Curis Inc., of Lexington, Mass., re-initiated dosing in the phase I single-agent trial of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphomas. CUDC-427 is an oral small molecule that is designed to promote cancer cell death by antagonizing an inhibitor of apoptosis proteins that support survival of cancer cells. (See BioWorld Today, Nov. 7, 2013.) Read More
Novavax Inc., of Gaithersburg, Md., said it plans to raise $100 million in a new public offering. Proceeds from the offering will be used for the advancement of its clinical-stage vaccine candidates, research, manufacturing and process development activities, capital expenditures and other strategic purposes. Read More
Ranbaxy Laboratories Ltd., of Mumbai, India, said European regulators finalized assessment of reports of noncompliance with GMP at the firm's manufacturing site in Toansa, India, which led to the suspension of the GMP certificate in the European Union in January, and said, while there were a number of deficiencies at the concerned site, assessment of all available information reassured regulators that there has been no risk to public health. Read More
Momenta Pharmaceuticals Inc., of Cambridge, Mass., said candidate necuparanib (formerly M402) received orphan drug designation from the FDA for treating pancreatic cancer. The company is testing the drug, a heparan sulfate mimetic, in a phase I/II study in combination with Abraxane (nab-paclitaxel, Celgene Corp.) and gemcitabine and anticipates reporting results from the first portion of the study and advancing into the phase II portion in the second half of this year. Read More
Entrepreneur Shankar Musunuri's newest venture, Ocugen Inc., is jumping into the race to develop a treatment for the rare disease retinitis pigmentosa (RP) and another therapy for wet age-related macular degeneration (AMD), with two preclinical biologics exclusively licensed from the University of Colorado. Read More
New studies this week gave new insights into the molecular mechanisms behind Parkinson's disease, and possibly mitochondrial disorders more generally, that could help develop treatments for the disorder. Read More
HONG KONG – Over the next decade, competition for market share between biosimilar products and their originator drugs is likely to grow fierce, but price differentiation may not be enough to ensure sales. Read More
TOKYO - Japan's drug approval process has come a long way, marking a shift in the mindset at Japan's Pharmaceuticals and Medical Device Agency (PMDA). Read More
HONG KONG – Despite all the talk of the bright future of China's biotech industry, the sector in this huge country remains in its infancy. Challenges in areas like funding and regulatory procedures have to be taken into account before stepping into the market, said investors at the Asia Biotech Invest conference. Read More
Edge Therapeutics Inc. could cut to the front of the line in aneurysmal subarachnoid hemorrhage (aSAH) therapy with its polymeric microparticle form of the calcium channel blocker nimodipine, EG-1962, advancing into the second cohort of a phase I/II trial. Read More
