Recon: UK approves fifth COVID vaccine with Novavax approval; Lilly delays the deadline to submit A

Posted on February 03, 2022 | Through Michael Mezher

Welcome to Regulatory Reconnaissance, your daily update on regulatory news and intelligence.

In brief: United States

  • Former Pfizer researchers stole secrets to launch diabetes drug, lawsuit says (Reuters) (Endpoints) (STAT)
  • Licensed drug distributors would face greater scrutiny under the FDA plan (Bloomberg)
  • Eli Lilly pushes back timeline for Alzheimer’s drug demand (Reuters)
  • FDA Will Rigorously Review Vaccines for Children Under 5, Surgeon General Says (Washington Post) (NYT)
  • Biden’s revived cancer moonshot needs funding to get off the ground (Politico)
  • Merck sees sales in 2022 increase by almost 20%, mainly on the new COVID pill (Reuters)
  • UPenn sues Genentech for patent infringement with four cancer drugs (Endpoints)
  • Key legislator: ARPA-H will not be part of NIH (STAT)
  • US FDA Advisory Committee Policy (The Pink Sheet)
  • Pricing of COVID treatments from Pfizer, Merck and GSK aligns with patient benefits – report (Reuters)
  • Biogen 2022 forecast below Street View on Alzheimer’s disease drug uncertainty (Reuters)

Focus: International

  • UK medicines regulator approves Novavax Covid-19 Shot (Bloomberg) (Reuters)
  • EU eases rules on COVID pass to remove barriers to vaccine trials (Reuters)
  • EU watchdog says it backs rapid development of an Omicron-only vaccine (Reuters)
  • PhRMA goes on the offensive, attacks WHO and warns EU, UK, Australia and others (Endpoints)
  • Roche says it wants to clarify the effectiveness of drugs against Alzheimer’s disease (Reuters)

Coronavirus pandemic

  • Global diplomatic failure has made COVID ‘much worse’, says leading expert (Reuters)
  • Africa must speed up vaccinations despite perception that Omicron is milder, WHO says (Reuters)
  • German vaccine commission backs Novavax COVID vaccine for adults (Reuters)
  • In a world first, South Africa’s Afrigen is making a COVID mRNA vaccine using data from Moderna (Reuters)
  • Singapore approves Pfizer’s oral COVID-19 drug Paxlovid (Reuters)
  • US to cover cost of over-the-counter COVID tests through Medicare (Reuters) (Washington Post)

Pharmaceuticals and biotechnology

  • COVID-19 sales slowdown will drag Roche into 2022 (Scrip)
  • Eli Lilly results beat diabetes drugs and COVID antibody therapies (Reuters)
  • 2022 will be a test for Gilead, starting with the TROPiCS-2 study by Trodelvy (Scrip)
  • J&J’s Janssen signs $1 billion biobucks deal for Mersana’s ADC technology in 3 targets (Fierce)
  • Dewpoint, along with a handful of Big Pharma partners from Merck to Pfizer, is raising $150 million to advance its 20 programs (Fierce)
  • J&J halts work on eczema drug, resulting in $610 million in impairment charges for former XBiotech (Fierce) asset (Endpoints)
  • AbbVie’s Gonzalez: Skyrizi and Rinvoq will become Humira 2.0 — while adding an indication for atopic dermatitis (Endpoints)
  • AstraZeneca launches mid-stage cardiovascular perspective at startup (Fierce)
  • Amgen, searching for path to glowing ‘molecular glues’, signs deal with Plexium for 2 programs, potentially more (Endpoints)
  • Takeda’s longtime vaccine chief Rajeev Venkayya leaves to lead pandemic-focused stealth biotech (Endpoints)
  • Al Sandrock takes his first step after Biogen, joining the turnaround effort of a struggling gene therapy startup (Endpoints)
  • In search of CRISPR 2.0, Intellia spends $45 million in cash on an unknown Berkeley spin-out (Endpoints)
  • With cancer biomarkers, experts say the future has finally arrived (STAT)
  • A scientific pioneer finds herself on the sidelines of the xenotransplantation race (STAT)

medical technology

  • JAMA: “General wellness” apps could pose patient safety dilemma (MedTech Insight)
  • Quest CEO Rusckowski to step down after a decade, following 2021 record (Fierce)
  • BD’s Q1 revenue tops Street despite drop in COVID-19 testing (MedTech Dive)
  • Siemens Healthineers raises 2022 forecast after COVID-19 testing boom, but sees increased competition (MedTech Dive)
  • Thermo Fisher and Hologic anticipate expanded test demand in 2022 (MedTech Dive)

Government, regulation and legal

  • Ex-drug co-op CEO convicted in landmark opioid case (Law360)
  • Drug distributor stuck on FDA subjects in Washington crossover trial (Law360)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.

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