Recon: Lilly to sell highest doses of Zepbound on its website; Supernus to acquire Sage for $795M
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Senators Propose Ban on Drug Advertising to Consumers (The Wall Street Journal)
- Sarepta reports second patient death after treatment with Duchenne gene therapy (STAT)
- RFK Jr.’s new vaccine panel raises questions of how Kennedy defines conflicts of interest (STAT)
- Kennedy allows US Senator Cassidy a pick in revamped CDC vaccine panel (Reuters)
- Lilly to offer highest doses of weight-loss drug Zepbound on website (Reuters)
- Lilly posts encouraging early-stage weight loss data on amylin candidate (Endpoints)
- Another round of consolidation is coming, FDA commissioner tells staff (Endpoints)
- Big Pharma's 10 highest-paid CEOs of 2024 (Fierce Pharma)
- Purdue Pharma $7.4 billion opioid settlement wins broad support from US states (Reuters)
- NextCure inks ADC deal with Shanghai drugmaker (Endpoints)
- US pharma bets big on China to snap up potential blockbuster drugs (Reuters)
- China Joins US in Brain Implant Race With Clinical Trial (Bloomberg)
- UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage (Pink Sheet)
- GSK applies to EU regulator for expanded use of RSV vaccine (Reuters)
- Supernus enters depression drug market with up to $795 million Sage deal (Reuters) (Endpoints)
- Gilead, Arcellx continue to spotlight safety of multiple myeloma cell therapy (Endpoints)
- Former CEO Anne Wojcicki wins bid for 23andMe (Endpoints)
- KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’ (Endpoints)
- FDA's oncology adcomm to review GSK's Blenrep relaunch plans (Endpoints)
- AbbVie says blood cancer drug fails late-stage trial (Reuters)
- Sixth Street-backed Caris lifts IPO price range, eyes $5.7 billion valuation (Reuters)
- AZ touts Ultomiris results in post-transplant complication trial (Fierce Pharma)
- Biogen leads Cannes Lions Pharma shortlist, with BMS, Novartis cracking Health & Wellness category (Fierce Pharma)
- Body Scan Makers Are Trying to Cash in on Obesity Drug Boom (Bloomberg)
- Centerline recalls guidewire over risk of coating being left in patients (MedTech Dive)
- Joint Commission, CHAI partner to develop guidance on health AI (MedTech Dive)
- Quest partners with MD Anderson to develop cancer risk blood test (MedTech Dive)
- Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist (MedTech Insight)
- Increasing Safety Concerns Spur Scrutiny of Device Plastics Use (MedTech Insight)
- Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems (MedTech Insight)
- More states sign up for SNAP waivers (Food Dive)
- David responds to lawsuit, denies hoarding ingredient (Food Business News)
- HHS Budget Request Beats Familiar Drum (Food Safety)
- I’m a fertility doctor, and I think IVF needs more regulation (STAT)
- Hospitals would be hit hardest by Medicaid cuts in GOP tax bill, report finds (STAT)
- Don’t cut NIH and NSF budgets — let the government invest like a venture capitalist (STAT)
- With LDT Rule DOA, Could FDA Shift Focus To RUOs? (MedTech Insight)
- US FDA Teases Disclosure Program, But Industry Has Seen This Before (Pink Sheet)
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