Recon: Biogen, between layoffs, announces $7.3B deal to acquire Reata; Quest launches consumer blood test for Alzheimer’s
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Biogen makes its move, announcing a $7.3B deal for Reata (Endpoints) (Bloomberg) (Fierce) (Reuters)
- US FDA approves second over-the-counter opioid overdose reversal drug (Reuters) (MedScape) (FDA)
- Apellis Eye Injection Treatment Flagged for Safety Issues (BioSpace) (STAT) (Endpoints)
- The future of accelerated approval for FDA’s Marks? More rare disease drugs and no ‘hanging chads’ (Fierce)
- FDA asks Citius for enhanced product testing in CRL for non-Hodgkin lymphoma drug Lymphir (Endpoints)
- How Drugmakers Can Dodge Medicare Price Negotiations: Explained (Bloomberg)
- PET Imaging Drugs: US FDA Considers Streamlining Pre-IND Dosimetry Data Requirements (Pink Sheet)
- House Republicans Propose Drug Shortage Legislation After Gutting Democrats’ Bill (BioSpace) (Endpoints)
- National panel will explore requiring free Covid tests (STAT)
- Biosimilars Could Give Brands the Boot Mid-Year Under Amendment Added to Senate PBM Reform Bill (Generics Bulletin)
- US announces trial payment program for care providers of dementia patients (Reuters) (Bloomberg)
- Quest Diagnostics launches Alzheimer's blood test for consumers (Reuters)
- EU Partnership Offers Funding For Projects On Inclusive Clinical Trials, Synthetic Data & Theranostics
- (Pink Sheet)
- New EU Approvals (Pink Sheet)
- England’s NICE Turns Down Pfizer’s Talzenna In HER2-Negative Breast Cancer (Pink Sheet)
- Switzerland, US Agreement On GMP Inspections Comes Into Play (Pink Sheet)
- Novo Nordisk weight-loss drug Wegovy launched in Germany, first big EU market (Reuters) (MedWatch)
- Promising new Alzheimer's drugs may benefit whites more than Blacks (Reuters)
- Early-Stage Biopharma Funding to Drop 40% This Year: Report (BioSpace)
- FDA Action Alert: Mesoblast, Sage/Biogen and Galera (BioSpace)
- Pharma giants tout AI tools as high priority in half-year earnings reports (Endpoints)
- Demise of Intercept’s NASH Program Highlights Safety Hurdles Facing the Space (BioSpace)
- Sumitomo, Otsuka’s Schizophrenia Candidate Fails Phase III Trials (BioSpace) (Endpoints)
- Merck touts topline PhIII Keytruda data in pre-surgery breast cancer treatment (Endpoints)
- Will More Indian Family-Owned Firms Hand Over The Baton To PEs? (Scrip)
- Okyo Pharma withdraws offer to sell shares after just 3 days citing ‘changing market conditions’ (Fierce)
- AstraZeneca buys early-stage gene therapies from Pfizer in boon for struggling field (STAT)
- Gene therapy is in crisis. For nine hours, the field’s leading minds looked for a solution (STAT)
- Remote Urine Drug Screening Feasible for Opioid Use Disorder, Study Shows (MedPage Today)
- FDA Device User Fees Up 9.5% For FY2024 (MedTech Insight)
- MDR Amending Regulation Improves Communication and Workflow But Thorny Issues Remain (MedTech Insight)
- UK Government Sends Medtech Post-Market Surveillance Proposal To WTO (MedTech Insight)
- US FDA Diagnostic Test Regulation Bill Stays On Back Burner (Pink Sheet)
- GE HealthCare oxygen sensor recall gets Class I label from FDA (MedTech Dive)
- Baxter issues urgent medical device correction for certain infusion pumps (Reuters)
- Integra warns impact of plant closure will continue into 2024, with delays possible (MedTech Dive)
- Pain clinic chain to pay $11.4M to settle Medicare and Medicaid fraud claims (Fierce)
- RapidAI racks up $75M for software to spot strokes, aneurysms (Fierce)
- US asks Supreme Court to delay Purdue Pharma bankruptcy settlement (Reuters) (Bloomberg)
- J&J effort to resolve talc lawsuits in bankruptcy fails a second time (Reuters) (Bloomberg)
- Mothers Lose Appeal in Suit Over Lexapro and Autism in Babies (Bloomberg)
- Ceva drops appeal over French bird flu vaccine tender (Reuters)
- Michigan Justices Imperil $3 Billion in Rebates, Insurers Say (Bloomberg)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
