On Thursday, Cempra Inc. disclosed a successful end-of-Phase II meeting with the FDA, citing only the need for additional funding to proceed with the planned Phase III trial testing intravenous (I.V.)-to-oral administration of macrolide antibiotic solithromycin in community-acquired bacterial pneumonia (CABP). Read More
Conatus Pharmaceuticals Inc., which has quietly labored on liver drug emricasan (IDN-6556) since gaining global rights to the asset in its 2010 acquisition of Pfizer Inc. spin-out Idun Pharmaceuticals Inc., became the latest biotech to register with the SEC for an initial public offering (IPO). Read More
When Trevor Baglin, a hematologist at Addenbrooke's Hospital at Cambridge University had a head injury patient with a much better-than-expected outcome, he did something unusual. He got very curious. Read More
Valneva SE priced its previously flagged and fully underwritten €40 million (US$53.3 million) rights issue at €2.65 per share, a steep discount on the company's prevailing share price of €4.61 immediately prior to the final pricing decision. Read More
Mast Therapeutics Inc.'s $22.9 million from a public offering will fund the second Phase III trial with the sickle cell disease candidate MST-188, a purified form of a nonionic, triblock copolymer (poloxamer 188) that was first developed for the treatment of heart attacks. Read More
SHANGHAI, China – A licensing agreement may help troubled Israeli Biolinerx Ltd. get a toehold in China with its hepatitis C virus (HCV) treatment BL-8030. Read More
• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said a preclinical study of its influenza DNA vaccine against the newly emergent virulent H7N9 flu virus showed that the vaccine achieved immune response levels exceeding what are considered protective levels in other common influenza subtypes. Read More
• Updated results of a Phase I/II study of daratumumab in heavily pretreated patients with multiple myeloma show that it is well tolerated and 31 percent of patients have achieved a response at the 2 mg/kg dose, and 67 percent in dose cohorts above 4 mg/kg achieving response. Daratumumab is a product in development by Genmab A/S, of Copenhagen, Denmark. Read More
• Bristol-Myers Squibb Co. (BMS), of New York, and Simcere Pharmaceutical Group, of Nanjing, China, expanded their strategic relationship formed in 2010. Read More
• Eli Lilly and Co., of Indianapolis, stopped its Phase II study (BACC) for LY2886721, a beta secretase inhibitor being investigated as a once-daily treatment for its potential to slow the progression of Alzheimer's disease. Read More
Scientists at the University of California at Santa Barbara and Sanford-Burnham Medical Research Institute have demonstrated that changing the shape of nanoparticles can affect their targeting to certain cell types. Read More