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106-120 of 2270 results
FDA gives priority review status to Novartis’ breast cancer drug
By PBR Staff Writer
Pharma giant Novartis has secured the US Food and Drug Administration (FDA) Priority Review for its advanced breast cancer drug ribociclib (LEE011).
Production & Manufacturing > Manufacturing > News
Portola expands collaboration with Daiichi to develop AndexXa in Germany
Portola Pharmaceuticals (PTLA) has expanded its existing clinical collaboration agreement with Daiichi Sankyo to develop AndexXa (andexanet alfa) as an antidote for the former’s Factor Xa inhibitor named as edoxaban.
Production & Manufacturing > Manufacturing > News
Nimbus secures $200m from Gilead for inhibitor program acquisition
Nimbus Therapeutics secured a $200m from Gilead Sciences in a payment related to the latter’s allosteric Acetyl-CoA Carboxylase (ACC) inhibitor program with NDI-010976 (now GS-0976) which was previously acquired from Nimbus.
Production & Manufacturing > Manufacturing > News
Celgene and IBM Watson to develop new offering for patient safety monitoring
Celgene and IBM Watson Health will co-develop a new offering that aims to enhance pharmacovigilance methods used to collect, assess, monitor, and report adverse drug reactions.
Production & Manufacturing > Manufacturing > News
Valeant in talks to divest gastroenterology business unit
By PBR Staff Writer
Valeant Pharmaceuticals International is in talks with third parties to divest its various assets, including Salix gastroenterology business unit.
Production & Manufacturing > Manufacturing > News
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
106-120 of 2270 results