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US Supreme Court’s EPA Ruling Expected To Have Limited Impact On FDA Regulations

Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.

FDA Legal Issues Regulation

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 Clinical Trials

US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement

After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign. 

Coronavirus COVID-19 Vaccines Pediatrics

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

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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

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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 European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Advisors Intrigued by Novavax As Booster

Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

Coronavirus COVID-19 Vaccines

Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs

CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.

Gene Therapy Rare Diseases

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

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process

The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Prescription To OTC Switch Drug Approval Standards

EU Targets Generics, Inspection Shortfalls & Environmental Assessments

As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.

Europe Regulation

Latest From Policy

Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate

A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.

Guidance Documents Clinical Trials

Medicare Part D Coverage For Obesity Drugs Urged By House Appropriations Panel

In the report accompanying FY 2023 HHS appropriations legislation, the House committee also addresses biosimilar uptake in Part D, Medicare dispensing fees for oral COVID-19 drugs and NIH grants for expanded access to investigational ALS drugs.

Reimbursement Medicare

England: HTA Body NICE Makes Big RWE Push

England’s health technology appraisal institute, NICE, has published its real-world evidence framework.

Real-World Evidence Europe

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Latest From Research & Development

US FDA’s Science Strategies Program Aims To Proactively Tackle Drug Development Hurdles

The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.

Clinical Trials Research & Development

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

Advisory Committees Vaccines

Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products

The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.

Clinical Trials Research & Development

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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

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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

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

ICMRA’s Pilot On Hybrid Inspections And CMC Changes Seeks Participants

Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.

Manufacturing Quality
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