Basilea nominates Domenico Scala as new chairman
March 15, 2016Business Services, Manufacturing and Production Basilea, Chariman, Executive appointment
Switzerland-based Basilea Pharmaceutica on Tuesday nominated Domenico Scala as the new chairman of the board. The current Chairman, Martin Nicklasson …
PTC Therapeutics to file new Phase III data for genetic muscle disorder drug in Canada
March 15, 2016Manufacturing and Production, Research and Development Canada, PTC Therapeutics, Translarna, nonsense mutation Duchenne muscular dystrophy, phase III
PTC Therapeutics (Nasdaq: PTCT) said it does not expect the Canadian regulators to review its trial drug to treat a …
Adocia and Lilly report positive early results for ultra-rapid insulin
March 15, 2016Manufacturing and Production, Research and Development Adocia, BioChaperone Lispro, Eli Lilly, insulinm
Eli Lilly and development partner Adocia have announced today positive topline results from a Phase 1b clinical trial of ultra-rapid …
UPDATE: Pfizer gets interim stay on cough syrup ban
March 15, 2016Manufacturing and Production, Research and Development Abbott Laboratories, Corex, Pfizer, Pfizer India
Shares in Pfizer India continued to tumble for a second day even as an Indian court granted the company a …
Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer
March 15, 2016Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review
The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …
GW Pharma shares more than double after positive Phase III trials for epilepsy drug
March 15, 2016Manufacturing and Production, Research and Development Epidiolex, GW Pharma, US FDA, epilepsy in children, phase III
Shares in UK-based GW Pharmaceuticals (Nasdaq: GWPH) more than doubled on the Nasdaq Monday after the company announced positive results …
COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?
March 14, 2016Medical Communications, Sales and Marketing Amarin, FDA, off label, off-label, vascepa
Last week, Pharmafile.com reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow …
Cambridge Epigenetix says raised $21 million, appoints Geoff Smith CEO
March 14, 2016Business Services, Sales and Marketing CEGX, CEO, Cambridge Epigenetix, fundraising, genome sequencing
Cambridge Epigenetix (CEGX) on Monday said it has raised about $21 million via Series B financing and named Geoff Smith …
Ariad names Manmeet Soni CFO
March 14, 2016Business Services, Sales and Marketing Ariad, CEO, appointment, boardroom, cfo
Ariad Pharmaceuticals Inc (Nasdaq: ARIA) named Manmeet Soni chief financial officer, effective March 21, 2016, succeeding Edward Fitzgerald. Mr Soni will …
Janssen’s Zytiga boosts survival in early-stage prostate cancer
March 14, 2016Research and Development, Sales and Marketing Janssen, Zytiga, abiraterone, prednisone, prostate cancer
Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall …
FDA approves Pfizer sNDA for Xalkori
March 14, 2016Research and Development, Sales and Marketing Cancer, EMA, NSCLC, Pfizer, Xalkori (crizotinib)
The US FDA has approved Pfizer’s supplemental new drug application (sNDA) for its kinase inhibitor Xalkori in treating patients with …
EMA starts review of Gilead Sciences’ Zydelig following safety concerns
March 14, 2016Research and Development, Sales and Marketing EMA, Gilead Sciences, blood cancer, clinical trials, zydelig
Regulators in Europe have initiated a safety review of Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib) following reports …
GSK terminates Five Prime Therapeutics mesothelioma collaboration
March 14, 2016Research and Development, Sales and Marketing Five Prime Therapeutics, GSK, mesothelioma
GSK is to back out of a licensing deal with California-based Five Prime Therapeutics to develop a mesothelioma drug. Announcing …
Pfizer’s India unit stops production of cough drug, shares drop almost 8%
March 14, 2016Business Services, Sales and Marketing Bombay Stock Exchange, Corex, Pfizer Inc, Pfizer Ltd, Shares
Shares in the Indian arm of drug major Pfizer Inc (NYSE: PFE) dropped nearly 8% on the Bombay Stock Exchange …
MSF challenges Pfizer’s pneumonia vaccine patent in India
March 11, 2016Medical Communications, Research and Development, Sales and Marketing GSK, Pfizer, Prevnar 13, pneumonia vaccine
The charity Médecins Sans Frontières (MSF) has formally opposed Pfizer’s bid to obtain a patent for the pneumonia vaccine PCV13, …
Spanish firm Grifols to spend a total of $360 million on four new plants
March 11, 2016Manufacturing and Production, Medical Communications grifols, manufacturing, pharma, plasma, production
Grifols (Nasdaq: GRFS) said it will invest a total of $360 million over 2016-2021, to increase the plasma fractionation capacity …
Dr. Reddy’s, TR-Pharm to collaborate on 3 biosimilars in Turkey
March 11, 2016Manufacturing and Production, Medical Communications, Sales and Marketing Dr Reddy's Laboratories, TR-Pharm, biosimilar, generics, marketing collaboration
Three biosimilar products by the Indian generics company Dr. Reddy’s will be marketed by TR-Pharm in Turkey, the companies said …
Novartis seeks expanded Arzerra use in US
March 11, 2016Research and Development Arzerra, CLL, FDA, Genmab, Novartis
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US FDA for the use of Arzerra (ofatumumab) in …
Spark Therapeutics buys Genable Tech for $6 million in cash and stock deal
March 11, 2016Business Services, Medical Communications Genable Technologies, Spark Therapeutics, cash & stock, genetic technologies, merger & acquisitions
Spark Therapeutics (Nasdaq: ONCE) said it has acquired Ireland-based Genable Technologies, a privately-held gene therapy firm for $6 million in a cash …
US FDA sets April 25 date to review Sarepta’s DMD drug, shares jump
March 11, 2016Medical Communications, Research and Development Duchenne Muscular Dystrophy, Eteplirsen, Sarepta Therapeutics, US FDA
Shares in US-based Sarepta Therapeutics (Nasdaq: SRPT) jumped nearly 15% Thursday after the US Food and Drug Administration (FDA) said it …
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