Novavax

The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups.

Kancera AB has partnered with US biotech Recardio Inc. to create a cardiovascular disease-focused specialty care company, with Recardio licensing candidate drugs KAND567 and KAND145.

• The FDA has granted full approval for Novavax's protein-based COVID-19 vaccine, but with unusual restrictions limiting its use to adults 65 and older or those 12-64 with health risk factors. • Novavax's vaccine represents the only traditional protein-based coronavirus vaccine option in the US market, previously available under emergency authorization for anyone 12 and older. • The restricted approval comes amid shifting vaccine policies under the Trump administration, with the FDA requiring Novavax to conduct additional post-approval studies on potential heart conditions and benefits for certain age groups.

The FDA has requested an additional clinical trial for Novavax's protein-based COVID-19 vaccine (NVX-CoV2601) before granting full approval, despite promising Phase 2/3 results showing a 5.8-fold increase in neutralizing antibodies.

• AstraZeneca has inaugurated a new $300 million cell therapy manufacturing facility in Rockville, Maryland, designed to produce CAR-T cell therapies for cancer treatment and create over 150 specialized jobs. • The 84,000-square-foot facility is part of AstraZeneca's broader $3.5 billion investment in U.S. research and manufacturing, strengthening Montgomery County's position as a leading bio-life sciences hub. • The project received combined support of $600,000 from Montgomery County and Maryland state agencies, along with job creation tax credits and expedited permitting to accelerate the facility's completion.

• The FDA has missed its May 7 target decision date for GSK's application to expand Nucala (IL-5 blocker) for use in chronic obstructive pulmonary disease. • GSK confirmed the delay but remains optimistic, stating they are "working closely" with the FDA and "continue to expect approval" based on recent discussions with regulators. • This incident adds to a pattern of FDA regulatory delays, including missed deadlines for Novavax's COVID-19 vaccine and Stealth BioTherapeutics' elamipretide, amid reports of significant staff reductions at the agency.

• Novavax has secured significantly improved financial terms in its amended collaboration agreement with Takeda for Nuvaxovid, including upfront payments, seasonal milestones, and ongoing royalties. • The strengthened partnership ensures continued availability of Nuvaxovid, a protein-based non-mRNA COVID-19 vaccine, in Japan's pharmaceutical market, the third largest globally. • This agreement validates Novavax's technology platform featuring protein-based nanoparticles and proprietary Matrix-M adjuvant, supporting the company's strategy to become a preferred partner through strategic collaborations.

• Recent government efficiency cuts at the FDA appear to be causing delays in drug approval timelines, with 66% of healthcare professionals surveyed expressing concern about potential PDUFA date postponements. • Stealth BioTherapeutics' treatment for rare Barth syndrome, elamipretide, has experienced an unexplained decision delay, with no typical safety or manufacturing concerns cited as reasons for the postponement. • Industry experts warn that while widespread disruption isn't yet evident, continued FDA resource constraints could significantly impact clinical trial oversight and create approval backlogs lasting years.

The FDA has missed its April 29 deadline to decide on Stealth Biotherapeutics' elamipretide for Barth syndrome, with no new decision date announced yet.

The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.