AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA
July 1, 2016Medical Communications, Research and Development, Sales and Marketing AbbVie, US FDA, drug trial, imbruvica
US pharma firm AbbVie (NYSE: ABBV) said the US Food and Drug Administration has granted Imbruvica a fourth breakthrough therapy …
Shire says Phase II trial for rare eye condition in premature infants fails
July 1, 2016Medical Communications, Research and Development Shire, US FDA, drug trial, rare eye condition in infants
Shire plc (LSE: SHP) said its drug compound to treat a rare eye condition in infants failed mid-stage trials. The …
Bayer says its Stivarga improved overall survival in liver cancer in late-stage trials
June 30, 2016Research and Development, Sales and Marketing Bayer, Stivarga, drug trial, liver cancer
German pharma and crop sciences giant Bayer (ETR: BAYN) said late-stage trials for its drug to treat liver cancer showed a …
Galena’s breast cancer immunotherapy fails in late-stage trials; shares plunge
June 30, 2016Research and Development, Sales and Marketing Galena Biopharma, Stock, breast cancer, drug trial
Shares in Galena Biopharma (Nasdaq: GALE) dropped over 80% after the company said an independent Data Monitoring Committee recommended that …
Tesaro’s niraparib hits primary goal in late-stage trials for ovarian cancer trial; shares jump
June 30, 2016Research and Development, Sales and Marketing Tesaro, drug trial, niraparib, ovarian cancer
Shares in Tesaro (Nasdaq: TSRO) jumped to more than double after the company reported late-stage trials for its drug to …
Eli Lilly says FDA panel backs approval of Jardiance for cardiovascular indication
June 30, 2016Research and Development, Sales and Marketing Eli Lilly, cardiovascular, diabetes, jardiance
US drugmaker Eli Lilly (NYSE: LLY) said a US regulatory panel has backed its Jardiance (empagliflozin) for reducing cardiovascular death …
Shire says trial drug for ADHD shows positive results
June 30, 2016Research and Development, Sales and Marketing ADHD, Shire, US FDA, drug trial, regulation
UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results. Philip …
Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold
June 29, 2016Research and Development, Sales and Marketing Regulus Therapeutics, US FDA, drug trial, hepatitis C virus, regulation
Shares in Regulus Therapeutics (Nasdaq: RGLS) plunged as much as 60% after the company said the US Food and Drug …
Mayne Pharma to buy a portfolio of Teva’s generic drugs for $652 million
June 29, 2016Research and Development, Sales and Marketing Allergan, Deals, Mayne Pharma, Teva, generics, merger and acquisition
Australia’s Mayne Pharma Group Ltd (ASX: MYX) said it will acquire US generic products from Israel-based drugmaker Teva Pharmaceuticals (NYSE: …
Pfizer to invest about $350 million in China biotech facility, first in Asia
June 29, 2016Research and Development, Sales and Marketing Biotech Plant, China, Pfizer, research
US pharma giant Pfizer (NYSE: PFE) said it will invest about $350 million for a global biotechnology center in the …
Gilead says US FDA approves Epclusa to treat hepatitis C
June 29, 2016Research and Development, Sales and Marketing Epclusa, Gilead, HCV, US FDA, drug approval, regulation
US drug firm Gilead Sciences (Nasdaq: GILD) said the US Food and Drug Administration has approved its Epclusa (sofosbuvir/velpatasvir), in …
AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections
June 29, 2016Research and Development, Sales and Marketing AstraZeneca, European Commission, Zavicefta, bacterial infections, regulation
UK drug firm AstraZeneca (LSE: AZN) said the European Commission has granted marketing authorisation for its Zavicefta (ceftazidime-avibactam), a new combination …
Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation
Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …
Novo Nordisk says its insulin pump secures EMA marketing authorisation
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Novo Nordisk, insulin pump, marketing, product launch
Diabetes drugmaker Novo Nordisk (NYSE: NYO) said it has secured European Medicines Agency (EMA) marketing approval for its insulin pump. …
Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, bladder cancer, opdivo, regulation
Bristol-Myers Squibb (NYSE:BMY) said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its immunotherapy Opdivo for the …
MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing CHMP, EMA, MSD, Merck & Co, keytruda, lung cancer
MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive …
Novartis signs $150 million deal with Xencor to develop bispecific antibodies
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing Cancer, Novartis, Xencor, bispecific antibodies, deal, drug development, drug trial
Swiss drugmaker Novartis (VTX: NOVN) said it has signed a $150 million upfront collaboration and licensing agreement with Xencor to …
Takeda to return molecules/ products for Japan to Amgen
June 27, 2016Manufacturing and Production, Research and Development, Sales and Marketing Amgen, Cancer, Japan, Takeda Pharmaceutical, drug development, drug trial
Japanese firm Takeda Pharmaceutical (TSE: 4502) said it will return the rights to develop and market multiple molecules/ products from …
GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results
June 27, 2016Research and Development, Sales and Marketing Epidiolex, GW Pharmaceuticals, NDA, US FDA, drug trial, orphan drug
GW Pharmaceuticals (Nasdaq: GWPH) said late-stage trials for its Epidiolex (cannabidiol or CBD) to treat Lennox-Gastaut syndrome (LGS), a rare …
Boehringer Ingelheim says Phase III trials for its Ofev slowed progression of fatal lung disease
June 27, 2016Research and Development, Sales and Marketing Boehringer Ingelheim, drug trial, idiopathic pulmonary fibrosis, research
German drugmaker Boehringer Ingelheim said late-stage trials for its Ofev (nintedanib) to treat a fatal lung condition slowed progression of …
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