As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks said the agency is ready to review the shots despite AI-related unknowns.
CureVac and GSK have been racing behind Moderna to try and get the first mRNA flu vaccine to market. But now the European partners have come up against the exact same problem as their U.S. competitor when it comes to the "historically challenging" B strains of influenza.
Explore cutting-edge NASH research with a novel NAFLD/NASH animal model mirroring patient experiences. Witness Resmetirom's impact on fat accumulation using human cell-based in vitro models. Expect clinical relevance, quick insights in 12-16 weeks, and cost savings. Register now!
Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.
Lindus Health has developed another full-service CRO package for a specific therapeutic area, this time geared toward clinical trials for drugs to treat respiratory diseases like COPD, asthma, and pulmonary hypertension.
Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. The FDA has approved Basilea’s Zevtera for three different kinds of infections.
This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode.
Navigating the complexities of the rapidly evolving landscape of cell therapy manufacturing poses significant challenges. Access this discussion on-demand to learn more about the top challenges cell therapy developers are facing. We explore the need for closed, automated, and flexible manufacturing workflows that are designed to de-risk the process for clinical and commercial success. View now.
This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation.
Presented by Blue Matter, strategic consultants in the life sciences
Choosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future.
