Recon: Senate Democrats agree on $430 billion reconciliation bill with drug pricing measures; Cassava faces criminal probe over falsified data for Alzheimer's drug

ReconRecon
| 28 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Democrats Manchin, Schumer agree on $430 billion tax, drugs, energy bill (Reuters) (Endpoints) (Inside Health Policy) (Politico)
  • Two sides of 'historic' drug pricing bill: Pharma industry blasts 'mistake' while advocates plan for 'first ever' gains (Endpoints)
  • Merck CEO concerned about proposed drug pricing bill hurting innovation (Reuters)
  • GSK’s Benlysta Becomes First Biologic Approved for Lupus Nephritis in Kids (Biospace) (Reuters)
  • Bavarian Nordic's Danish facility gets FDA thumbs up to expand monkeypox vaccine production (Endpoints)
  • Monkeypox funding Plans at Risk With Coronavirus Aid in Gridlock (Bloomberg)
  • Senate Finance chair calls on Merck and Abbott to comply with his investigation into their offshore tax schemes (Endpoints) (Fierce)
  • Warning letter issued to New Jersey generics manufacturer over quality control issues (Endpoints)
  • Fauci calls for development of pan-coronavirus and intranasal vaccines in fight against Covid variants (Endpoints)
  • Allergan Poised to Pay More Than $2 Billion in Opioid Settlement (Bloomberg) (Reuters)
In Focus: International
  • EMA reviews repurposed experimental cancer drug for Covid-19, even without a submission (Endpoints)
  • EMA To Track Monkeypox Medicines Stock & Boost Emergency Task Force Output (Pink Sheet)
  • EMA Restricts Rubraca’s Use Due To Concerns Over Benefit & Safety (EMA)
  • Access To Innovation Looking Brighter In France (Pink Sheet)
  • Indian state research body ICMR invites vaccine makers to make monkeypox shots (Reuters)
  • Australia makes monkeypox a disease of national significance (Reuters)
  • Cheap copies of GSK's HIV prevention drug could be ready in 2026 (Reuters)
  • China Innovative Drug Reimbursement Needs Major Revamp: Industry Group (Pink Sheet)
  • Didi, Data And New China Cross-Border Transfer Regulations (The Pink Sheet)
  • Sanofi lifts profit outlook as Dupixent sales surge 43% (Reuters)
Pharma & Biotech
  • Pfizer sends ‘enhanced’ COVID shot to clinic under strategy for next generation of vaccines (Fierce)
  • The NASH curse strikes again. Pfizer dumps early-stage asset for liver condition (Fierce)
  • Takeda axes clinical-stage program in $1B+ Turnstone Biologics collaboration (Endpoints) (Fierce)
  • Editas notches milestones for sickle cell disease therapy as FDA lifts partial clinical hold (Fierce)
  • Feeling the pressure, Bristol Myers pushes back timeline for production of Breyanzi (Fierce)
  • Cidara Therapeutics bags $30M cash in Melinta licensing deal, submits antifungal for FDA review (Fierce)
  • With Vertex and CRISPR some 30 patients in, Editas moves forward in sickle cell patients after FDA lifts hold (Endpoints)
  • 'Tip of the iceberg': Novartis-partnered UC Berkeley lab churns out a startup to tackle protein stabilization (Endpoints)
  • Two groups look to bring standardization to cell therapy manufacturing in their latest paper (Endpoints)
  • AbbVie is scolded by a trade group over sales rep ‘strategically loitering’ in a hospital (STAT)
  • How to close biopharma’s data science and engineering skills gap (STAT)
  • Internal documents show privacy lapses at a data powerhouse that holds health records and consumer information on millions of Americans (STAT)
  • Buprenorphine treatment for veterans with opioid use disorder increased as care shifted to telehealth during Covid, study finds (STAT)
  • Small Pennsylvania biotech lays off a fourth of its staff as it tries to navigate commercial landscape (Endpoints)
Medtech
  • As Senate passes $280 billion measure to bolster U.S. chip production, medtech industry applauds (MedTech Dive)
  • Labcorp to spin off clinical-development business (Reuters)
  • MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply (MedTech Dive)
  • How Expert Panel Deep Dive Reviews Are Challenging Clinical Data And Setting (MedTech Insight)
  • Will Commission heed COCIR’s Comprehensive And Sometimes Radical Solutions To MDR Delays? (MedTech Insight)
  • 3M Plans To Spin Off Health Care Business By The End Of 2023 (MedTech Insight)
  • Opinion: FDA Isn’t A Monolith. Engage The Agency Better By Answering These 5 Questions (MedTech Insight)
Government, Regulatory & Legal
  • Cassava Sciences faces US criminal probe tied to Alzheimer's drug, sources say (Reuters) (Fierce) (Endpoints)
  • Teva to pay $4.3B to settle opioid epidemic litigation with states (Endpoints)
  • Allergan Poised to Pay More Than $2 Billion in Opioid Settlement (Bloomberg)
  • Bausch Loses Mixed Patent Ruling That Tanks Part of IBS Drug (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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