Daiichi Sankyo Co. Ltd., of Tokyo, enrolled the first patients in large-scale, multinational clinical programs evaluating the safety and efficacy of investigational mirogabalin (DS-5565), the first preferentially selective alpha-2 delta ligand. Read More
CSL Behring, of King of Prussia, Pa., said the FDA has accepted its biologics license application for review for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Read More
Ironwood Pharmaceuticals Inc., of Cambridge, Mass., said top-line data from an exploratory, 93-patient phase IIa trial indicated that IW-3718, a gastric retentive formulation of a bile acid sequestrant, improved heartburn and certain other symptoms associated with refractory gastroesophageal reflux disease (GERD). Read More
QR Pharma Inc., of Berwyn, Pa., said it signed a new collaborative research agreement with Rockefeller University aimed at developing a treatment for Huntington's disease (HD). Read More
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said it priced its underwritten public offering of 10 million shares of its common stock at an offering price of $3.25 per share. Read More
TOKYO – Thanks to a series of policy initiatives, Japan's Pharmaceutical and Medical Device Agency (PMDA) has morphed into a much more nimble regulator, one that processes approvals as fast as the FDA or the EMA. Read More
LONDON – International funding bodies are called on to set up a dedicated fund to support the development of new antibiotics, in the second report from the independent commission established by the UK government in July 2014 to draw up a global plan to tackle antimicrobial resistance. Read More
HONG KONG – Looking to position itself as the biggest player in the rapidly growing traditional Chinese medicine (TCM) market in China, the TCM arm of Chinese state-owned Sinopharm Group is planning on a $1.3 billion acquisition of an industry rival and the sale of a biotech subsidiary to channel resources to the development of its TCM business, a move that will help consolidate the market. Read More
DUBLIN – Europe's bright start to the year continued, with two firms taking in more than €77 million (US$88.2 million) in oversubscribed public offerings on the Euronext Exchange Wednesday. Cell therapy developer Bone Therapeutics SA raised €32.2 million in an upsized IPO, while vaccines firm Valneva SE took in more than €45 million in a discounted follow-on offering, to fund its acquisition of the Dukoral oral vaccine against cholera and travelers' diarrhea. Read More
On the heels of a report that examined what is and isn't working at the FDA and the National Institutes of Health (NIH), the Senate Health, Education, Labor and Pensions (HELP) Committee is launching a bipartisan Innovation for Healthier Americans Initiative to examine the process for getting new cures to patients. Read More
HYDERABAD, India – India may have a proven track record developing generics, but it is limping far behind other countries in the discovery and development of new drugs, areas which call for entirely new skill sets and investments. Read More
What was described last week by Roche Holding AG CEO Severin Schwan as a "chance for readouts" this year with anti-CD20 therapy Gazyva (obinutuzumab) came to pass in a big way, as Roche unit Genentech scored a phase III win in the indolent form of non-Hodgkin's lymphoma (NHL), a slow-growing type of the disease in which patients are prone to multiple relapses. Read More
