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

E4 Pharmaceutical Consulting

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RSS FDA News

  • Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate
    The company plans on launching a phase 1 trial later this year.
  • Sanofi’s Tolebrutinib Phase 3 Clinical Trial Paused Globally After FDA Clinical Hold
    Sanofi said it plans to submit additional information the FDA requested by the end of September.
  • FDA Issues Warning Letter to Amazon for Selling Unapproved OTC Drug Products
    The agency noted that no OTC drugs can be legally sold in the U.S. market for mole or skin tag removal.
  • CorMedix Receives Second Complete Response Letter for DefenCath NDA
    The company plans on continuing to pursue the investigational drug’s approval.
  • FDA Expert Panel to Review First Fecal Microbiota Transplant
    The FDA is reviewing a Biologics License Application (BLA) for an innovative, first-in-class treatment for potentially fatal Clostridium difficile infections — an enema-delivered human stool transplant.

RSS Pharma Times

  • Medicines Discovery Catapult and Zeiss join forces
    Partnership will focus on driving the application of microscopy in drug discovery
  • Key blood clotting protein could be ‘warning light’ for COVID-19 cases
    University of Aberdeen team suggest results indicate that protein PAI-1 could be an early indicator of severe COVID-19
  • SMC approve Johnson & Johnson’s systemic light chain amyloidosis therapy
    Newly diagnosed patients will become the first to access systemic light chain amyloidosis treatment in the UK
  • Cerevance establishes strategic research collaboration with Merck
    Partnership will focus on the discovery of novel targets in Alzheimer’s disease
  • Verona’s ensifentrine meets primary endpoint
    Chronic obstructive pulmonary disease phase 3 study shows statistically significant improvements in lung function
  • Arecor granted European patents to protect Humira formulations
    Patents show potential of innovative Arestat technology and the development of enhanced formulations
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