The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Novartis has completed its acquisition of Takeda’s Xiidra (lifitegrast ophthalmic solution), a prescription drug for treating dry eye, in a $5.3-billion deal that includes $3.4 billion upfront and up to $1.9 billion in potential milestone payments....
Pfizer has completed its acquisition of Therachon Holding AG, a privately held clinical-stage biotechnology company, in a deal worth up to $810 million.
Under the agreement, Pfizer acquired Therachon for $340 million with an additional $470...
Bristol-Myers Squibb (BMS) has completed its previously announced divestiture of its consumer healthcare business, UPSA, to Taisho Pharmaceutical, an over-the-counter drug company in Japan, for $1.6 billion. BMS had announced the sale to Taisho in...
Pfizer has announced the election of Scott Gottlieb, MD, the former US Food and Drug Administration (FDA) Commissioner, to its Board of Directors, effective with its announcement on June 27, 2019. Dr. Gottlieb was also appointed to the Regulatory...
Glenmark Pharmaceuticals, a generics pharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding manufacturing issues relating to its new drug application (NDA) for Ryaltris...
Gilead Sciences and Carna BioSciences, a biopharmaceutical company developing kinase inhibitor drugs for oncology, autoimmune, and neurological diseases, have entered into a research and development collaboration to develop and commercialize...
Akorn, a specialty generic pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) related to an inspection by the FDA of its Somerset, New Jersey manufacturing facility conducted in July and August...
The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Sun Pharmaceutical Industries following a pre-approval inspection of the company’s facility in Halol, Gujarat, India, which was from June 3, 2019 to June 11,...
New Haven, Connecticut-based Valisure, an online pharmacy, has submitted a citizen petition to the US Food and Drug Administration (FDA) to request that the FDA take certain actions following the company detecting levels of an impurity,...
Gilead and Nurix Therapeutics, a drug-discovery company specializing in the body’s natural process to control protein levels, have entered into a global collaboration to discover, develop and commercialize targeted protein degradation drugs for...
Bristol-Myers Squibb (BMS) has provided an update on the approval process and timeline for its pending $74-billion acquisition of Celgene. To allow the transaction to close on a timely basis in light of concerns expressed by the US Federal Trade...
AbbVie and Allergan have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash-and-stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie’s...
Sanofi has teamed up with Google to create a new virtual Innovation Lab, where the two companies will apply Google’s technology and analytics with Sanofi’s data to change how Sanofi develops new treatments. Sanofi will use Google’s digital...
Momenta Pharmaceuticals, a biopharmaceutical company developing therapeutics for rare immune-mediated diseases and biosimilars, and Sandoz AG, the generics arm of Novartis, have settled litigation with Amphastar Pharmaceuticals, a specialty and...
Dr. Reddy’s Laboratories, a Hyderabad, India-based pharmaceutical company, has entered into a definitive asset purchase agreement with Upsher-Smith Laboratories, a generics and brands pharmaceutical company, in which Dr. Reddy’s would sell its US...
