Here are the latest stories being discussed in biopharma today:
US lawmakers demand investigation of Chinese clinical research giants
Bipartisan lawmakers have called on the US government to investigate Chinese contract research and manufacturing firms, WuXi AppTec and WuXi Biologics, due to suspected ties with the Chinese military. The officials express concerns over the potential danger of confidential US biotech intellectual property being inadvertently transferred to China.
FDA approves Ipsen’s Onivyde for the treatment of pancreatic cancer
The FDA has approved Ipsen’s cancer drug Onivyde as the first-line treatment for a specific type of pancreatic cancer. The endorsement follows evidence from a trial comprising 770 patients, which revealed that Onivyde extended patients’ lives by two months longer than the current standard care.
Incyte optimistic over skin disease drug Opzelura after seeing Q4 prescription growth
Incyte has reported a 78% increase in Q4 sales of the skin disease drug Opzelura, attributing the strong performance to new customers, expanded payer coverage, and prescription fulfillments. The company expects the medication to be a major growth contributor in 2024.
FDA extends approval date for Rocket’s gene therapy
The FDA has deferred its decision on Rocket Pharmaceuticals’ gene therapy for a rare white blood cell disorder by three months to June 30. This will allow the regulatory authority more time to review the drug’s chemistry, manufacturing, and controls.
Organon discontinues ‘natural’ contraceptive development
Organon has made the decision to terminate early its Phase III trial for its once-rejected “natural” contraceptive, NOMAC-E2. The company linked the move to “business reasons” and emphasised that it had nothing to do with the drug’s safety.
Federal judge puts end to PhRMA’s lawsuit over drug price negotiations
A federal court in Texas has thrown out a suit brought by industry group PhRMA and other associations over the Inflation Reduction Act’s drug price negotiations, marking a notable success for the Biden administration. Despite this, the administration is facing around ten other lawsuits filed in various federal courts.