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 …

astrazeneca_plaque

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 …

novo_flag

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 …

msd

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 …

novartis_outside_1

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 …

takeda_world

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 …

gwpharma

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 …

stocks1

Weekly Movers: Lpath, Paratek, Inovio…

June 27, 2016
Research and Development, Sales and Marketing

Shares in Lpath (Nasdaq: LPTN) jumped 55% after the company said it has secured a two-year $1.45 million grant by …

china-pharmaceutical-industry

Brexit may also create opportunities for UK’s pharmaceutical and medical device industries – report

June 27, 2016
Research and Development, Sales and Marketing

Even though UK’s exit from the European Union undoubtedly creates significant issues for the UK pharmaceutical and medical device industries …

Woodley Equipment Company the Specialist Global Provider of Equipment for Clinical Trials exhibits at DIA 2016

June 24, 2016

Woodley Equipment Company the Specialist Global Provider of Equipment for Clinical Trials

astellas_imageuk

Astellas UK suspended from ABPI for “deception” and other cultural failings

June 24, 2016
Medical Communications, Research and Development, Sales and Marketing ABPI, Astellas, cultural failings

Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) for a period …

Nice rejects AstraZeneca’s Tagrisso for lung cancer in preliminary recommendation

June 24, 2016
Medical Communications, Research and Development AstraZeneca, CDF, NICE, lung cancer, regulation

UK drugmaker AstraZeneca (LSE: AZN) said the National Institute for Health and Care Excellence (Nice) has rejected Tagrisso (osimertinib) to …

brexit

“Immediate challenges” for UK pharma post-Brexit, says ABPI

June 24, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, brexit

The UK life sciences industry has expressed dismay at the result of the EU referendum, but has pledged to work …

allergan

FDA approves expanded label for Allergan’s Avycaz

June 24, 2016
Medical Communications, Research and Development, Sales and Marketing Allergan, Avycaz, FDA, expanded label

Allergan (NYSE: FDA) has announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application …

cancer

Genmab’s CLL drug gets negative opinion from EMA committee

June 24, 2016
Medical Communications, Research and Development, Sales and Marketing Arzerra, CHMP, CLL, EMA, Genmab, blood cancer

Genmab A/S (Nasdaq Copenhagen: GEN) said its drug Arzerra (ofatumumab) received a negative opinion by the Committee for Medicinal Products …

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