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
Following last month’s $7.8 billion purchase of CAR T biotech Arcellx, Gilead’s dealmaking train chugs along with yet another acquisition—this time securing Ouro Medicines’ pipeline of T cell engagers for inflammatory diseases.
The biotech industry needs to stop waiting for a rebound. The pandemic changed everything, though not in the ways most people think.
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Healthcare investor Kevin Tang and his allies now hold almost every leadership position at Aurinia Pharmaceuticals, the company at the heart of former CDER Director George Tidmarsh’s exit from the FDA.
The multivalent candidate, being developed by Pfizer and French partner Valneva under a 2020 pact, generated higher than 73% efficacy against the tick-borne disease in a Phase 3 trial—but failed to hit a predetermined confidence interval.
Kali Therapeutics’ T cell engager, for which Sanofi is initially paying $180 million, could potentially be developed for a range of B cell–driven autoimmune disorders.
The FDA detected 14 cases of vitamin B6 deficiency–linked seizures and two deaths in patients with Parkinson’s disease taking carbidopa/levodopa drugs. Both AbbVie and Novartis market levodopa-based products.
Earendil Labs’ AI-centered platform has produced more than 40 programs, including anti-inflammatory assets that have attracted a pair of partnership agreements with Sanofi.
Oryon Cell Therapies’ lead cell therapy is an autologous treatment designed to replace dopaminergic neurons in patients with Parkinson’s disease. Phase 1b/2a data showed that the asset can improve motor function and mobility in patients.
Longevity is a long-standing buzzword in life sciences, but it now has staying power. The smart trajectory is to stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly target specific, age-related diseases, according to two investors in a discussion with BioSpace.