Recon: FDA approves 2mg dose of Novo’s diabetes drug Ozempic; Vaccine industry facing slowing demand, possible glut of COVID-19 vaccines
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA authorizes second coronavirus booster shot for people 50 and older (Washington Post) (Reuters) (Bloomberg)
- FDA approves Novo Nordisk's diabetes drug Ozempic in 2 mg dose (Reuters) (Pharmacy Times)
- Amylyx’s ALS Drug Brings Questions On Efficacy Data Robustness To US FDA Panel (The Pink Sheet) (STAT)
- US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch (The Pink Sheet)
- House to Vote on Insulin Cap as Senators Seek Bipartisan Deal (Bloomberg)
- FDA calls for Hatch-Waxman tweak, accelerated approval reforms in President Biden's 2023 budget proposal (Endpoints)
- World Moves From Shortages to Possible Glut of Covid-19 Vaccines (Bloomberg) (Pharmaceutical Technology)
- EU starts real-time review of Hipra's COVID vaccine (Reuters)
- J&J to suspend supply of personal care products to Russia (Reuters)
- Roche loses money in Russia, chief executive says (STAT)
- Sweden Says Yes To Vazkepa Reimbursement But England Says No For Now (The Pink Sheet)
- New UK Drug Applications At ‘Sustained Levels’ Post-Brexit (The Pink Sheet)
- GSK and Medicago have global plans for their Covid-19 vaccine. But WHO balks at Big Tobacco investor (Endpoints)
- Explainer: Omicron 'stealth' COVID variant BA.2 now dominant globally (Reuters)
- ‘A slow-moving glacier’: NIH’s sluggish and often opaque efforts to study long Covid draw patient, expert ire (STAT)
- What to know about the omicron variant and subvariant BA.2 (Washington Post)
- Pfizer’s $7B ulcerative colitis, drug racks up another phase 3 win, laying the groundwork for approval filings (Fierce)
- IGM Biosciences and Sanofi enter deal with USD 6bn potential (MedWatch)
- Slammed with fresh clinical failure, Biogen and Ionis discard early-stage ALS candidate (Endpoints) (Fierce)
- Sanofi targets Dupixent peak sales of over 13 billion euros (Reuters)
- With Bristol Myers in its sights, Pfizer declares itself the winner in the S1P drug race to come — but you’ll have to wait for proof (Endpoints)
- Top Five Takeaways From World's Largest Dermatology Conference (Scrip)
- Deal Watch: Lilly, Innovent Build On Long Alliance To Partner On Three Cancer Drugs (Scrip)
- Boston Tops Bay Area to Lead U.S. Life-Sciences Lab Construction (Bloomberg)
- CytoImmune Therapeutics opens clinical cell manufacturing facility in Puerto Rico (BioPharma Reporter)
- New MDR Notified Body Designations Pending, But None Under IVDR Until Late 2022 (MedTech Insight)
- FDA’s FY 2023 Proposed Budget Asks For Millions To Curb Device Shortages, Bolster Cybersecurity, And More (MedTech Insight)
- Osso VR lands $66 million to grow its virtual reality platform to train surgeons (STAT)
- Fresensius Sues Zydus Over Patents for Rare Thyroid Disease Drug (Bloomberg)
- Opioid Pill Peddling Case Threatens Future of Pain Treatment (Bloomberg)
- GreenSky to Defend ‘Stem Cell” Financing Suit in Federal Court (Bloomberg)
- Plaintiffs sue Ellume over 'ill-gotten gains' from recalled COVID-19 tests (MedTech Dive)
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