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

Latest News & Analysis

Biogen’s Big Day Arrives, But Aducanumab Results Don’t Answer Key Question

Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug? 

Clinical Trials Neurology

Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

Clinical Trials FDA

Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings

Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.

US FDA Performance Tracker Drug Review

Biosimilars: US FDA Considering ‘Guardrails’ To Prevent Misinformation

Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.


Biosimilars Biologics

Medicare Retail Drug Spending Accelerates In 2018 Despite Price Declines

Prices for retail drugs across US payers decreased for the first time in years, driven by a drop in generic prices and “little to no growth” in prices for brands.

Medicare Pricing Debate

Global Pharma Guidance Tracker – November 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

International Europe

Drug Shortages, AMR & Cancer High On New EU Commissioner’s Agenda

The new EU commissioner for health has been given a number of high-priority tasks, including medicines supply and tackling antimicrobial resistance. These topics will be taken up by the European Commission’s advisory body, the Pharmaceutical Committee, in its new work plan.

Europe Distribution

Future Unclear For EU Mandatory Joint Clinical Assessment Plans

Plans for EU-wide Joint Clinical assessments will come under scrutiny at an EU council meeting next week.

Europe Health Technology Assessment

US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients

Proposal could yield a bounty of new options for innovative drug delivery systems.

Manufacturing Quality

ANDA Approval Records Will End As US FDA Mops Up Backlog

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Generic Drugs Review Pathway

Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.
Generic Drugs Legal Issues

Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges

Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?

Drug Review Manufacturing
See All
UsernamePublicRestriction

Register