Research and Development

Showing 15 posts of 9578 posts found.

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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 …
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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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MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer

June 28, 2016 Manufacturing 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 …
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Novartis signs $150 million deal with Xencor to develop bispecific antibodies

June 28, 2016 Manufacturing 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 …
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Takeda to return molecules/ products for Japan to Amgen

June 27, 2016 Manufacturing 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 …
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GW Pharmaceuticals says Phase III trials for Epidiolex to treat rare epilepsy in children shows positive results

June 27, 2016 Research 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, 2016 Research 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 …

Sanofi, Boehringer Ingelheim sign definitive agreements for swap

June 27, 2016 Research and Development, Sales and Marketing Boehringer Ingelheim, Financial, Sanofi, business swap, merger and acquisition

French drugmaker Sanofi (Euronext: SAN) and German pharma firm Boehringer Ingelheim have signed a definitive agreement for a business swap announced …
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