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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

  • House Passes Bill to Promote Continuous Manufacturing of Pharmaceuticals
    The House of Representatives passed a bill in a bipartisan 368-56 vote late Tuesday that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process.
  • ICER Panel Weighs in on Two Expensive but Useful Myasthenia Gravis Therapies
    The Institute for Clinical and Economic Review (ICER) issued its final word on two treatments for the autoimmune disease Myasthenia Gravis (MG), saying both are useful medically but need colossal price reductions in order to make them at all affordable.
  • White House Secures 28 Million Pfizer COVID-19 Vaccine Doses for Kids in Advance of FDA and CDC Approvals
    The White House has secured 28 million doses of the Pfizer-BioNTech pediatric COVID-19 vaccine and plans to roll out the jabs for kids age five to 11 as soon as the FDA and Centers for Disease Control and Prevention (CDC) give the go-ahead for vaccines in that age group.
  • FDA Set to Authorize Moderna, J&J COVID-19 Boosters
    The FDA is poised to authorize booster shots of Moderna’s and Johnson & Johnson’s COVID-19 vaccines and may also allow a “mix and match” approach.
  • Medicare Has Spent $224 Million on Therapies with Confirmed Lack of Benefit, Study Shows
    In the last 10 months, the FDA evaluated drugs on the market for 10 cancer indications after having granted them accelerated approval (AA) based on surrogate endpoints, and eventually found that the drugs had a confirmed lack of benefit in several indications — but not before Medicare spent $224 million on them from 2017 to […]

RSS Pharma Times

  • Psychoactive compound to advance research in treatment of depressive disorders
    Lucid-PSYCH is a psychoactive compound potentially viable for the treatment of major depressive disorders
  • Biotage acquires DNA synthesis and purification company ATDBio
    ATDBio adds important platform solutions to Biotage within DNA and RNA oligonucleotide synthesis and purification
  • Scancell gains new facilities at The Oxford Science Park
    Scancell has taken new laboratory and office space in the Bellhouse Building at TOSP
  • Vertex’s type 1 diabetes therapy hits the mark in Phase I/II study
    Results are 'unprecedented' according to company
  • LovedBy and Dexom announce partnership to aid adolescent patients with diabetes
    This partnership is the latest in an ongoing collaboration between the companies
  • NICE approves Ofev for PF-ILD
    Interstitial lung disease (ILD) is a termed used to describe a collection of over 200 lung disorders
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