News
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
FEATURED STORIES
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
THE LATEST
Under the merger announced Thursday, Tourmaline shareholders will own nearly 80% of the new company, which will retain its name and continue to focus on developing its anti-IL 6 antibody.
The government asked a federal judge to overturn a verdict in which a Delaware jury ruled in favor of Gilead, deciding that its preventative HIV drugs Truvada and Descovy did not infringe on its patents.
The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.
With no well-controlled data to support its efficacy, the FDA rejected Aldeyra’s methotrexate injection for primary vitreoretinal lymphoma.
Pieris Pharmaceuticals announced partner AstraZeneca’s decision to discontinue clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor, based on a non-clinical toxicology study.
The majority of ALS patients are excluded from clinical trials. Experts say using biomarkers and stratifying trial populations can expand eligibility and provide additional scientific insights.
On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The Huntington’s disease space saw a flurry of activity Wednesday as PTC and uniQure released data from their respective mid-phase trials.
Argenx’s Vyvgart will now be available in the U.S. as a more convenient subcutaneous formulation 18 months after its first approval.
The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.