Pharma News

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

Mylan Inc.reports hat the US District Court for the District of New Jersey granted its motion for a temporary restraining order against Apotex Inc. and Apotex Corporation in litigation relating to Paroxetine CR, the authorized generic of...

The US Food and Drug Administration has approved Gilead Sciences' Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has...

Biogen Idec reports that the European Commission has granted marketing authorization for Plegridy (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis, the most common form of multiple...

Sandoz, a Novartis Group company, reports that the US Food and Drug Administration (FDA) has accepted its biologics license application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and...

GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. The submission will follow the Article 58 procedure, which allows the EMA to assess the quality, safety,...

Merck KGaA reiterated its commitment to investments in the Chinese market with the executive board of Merck KGaA, Darmstadt, Germany, meeting this week met in Shanghai, a month before the groundbreaking of its new pharmaceutical plant in Nantong,...

AstraZeneca reports that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies. The Phase I/II...

The biopharmaceutical company InterMune, Inc. reports that pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IFP), has been granted breakthrough therapy designation from the US Food and...

Astellas reports that the US Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis.  An invasive fungal infection product that is granted...

Teva Pharmaceutical Industries Ltd. has completed the acquisition of Labrys Biologics Inc,, a privately held development-stage biotechnology company focused on treatments for chronic migraine and episodic migraine. Teva had announced in...

Sandoz, the generics business of Novartis, has formed an agreement with Anacor Pharmaceuticals, Inc., a pharmaceutical company focused on discovering, developing, and commercializing small-molecule therapeutics derived from the company's boron...