An international task force launched in March to identify new approaches for analyzing and addressing competitive concerns arising from biopharma M&As is now seeking public comment to inform their review.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alume, Biocryst, Cstone, Endogena, Evofem, Fulcrum, Northwest, Wake Network.
Beigene Ltd.’s PARP inhibitor, pamiparib, won conditional approval from China’s National Medical Products Administration for treating patients with germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
The 2021 Special 301 Report recently released by the U.S. Trade Representative is mostly déjà vu for the 32 countries included on the Priority Watch and Watch Lists, as all of them have appeared before on the lists that call out U.S. trading partners for unfair IP practices that disadvantage foreign companies.
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
Since joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2017, China has approved clinical trials and marketing of drugs a lot faster with simultaneous clinical development at home and abroad.
Avenda Health Inc. has taken a page out of the breast cancer book with a new technology that offers very localized treatment of prostate tumors in a procedure the company refers to as a prostate cancer lumpectomy. The FDA granted breakthrough device designation to the product based on its potential to transform care for one of the most common cancers.
The controversy over the use of ethylene oxide (EtO) is back in play, thanks to a May 5 letter from the Office of Inspector General at the Environmental Protection Agency to the EPA. The letter recommends that the agency revisit its work on determining the status of EtO based on new data, data that may lead to more restricted use of EtO to sterilize medical devices.
RSS
