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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

  • WHO Calls for GMPs to Limit Wastewater-Driven Superbugs
    The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part of good manufacturing practices.
  • PBMs Dodge Bullet in New CMS Rule—But Remain in Washington’s Crosshairs
    Pharmacy benefits managers breathed a sigh of relief last week when the Trump administration backed off proposals that would set Medicare drug prices based on the discounts offered by the benefits managers.
  • EMA Should Restrict Xeljanz and Ban Fenspiride, PRAC Advises
    The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended limiting prescriptions of Xeljanz and cancelling fenspiride’s marketing authorization, citing safety concerns.
  • Canada Details New User Fees for Drug Sponsors
    Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes.
  • FDA Offers Advice for Topical OTCs
    The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets.

RSS Pharma Times

  • NICE recommends Revlimid as multiple myeloma alternative
    The new indication will benefit approximately 2,100 patients.
  • Rise in bowel cancer numbers among young adults
    The researchers retrieved data on 143.7 million people aged 20 to 49 years from 20 European countries.
  • Revlimid, Imnovid combos receive EU approval
    The approval of these combination therapies “Marks a significant milestone for patients with multiple myeloma in Europe".
  • Fragmin approved by FDA as first anticoagulant for children
    The drug was initially approved by the FDA in 1994 for adults and is a type of heparin.
  • Winners announced - 2019 International Clinical Researcher of the Year!
    The winners of the PharmaTimes International Clinical Researcher of the Year have been announced, find out who emerged victorious in the 2019 competition.
  • ICR launches ‘Darwinian’ cancer drug programme
    The programme is to be launched in a £75 million state-of-the-art global centre of expertise in anti-evolution therapies in London.
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