Recon: FDA lifts hold on BioNTech’s cancer drug trial; Humana settles Medicare drug overcharging suit for $90M
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- BioNTech says FDA lifts partial hold on its cancer drug trial (Reuters)
- What the newly released Medicare prices for 10 drugs do and don’t tell us (STAT)
- Harris pledges to scrap billions in medical debt with new presidential platform (STAT)
- Biden, Harris hail Medicare drug price cuts that will save billions (Reuters)
- Will the FTC challenge a deal that would give Novo Nordisk control of some Catalent plants? (STAT)
- Q&A: Lilly’s top scientists on genetic medicine ambitions, and how they’re not just for rare diseases (Endpoints)
- Medicare negotiations have concluded. What's next for court cases against the IRA? (Endpoints)
- Unpacking IRA price negotiations results; Lykos’ tough week; Genentech rethinks cancer immunology; and more (Endpoints)
- FDA approves AstraZeneca’s Imfinzi before and after lung cancer surgery (Endpoints)
- Liquidia's inhaled drug fails to get traditional approval in US, shares fall (Reuters)
- TYK Medicines seeks to launch new EGFR drug in China with $74M Hong Kong IPO (Endpoints)
- New EU Tool To Drive Adoption Of Fit-For-Purpose eConsent (Pink Sheet)
- Bavarian Nordic Accelerates Mpox Vaccine Production to Respond to Global Emergency (BioSpace)
- How the World Sleepwalked Into the Global Mpox Emergency (Bloomberg)
- Philippines detects first mpox case this year, yet to determine strain (Reuters)
- One case of clade 2 mpox detected in Pakistan, new strain not detected (Reuters)
- EU public health body raises mpox risk alert level (Reuters)
- Pfizer, BioNtech say combined flu-COVID vaccine misses a main goal of Phase 3 trial (Reuters)
- Rick Doblin, ‘unleashed,’ blasts FDA over Lykos drug rejection and turns to global push for MDMA therapy (STAT)
- Q&A: Lykos just cut 75% of its workforce after an FDA rejection. Here’s what the CEO has to say (Endpoints)
- Carbon Health CEO Eren Bali steps down (Endpoints)
- Avantor sells off CRO for $650M to private equity firm (Endpoints)
- Ipsen: Early Engagement With Regulators Can Help Biomarker-Driven Drug R&D (Pink Sheet)
- Exclusive: Repligen in bid for reagent vendor Maravai, sources say (Reuters)
- Canopy Growth CEO David Klein to retire in March (Reuters)
- AI drug firm Recursion moves from survival to industry domination (STAT)
- Boston Scientific resubmits Silk Road merger filing, giving FTC more review time (MedTech Dive)
- Routine lab tests fail to detect long COVID in 10,000-person study (MedTech Dive)
- Biden pledges $150M for medical tech to improve cancer surgery (MedTech Dive)
- Evidence Lacking On How Cyber Attacks Impact Patients (MedTech Insight)
- Survey: Panelists Open To Advisory Committee Reforms (MedTech Insight)
- Device Classifications For COVID, Acute Febrile Illness IVDs And Force Separation Catheters (MedTech Insight)
- Long Time Passing: Where Have All the De Novo Decision Summaries Gone? (FDA Law Blog)
- Private equity: health care’s vampire (STAT)
- 5 health issues to watch for at the Democratic National Convention (STAT)
- Peter Orszag wants the FTC and DOJ to stop challenging ‘vertical’ health care mergers (STAT)
- A Better Deal: Medicare Discounts Surpass Estimated PBM-Negotiated Rebates (Pink Sheet)
- US FDA And The Election: Watch The Center Directors (Pink Sheet)
- Humana to pay $90 mln to settle claim that it overcharged Medicare for drugs (Reuters)
- GSK to seek dismissal of Florida case against heartburn drug Zantac (Reuters)
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