Recon: FDA staff indicate support for full approval of Eisai Alzheimer’s drug; EU approves GSK’s RSV vaccine Arexvy

• Updated: FDA signals likely full approval for Eisai's new Alzheimer's drug ahead of Friday's adcomm (Endpoints) (Pink Sheet) (Reuters)
• AstraZeneca, Sanofi's RSV antibody set for FDA adcomm on Thursday (Endpoints)
• FDA shuts down Intarcia's requests to deviate from typical post-CRL hearing process (Endpoints)
• FDA Needs More Cell, Gene Therapy Mid Managers to Speed Reviews (Bloomberg)
• ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders (STAT) (Pink Sheet) (Endpoints)
• Weight-Loss Drug Coverage Deliberated by FDA, Medicare (Bloomberg)
• Senator Ron Wyden presses FDA and DEA on generic Adderall shortage (Endpoints)
• CDC comes under fire for inadequate information about its Covid response (STAT)
• Reanimated hearts donated after death work just as well for transplants, study finds (STAT)
• Rectal Cancer Patients Could Be Spared the Effects of Radiation (NYT)

• GSK’s RSV vaccine wins European approval (STAT) (Reuters) (Fierce)
• EMA Agrees Monovalent XBB Vaccines Best For Coming COVID-19 Campaigns (Pink Sheet)
• European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says (STAT) (Endpoints) (Reuters)
• France Trials Quicker Route To Patients For Innovative Medicines (Pink Sheet)
• Lords Call For UK Government To Secure A ‘Growth’ Pricing Deal With Pharma (Pink Sheet)
• China Further Tightens Oversight Of Human Genetic Research (Pink Sheet)
• Saudi Regulator Becomes First Arab Member Of PIC/S (Pink Sheet)

• Astellas takes another punt at tricky muscular condition despite past patient deaths (Fierce) (Endpoints) (STAT) (BioSpace)
• Samsung Biologics moves up plans to open its $1.5B+ plant (Endpoints)
• National cancer group reports widespread chemo shortages, calls on government and industry to help resolve them (Fierce)
• After missing vaccine glory in pandemic, GSK looks to dominate other diseases (STAT)
• Novartis sees Sandoz adding $3 bln in net sales over next five years (Reuters)
• Arvinas moves resistance-busting cancer drug into earlier settings after seeing signs of efficacy (Fierce)
• FibroGen faces more trouble in clinic as DMD drug fails phase 3 trial (Fierce)
• ASCO showcased the payoff for new cancer medicines: longer lives (STAT) (BioSpace)
• GSK employees to escalate strike action in June -union (Reuters)
• BIO: Moderna to test mpox vaccine in human this summer (Fierce)
• Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win (Fierce)
• Who pays the most (and least) in biopharma? We crunched median salary data from 175 companies (Endpoints)
• Fierce Biotech Layoff Tracker 2023: Oncorus lets go of almost all staff; Rain lays off 65% of staff (Fierce)

• Is The Implementation Of The EU Medtech Regulatory Structure Entering A New Phase? (MedTech Insight)
• Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic (MedTech Insight) (Fierce) (MedTech Dive)
• Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial (MedTech Dive)
• Akili Introduces Adult Version Of Video Game Therapy To Lessen ADHD Symptoms (MedTech Insight)

• Lilly, Takeda Face Class-Action Racketeering Lawsuit Over Diabetes Drug (BioSpace)
• Merck Suit Against Medicare: Constitutional Arguments Are Scathing, But Are They Persuasive? (Pink Sheet)
• Merck sued the US to block the drug pricing law. Will other pharma companies follow suit? (Endpoints)
• Moderna, Pfizer Face New Covid-Vaccine Patent-Royalty Lawsuits (Bloomberg)
• Regeneron Escapes Viatris Counterclaims Ahead of Patent Trial (Bloomberg)