“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced Aug. 15 for the 10 drugs selected for the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector. Read More
Wall Street promptly started speculating about the product’s odds in the graft-vs.-host disease (GVHD) marketplace shortly after Syndax Pharmaceuticals Inc. and Incyte Corp. scored U.S. FDA approval – well ahead of the Aug. 29 PDUFA date – of Niktimvo (axatilimab), an anti-CSF-1R antibody for the treatment of chronic disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.). Read More
As mpox has now been found in the EU, the race for an effective vaccine has accelerated, with a study failure but increased vaccine production from Europe. The U.S. NIH just released top-line results from a preliminary analysis of a placebo-controlled study of Siga Technologies Inc.’s antiviral, tecovirimat, showing it missed the primary endpoint of statistically significant improvement within 28 days post-randomization in time to lesion resolution for patients in the Democratic Republic of the Congo. Read More
In the wake of shortages for Novo Nordisk A/S’ Ozempic (semaglutide), Australia’s Therapeutic Goods Administration has announced that Wegovy, which has the same active ingredient, is now available in Australia and is advising prescribers to stop prescribing Ozempic off-label for weight loss. Read More
In response to the continuing opioid epidemic, researchers at the Massachusetts Institute of Technology and Brigham and Women’s Hospital developed a small implantable device that monitors heart rate, respiration and other vital signs indicative of an overdose, then automatically releases a dose of naloxone. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Genprex, Kezar, Monopar, Prota, Sellas, Verrica, Viracta. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bavarian Nordic, Evotec, Galera, Kezar, Oragenics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Astrazeneca, Atsena, Bavarian Nordic, Bioarctic, Eisai, Kiromic, Urogen, Veralox. Read More
