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)
- 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)
- 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)
- 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)
- 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)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
