Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo. Read More
While BioWorld’s Drug Developers Index appeared to be moving in the right direction last month, it did an about-face in April and is now at its lowest point this year, down 23.1%, following the same trajectory as both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average. Read More
Antibiotics drugs discovery, Ursula Theuretzbacher told the audience at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), has more than one challenge to overcome. Read More
Backed by fresh phase III data showing a combination of the IDH1 gene inhibitor Tibsovo (ivosidenib) and azacitidine significantly improved event-free survival and overall survival for adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) vs. azacitidine alone, Cstone Pharmaceuticals Co. Ltd. is working to bring the treatment to Chinese AML patients “as soon as possible,” a spokesperson told BioWorld. Read More
In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning. Read More
Mitorx Therapeutics Ltd. is poised to develop small molecules that reverse impaired sulphide signaling underlying degenerative diseases ranging from Duchenne muscular dystrophy to Alzheimer’s disease. The company was formed some time ago as a spinout from Exeter University, where the founding scientist Matt Whiteman is professor of experimental therapeutics. It is showing its colors for the first time after closing a seed funding round. Read More
New hires and promotions in the biopharma industry, including: Adaptive Phage, Albert Labs, Bluesphere, Compass, Flare, Pharmabcine, Phathom, Progenity, Relief. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adge, Apeiron, Bioeclipse, Black, Cyan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ardelyx, Astrazeneca, Autolus, Langsheng, Merck & Co., Obseva, Priothera, Quoin, Roche, Sol-Gel, Sorrento, Valneva. Read More
