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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. Many agencies offer pre-IND meetings where companies can present their research plans, discuss potential challenges, and receive guidance on the type of data required for approval.

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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Further, information presented on the adverse reaction data was inconsistent with the PI.

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Tackling complex manufacturing challenges in modern drug development

Drug Target Review

These innovative modalities present both exciting possibilities and unique challenges in drug discovery and development. However, the testing, release, and regulatory oversight required for these therapies present challenges at every stage of production. “Manufacturing of drugs is getting more complicated in many ways. .

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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

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Scientists Developing Vaccine Against Present and Future COVID Viruses

Drugs.com

MONDAY, May 6, 2024 -- Scientists are busy working on a vaccine that might fight strains of the COVID virus SARS-CoV-2 that haven't even emerged yet.The effort from a British team at the University of Cambridge is already showing promise in mouse.

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Immunization at Every Stage of Life: A Key to Lifelong Health

The Pharma Data

A Life-Course Approach to Immunization: Prioritizing Vaccination at Every Age to Unlock the Full Potential of Lifelong Health In a striking demographic milestone, the global population is undergoing a historic transformation: for the first time ever, the number of adults over the age of 65 now exceeds that of children under the age of five.

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Advancing vaccine design: potential of peptide mimicry

Drug Target Review

In a new development, a recent paper published in Biology Methods & Protocols by Oxford University Press has highlighted a promising avenue for enhancing vaccine efficacy against infectious pathogens like the COVID-19 virus. Since December 2019, SARS-CoV-2 (COVID-19) infection has become a worldwide urgent public health concern.

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