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FEATURED STORIES
Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
THE LATEST
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had deficiencies.
Cell and gene therapy investment rebounds; WuXi Biologics and other companies named in BIOSECURE Act mull options; Bayer, J&J and Pfizer’s recent layoffs; updates from the weight loss space.
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data.
Big Pharma can’t seem to get enough radiopharmaceutical biotechs. With Lilly, Sanofi and BMS chasing Novartis into the complex space, all eyes are on these specialty biotechs.
On the heels of Keytruda’s success in a Phase III perioperative trial for a disease where it had previously failed to improve event-free survival, Merck touts an I&I deal with UK biotech Mestag.
WuXi AppTec looks to unload its Philadelphia manufacturing sites and WuXi Biologics slows its rapid expansion in the U.S. as the companies await the Senate’s review of the BIOSECURE Act that threatens to cut them off from U.S. biopharma.
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year.
Tim Hunt, CEO of the Alliance for Regenerative Medicine, said Monday at the 2024 Cell & Gene Meeting on the Mesa that investments reached $10.9 billion in the first half of this year—outpacing 2019’s $9.8 billion total—but far below the pandemic peak.
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.