Novavax
FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children
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 Advances Cardiovascular Drug Pipeline with Recardio Partnership and FDA Engagement
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.
FDA Approves Novavax COVID-19 Vaccine with Restricted Use for High-Risk Groups
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.
FDA Demands Additional Trial for Novavax COVID-19 Vaccine, Delaying Full Approval
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 Opens $300 Million Cell Therapy Manufacturing Facility in Rockville, Maryland
• 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.
FDA Misses Review Deadline for GSK's Nucala COPD Expansion Amid Regulatory Delays
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.
Novavax and Takeda Strengthen Partnership with Improved Terms for COVID-19 Vaccine in Japan
Novavax has secured significantly improved financial terms in its amended collaboration agreement with Takeda for Nuvaxovid, including upfront payments, seasonal milestones, and ongoing royalties.
FDA Budget Cuts Linked to Drug Approval Delays as Small Biotech Faces PDUFA Postponement
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.
FDA Misses Deadline for Stealth Biotherapeutics' Rare Barth Syndrome Drug Elamipretide
The FDA has missed its April 29 deadline to decide on Stealth Biotherapeutics' elamipretide for Barth syndrome, with no new decision date announced yet.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
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.