Recon: US FDA gives thumbs up to GSK anemia drug; Vax makers kept $1.4 billion in COVID shot prepayments

ReconRecon | 02 February 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Approves Glaxo’s Jesduvroq as Oral Treatment for Anemia (Reuters) (Endpoints)
  • COVID-19 tracker: Merck pill linked to new mutations, study says (Fierce) (Bloomberg)
  • FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test (Inside Health Policy) (Endpoints)
  • What Changes When the COVID Emergency Ends in May? (MedPage Today)
  • Moderna Booster Vaccine Singled Out for Chronic Hives (MedPage Today)
  • Challenges Limit Ability to ID Cause of Pandemics, GAO Finds (Bloomberg)
  • Mailing abortion pills could break law, Republican AGs tell pharmacies (Reuters)
  • The IRA And US FDA: How Will Agency View Any Drug Development Changes? (Pink Sheet)
  • Innovation, investment in pain and addiction are not meeting the societal burden, report says (Fierce)
In Focus: International
  • Vaccine Makers Kept $1.4 Billion in Prepayments for Canceled Covid Shots for the World’s Poor (NYT) (Yahoo News)
  • Europe pharma sector risks lagging the world, say drug chiefs (MedWatch)
  • Draft WHO pandemic deal pushes for equity to avoid COVID ‘failure’ repeat (Reuters)
  • Germany drops to no. 2 WHO donor despite new pledge for $140 mln (Reuters)
  • Next UK Drug Pricing Scheme Needs ‘Single-Digit Fixed Rebates’ (Pink Sheet)
  • In a health system in crisis, Britain’s heart care suffers (Reuters)
  • Generics: a missing piece in China’s Covid-19 crisis response (STAT)
Pharma & Biotech
  • GSK Exceeded Expectations In 2022, Now Looking For Edge Over Pfizer In RSV Battle (Scrip)
  • Eli Lilly raises 2023 expectations (MedWatch)
  • Bristol Myers’ profit beats on better-than-feared Revlimid sales (Reuters)
  • CDC warns EzriCare eyedrops may be linked to bacterial infections, 1 death (Washington Post)
  • Incoming Roche CEO builds out his top team, tapping Genentech vet to lead pharma division (Endpoints)
  • Roche Sees Falling Sales, Profit as Covid Windfall Ebbs (Bloomberg)
  • Mesoblast gives allogenic cell therapy a 2nd try with FDA-but without a new trial (Fierce)
  • Pfizer brings Ibrance to new subset of breast cancer patients, regardless of menopausal status (Endpoints)
  • BioNTech Strengthens Manufacturing Capabilities with First In-House Plasmid DNA Manufacturing Facility (Biospace) (Reuters)
  • Lilly drops 2nd program against NASH target that caught Pfizer’s eye (Fierce)
  • Cell therapy biotech shifts focus to UK, makes deep cuts to US headcount (Endpoints)
  • Going blockbuster hunting, Vas Narasimhan outlines vision for ‘pure-play’ Novartis (Endpoints)
  • Inovio hopes Ebola vaccine booster data can provide a shot in the arm (Fierce)
  • Supply issues to continue in 2023, reports Novo Nordisk (MedWatch)
  • GreenLight's mRNA vaccine nabs trial OK; Ratio reels in radiotherapy funds (Endpoints)
  • After a busy year of buildouts, Thermo Fisher sets plans for growth in 2023 (Endpoints)
  • EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled (MedTech Insight)
  • Q&A Guidance Document Discusses Laser Product How-Tos (MedTech Insight)
  • Axonics clears FDA to bring latest version of 20-year neurostim implant to US (Fierce)
  • What We Have Here Is A Failure To Communicate (MedTech Insight)
  • ‘The worst is behind us’: Amid mounting order backlog, Stryker beats own estimates with $18.4B in 2022 sales (Fierce) (MedTech Dive)
  • Siemens Healthineers forecasts revenue growth to accelerate despite supply chain woes (MedTech Dive)
  • Boston Scientific’s endoscope sales beat predictions (MedWatch)
  • Baxter links up with Miromatrix to test bioengineered liver replacement therapy (Fierce)
Government, Regulatory and Legal
  • Boston Scientific Owed $42 million as Stents Infringe Patent (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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