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Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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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.
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The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings.
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
Neurocrine Biosciences’ potential competitor to Bristol Myers Squibb’s KarXT improved symptoms of schizophrenia in a Phase II trial, but only at the low dose tested.
Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition.
Genentech’s latest layoffs are the second round of workforce reductions this year, following the company’s announcement in April that it was letting go around 3% of employees.
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
Navigator Medicine is looking to push its lead asset NAV-240 targeting immune-mediated diseases through to clinical studies “in the coming months,” which the startup in-licensed from a South Korean biotech for $20 million upfront.
For reasons including downsizing, avoiding retirement and a tight labor market, senior-level biopharma professionals are increasingly turning to fractional roles, according to two recruitment experts.
The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.