After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. reported that they have a sufficient level of participation to move forward with a $5 billion nationwide settlement to resolve opioid-related claims and litigation by states, cities, counties and other government subdivisions in the U.S.
The U.S. is making strides in addressing the drug and device supply chain vulnerabilities revealed by the COVID-19 pandemic, but there’s still a lot of work to do to reduce dependance on sole source suppliers and foreign manufacturing, according to a new Health and Human Services (HHS) report.
Despite Reata Pharmaceuticals Inc.’s complete response letter (CRL) for bardoxolone in treating kidney function loss in those with Alport syndrome, the street treated the company well on Feb. 28. The stock (NASDAQ:RETA) rose 25.3% as the company decides how it wants to handle the CRL.
After a rejection by the FDA in June, it looks like Orphazyme A/S is headed for disappointment in Europe too with arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition in which fat builds in tissues and organs. The Copenhagen-based company said it was summoned before experts to give an “oral explanation” about the drug, something that only occurs if the European Medicines Agency’s CHMP has developed major doubts during its review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Chiesi, Mannkind, Orphazyme, Pfizer, Protalix, Rhythm, VBI.
PERTH, Australia – Biopharma stakeholders are furious about the consultation process the Australian government has pursued with its review of the country’s National Medicines Policy, and they are asking the government to hold off on making any changes until after the federal election that is scheduled for May.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Glaxosmithkline, Hightide, Sanofi.
RSS
