilly has announced late-stage trial data showing ixekuzimab treatment resulted in clinically meaningful improvements in as early as one …
Japan’s Ono Pharma focusing on building immuno-oncology portfolio with Opdivo
March 7, 2016Sales and Marketing Bristol-Myers Sqibb, Ono Pharma, immuno-oncology, opdivo
Japan’s Ono Pharmaceutical has said it is focused on building on its immuno-oncology portfolio following the success of its PD-1 …
Novo Nordisk reports five-year Victoza cardiovascular safety data
March 7, 2016Research and Development, Sales and Marketing Novo Nordisk, Victoza
Novo Nordisk has announced the top-line results from a trial investigating the cardiovascular safety of Victoza (liraglutide [rDNA origin] injection) …
FDA approves CSL Behring’s new haemophilia B treatment
March 7, 2016Research and Development, Sales and Marketing CSL Behring, haemophilia
The US Food and Drug Administration (FDA) has approved CSL Behring’s Idelvion (Coagulation Factor IX (Recombinant)), a novel, long-acting albumin …
Novartis says its psoriasis drug bests Janssen’s in comparison study
March 7, 2016Research and Development, Sales and Marketing Cosentyx, Novartis, Stelara
Novartis has announced new data from a study comparing its drug Cosentyx to Janssen’s Stelara, which it says demonstrates Cosentyx’s …
Teva suffers EpiPen generic setback after FDA rejection
March 4, 2016Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection
The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …
BioMarin reports positive early-stage results for trial drug to treat CLN2 disease
March 4, 2016Medical Communications
Biotechnology firm BioMarin Pharmaceutical has announced positive results from early stage trial for drug to treat neurodegenerative disease in children. …
Merck & Pfizer tie-up with Verastem to develop ovarian cancer drug
March 4, 2016Medical Communications
German drug major Merck along with Pfizer has joined forces with Verastem to develop the trial drug candidate avelumab to …
Sanofi Genzyme present positive Phase 2 results for fatal neuromuscular disease treatment
March 4, 2016Medical Communications, Research and Development Pompe disease, Sanofi, clinical trial, neuromuscular, phase 2
Sanofi Genzyme, the branch of the French-based pharma company that focuses on diseases difficult to diagnose and treat, have published …
Almost half of US physicians will prescribe more biosimilars, according to survey
March 4, 2016Medical Communications Obama, US, biosimilar, patent, prescribing
New data published by InCrowd has suggested that US physicians are very amenable to the prescription of biosimilars, with some …
Baxalta seeks European marketing rights for haemophilia drug
March 3, 2016Research and Development, Sales and Marketing Adynovi haemophilia a, Baxalta
Baxalta says it has filed for marketing authorisation for its haemophilia drug Adynovi with European regulators. The European Medicines Agency …
UCB targets regulatory filing for its osteoporosis drug in 2016
March 3, 2016Medical Communications, Research and Development, Sales and Marketing Romosozumab, UCB Pharma, osteoporosis
Belgian drug company UCB says it is looking at a regulatory filing for its trial drug romosozumab to treat osteoporosis …
Merck announces drug discovery collaboration with European Molecular Biology Laboratory
March 3, 2016Research and Development Cancer, Merck, biomarkers
Merck has announced that it has entered into a research collaboration with the European Molecular Biology Laboratory (EMBL), that will …
Amgen sues Novartis over Enbrel biosimilar
March 3, 2016Research and Development, Sales and Marketing Amgen, Novartis, Sandoz, biosimilars
Amgen has filed a suit in a US court against Novartis’ generics unit Sandoz, in a bid to protect bestselling …
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