Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

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...

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...

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...