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E4 Pharmaceutical Consulting

E4 Biotechnology and Pharmaceutical Consulting. Providing product development (CMC), regulatory, QA/QC and project management support to companies developing new small-molecule drugs, biologics and medical devices.

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E4 Pharmaceutical Consulting

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RSS FDA News

  • FDA Publishes Guidances on Amendments for Tentative ANDAs, CRL Responses
    The FDA has issued two guidances to help generic drug applicants through the abbreviated new drug application (ANDA) process, including a final guidance on the preferred timing and content for changes to tentatively approved applications.
  • Australia to Allow More Self-Test IVDs
    Australia plans to make more in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza beginning Oct. 1, although self-tests for cancer and genetic testing will not be allowed to be sold to consumers, the Therapeutic Goods Administration (TGA) said.
  • Operation Warp Speed Science Chief Supports Stricter EUA Reviews for COVID-19 Vaccines
    Operation Warp Speed, the Trump administration’s COVID-19 vaccine and treatment initiative, is in “full alignment” with the FDA raising the bar on what’s required for an Emergency Use Authorization of a COVID-19 vaccine, the top adviser to the initiative says. That contradicts what President Trump has been saying.
  • Gilead Settles Letairis Kickback Allegations for $97 Million
    “This settlement demonstrates the government’s commitment to hold accountable companies that pay illegal kickbacks, whether directly or through a third party,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the DOJ’s Civil Division.
  • New York to Review COVID-19 Vaccines, Citing Distrust in Administration’s Process
    New York Gov. Andrew Cuomo is threatening not to distribute FDA-approved COVID-19 vaccines in his state until they receive approval from a state task force of scientists, doctors and health experts.

RSS Pharma Times

  • Accenture reveals data science project for paediatric leukaemia
    Insights from project could potentially improve precision medicine use for paediatric AML
  • ABPI and EFPIA call for medicines prioritisation in UK/EU trade talks
    Pharma industry bodies call for medicine supply to be safeguarded in upcoming talks
  • Gilead’s oral JAK inhibitor filgotinib wins EU approval
    Treatment is indicated for use in adults with moderate-to-severe active rheumatoid arthritis
  • First UK patient given GSK’s experimental arthritis drug in COVID-19 trial
    Drug is being investigated in up to 800 hospitalised patients nationwide
  • Monte Rosa Therapeutics raises $96m to develop protein-degrading molecules
    ICR and Cancer Research UK spinout closes Series B financing
  • UK consumers seeking advice from pharmacists during pandemic, research finds
    Survey commissioned by Johnson & Johnson for World Pharmacists Day
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