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August 10, 2023
by Jason Scott

Recon: FDA Oks J&J’s Talvey for blood cancer; Novo agrees to buy obesity drugmaker Inversago for $1B

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • US FDA approves Johnson & Johnson's blood cancer therapy (Reuters) (Endpoints)
  • Obesity drug data could boost companies' case for US coverage (Reuters)
  • US hospital pharmacists ration drugs as shortages persist – survey (Reuters)
  • ‘Underwhelming’: NIH trials fail to test meaningful long Covid treatments — after 2.5 years and $1 billion (STAT)
  • Genentech weighs slow-walking ovarian cancer therapy to make more money under drug pricing reform (STAT)
  • Tainted Medication Fears Spur US Defense Department to Seek Outside Testing (Bloomberg)
  • Decentralized Trials: Stakeholders Press FDA On Design Flexibility, Role Of HCPs, Harmonization (Pink Sheet)
  • New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination (Pink Sheet)
In Focus: International
  • BioNTech and Twitter warned by PR body for trying to duck COVID-19 vaccine debate (Fierce Pharma)
  • Bumps On The Path To EU Harmonized Standards Path As Stakeholders Demand Speedier Progress (MedTech Insight)
  • Pakistan Acts To Harmonize Disclosure Of Medtech Payments To Doctors (MedTech Insight)
  • Coronavirus Notebook: WHO Issues New Recommendations On Access To COVID-19 Products Amid Spread Of New EG.5 Variant (Pink Sheet)
  • Regulators Still To Get To Grips With Neurodegenerative Outcome Measures (Pink Sheet)
  • How Do Japan’s Clinical Trial eConsent Rules Compare With The EU And US? (Pink Sheet)
  • Rare Diseases: European Market Access ‘Better Organized’ Than US, Says Rhythm (Pink Sheet)
Pharma & Biotech
  • Novo eyes other health benefits from weight-loss drug Wegovy after major trial (Reuters)
  • Novo Nordisk CEO sees US supply curbs on weight-loss drug Wegovy into 2024 (Reuters) (STAT)
  • Novo Nordisk to acquire obesity drug developer Inversago (Reuters) (BioSpace)
  • Pharma budget tightening trickles down to Doximity (STAT)
  • Anavex, maker of rare disease drug, keeps shifting the goalposts in its clinical trials (STAT)
  • DNA-sequencing giant Illumina slashes 2023 revenue projections (STAT)
  • Regeneron dials up in gene therapy with Decibel deal (Pharmaphorum) (BioSpace)
  • Exclusive: AstraZeneca’s outgoing R&D chief Mene Pangalos reflects on a 14-year R&D turnaround and the industry's future (Endpoints)
  • Galera Therapeutics to cut 70% of staff in wake of rejection for radiotherapy complication treatment (Endpoints)
  • Emergent commits to layoffs and C-suite trimmings, no longer focusing on CDMO activity (Endpoints)
  • Novartis Scores Phase III Chronic Hives Wins as Sanofi Challenges (BioSpace)
  • Mirati CEO Steps Down After Going Toe-to-Toe with Amgen in KRAS (BioSpace)
  • Bluebird Pins Hopes on Zynteglo Uptake, FDA Verdict Amid Cash Constraints (BioSpace)
  • Regeneron's high-dose Eylea shows staying power as company awaits FDA decision (Fierce Pharma)
  • Dyslipidemia space to 'undergo a massive shake-up,' but pharmas must price new drugs carefully: report (Fierce Pharma)
  • Despite mounting failures, analysts see NASH market as holding 'enormous untapped potential' (Fierce Pharma)
  • Elevidys Clinical Development: Confidence In Surrogate Endpoint A Longstanding Concern For FDA Reviewers (Pink Sheet)
Medtech
  • Boston Scientific receives FDA approval for cryoablation system (MedTech Dive)
  • Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts (MedTech Dive)
  • Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations (MedTech Dive)
  • Elon Musk’s brain implant company raises $280M to fund clinical trials (MedTech Dive)
  • Guardant, Illumina agree to end litigation, extend commercial partnership (MedTech Dive)
  • July Warning Letter Prompts Pause In Dialysis Accessory Distribution (MedTech Insight)
Government, Regulatory & Legal
  • CDC director overhauls leadership of center that oversaw response to Covid-19 (STAT)
  • Companies Advised To ‘Re-Think’ SPC & Regulatory Strategies For ‘Loose’ Combination Products (Pink Sheet)
  • Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant (Fierce Pharma)
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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