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September 28, 2023
by Jason Scott

Recon: J&J’s lung cancer combo bests AstraZeneca’s Tagrisso in study; Galen robot gains clearance for ENT surgeries

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

In Focus: US
  • FDA advisers vote overwhelmingly against ALS treatment from BrainStorm (STAT)
  • Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts (Reuters)
  • Ozempic label now notes potential side effect of intestinal blockage (Reuters)
  • Did the government get a bad deal on the Covid-19 boosters? (STAT)
  • US channels $104m into antimicrobial resistance project (Pharmaphorum)
  • Flu, Covid vaccination rates decline, as U.S. health officials make new push for inoculations (STAT)
  • As government shutdown looms, medical device reviews expected to continue (MedTech Dive)
  • 'We can't forget about this': As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions (Fierce Pharma)
  • UPDATED: Will Big Pharma engage in Medicare price negotiations? Merck, AZ and BMS say they will (Fierce Pharma)
 
In Focus: International
  • Pharma lobby says EU ban on 'forever chemicals' would halt drug production (Reuters)
  • Schott Pharma shares jump 11% on Frankfurt trading debut (Reuters)
  • Commission Text Clarifying Timelines For Annex XVI Devices May Leave Companies Dazed (MedTech Insight)
  • Hermes Pharma earmarks €25M to expand oral drug production capacity (Fierce Pharma)
 
Pharma & Biotech
  • A STAT analysis shows how top drug companies are starting to take action on climate (STAT)
  • Biogen shutters digital health group, nixes Apple study, as part of cost cuts (STAT)
  • Gene therapy death was caused by an unknown risk of the virus used, study suggests (STAT)
  • Newer antibiotic effective against deadly staph infection in trial (Reuters)
  • GSK lifts growth target for HIV business on demand for long-acting drug (Reuters)
  • J&J's lung cancer therapy succeeds in head-to-head study with AstraZeneca's drug (Reuters)
  • Bluebird taps Lonza to boost manufacturing capacity for its gene therapies Zynteglo, Skysona (Fierce Pharma)
  • Regulatory tracker: Akebia refiles oral anemia drug with FDA (Fierce Pharma)
 
Medtech
  • Machine learning could help predict risk of preterm birth using wearables data (STAT)
  • Harbinger Health raises $140M to study blood-based cancer screening test (MedTech Dive)
  • Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales (MedTech Dive)
  • Galen robot gets FDA de novo clearance for ENT surgeries (MedTech Dive)
  • Minute Insight: Vicarious’ Future Gets Precarious (MedTech Insight)
  • Oxford Biodynamics Releases EpiSwitch Prostate Cancer Test Early (MedTech Insight)
 
Government, Regulatory & Legal
  • CVS Faces Suit from Local Pharmacy Over ‘One-Sided’ Contracts (Bloomberg Law)
  • CureVac claims advantage in BioNTech patent dispute (Pharmaphorum)
  • Drug industry payments to eye docs boosted Medicare spending on pricier treatments (STAT)
  • Congress could stop free public access to government-funded research (STAT)
  • FDA’s International Harmonization Plan Points To Ongoing Priorities (MedTech Insight)
 
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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