The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Hospira, Inc. announced on June 17, 2014, that it will initiate a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (bupivacaine HCl Injection, USP), 30-mL, single-dose vial –preservative free (NDC 0409-1560-29), Lot...
Grifols, is a global healthcare company focused on developing plasma medicines, diagnostics systems, and hospital pharmacy products and headquartered in Barcelona, is investing $370 million for a new plasma-fractionation facility, North...
Actavis plc has confirmed that the United States District Court for the District of Delaware has found certain claims of United States Patent Nos. 6,335,031 and 6,316,023 valid and infringed by Actavis' generic version of Novartis' Exelon Patch...
Johnson & Johnson Innovation, LLC has announced 12 new alliances with life science companies and research institutions to explore early-stage innovation in a broad range of therapeutic areas and across pharmaceuticals, medical device, and...
In continuing its efforts to acquire Allergan Inc., Valeant Pharmaceuticals International, Inc. has commenced an exchange offer directly to Allergan stockholders for the common stock of Allergan, using the approximately $53-billion proposal...
Actavis plc and Forest Laboratories, Inc. report that their respective shareholder meetings held June 17, 2014, all proposals related to Actavis' planned $25-billion acquisition of Forest were approved by both Actavis' and Forest's shareholders....
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company have announced the resubmission of a new drug application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults...
Janssen Pharmaceuticals, Inc. has entered into an exclusive license agreement with Vertex Pharmaceuticals for the worldwide development, manufacturing, and commercialization of VX-787, a medicine in Phase II development for the treatment of...
For its first "Meet Novartis Management" investor day, Novartis gathered more than 20 of its top executives, drawn from the leadership of its Pharmaceuticals, Alcon, and Sandoz Divisions, and the Novartis Institutes for BioMedical Research (NIBR)...
Pfizer Inc. and Cellectis, a French company specializing in immunotherapy, have entered into a global strategic collaboration to develop Chimeric Antigen Receptor T-cell (CAR-T) immunotherapies in the field of oncology directed at select...
The US Food and Drug Administration has posted a Warning Letter dated, June 16, 2014, for Apotex Pharmachem India based on the agency's inspection from January 27 through January 31, 2014 of the company's pharmaceutical manufacturing...
The specialty pharmaceutical company Allergan, Inc. issued a statement to reiterate its opposition to Valeant Pharmaceuticals International, Inc.'s re-revised unsolicited proposal to acquire Allergan, dated May 30, 2014, which Allergan...
Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) will terminate their product collaboration and license agreement for Omontys (peginesatide), a drug to treat anemia due to chronic kidney disease in adult patients on dialysis,...
Amgen reports that it collaborate with the National Cancer Institute (NCI), part of the National Institutes of Health, and other public and private sector partners on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use...
AbbVie reports that the marketing authorization applications (MAAs) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been validated...