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Will Amylyx’s ALS Drug Benefit From US FDA’s Aduhelm Experience?

A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.

Advisory Committees Neurology Regulation

US FDA Backs EPCIS, Refines Advice As November 2023 DSCSA Deadline Approaches

Agency recommends the GS1 standard that stakeholders have been focusing on for working together to remove counterfeits from the US pharmaceutical distribution chain; adds its latest thinking on roles of additional types of trading partners.

Manufacturing Distribution Quality

Tennessee Medicaid Closed Formulary, Capped Spending Experiment Rejected By CMS

Biden Administration nixes Trump-era plan that would have allowed the state to exclude drugs from coverage even as it collected mandatory Medicaid rebates from manufacturers.

Reimbursement Policy Medicaid

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Pink Sheet Podcast

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

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Performance Trackers

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

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

Gene Therapy Approvals US FDA Performance Tracker


Global Pharma Guidance Tracker – May 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

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Latest From Regulation

Advanced Therapy Report Finds Problems With Australia’s Clinical Trial Approval Pathway

Advanced therapy stakeholders want the Therapeutic Goods Administration to provide clarity and improvements when it comes to conducting clinical trials.

Clinical Trials Australia

Access In Jeopardy If Generics Excluded From EU Centralized Procedure

Recent suggestions by the European Commission’s Pharmaceutical Committee that generics could be excluded from the centralized procedure for marketing authorizations would create barriers to access and put extra pressure on the European regulatory network overall, Medicines for Europe believes. The association has urged the authorities to abandon the idea.

Regulation Europe

How To Make Clinical Trials More Diverse

Applying modern marketing strategies and decentralized approaches to clinical research could improve diversity among participants.  

Clinical Trials Innovation

A New OTC Pathway At Last: The Acronym Isn’t The Only Thing That’s Changed

The US FDA is proposing a novel pathway to permit OTC drugs to be marketed with some additional controls to assure appropriate use, more than a decade after floating the idea. The pathway has a new name (“ACNU” not “NSURE”) and very different commercial dynamics.

Prescription To OTC Switch Drug Approval Standards

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add five new products, including VLA2001, Valneva’s vaccine for COVID-19.

Europe Approvals

Pfizer/BioNTech Vaccine Trial In Young Kids Marked By High Level Of Unblinding

The unblinding process began months before a third dose was added to the study in the 6 months-4 years group. Consequently, only about one-third of vaccine recipients in each age cohort received three doses of BNT162b2.

Coronavirus COVID-19 Vaccines

Latest From Policy

How To Make Clinical Trials More Diverse

Applying modern marketing strategies and decentralized approaches to clinical research could improve diversity among participants.  

Clinical Trials Innovation

ARPA-H Biomedical Research Agency Gets Funding Boost In US House Appropriations Bill

Progress on appropriations follows passage of legislation in the House formally authorizing the new agency dedicated to advancing cutting edge research.

Research & Development Legislation

Biopharma Dismayed US Supreme Court Declines To Take Up Case On Patent Eligibility

The Court denies a petition for review of American Axle and Manufacturing v. Neapco despite requests from the US government, BIO and former PTO director Kappos that it take up the case to  provide greater clarity on the types of inventions that may be patented.

Intellectual Property Legal Issues

Clinical / R&D Explore this Topic

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Latest From Research & Development

ARPA-H Biomedical Research Agency Gets Funding Boost In US House Appropriations Bill

Progress on appropriations follows passage of legislation in the House formally authorizing the new agency dedicated to advancing cutting edge research.

Research & Development Legislation

OCE ‘Project’ To Help Understand Trial Site Selection, Also May Inform Policy

Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.

Clinical Trials Cancer

Major EU Research Project Targets Personalized Medicine, Unlocking Of Health Data

Neurodegenerative and cardiovascular diseases, along with cancer and early feasibility studies, are among the topics to be addressed by consortia interested in taking part in the EU’s latest research partnership.

Europe Health Technology Assessment

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Latest From Commercial

Citeline And Norstella Merge To Provide End-To-End Solutions For Pharma

Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.

Companies Commercial

After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

Prescription To OTC Switch Drug Approval Standards

BIO 2022 Notebook: Future Directions For R&D

News and views from day four of the BIO annual meeting include a fireside chat with FDA commissioner Robert Califf, gene therapy insights, and pharma efforts to provide cancer medicines in lower income countries.

Business Strategies Diversity & Inclusion

Manufacturing Explore this Topic

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Latest From Manufacturing

HHS OIG: US FDA Inspection Manual Revision Could Reduce Unannounced Inspections Abroad

Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?

Manufacturing Quality

UK Must Act Now To Reverse Decline In Life Sciences Sector

A new industry report has painted a sobering picture of the UK life sciences sector, which is facing challenges on a number of fronts including clinical research, market access and manufacturing. On the bright side, the report says that implementing the measures in the government’s Life Sciences Vision could make the UK a “world-leading” hub for drug discovery and development.

Europe United Kingdom

US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch

If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.

Advisory Committees Vaccines
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