The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
The US Food and Drug Administration (FDA) has approved Amgen’s and Allergan’s biosimilar of Roche’s Herceptin (trastuzumab). Their biosimilar, Kanjinti (trastuzumab-anns), was approved for the treatment of HER2-overexpressing adjuvant and...
Vertex Pharmaceuticals has made two deals, worth up to $1 billion each, to enhance its gene-editing capabilities in drug development. The company is expanding its collaboration with CRISPR Therapeutics, a gene-editing company developing gene-based...
Amgen, along with Merck and Co., Eli Lilly and Company, and the Association of National Advertisers, have filed suit against the US Department of Health and Human Services’ (HHS) regarding a recent HHS rule requiring list prices to be included for...
Pfizer has entered into a merger agreement with Array BioPharma, a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule medicines for cancer and other diseases, for a total...
Genmab, a biotechnology company specializing in antibody therapeutics for the treatment of cancer, has entered into a worldwide license and option agreement with Janssen Biotech, part of Johnson & Johnson, to develop and commercialize...
Boehringer Ingelheim (BI) has opened a new production plant in Sant Cugat del Valles, Spain, to produce and package Respimat, an inhalation device for patients with asthma and chronic obstructive pulmonary disease (COPD).
BI invested more than EUR...
In another recall of “sartan”-containing products, Teva Pharmaceuticals USA has expanded its voluntary recall to the consumer level in the US of losartan potassium tablets, used in antihypertensive drugs. The expanded recall includes six lots of...
Merck and Co. has been selected by the US Food and Drug Administration (FDA), along with Walmart, IBM, and KPMG, to participate in a pilot program in support of the US Drug Supply Chain Security Act (DSCSA) to identify, track and trace prescription...
