Onlookers may have had their doubts about the setup between Avalon Ventures and Glaxosmithkline plc (GSK) that led to last November's launch of Sitari Pharmaceuticals Inc. by way of $10 million in series A cash with a buyout option for GSK, and brought a promise of as many as 10 companies to be established the same way. Read More
Taurx Therapeutics Ltd. hit full enrollment in the second of two phase III trials of LMTX, the company's tau aggregation inhibitor (TAI) for the treatment of Alzheimer's disease. The multicenter, placebo-controlled trial will assess the therapy's efficacy in 700 subjects with mild Alzheimer's disease over as much as 21 months through both clinical assessments and brain imaging. Completion of both trials is expected in the first quarter of 2016. Read More
BOSTON – How to navigate the push-pull when pricing buyback options, handle pharma's "not-big-enough" complaints about pre-contract trials and manage the tension between venture capital and biotech management in forging deals: Such were among the topics taken up at BioPharm America, which opened Monday. Read More
Tracon Pharmaceuticals Inc. raised $27 million for its targeted cancer and ophthalmology therapies with a series B round that added New Enterprise Associates (NEA), Biomed Ventures and an undisclosed institutional investor to its global roster of investors, which include Jafco Co. Ltd., Switzerland's Nextech Invest Ltd., Brookline Investments, Arcus Ventures and Japan's BHP – all of whom also participated in the round. Read More
HONG KONG - Treatment with cholesterol-lowering statins has been shown to induce partial recovery of bone growth in mouse models of dwarfism, suggesting those agents could be useful for the medical treatment of infants and children with growth disorders such as achondroplasia and thanatophoric dysplasia. Read More
HONG KONG – China is gradually moving toward a new medicine distribution system where pharmacies and external retailers take over sales of prescription drugs from hospitals. The gradual change could ultimately eliminate "commissions" for doctors and hospitals. Read More
After a year of listening, the FDA is proposing four projects to reduce the burden of risk evaluation and mitigation strategies (REMS) on doctors, patients and pharmacies, but noticeably missing is any discussion of balancing the burden among drugmakers of a shared REMS. Read More
BOGOTA, Colombia – After years of heated debate, Colombian President Juan Manuel Santos and the Ministry of Health signed a decree establishing biotechnology regulations for the country's pharma industry. Read More
Novadel Pharma Inc., of Bridgewater, N.J., said it sold its Zolpimist new drug application (NDA) to specialty pharma company Amherst Pharmaceuticals LLC, of Basking Ridge, N.J. The transaction also includes patents and trademarks covered by a license agreement with ECR Pharmaceuticals Co. Inc., of Richmond, Va., for U.S. rights to Zolpimist as well as the license agreement itself. Read More
Threshold Pharmaceuticals Inc., of South San Francisco, said the independent data monitoring committee completed the planned interim efficacy and safety analyses of unblinded data for the firm's pivotal phase III trial of TH-302 in combination with doxorubicin vs. doxorubicin alone in patients with locally advanced unresectable or metastatic soft-tissue sarcoma. Read More
Merck KGaA, of Darmstadt, Germany, said it is acquiring St. Louis-based Sigma-Aldrich Corp. for $140 per share, valuing the company at about $17 billion. Read More