Recon: Novo Nordisk signs $1.1B deals with two biotechs for obesity drugs; Health Canada approves Pfizer’s hemophilia B gene therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Where are the adcomms? FDA has scheduled no drug or biologic meetings for 2024 so far (Endpoints)
- Biden administration to use Defense Production Act to tackle drug shortages (Endpoints)
- Updated: FDA says it has no plans for Israel-based office (Endpoints)
- ANDA Sponsors Need US FDA Permission To Avoid Last-Minute Label Update Delays (Generics Bulletin)
- FDA slams trio of Indian drugmakers with Form 483 filings after December inspections (Fierce)
- US FDA Open To Innovative Statistical Approaches For Rare Disease (Pink Sheet)
- 2023 FDA approvals (Nature) (Reuters)
- Canada approves Pfizer’s gene therapy for bleeding disorder (Reuters)
- Switzerland Eases Parallel Importing & Allows Biosimilar Substitution (Pink Sheet)
- Brazilian Regulator OKs ‘Skinny Labeling’ But Legal Situation Remains Unclear (Pink Sheet)
- Singapore Making ‘Key Changes’ Ahead Of eCTD Implementation (Pink Sheet)
- Novo Deepens Obesity, MASH Expertise in Deals Worth $1B with Two Flagship Biotechs (Biospace) (Bloomberg) (Reuters)
- Lilly launches website, home delivery option for weight-loss drug (Reuters)
- Innate secures speedy resolution of FDA hold on lymphoma trials ahead of key regulatory talks (Fierce)
- Agios Pharma's blood disorder drug meets goals of late-stage study (Reuters)
- Bayer’s AskBio checks off another early win for gene therapy platform with Parkinson’s safety data (Fierce) (Bloomberg)
- Evotec Plunges After Pharma Firm CEO Unexpectedly Steps Down (Bloomberg)
- Boehringer Ingelheim and 3T Biosciences enter into a second partnership to develop next-generation cancer immunotherapies (Biospace)
- An injectable gel enters the male birth control fray with early positive clinical data (STAT)
- AGC Biologics to build new government-funded $350M Japanese facility (Endpoints)
- Backed by CRISPR pioneer Feng Zhang, epigenetics biotech Moonwalk debuts with $57M (Endpoints)
- Roche Signs Up Medilink As China Biotech ADC Deal Spree Continues (Scrip)
- FDA warns providers not to buy or implant Synovo’s total hip system (MedTech Dive)
- EU Regulatory Roundup, December 2023: Sector Poised For A Rethink (MedTech Insight)
- Experts: Watch For FCA Scrutiny On Debt Forgiveness, Free Repairs (MedTech Insight)
- Boston Scientific pulls forward expected approval for Farapulse PFA system (MedTech Dive)
- Roche to buy LumiraDx’s point-of-care technology for $295M (MedTech Dive)
- AstraZeneca Sues Samsung Bioepis to Block Soliris Biosimilar (Bloomberg)
- Icosavax Sued Over AstraZeneca Takeover Conflicts, Projections (Bloomberg)
- Daiichi Sankyo to Pay Esperion $125M in Settlement of Milestone Payment Lawsuit (BioSpace)
- Shriners Hospital Beats Worker Covid Vaccine Religious Bias Case (Bloomberg)
- CVS will remove AbbVie’s Humira from some drug reimbursement lists in April (Reuters)
- FDA ordered to reconsider denial of approval for vape products (Reuters)
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