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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

  • Senate Finance Committee Unveils Bipartisan Plan to Curb High Drug Prices
    The Senate Finance Committee Tuesday unveiled a far-reaching bipartisan legislative package that takes aim at the nation’s high drug prices, an effort that’s been in the works for over half a year.
  • Federal Court Denies Request to Block Amgen, Allergan From Marketing Two Oncology Biosimilars
    A federal judge in Delaware denied requests from Genentech to block the launch of biosimilars for its blockbuster treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Following the court’s decision, Amgen and Allergan announced their products Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) were available for sale.
  • Amgen’s Repatha Patent Challenge Continues
    On July 11, Amgen won an injunction against Praluent in a German court and the company’s attorneys have referenced that injunction in their U.S. court filing.
  • Connecticut Drugmaker Warned for Misuse of Equipment
    “It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture toxic products,” the agency said.
  • Australia’s TGA Updates Testing Guidance for Biologicals
    The Australian Therapeutic Goods Administration (TGA) has released updated guidance on the testing of biological drugs to reflect its most current practices.

RSS Pharma Times

  • Same-day pharmacy consultations could ‘help relieve GP pressures’
    The service will offer local pharmacy appointments to anyone calling NHS 111 about the minor conditions, such as earache or a sore throat.
  • Flow raises $1.5m for depression treatments
    The treatment combines clinical psychology, neuroscience and innovative technology including machine learning.
  • AI used to help diagnose and treat birdshot uveitis
    The Fight for Sight funded project uses AI to extract ‘hidden’ information from retinal images of patients with the rare eye condition.
  • New gene test could single out cancer patients eligible for ‘targeted nuclear medicine’
    Testing men for faults in DNA repair genes in their tumours could identify those most likely to respond to the new type of treatment.
  • ‘Ground-breaking’ service to help treat AF patients at risk of stroke
    The Oberoi SPAF & Case Finding Service ensures high-risk AF patients receive oral anti-coagulants, helping prevent strokes.
  • Finalists give their thoughts on the Medical & Scientific Excellence Awards
    The PharmaTimes Medical & Scientific Excellence Awards have been praised by last year’s finalists on it’s great learning and development process.
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