The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
Actavis plc has announced the proposed senior management team that will lead the specialty pharmaceutical company pending the successful close of the acquisition of Forest Laboratories, Inc., which is anticipated at...
Bristol-Myers Squibb Company and the biopharmaceutical company Celldex Therapeutics have formed a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of nivolumab, Bristol-Myers Squibb's...
AstraZeneca's MedImmune, its global biologics R&D arm, has formed a clinical study collaboration with the biopharmaceutical company Incyte Corporation. The Phase I/II oncology study will evaluate the efficacy and safety of...
GlaxoSmithKline (GSK) reported disappointing results for its late-stage cardiovascular drug candidate, darapladib, an Lp-PLA2 (lipoprotein-associated phospholipase A2) inhibitor currently being investigated as a potential agent...
In a letter to its shareholders, the specialty pharmaceutical company Valeant Pharmaceuticals International, Inc. said it plans "to improve" its offer for the specialty pharmaceutical company Allergan Inc. following the rejection by...
