The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Johnson & Johnson (J&J) and its Janssen Pharmaceutical Companies say they will appeal a $572-million civil judgement entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid...
Amgen has agreed to acquire worldwide rights to Celgene’s psoriasis drug, Otezla (apremilast), for $13.4 billion in cash in connection with Celgene’s pending $74-billion merger with Bristol-Myers Squibb (BMS). BMS had previously announced (June...
Gilead Sciences and Galapagos NV, a Mechelen, Belgium-based small-molecule drug company, have closed their previously announced global research and development collaboration agreement in a deal worth more than $5.0 billion.
Under the agreement,...
MSD, known as Merck & Co., Inc. in the U.S. and Canada, has agreed to a collaboration with Themis Biosciences, a developer of therapies for infectious diseases and cancer, for the discovery and development of undisclosed vaccine candidates...
Endo International and its subsidiaries have offered a $10-million settlement in principle to two Ohio counties in connection with pending opioid litigation. The settlement is effective only upon the execution of definitive documentation. In the...
A roundup of developments and the latest news from China (Cipla, Jiangsu Acebright, Sun Pharma), Europe (European Medicines Agency, Swissmedic), India (Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Natco Pharma), Israel (Mapi Pharma),...
Novo Nordisk reports that a securities lawsuit has been filed against the company in Denmark by a number of shareholders regarding disclosures of sales of the company’s insulin products in the US.
The claim is for a total amount of DKK 11.8...
Bayer has agreed to sell its animal health business to Elanco Animal Health, the former animal health business of Eli Lilly and Company, for a transaction value of $7.6 billion. Elanco Animal Health became a fully independent company earlier this...
A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), featuring NME approvals from Roche, AbbVie, Celgene, and Nabriva Therapeutics.
Roche Receives...
Pfizer is investing an additional $500 million in the construction of its gene-therapy manufacturing facility in Sanford, North Carolina. Pfizer says this facility will support its continuing investment in gene-therapy research and development,...
Roche’s Genentech and Enable Injections, a developer and manufacturer of investigational wearable infusion devices for combination products, have partnered for multiple programs using Enable’s en-Fuse platform, a drug-delivery device designed for...
Pfizer has issued a voluntary recall to the patient level of two lots of Relpax (eletriptan hydrobromide) 40 mg tablets, a drug to treat migraines, for potential microbiological contamination. Pfizer says it initiated the recall because these...
A roundup of approvals of new molecular entities (NMEs) from the US Food and Drug Administration’s (FDA)’s Center for Drug Evaluation and Research (CDER), featuring NME approvals from Bayer, Merck & Co., Daiichi, Shield Therapeutics and...
Perrigo, a pharmaceutical company of generic drugs and over-the-counter (OTC) products, specified in its second-quarter 2019 results that it has not set a specific date for its previously announced plan to separate its prescription pharmaceuticals...
A federal district court judge has ruled against Sandoz, the generics business of Novartis, in patent litigation relating to Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug, Enbrel (etanercept), an anti-inflammatory drug with...
