News & Articles

Biopharmaceuticals come in many modalities with varied shapes and sizes, and the manufacturing processes can vary considerably in complexity as a result. They can range from antibodies to antibody drug conjugates, cell and gene therapies, vaccines, live biotherapeutic products, enzymes and many more. Despite this, the overarching regulatory requirements remain the same and therefore, so do the concepts of the control strategy put in place.

The US Food and Drug Administration’s (FDA’s) February 2026 announcement, made public in the New England Journal of Medicine (NEJM), outlines that one adequate and well-controlled pivotal study, together with confirmatory evidence, will now be the agency’s default basis for product approval. This differs from the FDA’s previous general expectation of two independent, adequate, and well-controlled pivotal trials to demonstrate substantial evidence of effectiveness.

A regulatory starting material is a chemical compound that marks the point in the synthesis of an active pharmaceutical ingredient (API) where current Good Manufacturing Practices (cGMP) begin. It is formally designated in regulatory submissions and must be scientifically justified based on its impact on the quality and safety of the final drug product. 

FDA’s Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) program was established in 2012 as a financial incentive to encourage the development of therapeutics for rare pediatric diseases. The program officially ended as of September 30, 2024 due to a sunset clause. 

On December 15, 2025, the FDA published the final guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices  Dr. Makary said that the FDA is, “removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster.”

An overview of the key regulatory intelligence updates from FDA & EMA released in 2025.

FDA’s draft guidance streamlines biosimilar approval by reducing the need for comparative efficacy studies (CES). The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway.

This November, Scendea had the pleasure of attending BIO-Europe Autumn 2025 in Vienna, Austria. The focus of BIO-Europe Autumn 2025 was gene therapy, precision medicine, funding strategies and challenges across the industry. 

When market protection ends, it triggers a shift in the competitive landscape for a product and often has a significant effect on the originator company which can see an overnight loss in revenue and potential biosimilar manufacturers. There are generally two types of market protection.

The 8^th annual symposium for Life Science Innovation and Development was a day packed with timely topics for small and emerging biotech companies. As the welcome meeting highlighted, “With private investment still stalled and changes in federal funding along with tariffs and job reductions, the challenges for the industry have never been more serious”. 

A prefilled syringe (PFS) is a disposable syringe that comes preloaded with a specific dose of medication, ready for injection. This design simplifies the process of administering injectable drugs, as it eliminates the need to draw medication from a vial into a syringe before use.

Biotech companies, who are looking to secure investment to enable development of their medicinal products, must navigate a competitive funding landscape while optimizing their fundraising strategies. To de-risk and support fundraising strategies globally it’s imperative that product development and regulatory strategy are carefully considered and enacted upon.