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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

  • UK’s NICE Rejects Opdivo and Yervoy Combo for Lung Cancer
    The institute has invited comments by April 26 and said it may change its recommendations when its appraisal committee meets to consider the responses and prepare the final appraisal document.
  • FDA Revokes Five ANDAs for Generic Opioids
    The agency said the sponsors failed to respond to a Sept. 25, 2020, Federal Register notice that offered an opportunity to seek a hearing on the matter.
  • FDA Names Patricia Cavazzoni Permanent Head of CDER
    The FDA has selected Patricia Cavazzoni as permanent director of the Center for Drug Evaluation and Research (CDER), a position previously held for many years by Acting Commissioner Janet Woodcock.
  • Eli Lilly to Supply Bamlanivimab Only as Combination Therapy to U.S. Government
    Eli Lilly has revised its supply deal with the U.S. government to focus on distributing the company’s COVID-19 antibody bamlanivimab along with another antibody, etesevimab — a combination that has proven to be effective against variant strains of the Sars-CoV-2 virus which causes COVID-19 infections.
  • Former Indivor Executive Seeks FDA Hearing to Avoid Debarment
    Baxter’s lawyers have requested a hearing with the FDA to discuss the debarment proposal.

RSS Pharma Times

  • Antibiotic Research UK launches small research grants programme
    Charity will award grants for research projects into antibiotics and antibiotic resistance
  • Experts call for advanced radiotherapy funding to address COVID-19 cancer care backlog
    Cancer experts urge the government to address funding gaps for high-precision radiotherapy
  • Inhaled asthma drug accelerates recovery from COVID-19
    Self-reported recovery was three days shorter for patients receiving inhaled budesonide
  • Four medicines accepted for use by NHS Scotland
    Newly accepted medicines include treatments for multiple myeloma and severe migraine
  • Take the next step into CROY 2021
    The 2021 Clinical Researcher of the Year – The Americas competition is reaching out to the very best in the industry to take the next step and claim gold.
  • US approval for first AI device to help detect colon cancer
    Device designed to help clinicians detect lesions in the colon during a colonoscopy
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