U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
The U.S. Supreme Court's landmark decision in the case of Loper Bright continues to reverberate across the legal landscape, including in the realm of False Claims Act litigation.
The U.S. FDA urged doctors and patients to use CT imaging if possible, when the MRI compatibility of any electronic implanted devices is unknown because problems with CT imaging are "extremely low" in these circumstances.
Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The U.S. SEC filed insider trading charges against Ruimin Xie, the former director of analytical development at Bellus Health Inc., for allegedly receiving ill-gotten gains of $59,408.42 by acting on word of a potential acquisition by GSK plc.
With fresh phase II ovarian cancer data in hand, Verastem Oncology Inc. plans to file an NDA by the end of the month for its avutometinib and defactinib combination treatment. The NDA will be for adults who have recurrent KRAS mutant recurrent low-grade serous ovarian cancer, a direction that may have caused the stock to wilt.
The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
RSS
