The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Novartis has signed a licensing and commercialization agreement with Ophthotech Corporation for the exclusive rights to market Fovista, an anti-platelet-derived growth factor (PDGF) aptamer. outside the United States. Under the agreement,...
Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., report FDA approval for Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis (UC) and adult...
FDA has issued a Warning Letter to Sun Pharmaceutical Industries for data-integrity issues and related cGMP violations at the company's active pharmaceutical ingredient (API) and finished product manufacturing operations at the company's...
Roche reports that it will invest CHF 120 million ($134 million) to build new facilities at its headquarters in Basel, Switzerland, as well as to make upgrades to existing production operations at Basel. The company plans to build a new...
AbbVie and Bristol-Myers Squibb has received breakthrough therapy designation for elotuzumab for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior...
Novartis reports that FDA has issued a Complete Response Letter (CRL) regarding the bologics license application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure, stating that further evidence on the efficacy of RLX030 is...
AstraZeneca has rejected the latest and what Pfizer said was its final proposal for acquiring AstraZeneca. On Sunday, May 18, 2014, Pfizer had reported that on Friday May 16, 2014, it had raised its proposal and cash portion of the deal to...
Takashi Shoda, current chairman and representative director of Daiichi Sankyo Company, will be stepping down and taking on a position as senior corporate advisor to the company. The move is subject to approval at the company's annual...
In ongoing litigation over the safety of its diabetes drug Actos (pioglitazone HCl), Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., report that in the case of the Whitlatch v. Takeda ,...
Seeking to expand its branded generics business, Abbott has agreed to acquire the Latin American pharmaceutical company CFR Pharmaceuticals for approximately $2.9 billion, plus the assumption of net debt of approximately $430 million. ...
Eli Lilly and Company reports that the English High Court has determined that the vitamin dosage regimen patents for the anticancer drug Alimta (pemetrexed) would not be infringed by a generic competitor that has stated an intent to market...
Novartis Pharmaceuticals Corporation has settled its litigation with the United States subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of the anticancer drug Gleevec...
Hospira, Inc. issued a press release on May 14, 2014, to report that on January 10, 2014, it issued a nationwide recall to the user level for one lot of the cardiovascular drug, dobutamine Injection, USP, 250 mg, 20 mL, single-dose fliptop vial,...
The biopharmaceutical company Ligand Pharmaceuticals has entered into a licensing agreement and research collaboration with Omthera Pharmaceuticals, Inc., a wholly owned subsidiary of AstraZeneca plc, for the development of products to treat...
Dr. Reddy's Laboratories Ltd. reports that its board of directors has decided to have separate roles of the chairman of the company and the managing director and CEO. It has appointed Satish Reddy as chairman of the board. He...
