Top Biopharma News for 05/22/2024


Here are the latest stories being discussed in biopharma today:


Key Industry News

Pfizer Announces $1.5 Billion in Cost Cuts with More Expected

In a move to streamline operations, Pfizer has revealed plans for an additional $1.5 billion in cost cuts. These cuts are part of a broader, multi-phase savings strategy initiated earlier this year, aiming at operational efficiencies, network structure changes, and product portfolio enhancements. Pfizer’s spokesperson emphasized the focus would be on streamlining work processes and increasing productivity within Pfizer Global Supply. The company indicates that even more reductions are likely in the future.

Merck KGaA Invests $600 Million to Expand Viral Vector Manufacturing

Merck KGaA has committed $600 million to acquire Mirus Bio, a startup known for developing transfection reagents essential for viral cell and gene therapies. Merck KGaA plans to integrate Mirus Bio’s technology with its own bioprocessing capabilities to enhance viral vector development and manufacturing. This acquisition aligns with Merck’s broader strategy to bolster its regional manufacturing capabilities, including ongoing investments in South Korea.

FDA Raises Concerns Over Hypoglycemia with Novo Nordisk’s Weekly Insulin

The FDA has flagged concerns regarding the increased risk of hypoglycemia associated with Novo Nordisk’s experimental once-weekly insulin, icodec. These concerns were highlighted ahead of an upcoming advisory committee meeting. Regulatory documents revealed higher hypoglycemia rates in patients treated with insulin icodec compared to those on daily insulin degludec (Tresiba). The advisory committee will vote on whether the benefits of insulin icodec outweigh its risks in managing glycemic control for adults with type 1 diabetes.

House Committee Challenges FDA on Domestic Manufacturing and LDTs

The House Energy & Commerce subcommittee on health engaged FDA center directors in discussions about domestic drug manufacturing and lab-developed tests (LDTs). Committee Chair Cathy McMorris Rodgers expressed concerns that FDA policies hinder domestic manufacturing growth. The FDA’s drug center director Patrizia Cavazzoni acknowledged the need for greater supply chain resilience and emphasized the agency’s willingness to collaborate with Congress to address these issues.

Federal Appeals Court Favors Drugmakers on 340B Program Limitations

A federal appeals court ruled in favor of drugmakers, allowing them to set contractual limits on the distribution of discounted drugs under the 340B program. This ruling supports drug manufacturers’ right to impose conditions, such as limiting the number of pharmacies to which they will ship discounted drugs. This decision comes amid allegations that some health systems have been exploiting the program.

AGC Biologics and BioConnection Form Partnership as WuXi Alternative

AGC Biologics and BioConnection have announced a partnership to offer clinical-stage manufacturing services for gene therapies, presenting themselves as a viable alternative to WuXi Biologics. This collaboration will provide end-to-end solutions for biopharma companies seeking service providers outside of China. AGC Bio will handle protein-based biologic development and production, while BioConnection will manage aseptic vial and syringe filling.