Shingrix (varicella zoster vaccine [recombinant], adjuvanted) from Glaxosmithkline plc (GSK) sailed through a hearing by the FDA's Vaccines and Related Biological Products Committee, with panelists voting 11-0 in favor of the product's efficacy and safety in people 50 years of age and beyond. Read More
Amicus Therapeutics Inc. minced no words on the failure of its phase III study of SD-101 in epidermolysis bullosa (EB), the object of a potential $847 million take-out of Scioderm Inc., but John Crowley, Amicus chairman and CEO, was equally quick to defend the merits of the acquisition on a conference call Wednesday. Read More
Following the failure of Inotek Pharmaceuticals Corp.'s trabodenoson to move the needle in treating glaucoma, the company has found a new way forward: a proposed merger with New York-based gene therapy startup Rocket Pharmaceuticals Ltd. Led by former Novartis AG cell and gene therapies unit veteran Gaurav Shah, the combined company is developing a pipeline of gene therapies based on lentiviral virus and adeno-associated virus (AAV) platforms, with a focus on treating rare diseases. (See BioWorld, July 11, 2017.) Read More
LONDON – Governments across Europe have realized that biosimilars need a tailor-made framework and are disentangling their pricing policies from those applied to generic medicines, according to a review of policies in 31 countries. Read More
HONG KONG – Chinese biotech company Harbour Biomed Therapeutics Ltd. has entered a collaboration and licensing agreement with South Korea's Hanall Biopharma Co. Ltd. for novel biologics. Under the agreement, Harbour, of Shanghai, will have the rights to develop, manufacture and commercialize HL-161 and HL-036 for the Greater China market, which includes the territories of Hong Kong, Macau and Taiwan. Read More
HONG KONG – A recent University of Hong Kong (HKU) study has discovered a novel non-antibiotic drug with potent efficacy against methicillin-resistant Staphylococcus aureus (MRSA), which represents a promising lead compound for development of anti-virulence drugs against S. aureus. Read More
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it priced an underwritten public offering of 15.53 million shares of its common stock at $5.15 each for expected gross proceeds of $80 million. Read More
Akcea Therapeutics Inc., of Cambridge, Mass., an affiliate of Ionis Pharmaceuticals Inc., said it filed a new drug submission (NDS) to Health Canada for volanesorsen, an investigational medicine for the treatment of familial chylomicronemia syndrome (FCS). Read More
Moleculin Biotech Inc., of Houston, engaged Bioscience SA, a contract research organization based in Bydgoszcz, Poland, to prepare a proof-of-concept trial in Poland for Moleculin's WP-1220 in patients with cutaneous T-cell lymphoma. Moleculin has completed the IND-enabling studies and plans to make an application to the Polish regulators soon. Read More
