Pharmaceutical Industry News Roundup: May 2019

by Staff writer

Each month, MMS shares key stories on recent developments and news in the pharmaceutical industry. Here is a selection of top stories to keep an eye on:

Submitting documents utilizing real-world data and real-world evidence to FDA for drugs and biologics U.S. Food and Drug Administration (FDA)

A new guidance issued by the FDA encourages sponsors who are using real-world data and real-world evidence—as part of a regulatory submission to the FDA—to provide additional information in a uniform format. This guidance applies to applications that contain real-world evidence to support regulatory decisions regarding safety or effectiveness.

Download the draft guidance document here

Fighting diseases with data science: How the NHS wants to smash silos to supercharge healthcareZDNet

Despite being the world’s biggest healthcare organization possessing large amounts of data, the National Health Service (NHS) has siloed its data into many framgmented areas. To help solve this problem, Health Data Research UK is helping the NHS revamp its information handling to help identify rare diseases and discover new treatments.

Jo Best has the full story here

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market FDA

To help address the high costs of medicines, especially biologics, the FDA has provided final guidance on the pathway for “interchangeable biologics.” This will help create a competitive marketplace for drugs and hopefully lower prices. The final guidance is informed by the FDA’s experience and regular meetings with sponsors of proposed interchangeable products.

Read the full statement via the FDA newsroom

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies to capture more data to better understand effects of prescription drugs in pregnant and nursing women FDA

Amy Abernethy and Janet Woodcock discuss the risks and benefits of studying pregnant and nursing women. The agency has drafted a guidance document entitled, “Clinical Lactation Studies: Considerations for Study Design” to encourage women’s health and safety.

Read the full statement via the FDA newsroom

EMA annual report 2018 published – European Medicines Agency (EMA)

The 2018 annual report provides readers an overview of the EMA’s activities and achievements over the past year. Some important topics outlined in the report are the agency’s response to Brexit, newly-elected chairs, and regulatory science in the future.

View the entire report here

Dr. Mike Poole joins the Board of Scientific Advisors at top global CRO MMS Holdings – MMS Holdings

Dr. Poole joins MMS with more than 25 years of experience in the pharmaceutical industry, most recently leading external investments in the Office of the President for Global Health at the Bill and Melinda Gates Foundation. In his advisory role, Dr. Poole will provide guidance on the design, conduct, and reporting of global phase 2-4 clinical trials, the implementation of clinical development plans, and global regulatory filings.

Read the press release

< Back to MMS Blog