Recon: FDA rejects drugs from Amryt, Reata; Viatris settles EpiPen antitrust suit for $264M
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- J&J, drug distributors sign off on a mammoth $26B opioid settlement with 46 states (Endpoints) (STAT)
- Moderna faces new lawsuit over lucrative coronavirus vaccine (Washington Post) (Reuters) (Endpoints) (Bloomberg)
- FDA declines to approve Amryt's topical gel for rare skin diseases (Reuters) (Endpoints)
- FDA rejects Reata's kidney drug after adcomm voted unanimously against it (Endpoints)
- More than 100 House and Senate Republicans call on new FDA commish to reverse order on mail-order abortion pills (Endpoints)
- EpiPen antitrust litigation settled; Viatris to pay $264 million (Reuters)
- NIH official accused of ‘bias’ against using a controversial law to address high drug prices (STAT)
- EU drug regulator extends shelf life of J&J vaccine to 11 months (Reuters)
- Fears For Ukraine’s Access To Medicines And Trials As Russian Invasion Continues (The Pink Sheet) (Endpoints)
- Biotech leaders call on industry to cut ties with Russia amid Ukraine invasion (Fierce)
- Advantage Pfizer: GSK stops phase 3 trials of maternal RSV vaccine after seeing safety signal (Fierce) (Endpoints) (Reuters) (Bloomberg)
- Deaths in Keytruda combo study spur Celyad to pause trial of off-the-shelf CAR-T cell therapy (Fierce)
- EMA expands nods for BMS, Eli Lilly, Novartis drugs and backs Biohaven, VBI. Myovant therapies for the first time (Fierce)
- EMA shortens timeline for Moderna's Spikevax Covid booster (Endpoints)
- GSK still plans to list consumer arm in July despite market volatility (Reuters)
- CDC issues long-awaited new guidance on when to wear masks (STAT)
- Japan, UK pledge new funds to CEPI's $3.5B pandemic preparedness plan, with eye toward future outbreaks (Endpoints)
- China perseveres with mRNA COVID shot development amid Omicron, commercial uncertainty (Reuters)
- In latest setback for solid tumor CAR-T, Celyad pauses trial following two patient deaths (Endpoints)
- Ants, spiders, and mold: Why a big compounding pharmacy recently recalled all its products (STAT)
- Biosimilars unite: Looking for commercial consolidation, Biocon buys out longtime partner Viatris for $3.3B (Endpoints) (Fierce)
- Shionogi files for approval of oral COVID-19 antiviral in Japan, brushing off missed clinical endpoint in race to market (Fierce)
- Biohaven to take a chance on Bristol Myers’ once-failed DMD med (Fierce)
- Sanofi chases fourth Dupixent nod after late-stage eosinophilic esophagitis trial win (Fierce)
- Australia Plans 150-Day Priority Review For Novel Biologicals (The Pink Sheet)
- AZ Secures EU Fast-track Review For Nirsevimab (The Pink Sheet)
- WHO Biomanufacturing Training Hub Plan Offers Korea Chance on World Stage (The Pink Sheet)
- FDA approves Medtronic’s long-lasting neurostimulator implant for bladder, bowel incontinence (Fierce)
- Masimo’s brain-monitoring headset nabs FDA nod for use in kids (Fierce)
- If You Build It, Will They Come? Vital That UK MHRA Creates Right Environment For Medtechs (MedTech Insight)
- FDA Announces Class I Recall On Arrow International Cardiac Catheter Device (MedTech Insight)
- Judge backs Johnson & Johnson in bankruptcy ploy for talc litigation, clears way for settlement (Fierce) (Endpoints)
- FTC wants to know: How are PBMs affecting drug affordability and access? (Endpoints)
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