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Pharma’s attack on Medicare drug price negotiation might benefit Biden (STAT)
FDA seeks 'boxed warning' for CAR-T cancer therapies (Reuters) (Endpoints)
J&J's Balversa gets mixed approval in bladder cancer as FDA ratchets up scrutiny on subgroup data, patient survival (Fierce Pharma)
J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm (Fierce Pharma)
Johnson & Johnson still expects Carvykti to hit at least $5 bln peak sales -CFO (Reuters)
In Focus: International
Sanofi scoops up U.S. biotech Inhibrx for up to $2.2 billion as it seeks to bolster pipeline (STAT) (Endpoints) (Reuters)
Can TikTok help boost lagging MMR vaccine uptake? UK politician believes a social media campaign could help (Fierce Pharma)
Novo Nordisk continues to stack obesity pipeline, this time with Swiss zebrafish biotech (Endpoints)
Pharma & Biotech
Merck inks deal with Unnatural Products; CG Oncology’s upsized IPO; Locus gets $24M from BARDA (Endpoints)
J&J meets Q4 expectations with $21.4B in sales as it stares down patent cliff (Endpoints)
J&J profit edges past Street view after deals delay Stelara competition (Reuters)
Gene editing delivery biotech GenEdit partners with Genentech, raises another $24M (Endpoints)
Turquoise Health raises $30M to use AI to sort through healthcare pricing data (Endpoints)
Oncology biotech Accent raises $75M to enter the clinic (Endpoints)
Autolus eyes November for potential US approval of Tecartus rival (Endpoints)
Neuro companies are one of pharma's hottest M&A assets. But behind the scenes, there have been few bidders (Endpoints)
Lilly’s Jaypirca tipped to capture 60% of BTK leukemia market, leaving AstraZeneca, BeiGene in the dust (Fierce Pharma)
Medtech
Mammograms are less effective for women with dense breast tissue. Medical experts disagree on what to do about it (STAT)
What virtual physical therapy startup Hinge Health wants in M&A (Endpoints)
Orthopedics leaders watch procedure backlog, new technologies in 2024 (MedTech Dive)
J&J expects strong procedure volumes in 2024 (MedTech Dive)
Edwards risks TAVR market share slip amid challenges from Abbott, Boston Scientific: survey (MedTech Dive)
Fancy Making A Drug? You May Want To Create A Diagnostic First (MedTech Insight)
Priority Projects For 2024 To Aid IVDR Implementation (MedTech Insight)
News We’re Watching: Dexcom Expands In Ireland; Neurostim Updates From NANS; Novel Nanoparticles Treat Cancer In Mice; And More (MedTech Insight)
Government, Regulatory & Legal
Dana-Farber expands studies to be retracted to 6, plus 31 to be corrected over mishandled data (STAT)
J&J agrees to resolve 42 US states' talc investigations (Reuters)
Martin Shkreli's lifetime drug industry ban is upheld (Reuters)
CDC says JN.1 variant accounts for about 86% of COVID cases in US (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.