LONDON – It was third time lucky for Acacia Pharma Group plc, as the FDA finally gave approval to Barhemsys (amisulpride) as a rescue treatment for surgical patients suffering postoperative nausea and vomiting (PONV), despite standard-of-care treatment. Read More
Rated the No. 1 most prepared country in the world to tackle an epidemic, the U.S. could see its preparedness put to the test as it responds to the growing COVID-19 outbreak. While the administration is pointing to that rating from a recent global survey to calm fears about the risk in the U.S., the coronavirus emergency is spotlighting cracks in the nation’s preparedness. Read More
LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time. Read More
BEIJING – There was encouraging news when vaccine developer Moderna Inc. announced this week it that has shipped the first vials of its mRNA vaccine against COVID-19 for a phase I trial in the U.S. The vaccine was created just 42 days after the genetic sequence of the COVID-19 virus was released. That is record speed. Other vaccine developers are also working around the clock to respond to the epidemic. Read More
During a recent investor event related to early drug development, Basel, Switzerland-based Roche Holding AG touted research by the firm’s Genentech unit into the cancer target known as TIGIT, or T-cell immunoreceptor with Ig and ITIM domains, and the pharma giant is hardly alone in the sizzling space. Read More
New York-based Kadmon Holdings Inc.’s recent oral late-breaker session on KD-025 in chronic graft-vs.-host disease (cGVHD) at the Transplantation & Cellular Therapy (TCT) meeting – along with data that rolled out from two studies testing competitor Jakafi (ruxolitinib) from Incyte Corp. – signaled potential advantages in the former’s candidate, already highly regarded. Read More
Aivita Biomedical Inc.’s CEO, Hans Keirstead, just finished up a $12.5 million fundraiser and he’s prepping for another $12.5 million in a second effort. In the two months since he started raising the money, he has hired four more people and plans to hire four more by year-end, bringing the company’s headcount to 36 employees. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Anokion, Brainstorm, Clene, Gilead, Incysus, Inflazome, Iteos, Mapkure, Neurimmune, Polypid. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Annovis, Ascletis, Atyr, Basilea, Boehringer, Can-Fite, Chromadex, Farmacore, Hikma, Glenmark, Innovation, Nervgen, PDS, Pfizer, Soligenix, Tetra, Trutino, Univo, Y-mabs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acacia, GSK, Harbour, Kirin, Lilly, Steba, Tessa, Ultragenyx, Y-mabs, Zogenix. Read More