Recon: FDA approves 2mg dose of Novo’s diabetes drug Ozempic; Vaccine industry facing slowing demand, possible glut of COVID-19 vaccines

• 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)