Here are the latest stories being discussed in biopharma today:
1. Novo Nordisk Secures Early Victories in Legal Battle with Compounding Pharmacies, Wellness Centers
Novo Nordisk has recorded initial victories in its legal crusade against compounding pharmacies and wellness centers that are allegedly misusing its trademark to sell unapproved versions of its diabetes and weight loss drugs. Two Miami and Tallahassee courts have blocked two Florida wellness centers from associating semaglutide with their compound drugs. Novo Nordisk has pressed charges against several pharmacies and centers across various states, accusing them of potentially misguiding customers into thinking they’re purchasing its original products.
2. Regulators in the US and EU Offer Simultaneous Scientific Advice to Generic Drug Makers
For the first time, the FDA and Europe’s EMA are offering concurrent scientific advice to generic drug manufacturers as part of a pilot project. The co-advise initiative aims to help manufacturers streamline the development of complex generic drugs, particularly those in the early stages, and minimize redundancies.
3. Chinese API Manufacturer Receives FDA’s ‘Official Action Indicated’
Sichuan Friendly Pharmaceutical, a manufacturer of active pharmaceutical ingredients (API) in China, has received an Official Action Indicated (OAI) classification from the FDA after an inspection found numerous quality control and batch discrepancy issues. The organization has been flagged for poor recordkeeping, with one team leader admitting she kept some data results “in her mind.”
4. FDA Finalizes Rule on Master Files in Biologics Applications
The FDA has confirmed its existing approach of using master files in Biologics License Applications (BLAs) that contain product-specific information. The rule allows sponsors to continue using this information to help avoid wrecking drug production, potentially leading to shortages.
5. AstraZeneca Partners with NHL to Promote Cancer Screenings
AstraZeneca has expanded its “Hockey Fights Cancer” initiative with the National Hockey League (NHL) after a survey showed significant gaps in public awareness of preventive cancer screenings. The pharma giant has launched its “Get Body Checked Against Cancer” campaign to encourage early screening for cancer.
6. Synthetic Biology Firms Close Shop After Disappointing Pivotal Data
Synlogic Inc. is shutting down its operations and laying off over 90% of its staff after top-line data from a Phase III trial indicated disappointing results. The U.S. biotech devoted to harnessing synthetic biology for new therapies will retain a small team to help wind down the study and explore potential strategic alternatives.
