Skip to content

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.

Welcome!!

Categories

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

E4 Pharmaceutical Consulting

  • Log in
  • Entries feed
  • Comments feed
  • WordPress.org

RSS FDA News

  • FDA Extends Compliance Date for Supply-Chain Verification
    The FDA says it won’t take action against wholesale distributors that fail to verify a product identifier or standardized numerical label before distributing saleable returned products.
  • Walmart Sues Federal Government Over Opioid Obligations
    Walmart is suing the federal government seeking to block civil charges against the company over how it handled prescriptions for opioids that allegedly helped create the opioid epidemic.
  • UK Cancer Institute Urges NICE to Change How it Evaluates Immunotherapies
    The UK’s Institute of Cancer Research said it is “deeply disappointed” by a decision by the National Institute of Health and Care Excellence (NICE) to recommend Merck’s Keytruda (pembrolizumab) as a first-line treatment for certain head and neck cancer patients but not in combination with chemotherapy.
  • In Ongoing Hahn-Azar Feud, Azar Denies Plotting Hahn’s Ouster
    HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants.
  • New Report Sounds Alarm on Pandemic-Induced Drug Shortages
    The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis.

RSS Pharma Times

  • Evgen scores full approval for COVID-19 trial launch
    Investigational drug will be studied as treatment for ARDS in suspected COVID-19 patients
  • Parkinson’s UK partners with UCL on phase II trial
    Trial will investigate chemotherapy drug to alleviate hallucinations in people with Parkinson’s
  • Bayer to acquire cell and gene therapy specialist AskBio
    Deal could be worth up to $4bn dependent on success milestones
  • AZ presents new real-world chronic kidney disease data at ASN 2020
    Initial key findings from the DISCOVER-Chronic Kidney Disease study revealed
  • Merck KGaA, IAVI and Serum Institute link up to develop COVID-19 mAbs
    Agreement will see partners develop SARS-CoV-2 neutralising monoclonal antibodies
  • BMS partners with Sensyne Health for rare blood disease research
    Collaboration will involve applying machine learning for research into rare blood diseases
Proudly powered by WordPress / Theme: Shoreditch by Automattic.