• Galena Biopharma Inc., of Portland, Ore., presented a poster at the Society for Immunotherapy of Cancer Conference in National Harbor, Md., detailing results of the Phase I portion of its trial for the folate-binding protein vaccine, a cancer immunotherapy product in development for patients with HLA A2-positive cancers.
• Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA approved Aptiom (eslicarbazepine acetate), an antiepileptic drug, for use as adjunctive treatment of partial-onset seizures.
LONDON – Shire plc is paying $4.2 billion to acquire Viropharma Inc, giving it a stranglehold on the market for hereditary angioedema (HAE) treatments, with the leading products for prophylaxis and for treating acute attacks both residing in the same portfolio.
Something of a mystery surrounds the Phase II dashed hopes with Zalicus Inc.’s oral calcium channel blocker Z160, which missed its primary endpoints in two pain indications, testing patients with lumbosacral radiculopathy and postherpetic neuralgia.
Now that generic drugs are a fully grown industry in the U.S., the FDA said it’s time for generic drugmakers to take responsibility for the labeling of their products and face the same liability as the makers of brand drugs and biologics.
Alnylam Pharmaceuticals Inc. received coveted fast-track designation for its RNAi therapeutic, patisiran, to accelerate its development for treatment of transthyretin (TTR)-familial amyloid polyneuropathy (FAP). The company recently reported positive Phase II results for the product, and has begun a Phase III program.
Salix Pharmaceuticals Ltd.’s $2.6 billion buyout of Santarus Inc. for $32 per share in cash provides entry into the primary care physician space, while bringing aboard more products – albeit a couple that are facing patent expirations fairly soon.
Although 2013 is the third year for the BIO Convention in China – BIO China, as it’s more commonly known – it’s back to the basics this year as the Biotechnology Industry Organization (BIO) and the China Center for Pharmaceutical International Exchange seek to strengthen ties between their members and to connect Western biopharmas with players in the emerging Chinese biotech market.
The FDA released its briefing documents in advance of the Peripheral and Central Nervous System Drugs Advisory Committee meeting Nov. 13. The committee will discuss the supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) injection, submitted by Genzyme Corp., a Sanofi SA company, for use in multiple sclerosis (MS).
Shares of Arena Pharmaceuticals Inc. jumped 17.4 percent Friday on news of an expanded alliance with Eisai Inc. for obesity drug Belviq (lorcaserin), a deal that brings $60 million up front and aims to advance the drug into new commercial markets and possibly new indications.