Approval

UK Approves Fifth COVID Vaccine With Novavax Approval Lilly Delays Timeline For Submitting Alzheimers Drug Application

February 07,2022 10:13 AM
- By Admin

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)