Recon: Eisai seeks full approval for Alzheimer’s drug Leqembi; AstraZeneca buys Cincor Pharma for up to $1.8B

ReconRecon | 09 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • U.S. Supreme Court rebuffs Pfizer plan to help patients pay for heart medication (Reuters) (Bloomberg)
  • FDA grants priority reviews for Pfizer's Prevnar 20 for kids and Roche lymphoma candidate (Endpoints)
  • Lundbeck and Otsuka win FDA priority review of Alzheimer’s agitation drug (Medwatch)
  • Doctors inclined to prescribe new Alzheimer’s drug despite concerns (Endpoints)
  • Eisai files for full FDA approval for Alzheimer's drug Leqembi (Reuters)
  • Eisai Pricing For Lecanemab Reflects Concern With Medicare ‘Sustainability,’ ‘Giving Back,’ Firm Says (Pink Sheet) (Endpoints)
  • Precision BioSciences gets positive CMC feedback for allogeneic CAR-T candidate (Endpoints)
  • Emergent awarded $379M+ to supply the DOD with a skin decontamination lotion (Endpoints)
In Focus: International
  • Rozanolixizumab & Biosimilar Ustekinumab Among Raft Of New Drugs Filed In EU (Pink Sheet)
  • Pandemic Prompts Update To Belgian Rules On HCP Participation In Scientific Events (Pink Sheet)
  • Omicron COVID booster cuts hospitalization in over 65s, Israeli study finds (Reuters)
  • Ocugen-Bharat Biotech COVID vaccine meets main goals in U.S. trial (Reuters)
  • Korea’s Key Words For 2023: Regulatory Innovation, Digital Healthcare (Pink Sheet)
  • Pakistan Consolidates GMP Expectations For The First Time (Pink Sheet)
Pharma & Biotech
  • AstraZeneca to Buy Cincor Pharma for Up to $1.8 Billion (Bloomberg) (Biopace) (Endpoints)
  • Chiesi Ups Rare Disease Game with $1.48B Amryt Acquisition (Biospace) (Fierce)
  • BioNTech inks partnership with UK to speed up recruitment of mRNA cancer trials (Endpoints)
  • Pharvaris to embark on 6-month tox test in hopes of reversing US clinical hold for HAE asset (Fierce)
  • Emergent BioSolutions to reduce workforce by about 5% (Reuters)
  • JPM23: Bluebird touts gene therapy launch progress, extends cash runway to 2024 (Fierce)
  • Boehringer offers 3T Biosciences $268M to plug its data into biotech’s TCR cancer platform (Fierce)
  • Novavax CEO Stanley Erck retires after overseeing COVID shot launch (Fierce)
  • Qiagen acquires DNA-biometrics firm Verogen in $150 mln deal (Reuters)
  • Editas edits pipeline, lays off 20% and says bye to CSO to kick off #JPM23  (Endpoints)
  • Novartis offloads neurodevelopmental disorder asset to small Swiss biotech (Endpoints)
Medtech
  • Avoiding MDR Pitfalls On Cybersecurity: How EU Rules Could Catch Manufacturers Out (MedTech Insight)
  • Baxter bids adieu to $5B kidney care division with spinout plan (Fierce) (MedTech Dive)
  • Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment (MedTech Dive)
  • Newly solo GE HealthCare begins bulking up C-suite, naming Amazon, FDA alum first tech chief (Fierce)
  • Medtech Connect Episode 1: How Do We Regulate Software As A Medical Device? (MedTech Insight)
  • Women’s health drugmaker Organon places bet on hysterectomy hardware developer Claria Medical (Fierce)
Government, Regulatory & Legal
  • Teva says opioids settlement to move forward in U.S. (Reuters)
  • This Week in Chancery Court: Damages for Cancer Drug Delays (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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