Recon: EMA to discuss Pfizer, Moderna bivalent boosters on 1 September; AstraZeneca on the hunt for new deals

ReconRecon | 23 August 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Califf: The FDA and the Clinical Community (JAMA)
  • Pfizer seeks U.S. authorization for vaccine booster retooled for Omicron (Reuters) (STAT)
  • Pfizer's COVID vaccine 73.2% effective in kids under 5, new data shows (Reuters)
  • Foghorn downgraded to full clinical hold, with more patent deaths clouding AML, MDS trial (Fierce) (Endpoints) (Biospace)
  • U.S. CDC recommends use of Novavax's COVID shot for adolescents (Reuters)
  • Merck, seeking XI factor in race with Bayer, gets FDA fast-track tag for anticoagulant (Fierce)
  • U.S. plan to stretch monkeypox vaccine supply already hitting hurdles (STAT)
  • In Trials We Trust: US FDA’s Pazdur Urges Diversity To Build Confidence In Medicine (Pink Sheet)
  • Time To Focus On GMP Activities Deferred By Pandemic, CDER Compliance Director Says (Pink Sheet)
  • N.Y. State Getting Fewer Monkeypox Vials Per New US Strategy (Bloomberg)
In Focus: International
  • EU regulator to discuss Moderna, Pfizer Omicron shots applications on Sept 1 (Reuters)
  • AstraZeneca on hunt for deals, but may not stay in vaccines (Reuters)
  • EMA To Up Transparency On Drug Safety By Publishing Risk Management Plans In Full (Pink Sheet)
  • Years after Sanofi's Dengvaxia fiasco, Takeda lands first OK for its own dengue vaccine (Endpoints)
  • Pfizer Picks China Firm Involved in Drug Recall for Covid Pill (Bloomberg)
  • Analysis: Experts question reliance on monkeypox vaccine with little data, short supply (Reuters)
  • Delisting Looms As More US-Listed China Companies Seek To Move Closer Home (Scrip)
  • British scientists behind key COVID trial launch study to test monkeypox treatment (Reuters) (Endpoints)
  • Mexico to protest to U.N. over missing COVAX vaccines (Reuters)
  • EU, UK & Brazil Take Steps To Boost Access To Monkeypox Vaccines (Pink Sheet)
Pharma & Biotech
  • Hospira’s recall, Teva’s shuttering of troubled plant tighten supply pinch on propofol (Fierce)
  • Atara set to lay off 77 in California as company seeks to reduce cash burn, transition into new phase (Endpoints)
  • AstraZeneca's Soriot warns new U.S. drug price law will hurt innovation (Reuters)
  • Novo Nordisk Combo Bests Monotherapies in Type II Diabetes Weight Loss (Biospace)
  • Thermo Fisher opens new $105M biologics manufacturing site outside of Nashville (Endpoints)
  • Mereo Under Fire As Shareholder Unrest Erupts (Scrip)
  • Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline (Fierce)
  • Faster drug approval route sparks investment in rare kidney disease treatments (STAT)
  • US contract manufacturer’s Covid-19 vaccine success and facility expansion wooed Bavarian Nordic (MedWatch)
  • Regen BioPharma files patent on mRNA cancer immunotherapy vaccine (BioPharma Reporter)
  • Innovation Hubs are Driving Economic Growth Across the US (Biospace)
  • Scientists are racing to develop home tests that measure protection against Covid-19 (STAT)
  • CEO of Michigan CDMO explains how he nabbed monkeypox vaccine contract (Endpoints)
  • Not all cancer associated fibroblasts are created equal- some promote, some suppress drug resistance (Fierce)
  • Medical device industry poised to withstand an economic slowdown, experts say (MedTech Dive)
  • Medtronic still eyeing modest year-over-year growth as fiscal 2023 kicks off with slipping revenues (Fierce)
  • Laser vision correction procedures fell 16% in the second quarter (MedTech Dive)
  • Akili raises $163M in ‘blank-check’ merger, plans to commercialize digital treatment for ADHD (MedTech Dive)
  • Medtronic’s New Legal Chief Got %11.7 Million After 3M Departure (Bloomberg)
  • Ladies! Meet Movano: The Fashion-Forward Smart Ring Backed By Medical-Grade Accuracy (MedTech Insight)
Government, Regulatory & Legal
  • Baxter Loses Patent Suit on Becton Dickinson Drug-Transfer Tech (Bloomberg)
  • Mifepristone Restriction Suit Might Be Refiled In Another Court After GenBioPro Drops Challenge (The Pink Sheet)
  • Using FOIA to Compel Federal Agencies to Prove Claims (Bloomberg)
  • Medication abortion manufacturer withdraws Mississippi lawsuit (Endpoints)
  • High Court Wants US View on Drug Fraud Claims Against SuperValu (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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