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Dengue Swells As US Vaccine Prospects Recede

Sanofi’s voluntary Dengvaxia withdrawal due to low demand leaves the US with no dengue vaccine, even as Puerto Rico declares a public health emergency and global cases rise.

Vaccines Infectious Diseases Regulation

Lilly’s Kisunla: Labeling Allows For Stopping Treatment Based On Amyloid Plaque Reduction

However, the US FDA’s approval of donanemab comes with little guidance on when to stop treatment or when the anti-amyloid agent may need to be restarted in Alzheimer’s patients.

Approvals Neurology Regulation

Wave Chasing Huntington’s Accelerated Approval Based On Caudate Atrophy Surrogate

The biotech plans a pivotal trial that would support accelerated approval of the Takeda-partnered antisense oligonucleotide, WVE-003, and will discuss it with regulators before the end of the year.

Clinical Trials Neurology Regulation

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Pink Sheet Podcast

Performance Trackers

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – April 2024

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


Multimedia

US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals

Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.

US FDA Performance Tracker Review Pathway

China Sets Clinical Trial Record But Starting Studies Can Be Challenging

Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?

China Clinical Trials

US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

User Fees Drug Review

Advisory Committee Consumer Reps Often Fail To Represent Consumer Interests, Groups Tell US FDA

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Advisory Committees FDA
Regional Comparisons

Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns

Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.

Drug Review Regional Comparisons

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs Regional Comparisons

For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Generic Drugs Regional Comparisons

How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Artificial Intelligence Digital Health
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Recent Stories

New Danish ‘Critical Medicine’ Stockpiling Rules Take Effect, With 6-Month Grace Period

The Danish regulator says the new stockpiling and reporting requirements will give stakeholders time to take steps to mitigate the impact of long-term supply issues, but the pharma industry body, LIF, fears the move could create more problems than it will solve.

Europe Denmark

EMA To Update COVID-19 Vaccine Guides Amid Rapidly Changing Landscape

The EMA is proposing to update its two previous guidelines on COVID-19 vaccines to offer consolidated advice on the non-clinical and clinical development of new SARS-CoV-2 or related sarbecovirus vaccines.

Europe Coronavirus COVID-19

Europe Must Not Squander Potential Of Reformulation

At a panel on value added medicines at Medicines for Europe’s 30th annual conference in Dublin, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing.

Value-Added Medicines Europe

Can BIOSECURE Maintain Its Virality In The TikTok Era?

With the sheen of inevitability now scuffed off the BIOSECURE Act, diplomatic efforts to reduce US dependence on Chinese APIs are increasing in prominence. And the power of the legislation itself could be determined by litigation about a video app.

China Supply Chain

US FDA Drug Center ‘Snapshots’ Show Progress, But Are They Measuring The Right Thing?

US FDA trial enrollment data show improving enrollment across broad demographic definitions, but stakeholders agree more attention is needed for complex subgroups. Could larger trials be part of the answer?

Clinical Trials Diversity & Inclusion

Clinical Trial Diversity: US FDA’s Califf Calls For Global Focus

Commissioner Robert Califf urged a change in clinical trial diversity discussions, emphasizing the need to consider the realities of US leadership in a global drug development ecosystem.

Clinical Trials Diversity & Inclusion

INTERACT Meeting Timing Remains Point Of Confusion

US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.

Review Pathway User Fees

Hemophilia Gene Therapy Hemgenix Gets Funding In England, With More Talks Underway In Europe

After an initial funding rejection last year, CSL Behring’s gene therapy for hemophilia B is to be made available to English patients under the Innovative Medicines Fund via a “first-of-its-kind” agreement. Hemgenix is also the subject of a funding deal in Denmark.

Europe Denmark

EMA Seeks Input on Modernizing 17-Year-Old Psoriatic Arthritis Guide

The EU guideline on clinical investigation of medicinal products for psoriatic arthritis needs updating, including revised recommendations on the selection of the primary endpoint.

Europe Guidance Documents

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

India’s Drug Regulatory Apparatus Set For ‘Big Ticket’ Changes

India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.

India Regulation

Pink Sheet Podcast: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.

Artificial Intelligence Diversity & Inclusion
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