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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

  • Immunomedics Hit With CRL Over Breast Cancer Drug
    The FDA issued Immunomedics a complete response letter for a BLA seeking accelerated approval for its antibody-based breast cancer treatment, sacituzumab govitecan, for patients who have tried at least two prior treatments.
  • Gottlieb: FDA Will Have to Furlough Drug Reviewers
    Marking the end of the fourth week of the partial government shutdown, FDA Commissioner Scott Gottlieb said the agency will be forced to furlough drug reviewers as user fee funding runs out.
  • Louisiana Seeks Partner for ‘Netflix’ Subscription Model for Hep C Drugs
    Hepatitis kills more individuals in the state than all other infectious diseases combined.
  • FDA Panel Splits on Sanofi’s Diabetes NDA
    An FDA advisory committee deadlocked Thursday on the safety profile for Sanofi’s NDA for type 1 diabetes drug sotagliflozin.
  • FDA Releases Naloxone Drug Facts Labels to Spur OTC Development
    FDA Commissioner Scott Gottlieb announced on Thursday that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone.

RSS Pharma Times

  • MAGI Boston conference 2019 - benefits available for clinical researcher of the year finalists
    MAGI and PharmaTimes have teamed up to offer Clinical Researcher of the Year - The Americas finalists discounts at the MAGI Boston conference in May.
  • Canopy Growth to open UK medicinal cannabis branch
    US based Canopy Growth has declared its intent to enter the UK market, by unveiling new pharmaceutical company Spectrum Biomedical UK - a joint venture between Canopy Growth and Beckley Canopy.
  • NAO report highlights NHS financial deficit
    NHS trusts and foundation trusts have booked a combined deficit of £991 million for 2017/18, according to the National Audit Office's latest report on NHS financial sustainability.
  • Trivalent gets UK green light for flu in over 65s
    UK marketing authorisation has been granted for Sanofi Pasteur’s Trivalent Influenza Vaccine High Dose for people 65 years and older.
  • Imbruvica fails Phase III pancreatic cancer trial
    A late-stage trial testing AbbVie's Imbruvica in combination with chemotherapy for metastatic pancreatic adenocarcinoma (cancer) has failed to meet its primary endpoint.
  • Researchers identify new genes linked to age-related macular degeneration
    Fight for Sight has announced a breakthrough in identifying new genes in age-related macular degeneration, the leading cause of blindness.
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