Moleculin Biotech Inc., of Houston, said it entered a definitive agreement with institutional investors for a registered direct offering of securities with gross proceeds of approximately $9 million. Read More
Alk-Abelló A/S, of Copenhagen, said that its partner Torii Pharmaceutical Co. Ltd., of Tokyo, gained approval from the Japanese Ministry of Health, Labour and Welfare to expand the use of Miticure, a sublingual allergy immunotherapy tablet, to include treating pediatric allergic rhinitis patients. Read More
Glenmark Pharmaceuticals Inc., of Paramus, N.J., presented findings from a phase IIa study of GBR 830, an investigational anti-OX40 monoclonal antibody that evaluated the safety, biological and clinical activity, and pharmacokinetics of GBR 830 in 64 patients with moderate-to-severe atopic dermatitis (AD). Read More
In their rapid division, cancer cells have some similarities to early development, and cells often have embryonic cell-like features. Researchers from Stanford University have shown that those parallels can be exploited to make autologous therapeutic vaccines from induced pluripotent stem cells (iPSCs). Read More
A new report published by Boston's Institute for Clinical and Economic Review (ICER) concludes that two pricey new CAR-T cell therapies, Novartis AG's Kymriah (tisagenlecleucel) and Gilead Sciences Inc.'s Yescarta (axicabtagene ciloleucel), both provided moderate certainty of a small to substantial net health benefit compared to commonly used chemotherapies or no therapy at all in their respective indications. Read More
A two-part webinar on drug pricing by sponsor USC-Brookings Schaeffer Initiative for Health Policy dragged somewhat during the first half, which dealt with the subject of whether and in what ways to retool Medicare Part D. But the livelier second half – on strategies to reduce cost sharing for commercially insured patients – included a talk by Fiona Scott Morton, professor of economics at the Yale School of Management, who raised some eyebrows on the panel. Read More
Shares of Apricus Biosciences Inc. plunged 70 percent Friday on word that the FDA issued another complete response letter (CRL) for the resubmitted new drug application (NDA) of Vitaros (alprostadil, DDAIP.HCl) to treat erectile dysfunction (ED). In late 2016, the San Diego-based company was hopeful that it had found a road forward in the U.S. for Vitaros – approved in Canada and in certain countries in Europe, Latin America and the Middle East – by resolving issues in the CRL dating back to 2008. Read More
AUSTIN, Texas – Roswell Park Cancer Center is about to form a 50:50 joint venture (JV) with Cuba's Center for Molecular Immunology (CIM) to commercialize cancer vaccines developed by CIM. Read More
To some observers, Vertex Pharmaceuticals Inc. would seem to have the cystic fibrosis (CF) market wrapped up. With Kalydeco (ivacaftor) and Orkambi (lumacaftor/ivacaftor) already market-leading CF drugs, the Boston-based firm wowed investors and analysts this month with prospects for next-generation correctors, VX-659 and VX-445, which are moving into phase III development as part of separate triple-combination regimens. Read More
