Recon: FDA staff indicate support for full approval of Eisai Alzheimer’s drug; EU approves GSK’s RSV vaccine Arexvy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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