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. Read More
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. Read More
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. Read More
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. Read More
Just two years after bursting onto the rare disease scene with a $45 million Series A, Ultragenyx Pharmaceutical Inc. filed an S-1 with the SEC seeking to raise up to $86.3 million in an initial public offering (IPO). Filing, like other biotechs, as an emerging growth company, the Novato, Calif.-based company applied to list on Nasdaq under the symbol “RARE.” Read More
LONDON – GW Pharmaceuticals plc has advanced its expertise in cannabis pharmacology to the next stage, starting the first formal clinical trial of a cannabinoid as an antitumor therapeutic. Read More
LONDON – The mystery of how HIV manages to infect the very cells that should react to its presence by triggering an immune response has remained unsolved for decades. Now, a new study has shown how the virus “cloaks” itself with proteins from the host cells in order to avoid triggering the immune response. Read More
• Horizon Pharma Inc., of Deerfield, Ill., said its Swiss subsidiary signed an exclusive agreement with Mundipharma International Ltd., of Cambridge, UK, for the commercialization and distribution of Lodotra, a delayed-release formulation of prednisone, in the Middle East and African region. Read More
• 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. Read More
• 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. Read More
