Recon: CDC authorizes fourth COVID-19 vaccine; Merck’s Keytruda hit with a backhand after the header and n miss

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| July 20, 2022 | By Joanne S. Eglovitch

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Welcome to Regulatory Reconnaissance, your daily news outlet for regulatory news and intelligence.

In brief: United States

  • A fourth Covid vaccine is cleared for use in the United States. (NYT) (STAT) (Reuters)
  • ACIP’s nod to Novavax’s COVID vaccine comes with criticism of lack of expiration date packaging (The pink leaf)
  • The FDA’s deferral funds to pay staff through November, Burr says (Policy)
  • FDA slaps ImprimisRx with warning letter about sponsored articles in medical journals (Endpoints)
  • PhRMA and BIO descend on DC and unpack Senate FDA funding drama (STAT)
  • With a new CEO, Invitae is laying off more than 1,000 employees and reducing its international presence (Fierce)
  • An Abundance of CAR-Ts: $37 Billion Cell Therapy Cancer Market Can’t Sustain ‘Congested’ Pipeline, Says Report (Fierce)
  • Soaring overdose rates during the pandemic reflect widening racial disparities (NYT)
  • FDA Announces External Review of Food and Tobacco Regulatory Offices (Policy)

Focus: International

  • CTIS: EU member states request prior ‘warning’ on lead evaluator requests (The pink leaf)
  • The European Health Emergency Response Authority appeals to the non-patent sector (The pink leaf)
  • High-stakes meetings with EMA in store for sponsors of EU filings (The pink leaf)
  • EU signs COVID drug supply agreement with Gilead (Reuters)
  • llumina fails to block EU antitrust review of $8 billion Grail merger (MedTech Diving) (Bloomberg)
  • WHO reports 14,000 cases of monkeypox worldwide, five deaths in Africa (Reuters)
  • With monkeypox spreading around the world, many experts believe the virus cannot be contained (STAT)
  • Japanese health panel delays emergency approval of Shionogi COVID-19 pill (Reuters)
  • China’s compliance risks in the spotlight as digital tools spread (The pink leaf)
  • Policies that could lead to the growth and competitiveness of Korean biopharmaceuticals (The pink leaf)
  • Pharma’s new “Berlin Declaration” aims to reserve vaccines and therapeutics in production for low-income countries (Endpoints)
  • MDMA psychotherapy trial paused after Health Canada inspection (Endpoints)
  • Vaccine group urges African states to request aid for malaria vaccine (Reuters)

Pharmaceuticals and biotechnology

  • WuXi Biologics serves the $1.4 billion expansion of the research and manufacturing center in Singapore (Endpoints)
  • Keytruda hit with a second PhIII backhand this year as Merck’s blockbuster flopped some head and neck tries (Endpoints) (Biospace) (Fierce) (Reuters)
  • BioMarin targets European gene therapy market after US setback (Bloomberg)
  • Diversity of clinical trials: PhRMA, Academia Lay Foundation For Network Of Community-Based Sites (The pink leaf) (PhRMA)
  • Biogen Axes Schizophrenia Program, touts potential for next Alzheimer’s drug (Biospace) (Endpoints)
  • San Francisco cell therapy player lays off 94 staff pending data on lead candidate (Endpoints)
  • Top 10 game-changing biotech layoffs in the first half (Fierce)
  • Novartis drops key PD-1 bid, while touting “significant M&A firepower” (Endpoints)
  • Growing demand for organ-on-a-chip services drives CN Bio’s expansion (Fierce)

medical technology

Government, regulation and legal

  • US announces $1.2 billion healthcare crackdown linked to telehealth and cardiovascular testing (Reuters)
  • Biogen pays $900 million to solve MS whistleblower bribe as competition slows sales (Fierce)
  • Amgen, GSK, Regenxbio and others urge SCOTUS to review ‘damaging’ decision on biomedical patents (Endpoints)
  • Daiichi Sankyo deliberately infringed Seagen’s patent by creating Enhertu, court rules (Fierce)
  • (Bloomberg)
  • Clinical Labs Group wins appeal in Medicare payment case (Overview of medical technologies)

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

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

© 2022 Society of Regulatory Affairs Professionals.


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