Here are the latest stories being discussed in biopharma today:
1. FDA Advisors Support Use of Minimal Residual Disease for Myeloma Trials
FDA advisors have backed the use of minimal residual disease (MRD) as a new interim endpoint for accelerated approvals in multiple myeloma. This could expedite the timelines for cancer drugs, potentially cutting years off development stages. The increase in treatment options for multiple myeloma patients has made it more challenging to evaluate new drug success, say the FDA.
2. No Link Found Between Semaglutide and Suicidal Thoughts – EMA
The European Medicines Agency (EMA) has ended its probe into semaglutide after finding no link between the drug and suicidal tendencies. This echoes a similar conclusion reached by the FDA last year. Manufactured by Novo Nordisk, semaglutide is not currently set to face any changes to its safety labeling.
3. Recipharm’s New CEO Ramps Up Changes, Eyes GLP-1 and Biologics Manufacturing
Greg Behar, the new CEO of Recipharm, is swiftly enacting changes to the company’s structure and focus. The company recently divested seven manufacturing sites and announced plans to spin out its inhaler business.
4. GoHealth Trims Jobs Across Departments
Health insurance broker GoHealth cut 69 jobs across various departments last month. From a total workforce of approximately 2,500, the layoffs represent a significant reduction, affecting employees across different teams. GoHealth didn’t respond to requests for comment.
5. Illumina Granted EU Approval for Grail Divestment
Illumina has received approval from the European Commission for its divestment plan for Grail, its cancer diagnostic subsidiary. The company is still exploring various divestment strategies which include a potential sale or capital market transaction.
6. Adaptimmune Loses Genentech Deal Worth Potential $3B
Pharmaceutical giant Genentech, a subsidiary of Roche, has terminated its collaboration with Adaptimmune. The off-the-shelf T-cell therapies partnership was worth an estimated $3 billion in downstream payments.
7. Japanese Pharmaceutical Regulations being Reviewed
In other news, Japanese pharmaceutical regulations are under review to address persistent drug shortages and guarantee stable supplies. Further details are still awaited.
