In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Janssen Biotech Inc.

http://www.janssenbiotech.com

Latest From Janssen Biotech Inc.

Korea Q3 Roundup: China Sales, Prescription Drugs, Vaccines Boost Results

Notable third-quarter developments at major Korean pharma firms included the domestic reimbursement of Yuhan’s Leclaza, the approval of Hanmi’s Rolontis and SK Bioscience's approval filing for Novavax's COVID-19 vaccine for supply in the country, a roundup of results by Scrip shows.

South Korea Companies

Real-World Evidence More Helpful To US FDA In Cases Of High Clinical Trial Efficacy

Pfizer-funded systematic review of approved oncology applications that contained RWE highlights common deficiencies flagged by FDA and says strength of trial data is a key determinant of the extent to which RWE is needed and considered by the agency.

Real-World Evidence Drug Review

Khushboo Sharma: Improving Regulatory Science, From Industry To FDA And Back

From pre-med to pharma lab rat to deputy director of operations at the FDA, Khushboo Sharma, a 2021 In Vivo Rising Leader and current VP of science and regulatory affairs at BIO, has spent her career pursuing a goal she says the FDA and biopharma industry have in common: ensuring that innovative drugs get to patients. 

Leadership Regulation

Pfizer AdComm Asks Many Questions About COVID Vaccine For Ages 5-11, But Gets Few Answers

Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.

Advisory Committees Vaccines
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
UsernamePublicRestriction

Register