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Recon: Lilly's obesity pill reduced weight, blood sugar in late-stage trial; EU approves Gilead’s HIV PREP injection
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
HHS terminates NIH program aimed at diversifying biomedical workforce (STAT)
BARDA awards nearly $20M to flu vaccine maker Osivax, following mRNA pullback (Endpoints)
Overall survival in cancer drug trials: New FDA draft guidance sets the bar (Endpoints)
Somewhere in Time: FDA Releases Its FY 2024 Report on Pharma Quality As Industry Looks to 2026 (FDA Law Blog)
Trump and RFK Jr. to Ban COVID-19 Vaccine ‘Within Months’ (Daily Beast) (Newsweek)
In Focus: International
Top pharma companies work to launch first weight-loss pill (Reuters)
EU approves Gilead's new injection for preventing HIV (Reuters)
Bayer is charting $43M in upgrades to API plant in Mexico (Fierce Pharma)
Mubadala-Backed Ignis Therapeutics Is Said to Mull Hong Kong IPO (Bloomberg)
Bavarian Bidders Lower Takeover Threshold After Pushback (Bloomberg)
Pharma & Biotech
Illumina CEO sees path to stable growth, even as its academic customers face funding uncertainty (STAT)
Eli Lilly’s obesity pill helped lower weight, blood sugar in key Phase 3 trial (STAT)
Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff (Pink Sheet)
Regeneron's rare immune disorder therapy meets main goal of late-stage trial (Reuters)
Exclusive: Neuro startup Leal raises $30M Series A for schizophrenia and ALS trials (Endpoints)
Why former Walmart Health head Cheryl Pegus joined weight loss startup FlyteHealth (Endpoints)
Pfizer lays off 100 workers at former Seagen HQ (Fierce Pharma)
Health-Care Deal Creates $6 Billion Company Aiming to Upend Drug Middlemen (Bloomberg)
Thomson Medical Jumps 39% on New Project in Johor Special Zone (Bloomberg)
Interactive Brokers Climbs on Replacing Walgreens in S&P 500 (Bloomberg)
Good News on GLP-1s and Cancer Risk, With One Exception (MedPage Today)
Medtech
Terumo to buy OrganOx for $1.5B to enter transplant field (MedTech Dive)
Tempus inks $81M Paige buyout to support AI model development (MedTech Dive)
Study Finds Public Companies Behind Most Recalled AI Devices (MedTech Insight)
Reports Put $4B Price Tag On Versius Maker CMR. Will This Change Surgical Robot Valuation? (MedTech Insight)
Food & Nutrition
Kraft, other companies defeat test lawsuit over ultra-processed foods (Reuters)
Radioactive shrimp and rodent-infested warehouses: Why food recalls still shock us (Food Safety News)
Alzheimer's Genetic Risk May Be Effectively Countered With Diet (MedPage Today)
Government, Regulatory & Legal
We surveyed hundreds of biomedical researchers about the instability in federal funding. Here’s what they said (STAT)
HHS winds down pediatric brain tumor pact after 26 years, prioritizing other childhood cancer work (Endpoints)
Private-Equity Firm Said to Prioritize Profit Over Patients (Bloomberg)
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.