Recon: FDA advisors to discuss additional COVID boosters this week; Novartis restructuring aims to cut $1B, top execs ousted
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA advisers to discuss additional COVID vaccine shots, booster design (Reuters)
- FDA approves Gilead cell therapy for earlier lymphoma (Reuters) (Bloomberg) (FDA)
- House Passes Bill to Limit Cost of Insulin to $35 a Month (NYT) (Politico) (NPR) (WebMD)
- FDA puts Curis’ leukemia trial on partial hold after patient death spurs review of muscle breakdown (Fierce) (Endpoints)
- Roche says FDA grants priority review to Actemra for COVID-19 (Reuters)
- FDA cuts off use of GSK's Covid treatment in almost half of the US as BA.2 spreads (Endpoints)
- Decorating The 'Christmas Tree’: US House Bills That Could Be Tacked Onto FDA User Fee Legislation (The Pink Sheet)
- Califf Says Accelerated Approval A ‘Different Objective’ And ‘Lower Hurdle’ (The Pink Sheet)
- More biosimilar use could've saved Medicare and beneficiaries $84M in 2019, HHS OIG says (Endpoints)
- Lawmakers agree on $10 billion in covid funds, but drop global aid from deal (Washington Post)
- National Cancer Institute Director Sharpless Steps Down (Bloomberg) (STAT)
- Novartis CEO Vas Narasimhan restructures the pharma giant, cutting costs $1B+, ousting top execs and signaling layoffs ahead (Endpoints) (Fierce) (Reuters) (Scrip)
- Three-Month Dry Spell For EU PRIME Scheme (The Pink Sheet)
- UK Highlights Common Pitfalls In Safety Updates To Marketed Products (The Pink Sheet)
- In the wake of Covid, a World Health Assembly proposal would bolster quality of clinical trials (STAT)
- WHO suspends U.N. supply of Bharat Biotech's Covaxin vaccine for COVID-19 (Reuters)
- Most Chinese firms could keep their US listings under draft framework — report (Endpoints)
- CanSinoBIO's mRNA COVID vaccine candidate cleared for trials in China (Reuters)
- China Variants and Omicron XE Put Fresh Focus on Covid Mutations (Bloomberg)
- Deliberate infection trial finds COVID symptoms don't indicate viral shedding (Reuters)
- Global Uncertainty Is Impacting Deal-Making, Investment Decisions (Scrip)
- Y-mabs resubmits cancer drug for marketing approval in the US (Medwatch)
- Leaping forward: Bayer VC arm commits $1.4B to double investment pace through 2024 (Fierce) (Scrip)
- Sage touts positive early signals in Alzheimer's. Will they be able to repeat it in a blinded study? (Endpoints)
- Lundbeck Drug Linked to Improvement for Some Migraine Sufferers (Bloomberg)
- Bristol Myers touts upbeat data for its blockbuster heart drug candidate (Endpoints)
- With 2023 launch in sight, Pharming shares pivotal data on ex-Novartis rare disease drug (Fierce)
- Mark Cuban’s company is building a ‘parallel supply chain’ for prescription drugs (STAT)
- Ontario antes up $580M for C&G therapy plant in Hamilton (Endpoints)
- Meet Embecta! Becton Dickinson Completes Diabetes Spin-Off (MedTech Insight)
- Medtronic recalls IN.PACT catheters due to damage during manufacturing (MedTech Dive)
- After decades, researchers deliver first complete human genome using long-read DNA sequencers (Fierce)
- Gilead Must Face Whistleblower’s Hepatitis Drug Kickback Claims (Bloomberg)
- Roche Wants Novartis Units’ Launch of Esbriet Copies Blocked (Bloomberg)
- California Top Court Asked to Weigh Medical Device Warning Issue (Bloomberg)
- Bayer, J&J Beat Whistleblower’s Antibiotics False Claims Suit (Bloomberg)
- ‘Don’t Threaten Me,’ Judge Warns Balwani After Fraud Trial (Law360)
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