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)
- 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)
- 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)
- 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)
- 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)
- 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)
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