Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022. Read More
After a six-month long trial, a jury found Teva Pharmaceuticals USA Inc., a subsidiary of Jerusalem-based Teva Pharmaceutical Industries Ltd., liable in contributing to New York state’s opioid crisis that saw thousands die. Read More
Nurix Therapeutics Inc.’s Dec. 12 disclosure that the U.K. Medicines & Healthcare products Regulatory Agency granted to clearance for the company to kick off a phase I study with Bruton tyrosine kinase (BTK) inhibitor NX-5948 pumped more juice into the space, which has been consistently intriguing since the first drug in the class was approved about eight years ago by the FDA. The San Francisco-based firm will start an experiment in patients with relapsed and refractory B-cell malignancies at clinical sites in the U.K., with dosing of the first subject expected in the first half of 2022. Read More
In what is undeniably one of the busiest years for governmental agencies across the globe, 2021 churned out a 12% increase in regulatory news over the previous record year of 2020. Read More
Pfizer Inc.'s oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Great Britain after the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorization for the medicine, called Paxlovid (PF-07321332, ritonavir). Read More
Every year, the BioWorld team takes time to look back and assess the market-moving and life-changing stories and trends of the year. Without a doubt, COVID-19 shook humanity to the core, again. And like glioblastoma, the tentacles of COVID-19 invaded far beyond the obvious and ultimately changed the world. So that’s our top story of the year. But the biopharmaceutical industry is resilient and responsive. Even though there were tectonic shifts in efforts to bring an armamentarium of COVID-19 vaccines and therapeutics to patients with record-breaking speed, work continued on other fronts. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lexicon, Mesoblast, Xeris. Read More
