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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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    • Regulatory Strategy (1)
    • Regulatory Submissions (2)

E4 Pharmaceutical Consulting

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RSS FDA News

  • CDC Reports Infections Resistant to All Antifungal Drugs
    This marks the first time in the U.S. that a strain has been found to be “pan-resistant,” the CDC said.
  • NHS Launches Innovative Medicines Fund to Fast-Track Novel Drugs
    The initiative, which will receive $467 million in initial funding, is intended to complement the NHS’ Cancer Drugs Fund.
  • Magenta’s AML and MDS Drug Trial Put on Hold
    The FDA has asked the company to develop an additional bioassay to inform dose escalation decisions and safety monitoring.
  • Biogen Claims Aduhelm Critics Just Don’t Get Science
    The anti-Aduhelm uproar consuming the Alzheimer’s community is due to a campaign of “extensive misinformation and misunderstanding,” Biogen executives claim.
  • House E&C Committee Advances Bill on Continuous Manufacturing to the Floor
    The House Energy and Commerce Committee marked up two dozen health and technology bills this week, sending them to the House floor for consideration — including one aimed at bolstering the drug supply chain.

RSS Pharma Times

  • NICE, PHE publish new antimicrobial prescribing guideline on C. difficile infection
    New recommendations outlined include advice for managing C. difficile infection in both community and hospital settings
  • New plans to improve patient access to mental health services unveiled in England
    NHS England has set out new plans to introduce five new waiting time guarantees for mental health services
  • Seres’ ulcerative colitis candidate misses primary endpoint in mid-stage study
    Microbiome-based therapeutic failed to improve clinical remission rates among mild-to-moderate ulcerative colitis patients
  • AZ says its COVID-19 vaccine protects against severe disease caused by variants
    Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants
  • Albireo’s Bylvay approved in EU and US for rare paediatric liver disease
    PFIC is a rare and progressive liver disease affecting young children which can lead to cirrhosis and liver failure
  • Nanopharm and Leyden Labs link up in nasal spray partnership
    Partnership will aim to develop nasal spray drug products for prophylactic use against respiratory viruses
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