News
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.
FEATURED STORIES
Eli Lilly and Regeneron are leading the push to treat congenital deafness with gene therapies, seeking a piece of a potential billion-dollar market and banking on local delivery and the small amount of drug required to overcome key safety concerns.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
As Congress debates renewing the Act for ALS, it must prepare for the coming era of precision ALS medicine by prioritizing early-stage research to more quickly bring effective treatments to the market.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
THE LATEST
Total assets under management for Novo Holdings, Novo Nordisk’s controlling shareholder, fell by more than one-third last year. The report caps off a tumultuous year for the Novo group of companies.
Combining tirzepatide with vitamin B12, a common additive in compounded versions of the drug, yields an impurity that could alter the drug’s toxicity profile and pose safety risks to patients, the company said in an open letter.
Data from BridgeBio Pharma’s Phase 3 FORTIFY study show that BBP-418 significantly increases levels of a key disease biomarker that helps stabilize muscles in patients with limb-girdle muscular dystrophy.
Data presented at the 2026 Muscular Dystrophy Association meeting could have readthroughs to companies developing therapies for spinal muscular atrophy, Duchenne muscular dystrophy and Becker muscular dystrophy.
The chief executives of AbbVie and Johnson & Johnson are now among the highest-paid pharma leaders after pay bumps pushed their 2025 compensations past $30 million.
In this episode of Denatured, you’ll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA’s latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.
Last month, for the first time in nearly four years, average job postings live on BioSpace did not decline year over year. In another encouraging sign, the number of biopharmas letting employees go fell.
Looking for a biopharma job in Cambridge? Check out the BioSpace list of six companies hiring life sciences professionals like you.
Orforglipron, Eli Lilly’s oral obesity drug, is under FDA review with a decision expected in April. The pharma has also filed for marketing authorization for the pill in China.
Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.