News
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
FEATURED STORIES
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
THE LATEST
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.
The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO of Zymeworks and Josh Smiley, president and COO of Zai Lab, about how renewed confidence is driving biotech entering 2026.
The money replaces a small portion of a contract Moderna lost when the Department of Health and Human Services canceled $760 million in backing to develop the vaccine, called mRNA-1018.
Participants in a Phase III trial who switched to Eli Lilly’s orforglipron after 72 weeks of treatment with Wegovy or Zepbound largely maintained their weight loss for up to a year.
The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news.
Novartis has discontinued two undisclosed programs under its current partership with Voyager, the biotech announced last month. Projects under the deal for spinal muscular atrophy and Huntington’s disease continue to advance.
The Massachusetts biotech will also be eligible to milestone payments, though the exact amount has yet to be disclosed.
If you’re looking for a biopharma job in Philadelphia, here are eight companies on BioSpace hiring right now.
Clarity on employment terms is essential to protect careers. In this column, Kaye/Bassman’s Michael Pietrack speaks to employment attorney Howard Matalon, JD, partner at OlenderFeldman, on how to evaluate the fine print of an employment agreement.