Recon: PTC gets FDA CRL for Friedreich’s ataxia drug; Pediatrics group breaks with HHS to recommend COVID vaccines for young children

• Trump may push hard for lower drug prices using a tool created by Democrats (STAT)
• National pediatrics group splits with RFK Jr. on Covid vaccinations (STAT) (Reuters)
• Stealth BioTherapeutics discloses FDA rejection letter in effort to rally support for rare disease drug (STAT)
• Why direct-to-consumer sales are unlikely to significantly lower drug costs (STAT)
• FDA rejects PTC's Friedreich’s ataxia drug (Endpoints) (Reuters)
• New vaccine may prevent some cancers from returning (The Hill)
• Copycat Ozempic, Mounjaro proliferate even in postshortage era (The Hill)

• Irish pharma exports to the US decrease after months of stockpiling (Endpoints)
• Canada approves Ozempic to cut risk of kidney failure, heart-related deaths (Reuters)
• Somalia faces diphtheria surge amid vaccine shortages and aid cuts (Reuters)
• Health Crisis Spirals in Colombia as ERs and Maternity Wards Close (Bloomberg)
• Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group (Pink Sheet)
• ‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul (Pink Sheet)
• UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments (Pink Sheet)

• Viking Therapeutics oral weight loss drug hits mark in mid-stage trial but disappoints investors (STAT)
• George Church’s lab gets closer to creating human eggs in a dish, and a new startup plans to finish the job (Endpoints)
• BiomX’s mid-stage cystic fibrosis trial put on clinical hold; Santen makes a deal with RemeGen (Endpoints)
• Exclusive: Sensorium raises $25M to test succulent-derived drug for anxiety (Endpoints)
• Exclusive: Longevity startup Superpower is cutting its price by 60% (Endpoints)
• CSL to axe up to 3,000 employees and spin off vaccine arm; shares tumble (Reuters)

• Medtronic plans to add two independent directors after Elliott takes large stake (Reuters)
• Inotiv’s Business Operations Disrupted by Cybersecurity Incident (Bloomberg)
• CMR Surgical hires Chris O’Hara to drive US robot expansion (MedTech Dive)
• Medtronic recall of heart vent catheters tied to 3 serious injuries (MedTech Dive)

• Natural M&M’s and Skittles Add to the Sugar Glut (Bloomberg)
• Trump administration to explore limits on advertising unhealthy foods to kids (Food Dive)

• Can a humble, Harley-riding professor and former Trump adviser fend off science cuts? (STAT)
• Right to Try Movement Finds Powerful Allies Under Trump (Bloomberg)
• Amgen's ChemoCentryx prevails in investor lawsuit (Fierce Pharma)
• HHS will allow emergency use of animal drugs in New World screwworm fight (The Hill)
• ‘Designer Xanax’ designated Schedule I controlled substance in Kentucky (The Hill)