Recon: FDA rejects drugs from Amryt, Reata; Viatris settles EpiPen antitrust suit for $264M

• 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)