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Recon: Patent office sides with Merck in fight over injectable Keytruda; Sarepta picks up platform technology designation for gene therapy vector
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Merck gets lift from U.S. patent office in battle over injectable form of Keytruda (STAT)
FDA’s AI tool, Elsa, is here. ‘The stupidest big fuss they ever made’ (STAT)
Rewriting of Covid vaccine recommendations has doctors and other experts worried (STAT)
CDC official resigns from COVID vaccine committee advisory role, sources say (Reuters)
Internal document shows how UnitedHealth executives prepared to tamp down investor unrest (STAT)
This Isn’t How You ‘Restore Gold Standard’ Science (Bloomberg)
Ex-HHS workers accuse Trump administration of using flawed data to issue firings (Endpoints)
US Health Secretary Kennedy looks to fast-tracking approvals for rare disease drugs (Reuters)
In Focus: International
Cullinan's deal for T cell engager from China; Kardigan buys late-stage heart drug (Endpoints)
Surge in new opioids and designer drugs threatens Europe, EU drug agency warns (Reuters)
Italy's Chiesi Group plans acquisitions to boost sales to 6 billion euros by 2030 (Reuters)
A cautious culture cost Novo Nordisk its lead in the obesity drug race, former employees say (STAT)
Pharma & Biotech
A cautious culture cost Novo Nordisk its lead in the obesity drug race, former employees say (STAT)
MoonLake Immunotherapeutics is for sale? This sounds like a cry for help (STAT)
Regenxbio’s Gene Therapy Helps Kids with Deadly Muscle Disease (Bloomberg)
How Covid Can Break Blood Vessels and Clog Arteries (Bloomberg)
In a first, Sarepta announces platform technology designation for gene therapy vector (Endpoints) (Press Release)
Exclusive: Tech VC Amplify raises $200M for first biotech fund, hires Elliot Hershberg as new partner (Endpoints)
Allay reaches $57.5M Series D milestone for post-surgical pain drug (Endpoints)
After cutting most staff, Casma eyes path to clinic with its first autophagy-boosting drug (Endpoints)
Fujfilm, Coherus among slew of recent biopharma rebrands (Fierce Pharma)
Medtech
These blood tests for cancer are increasingly popular. Experts still aren’t sure how best to use them (STAT)
23andMe’s DNA Data Soars in Value With New $305 Million Bid (Bloomberg)
Digital health startup Virta stakes fees on curbing GLP-1 prescriptions (Endpoints)
Food & Nutrition
FAO Leaders Call for Science as Shared Language Ahead of World Food Safety Day (Food Safety)
FDA elevates tomato recall to highest risk level over potential salmonella contamination (ABC News)
Government, Regulatory & Legal
Exclusive: OpenEvidence’s new JAMA deal & Medicare’s DC tech party (STAT)
US Health-Care Policy Makes Deals ‘Incredibly Hard’, Advent Says (Bloomberg)
Ex-Amazon employees are betting their new venture changes online shopping for healthcare (Endpoints)
Ending U.S.-global health research partnerships will cost America (STAT)
10.9 million people would lose health insurance under Trump’s tax cut bill, CBO projects (STAT)
Do you remember the Human Genome Project? I’m not sure the Trump administration wants you to (STAT)
Dismantling CDC’s chronic disease center ‘looks pretty devastating’ to public health experts (STAT)
Humana to back curbs to Medicare Advantage billing practices, WSJ reports (Reuters)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.