Recon: FDA labels Novo’s Indiana plant out of compliance; WHO warns of surging antibiotic resistance
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Parents are flocking to natural and ‘clean medicine’ brands. Medical experts are worried (STAT)
- Deep cuts made to CDC’s flagship MMWR publication reversed hours later (STAT)
- FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance (STAT)
- CDC battered by government shutdown firings, while some are rescinded (STAT)
- Regeneron heads to FDA to seek approval for hearing loss gene therapy (Endpoints)
- Roche, Lilly's blood test for Alzheimer's diagnosis gets US approval (Reuters)
- Senate Republicans face states' healthcare concerns in high-stakes shutdown standoff (Reuters)
- Pharma companies announce direct-to-consumer sales and price cuts in US (Reuters)
- Banquets and billions: How AstraZeneca sealed a US medicine deal with Trump (Reuters)
- FDA adds warning to label of J&J, Legend's Carvykti for potentially fatal intestinal disorder (Fierce Pharma)
- India's Tamil Nadu cancels licence of cough syrup-maker linked to child deaths (Reuters)
- WHO warns of contaminated India cough syrups (Reuters)
- WHO warns of surging levels of antibiotic resistance (Reuters)
- German drug delivery specialist LTS grows US footprint with buyout of CDMO Renaissance Lakewood (Fierce Pharma)
- Is the worst over? Biopharma dealmaking shows an uptick in third quarter (Endpoints)
- Tvardi's stock crashes as STAT3 drug fails in Phase 2 after extensive dropouts from side effects (Endpoints)
- A fresh biotech has a radical plan to treat inflammation and allergies, setting its sights on Xolair (Endpoints)
- Novo Nordisk quits cell therapy as restructure continues (Endpoints)
- Moderna previews cancer antigen therapy in melanoma ahead of ESMO (Endpoints)
- Gilead, Arcus’ TIGIT approach exceeds two years of median survival in Phase 2 gastric cancer trial (Endpoints)
- SystImmune’s $250M milestone; Teva’s Uzedy approved to treat bipolar disorder (Endpoints)
- BMS cooks up schizophrenia stigma-busting push with Gail Simmons (Fierce Pharma)
- Why this cardiologist is cautious about the Apple Watch’s blood pressure feature (STAT)
- One Mass. health system is turning to AI to ease shortage of primary care doctors. Some don’t like it (STAT)
- Rich Feedback On MDR And IVDR Leaves EU Commission With Food for Thought (MedTech Insight)
- Tarver Celebrates CDRH Wins After ‘Roller Coaster’ First Year (MedTech Insight)
- Color manufacturers sue to strike down West Virginia artificial dye law (Food Dive)
- Peanut allergies may be prevented, new research finds (The Hill)
- Medicare Advantage insurers still in retreat as annual enrollment kicks off (STAT)
- Drug developers shouldn’t shortchange the autoimmune community (STAT)
- Trump Turns His Sights on Aluminum in Vaccines (Bloomberg)
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