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

• 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)

• 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)

• 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 2^nd 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)

• Boston Scientific Owed $42 million as Stents Infringe Patent (Bloomberg)