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61-75 of 2220 results
FDA delays approval of Sanofi and Regeneron's rheumatoid arthritis drug sarilumab
By PBR Staff Writer
The US Food and Drug Administration (FDA) has delayed approval for Sanofi and Regeneron Pharmaceuticals' experimental treatment for rheumatoid arthritis (RA) due to manufacturing deficiencies.
Production & Manufacturing > Manufacturing > News
FDA accepts for priority review Bristol-Myers' sBLA for Opdivo for urothelial carcinoma use
The US Food and Drug Administration (FDA) has accepted for priority review Bristol-Myers Squibb's supplemental biologics license application (sBLA) for Opdivo (nivolumab) in previously treated patients With advanced form of bladder cancer.
Production & Manufacturing > Manufacturing > News
Virtus sues FDA for clearing potassium chloride market of competition
Virtus Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), seeking to prevent a monopoly, and potential price hikes, in the marketplace for potassium chloride products.
Production & Manufacturing > Manufacturing > News
VBL Therapeutics unveils plans to build new manufacturing facility in Israel
VBL Therapeutics has entered in to a long-term lease contract for a new stand-alone facility in Modiin, Israel.
Production & Manufacturing > Manufacturing > News
Merck opens biopharmaceutical support center in Korea
By PBR Staff Writer
German life sciences firm Merck has opened a new biopharmaceuticals production and development support center in the Songdo district of Incheon, Korea.
Production & Manufacturing > Manufacturing > News
Intas to buy Actavis UK and Ireland business form Teva
By PBR Staff Writer
Indian drugmaker Intas Pharmaceuticals has agreed to acquire Actavis Generics’ assets and operations in the UK and Ireland from Teva Pharmaceutical Industries for about £603m.
Production & Manufacturing > Manufacturing > News
Depomed gets favorable patent ruling in US for NUCYNTA ANDAs
Judge Claire C. Cecchi of the United States District Court for the District of New Jersey has ruled in favor of Depomed in the company's patent litigation against all three filers of Abbreviated New Drug Applications (ANDAs) for Depomed's NUCYNTA franchise.
Production & Manufacturing > Manufacturing > News
Novo Nordisk plans to cut 1,000 jobs amid increasing competition
By PBR Staff Writer
Danish drug maker Novo Nordisk is planning to lay off about 1,000 employees globally in order to reduce operating costs.
Production & Manufacturing > Manufacturing > News
Pfizer scraps plan to split into two companies
By PBR Staff Writer
Pfizer said it would remain a single company, deciding not to split its branded drugs and generics businesses into two stand-alone firms.
Production & Manufacturing > Manufacturing > News
Pharmaron enters into non-binding heads of terms with MSD over Hoddesdon UK site
Pharmaron has entered into a non-binding Heads of Terms (HoTs) with Merck Sharp & Dohme Limited (MSD) for the sale of the Hoddesdon UK site which includes MSD’s process development and research facility.
Production & Manufacturing > Manufacturing > News
GSK names Emma Walmsley as new CEO
GlaxoSmithKline (GSK) has named Emma Walmsley as its new chief executive officer (CEO).
Production & Manufacturing > Manufacturing > News
Sanofi files patent infringement suit against Merck
By PBR Staff Writer
French pharmaceutical firm Sanofi has filed a lawsuit against Merck’s international unit over alleged patent infringements.
Production & Manufacturing > Manufacturing > News
Horizon Discovery licenses biomanufacturing Cell Lines to CPI and NIBRT
Horizon Discovery Group has formed new partnerships with both the Centre for Process Innovation (CPI) and the National Institute for Bioprocessing Research and Training (NIBRT) to support biologic therapeutic manufacturing in the UK, Ireland and beyond.
Production & Manufacturing > Manufacturing > News
Thermo Fisher Scientific opens new clinical services facility in South Korea
Thermo Fisher Scientific has opened a new GMP standard facility in South Korea to address the growing global demand for clinical services.
Production & Manufacturing > Manufacturing > News
Avara to buy AstraZeneca's UK manufacturing facility
Avara Pharmaceutical Services has agreed to acquire AstraZeneca's manufacturing facility located in Avlon, Avonmouth, England, UK.
Production & Manufacturing > Manufacturing > News
61-75 of 2220 results