Research and Development

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AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA

July 1, 2016 Medical 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 …
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Shire says Phase II trial for rare eye condition in premature infants fails

July 1, 2016 Medical 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 …
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Bayer says its Stivarga improved overall survival in liver cancer in late-stage trials

June 30, 2016 Research 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 …
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Galena’s breast cancer immunotherapy fails in late-stage trials; shares plunge

June 30, 2016 Research 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 …
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Tesaro’s niraparib hits primary goal in late-stage trials for ovarian cancer trial; shares jump

June 30, 2016 Research 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 …
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Eli Lilly says FDA panel backs approval of Jardiance for cardiovascular indication

June 30, 2016 Research 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 …
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Shire says trial drug for ADHD shows positive results

June 30, 2016 Research 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 …
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Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold

June 29, 2016 Research 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 …
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Mayne Pharma to buy a portfolio of Teva’s generic drugs for $652 million

June 29, 2016 Research 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, 2016 Research 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-sciences

Gilead says US FDA approves Epclusa to treat hepatitis C

June 29, 2016 Research 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 …
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AstraZeneca’s new antibiotic Zavicefta gets European approval for serious bacterial infections

June 29, 2016 Research 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, 2016 Manufacturing 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 …
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Novo Nordisk says its insulin pump secures EMA marketing authorisation

June 28, 2016 Manufacturing 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, 2016 Manufacturing 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 …
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