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March 16, 2022
by Joanne S. Eglovitch

Recon: Pfizer seeks FDA authorization for second COVID-19 booster shot for people 65 and older; Growing list of drugmakers cutting Russia investments

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer and BioNTech seek authorization of second coronavirus booster shot for people 65 and older (Washington Post) (Endpoints)
  • Biogen says Aduhelm reduces Alzheimer's indicators in long-term trial (Reuters) (STAT)
  • CDER, CBER Staff Say Pandemic Had Negative Effect On Hiring, Retention (The Pink Sheet)
  • Warren: Drug Makers Give Misleading Info on High Drug Prices (Bloomberg)
  • White House begs Congress for Covid funding amid concern about Omicron sister variant (STAT) (The Pink Sheet)
  • Ex-JHL Execs Sentenced to Prison for Stealing Genentech Secrets (Bloomberg)
  • Lawmakers and PhRMA trade accusations of ‘misleading’ information on drug price hikes (STAT)
In Focus: International
  • Novartis, Eli Lilly and AbbVie join growing list of Big Pharmas severing ties with Russia (Endpoints)
  • Europe begins reviewing application for AstraZeneca COVID drug (Reuters)
  • EU, India, South Africa, US Reach Vaccine TRIPS Waiver Deal (Law360) (Reuters)
  • Merck pauses Russia investments, to supply essential medicines (Reuters)
  • EU plans to buy measles, polio vaccines for Ukraine refugees (Reuters)
  • Cytiva opens doors at Cardiff site as part of $1.5B global expansion (Endpoints)
  • Concerns over sanctions latest blow to China biotechs (BioCentury)
  • In U-turn, U.S. backs WHO budget overhaul, but LatAm is opposed – sources (Reuters)
  • WTO chief welcomes COVID shot patent plan, drugmakers balk (Reuters)
Coronavirus Pandemic
  • A compromise is reached on an intellectual property waiver for Covid-19 vaccines, but does it go far enough? (STAT)
  • Lawmakers push pandemic probe modeled on 9/11 Commission (Washington Post)
  • As Virus Data Mounts, the J.&J. Vaccine Holds Its Own (NYT)
  • Germany to secure COVID-19 vaccine production through 2029 (Reuters)
  • Japan to buy 145 mln Pfizer, Moderna COVID vaccines for 4th shots -Kyodo (Reuters)
  • Sinovac COVID vaccine 38% effective in young kids - Chilean study (Reuters)
  • India rolls out COVID vaccine doses for children aged 12-14 (Reuters)
Pharma & Biotech
  • Back to the fundamentals: Frazier rolls out $1B fund to ramp up a new slate of biotech startups (Endpoints)
  • Trying to nip at AstraZeneca's heels, Lilly and Boehringer Ingelheim stop a PhIII Jardiance study early in kidney disease (Endpoints)
  • Rare Setback For Merck & Co And AstraZeneca’s Keytruda-Lynparza Combo In Prostate Cancer (Scrip)
  • With clinical holds lifted, Aprea embarks on ‘show me’ year for key cancer candidates (Fierce)
  • Biogen jettisons AMD drug, providing Catalyst for ex-partner’s hunt for strategic alternatives (Fierce)
  • An Altos Labs rival? Genentech throws its hat into buzzy 'cellular rejuvenation' field (Endpoints)
  • Sanofi steps off the sidelines to ink 3 ADC deal with Seagen, reigniting long-held interest in the modality (Fierce)

Medtech

  • Some 20 Key EU Guidance Documents Still Needed For MDR And IVDR Implementation (MedTech Insight)
  • FDA Approves First Generic of Symbicort to Treat Asthma and COPD (FDA)
  • US replaces EU as priority market for medtech industry: survey (MedTech Dive)
  • Minute Insight: Abbott’s Libre 3 Breaks In To UK Market (MedTech Insight)
Government, Regulatory & Legal
  • Kansas court preliminarily approves Viatris' $264M EpiPen settlement (Endpoints)
  • Teva Migraine Drug Patent Suit Against Eli Lilly Can Proceed (Bloomberg)
  • J&J’s DePuy Synthes found guilty of infringing orthopedic device patent in $20M verdict (Fierce)
  • Ultrasound Provider Fails to Nix Philips Medical Hacking Lawsuit (Bloomberg)
  • Jury Empaneled In Ex-Theranos Exec Balwani’s Fraud Trial (Law360)
  • Walgreens Hit With Prescription Drug Fraud Suit by Blue Cross  (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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