Recon: Eisai seeks full approval for Alzheimer’s drug Leqembi; AstraZeneca buys Cincor Pharma for up to $1.8B
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)
- 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)
- 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)
- 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)
- Teva says opioids settlement to move forward in U.S. (Reuters)
- This Week in Chancery Court: Damages for Cancer Drug Delays (Bloomberg)
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