The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The biopharmaceutical company Ambrx Inc. and Zhejiang Hisun Pharmaceutical Company Ltd. have formed a collaboration for the development and commercialization of bispecifics for the treatment of cancer based on Ambrx technology. Hisun will have...
FDA has approved AstraZeneca's Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500 mg/dL). Epanova is the...
Merck & Co. has received FDA approval for Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or...
GlaxoSmithKline plc (GSK) and Theravance, Inc. have been granted marketing authorization by the European Commission for Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult...
H. Lundbeck A/S (Lundbeck) has agreed to acquire for $658 million Chelsea Therapeutics International, Ltd., a biopharmaceutical company based in Charlotte, North Carolina. In February 2014, Chelsea Therapeutics received FDA approval for its...
Bayer has agreed to acquire the consumer care business of Merck & Co., Inc. for $14.2 billion. The move follows Merck's announcement in January 2014 that it was evaluating strategic options for its business. Last week Reckitt Benckiser...
The Swedish specialty pharmaceutical company Meda has rejected a proposal by Mylan Inc for a possible combination of the two companies. "The Board hereby confirms that it has been contacted by Mylan, Inc. ("Mylan") regarding a revised...
Shire plc has agreed to acquire Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a fibrosis for an upfront payment of $75M and certain contingent payments based on the achievement of development and...
Merck & Co. Inc. and the biopharmaceutical company Endocyte, Inc. have suspended a Phase III trial for vintafolide, a drug being developed to treat ovarian cancer. The Phase III trial (PROCEED) was evaluating vintafolide in combination...
Sun Pharmaceutical Industries Ltd announced that, as a part of its manufacturing consolidation in the US, it will cease manufacturing operations and close the Detroit facility of Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma USA,...
In the latest round of a proposed combination of Pfizer and AstraZeneca, AstraZeneca has rejected a proposal by Pfizer to acquire AstraZeneca for £50.00 ($84.47) per share or $106 billion. Pfizer made its latest proposal under which...
BioMarin Manufacturing Ireland, a subsidiary of BioMarin Pharmaceutical Inc.,announced that it expects to expand its Dublin operation, according to IDA Ireland, the economic development agency of Ireland. The Dublin operation has responsibility for...
Watson Laboratories, Inc, a subsidiary of the generic-drug company Actavis plc, has filed suit against FDA, challenging the agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex®...
Reckitt Benckiser, which reported earlier this week that it was in discussions with Merck & Co. for Merck's over-the-counter business, issued a statement on April 30, 2014, to say "it is no longer in active discussion regarding an offer for...
GlaxoSmithKline plc (GSK) has received FDA approval for Incruse™ Ellipta® (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary...
