Recon: FDA advisors to discuss additional COVID boosters this week; Novartis restructuring aims to cut $1B, top execs ousted

ReconRecon | 04 April 2022 |  By 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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