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Iran war has not disrupted pharma supply chains. That could change if conflict is prolonged (STAT)
Britain medicine supply at risk if Middle East conflict persists, trade group warns (Reuters)
Novartis to buy experimental breast cancer drug in up to $3 billion deal (Reuters)
WuXi AppTec’s bet on the US pays off as revenues dip elsewhere (Endpoints)
Indian drugmakers flood market with cheaper versions of Novo's Ozempic, Wegovy (Reuters)
Kent meningitis outbreak triggers surge in UK vaccine demand, policy debate (Reuters)
Beijing-backed brain chip firm says it is 3 years behind Musk's Neuralink (Reuters)
Pharma & Biotech
Gilead nearing up to $2 billion buyout of biotech Ouro Medicines, FT reports (Reuters)
Insmed drug benefits patients with rare, bacterial lung disease, study shows (STAT)
Apogee Therapeutics data show long-acting eczema drug induced relief with less frequent injections (STAT)
FDA solicits feedback on controversial national priority voucher review pathway (Fierce Pharma)
Doctronic raises $40 million as race to apply AI in clinical care heats up (STAT)
Aurinia's CEO and C-suite are out as investor Kevin Tang consolidates control (Endpoints)
Former Acorda CEO Ron Cohen emerges at Parkinson’s cell therapy biotech Oryon (Endpoints)
A California startup wins $180M in support as Sanofi rebuilds presence in T cell engagers (Endpoints)
Oryon Cell Therapies launches with $21 million to advance Parkinson's treatment (Reuters)
Medtech
Labcorp closes purchase of New York pathology reference lab assets (MedTech Dive)
Abbott to close $21B Exact Sciences acquisition Monday (MedTech Dive)
CISA urges organizations to harden endpoint security following Stryker attack (MedTech Dive)
In Medtech, AI Is No Longer An Add-On, It’s Becoming Part of Operations, LSI Panelists Said (MedTech Insight)
Screenless, Smartphone-Controlled Pump: MiniMed Flex Cleared By FDA Weeks After IPO (MedTech Insight)
Verily Raises $300M To Advance Precision Health Platform As Independent Firm (MedTech Insight)
MEPs Vote To Delay And Simplify AI Act Rules For Medical Devices (MedTech Insight)
Food & Nutrition
After funding collapse, what’s next for food startups? (Food Dive)
Bill to lift ban on transporting raw milk is back (Food Safety News)
Government, Regulatory & Legal
Her son needed a fecal transplant for a fearsome C. diff infection. Getting one required a tortuous journey (STAT)
Epic says it has uncovered rot in patient record sharing. Will HHS act? (STAT)
The AI push in health care is deepening medicine’s trust crisis (STAT)
EyePoint sues rival Ocular Therapeutix, alleging false claims about eye drug (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.