Recon: UK approves fifth COVID vaccine with Novavax approval; Lilly delays timeline for submitting Alzheimer’s drug application

ReconRecon | 03 February 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Ex-Pfizer researchers stole secrets to launch diabetes drug, lawsuit says (Reuters) (Endpoints) (STAT)
  • Licensed Drug Distributors Would Get More Scrutiny in FDA Plan (Bloomberg)
  • Eli Lilly pushes back timeline for Alzheimer's drug application (Reuters)
  • FDA will rigorously review vaccines for children under 5, surgeon general says (Washington Post) (NYT)
  • Biden’s relaunched cancer moonshot needs funding for liftoff (Politico)
  • Merck sees 2022 sales up nearly 20%, mostly on new COVID pill (Reuters)
  • UPenn sues Genentech over patent infringement with four cancer drugs (Endpoints)
  • Key lawmaker: ARPA-H won’t be part of NIH (STAT)
  • The Politics Of US FDA Advisory Committees (The Pink Sheet)
  • Price of COVID treatments from Pfizer, Merck, GSK align with patient benefits -report (Reuters)
  • Biogen 2022 forecast below Street view on Alzheimer's drug uncertainty (Reuters)
In Focus: International
  • UK Drug Regulator Approves Novavax Covid-19 Shot (Bloomberg) (Reuters)
  • EU to ease rules on COVID pass to remove hurdle for vaccine trials (Reuters)
  • EU watchdog says supports fast development of Omicron-only vaccine (Reuters)
  • PhRMA goes on the offensive, attacking the WHO and putting the EU, UK, Australia and others on notice (Endpoints)
  • Roche says aiming to provide clarity on Alzheimer's drug efficacy (Reuters)
Coronavirus Pandemic
  • Global diplomatic failure made COVID 'far worse', says leading expert (Reuters)
  • Africa must speed up vaccinations despite perception Omicron is milder, WHO says (Reuters)
  • German vaccine commission backs Novavax COVID vaccine for adults (Reuters)
  • In world first, S. Africa's Afrigen makes mRNA COVID vaccine using Moderna data (Reuters)
  • Singapore approves Pfizer's oral COVID-19 medicine Paxlovid (Reuters)
  • US to cover cost of over-the-counter COVID tests through Medicare (Reuters) (Washington Post)
Pharma & Biotech
  • Slowing COVID-19 Sales Will Drag On Roche In 2022 (Scrip)
  • Eli Lilly results beat on diabetes drug, COVID antibody therapies (Reuters)
  • 2022 Will Be A Test For Gilead, Starting with TROPiCS-2 Study Of Trodelvy (Scrip)
  • J&J’s Janssen inks $1B biobucks pact for Mersana’s ADC tech in 3 targets (Fierce)
  • Dewpoint, with a handful of Big Pharma partners from Merck to Pfizer, collects $150M to advance its 20 programs (Fierce)
  • J&J discontinues work on eczema drug, leading to $610M in impairment charges for ex-XBiotech asset (Fierce) (Endpoints)
  • AbbVie's Gonzalez: Skyrizi and Rinvoq to become Humira 2.0 — while adding an indication for atopic dermatitis (Endpoints)
  • AstraZeneca punts midphase cardiovascular prospect to startup (Fierce)
  • Amgen, looking for a path into red-hot 'molecular glues,' inks a deal with Plexium for 2 programs, potentially more (Endpoints)
  • Rajeev Venkayya, Takeda’s longtime vaccines chief, departs to lead a stealth pandemic-focused biotech (Endpoints)
  • Al Sandrock makes his first post-Biogen move, joining turnaround effort at a troubled gene therapy startup (Endpoints)
  • Searching for CRISPR 2.0, Intellia spends $45M cash on an unknown Berkeley spinout (Endpoints)
  • With cancer biomarkers, experts say the future has finally arrived (STAT)
  • A scientific pioneer finds herself on the sidelines of the race in xenotransplantation (STAT)
Medtech
  • JAMA: ‘General Wellness’ Apps Could Pose Patient Safety Quandary (MedTech Insight)
  • Quest CEO Rusckowski to step down after a decade, following record-setting 2021 (Fierce)
  • BD's Q1 revenue beats Street despite COVID-19 testing decline (MedTech Dive)
  • Siemens Healthineers ups 2022 forecast after COVID-19 test boom, but sees increased competition (MedTech Dive)
  • Thermo Fisher, Hologic plan for extended test demand in 2022 (MedTech Dive)
Government, Regulatory & Legal
  • Ex-Drug Co-Op CEO Convicted In Landmark Opioid Case (Law360)
  • Drug Distributor Stymied On FDA Topics In Wash. Cross Trial (Law360)
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.

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

5;6;11;16;18;20;25;31;