Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

FDA Approves Bionovo’s Clinical Development Plan for Menerba

By Pharmaceutical Processing | November 10, 2010

Bionovo today announced that the FDA has approved the company’s total clinical
development plan for Menerba, the company’s drug candidate for menopausal hot
flashes.

“We had a very positive meeting with the FDA on our
clinical program for Menerba. As anticipated, they agreed with our overall
clinical development plan which included the number of clinical trials, number of
subjects and length of exposure as well as non-clinical studies necessary for
New Drug Application (NDA) submission for a non-estrogen drug such as Menerba.
They also provided useful suggestions for improving the clinical trial
protocols,” said Mary Tagliaferri, M.D., Bionovo’s President and Chief
Medical Officer. “While we are awaiting the formal minutes from the FDA
meeting, we are moving forward to implement the agency’s suggestions and have
forwarded the approved clinical trial design to our investigators and their
investigational review boards, or IRBs.”

“Menerba is a
first-in-class, unique drug candidate that is intended for a large medical
need, for the safe and effective treatment of menopausal symptoms,” said
Isaac Cohen, Bionovo’s Chairman and Chief Executive Officer. “We want to
do everything necessary to bring Menerba to market for the treatment of hot
flashes, while we also investigate its potential use in the treatment of breast
cancer prevention. Now that we have agreements with the FDA and the EMA (the European
Medicines Agency) on the overall development of Menerba, we have accelerated
discussions with potential partners to successfully bringing Menerba to market.”
 

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE