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April 11, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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