Recon: Drug shortages climbed to record high in Q4; Vertex to acquire Alpine Immune for nearly $5 billion
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- $10 billion long Covid ‘moonshot’ is being floated by Bernie Sanders (STAT)
- Vertex to buy Alpine Immune Sciences for $4.9 billion (STAT)
- Drug shortages reached a record high as 2023 drew to a close (STAT)
- Regeneron accused by Justice Department of manipulating Medicare pricing (STAT)
- Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025 (STAT)
- NCI director expresses optimism about next era of cancer research, despite shrinking budget and brain drain (STAT)
- Pfizer settles 12-year-old lawsuit in alleged pay-for-delay scheme for $39M (Fierce Pharma)
- Bausch wins US appeal to block Alvogen generic of diarrhea drug (Reuters)
- European Parliament votes in favor of updated pharma legislation, prompting mixed reactions (STAT)
- EU Parliament Adopts Updated Pharma Package Despite Some Political Disagreement (Pink Sheet)
- Moderna halts African facility build as Covid-19 vaccine demand plummets (Endpoints)
- English Funding For Aquipta Targets AbbVie’s Migraine Drug To 170,000 People (Pink Sheet)
- Industry Calls On G20 To Boost Regulatory Harmonization & Tackle AMR (Pink Sheet)
- When a cancer drug fails, oncologists often fly blind. A precision technique might light the way (STAT)
- Gas prices are hurting biotech (STAT)
- AskBio CSO steps down, has new project in stealth mode (STAT)
- Did you say 486%? Why one company thinks such a price hike for its drug is justified (STAT)
- Cancer vaccines gain momentum, after years of disappointing results (STAT)
- Novartis wanted just one drug from MorphoSys before upping bid for whole company, document reveals (STAT)
- Fresh off ALS drug withdrawal, Amylyx touts interim rare disease data for the same therapy (Endpoints)
- After approvals for one of cancer's 'undruggable' targets, research into new KRAS therapies booms: #AACR24 (Endpoints)
- Exclusive: Genentech plans to cut 3% of workforce across several units, company says (Endpoints)
- Novartis lines up protein degrader deal with Pfizer-allied Arvinas (Endpoints)
- API Innovation Center looks to bolster US cancer drug supplies with Apertus deal, new tech (Fierce Pharma)
- FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too (Fierce Pharma)
- Steris to sell dental segment for $787.5M (MedTech Dive)
- Illumina CFO steps down amid executive shakeup (MedTech Dive)
- Consent Decree Against Philips Entered In Federal Court, Outlines ‘Roadmap’ For Compliance (MedTech Insight)
- ‘Biggest Transformation In The History Of Medicine’: Oncologist And Cardiologist Talk AI-Enabled Health Care (MedTech Insight)
- FDA expands import alert to block all plastic syringes from Chinese manufacturer (MedTech Dive)
- Medicaid redetermination cost community health centers an average of $600K each (STAT)
- Telehealth providers can drive antibiotic overuse — or choose to combat it (STAT)
- To rebuild trust in public health: Better communication, fewer mandates, and small wins (STAT)
- Mental health screening tools for kids are 30 years out of date (STAT)
- Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations (Pink Sheet)
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