Pink Sheet 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
UsernamePublicRestriction

Precision Medicine Evidence Gaps Could Be Filled With Real-World Data, Central Repository

Executive Summary

While not recommending changes in US FDA approval standards, Harvard researchers urge more disclosure about what is known and not yet known about targeted medicines. A central repository of data should be created, they suggest, allowing drug makers, test makers and pathology labs to share real-world data after approval. The journal article considers existing data for Novartis and Roche's approved BRAF inhibitor therapies to illustrate gaps in understanding about precision medicines.

You may also be interested in...



Pfizer Appears Slightly Ahead Of Moderna In COVID-19 Vaccine Race

Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.

Addyi Radio Ad’s Lack Of Alcohol Risk Information Elicits New Clash With US FDA

Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.

Trump’s Executive Order Limiting Medicare Drug Payments Faces Hurdles

Under test payment model, Medicare would pay no more than most-favored-nation price for Part B and Part D drugs, but how and when the model program would be implemented remains unclear. BIO may pursue legal action as questions on how plan would be implemented and if the administration will provide notice and comment period for stakeholder input remain.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133951

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel