Crescita Therapeutics Inc., of Mississauga, Ontario, signed an exclusive license agreement with a U.S.-based dermatological contract research company to develop prescription treatments of skin diseases using Crescita's patented Multiplexed Molecular Penetration Enhancer technology. Read More
Syntimmune Inc., of New York, said research findings for SYNT002 – the company's second most advanced pipeline program and lead monoclonal antibody therapy targeting albumin-FcRn interactions – demonstrate that inhibition of FcRn (neonatal Fc receptor) provides protection against toxin-induced liver injury and causes removal of toxins from circulation via a newly described mechanism that is engaged by SYNT002. Read More
Axsome Therapeutics Inc., of New York, said it priced its underwritten public offering of 3.74 million shares of its common stock at $3.74 each for gross proceeds of approximately $14 million. Read More
HONG KONG – The CFDA has issued a new rule that cuts the timing and pricing gaps between overseas and domestic drug launches, which is likely to improve access to innovative drugs for patients and accelerate drugmakers' strategies in China. Read More
LONDON – Pediatric medicines specialist Advicenne SA closed a €16 million (US$17.3 million) round, providing the means to complete phase III development of ADV7103 for treating renal tubulopathy and to register ADV6209, a child-friendly formulation of benzodiazepine. Read More
PERTH, Australia – Australian cell therapy developer Mesoblast Ltd. is moving to phase III trials with its allogeneic mesenchymal precursor cell therapy to treat chronic low back pain due to intervertebral disc degeneration. Read More
BARCELONA, Spain – With drug pricing in the political crosshairs and the first gene therapies advancing toward the market, the health care sector will have to figure how to put a price tag on therapies that provide durable, curative responses. Read More
BARCELONA, Spain – Biotechnology is more globalized than ever but is also, in certain respects, hyper-localized. That was the contradictory but, at the same time, defensible conclusion one could draw from a panel discussion titled "Stirring the Entrepreneurial Pot in Europe" here at the BIO-Europe Spring meeting. Read More
Defending his decision to go ahead with a U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing Tuesday on the next renditions of the FDA drug and device user fee agreements, Sen. Lamar Alexander (R-Tenn.) stressed the importance of getting the agreements signed into law quickly. Read More
With Pfizer Inc.'s oxycodone Troxyca ER still unlaunched after approval last summer and Collegium Pharmaceutical Inc. hammering away for market share with April-cleared Xtampza ER, the quest for a better abuse-resistant, extended-release oxycodone goes on, as does Purdue Pharma LP, selling Oxycontin in the $2.5 billion pain market. Read More
Italy's Newron Pharmaceuticals SpA has gained FDA approval to market its Parkinson's disease (PD) drug, Xadago (safinamide), for patients who are currently taking levodopa/carbidopa and experiencing "off" episodes, or periods in which their medications are not working well, causing an increase in PD symptoms. Read More
