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Recon: FDA, CDC link Pfizer’s bivalent COVID booster to possible strokes in older adults; Eisai files for Japanese approval of Alzheimer’s drug Leqembi

ReconRecon | 16 January 2023 |  By 

Recon: FDA, CDC link Pfizer’s bivalent COVID booster to possible strokes in older adults; Eisai files for Japanese approval of Alzheimer’s drug Leqembi

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer Bivalent Shot Shot Linked to Stroke in One Safety Database (Bloomberg) (MMWR) (Reuters)
  • Novo Nordisk's GLP-1 for Type II diabetes approved for first-line treatment (Endpoints) (Biospace)
  • AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales (Fierce)
  • David Kessler, Biden official key to covid vaccine effort, steps down (Washington Post) (STAT)
  • Biocon Receives CRL Over Unresolved Manufacturing Issues (FDAnews)
  • Study: Harvard Scientists Pinpoint Epigenetics as Potential Key to Reverse Aging  (Biospace)
  • R.J. Reynolds Pivots to New Cigarette Pitches as Flavor Ban Takes Effect (NYT)
 
In Focus: International
  • Eisai files for approval of Alzheimer’s drug in Japan (Reuters) (Biospace)
  • EMA looks to warn doctors of Zolgensma’s liver failure deaths amid discussion with Novartis (Fierce) (Endpoints)
  • Blow For Pfizer As UK's NICE Rejects Oxbryta For Sickle Cell Disease (Pink Sheet)
  • JPM23: Illumina could face the EU’s maximum fine for jumping the gun with Grail deal: report (Fierce)
  • A Tech Company’s Wishlist To Increase Digitization In UK Clinical Trials (Pink Sheet)
  • AbbVie, Eli Lilly exit UK drug pricing agreement (Reuters) (Pink Sheet)
  • In China, no easy way to get Pfizer’s COVID drug Paxlovid (Reuters)
  • Canadian Court Upholds New Drug Price Comparison Basket – With Caveats (Pink Sheet)
 
Pharma & Biotech
  • Scoop: Roche-backed startup gives up on CD47, lays off all employees (Endpoints)
  • Pharma knocks tech off the top spot as most trusted industry in Ipsos' latest global report on Trust (Ipsos)
  • Chutes & Ladders-Novavax CEO Erck bids adieu after 12 years, overseeing COVID vax development (Fierce)
  • CureVac Converts To Modified mRNA And Stock Soars (Scrip)
  • Asia Deal Watch: Astellas Begins 2023 Signing Rare Disease Tie-Ups With Selecta, Twist (Scrip)
  • Three Ohio-based contract organizations win $149M deal for neurological candidates (Endpoints)
  • A Takeda-backed GI and pain biotech quietly shutters (Endpoints)
  • Invitae’s new CEO on why the genetic testing firm stopped chasing ‘volume at all costs’ (STAT)
  • How to Prepare if Your Company is Being Acquired (Biospace)
 
Medtech
  • How The Commission Proposes Changing The MDR: What You Need To Know To Comment (MedTech Insight)
  • Micronoma Gets Breakthrough Device Nod for Early Lung Cancer Test (FDAnews)
  • Penumbra’s Lightning Flash Cleared for Large Blood Clot Removal (FDAnews)
  • JPM23: Caris teams up with ConcertAI on cancer trial data platforms  (Fierce)
  • Akili cuts 30% of staff to focus cash on growing prescription video game sales (MedTech Dive)
Government, Regulatory & Legal
  • Ex-Takeda staffer's 'small hustle' ends with arrest and $2.3M fraud scheme charge (Endpoints)
  • Federal Appeals Court Denies Sandoz’s Challenge to Sanofi on Aubagio (FDAnews)
  • California is the latest state to sue drugmakers and PBMs over insulin pricing (STAT)
  • Supreme Court Will Review SuperValu Drug Price Fraud Claims (Bloomberg)
 
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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