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March 14, 2022
by Joanne S. Eglovitch

Recon: Lawmakers want opioid settlement tax breaks examined; Pfizer stops clinical trials in Russia but will continue to send drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • US should review drugmakers' opioid settlement tax breaks -House panel (Reuters) (Bloomberg)
  • Astra, Merck’s Lynparza Approved in US as Adjuvant Treatment (Bloomberg)
  • FDA declines to approve AstraZeneca treatment for chronic nasal condition (Reuters) (Endpoints)
  • FDA orders Incyte to hold up yet again in the hunt for blockbuster franchise (Endpoints)
  • Appeals court sides with Bristol Myers Squibb in years-long battle with investors over Opdivo fail (Endpoints)
  • What to know about Amylyx’s ALS drug and a highly anticipated advisory panel meeting (STAT)
  • Rhode Island takes Teva to trial in multibillion-dollar opioid case (Reuters)
  • In New York appearance, CMS administrator pushes for Congress to act on drug prices (STAT)
In Focus: International
  • Pfizer Pauses Trials in Russia, Will Continue to Send Drugs (Bloomberg) (Endpoints)
  • WHO says it advised Ukraine to destroy pathogens in health labs to prevent disease spread (Reuters)
  • Pfizer’s Covid Pill Unlikely to Reach Much of World for a Year (Bloomberg)
  • Novel Malaria Treatment for Children Receives First Approval (NYT)
  • India CEOs On Automated Plants, New Modalities, Tackling 'The Great Talent Reshuffle' (Scrip)
Coronavirus Pandemic
  • COVAX & Team Europe ‘Not Structural Solutions’ To COVID-19 Vaccine Inequity (The Pink Sheet)
  • Pfizer Signs Paxlovid Agreement As China Cases Soar (Scrip)
  • Which Coronavirus Vaccine Will Work in the Youngest Children? (NYT)
  • Mexico to uphold existing agreements for Russian COVID vaccine (Reuters)
Pharma & Biotech
  • Sanofi Cancer Drug Setback Hobbles Potential Blockbuster (Bloomberg) (Fierce)
  • Top 10 pharma R&D budgets in 2021 (Fierce)
  • BMS-Nektar’s Opdivo combo fails phase 3 in upset to once-largest licensing deal in biotech history (Fierce) (STAT)
  • BridgeBio plots path to market for muscular dystrophy drug after posting phase 2 data (Fierce)
  • After first FDA win last year, Ascendis touts a new PhIII success in hypoparathyroidism (Endpoints)
  • GMP-in-a-box company with Bob Nelsen backing lands $167M to develop its own cancer drugs (Endpoints)
  • With a make-or-break PhIII readout looming, a struggling Concert offloads a 'portfolio' of drugs (Endpoints)
Medtech
  • MDCG Meeting Updates Expected To Break Implementation Silence On EU IVDR (MedTech Insight)
  • Minute Insight: Philips’ Collaboration Live Ultrasound Platform Gets 510(k) For Mobile Devices (MedTech Insight)
  • Dexcom’s next-gen G7 diabetes sensor scores European approval (Fierce)
  • FDA upgrades Baxter infusion pump safety issues to Class I recall (Fierce)
  • ZimVie CEO talks company spinoff, new technologies (MedTech Dive)
Government, Regulatory & Legal
  • Key Opioid Cases To Watch As Massive Wave Of Trials Looms (Law360)
  • Balwani Wants Altered Theranos Pharma Reports Out Of Trial (Law360)
  • Cigna Gets $6 Million Covid Testing Reimbursement Suit Trimmed (Bloomberg)
  • SEC Puts US-Listed Chinese Biopharma Firms On Notice To Comply With 2020 Law (The Pink Sheet)
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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