Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Featured Stories



Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation

Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.

Artificial Intelligence FDA Regulation

EU Falsified Medicines Directive ‘Not Working’ In Northern Ireland

Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”

Europe United Kingdom Regulation

Teva Quits PhRMA As Financial, Policy Challenges Loom For The Brand/Generic Hybrid Giant

With a leadership position in the US generics association and a new CEO focused on how to reallocate resources, Teva leaves the brand trade association after a review of the ‘effectiveness and value of engagements.’

Business Strategies Legislation Policy

Latest News

Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

More Podcasts

Performance Trackers

Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals Review Pathway Drug Review


Global Pharma Guidance Tracker – December 2022

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.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

Japan Changes Rules On Drug Names, Study Codes In Sponsors' Trial Sites

Japanese health ministry makes changes around the allowance of drug generic names and study codes in information provided by pharma companies on their websites for clinical studies, with the aims of improving transparency and facilitating patient participation.

Japan Clinical Trials

Hot Spots In 2023: US FDA Goal Dates Portend Battles In Diseases From RSV To Ulcerative Colitis

Novel agents targeting similar indications suggest potential commercial struggles across the therapeutic landscape, with battlegrounds taking shape between RSV vaccines, new mechanisms in major depression, and bispecifics for large B-cell lymphoma.

US FDA Performance Tracker Pink Sheet Perspectives

Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review

The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.

Pink Sheet Perspectives US FDA Performance Tracker

Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

Pricing Debate Leadership

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Advisory Committees Drug Review

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Latest From Policy

Bridge Too Far? BMS Launch Plan For Sotyktu Pressured By Prospect Of Medicare Price Controls

With price controls in Medicare looming nine years after approval, launch strategies such as ‘bridge’ programs that build initial volume with free drug may have to be adjusted.

Medicare Reimbursement

UK Industry Urges Government To Drop Statutory Pricing Scheme Rate Hike

The ABPI, which represents the R&D-based pharmaceutical industry in the UK, says the proposed increase in the statutory scheme rebate sends "the worst possible signal" to global investors and boardrooms.

Europe United Kingdom

Medicare Wastage Rebate Exceptions For Small Volume Products, Cell/Gene Therapy Urged

Packaging for such products reflects ‘unique circumstances’ that should exempt them from the rebates on discarded drugs otherwise required by the policy, stakeholders tell CMS at a ‘town hall’ forum.

Reimbursement Pricing Debate

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

The IRA And US FDA: How Will Agency View Any Drug Development Changes?

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

Research & Development Legislation

US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests

Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.

Advisory Committees Coronavirus COVID-19

Requests For EMA PRIME Designation Fall But Improvements Are On The Way

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

Review Pathway Innovation

Commercial Explore this Topic

Set Alert for Commercial

Latest From Commercial

The Immortal Humira? In Huge Test For US Biosimilar Policy, Brand May Still Have Edge

First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.

Biosimilars Biologics

In Medicare Drug Price Negotiations, Industry Sees Drawbacks And Silver Linings

Industry leaders are concerned about the outlook for small molecule drugs in particular, but execs at the J.P. Morgan Healthcare Conference were also optimistic there could be chances to shape the implementation of certain policies.

Pricing Debate Innovation

Novartis’ Kisqali Consumer Promos Inappropriately Convey Superiority, NAD Finds In Unusual Ruling

However, similar claim in materials directed at health care providers need not be discontinued, National Advertising Division says in challenge brought by Lilly; NAD decisions in Rx promotion disputes are rare, but voluntary resolution process could become more appealing to pharma firms.

Ad Complaints Advertising, Marketing & Sales

Manufacturing Explore this Topic

Set Alert for Manufacturing

Latest From Manufacturing

Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

Quality Safety

US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections

A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.

Manufacturing Regulation

US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA

The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.

Manufacturing Legislation
UsernamePublicRestriction

Register