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Set Alert for Global

Preparing For The Next Pandemic: Experts Talk AI Vaccines, Regulatory Acceptance & Earlier Human Trials

AI-generated vaccines, fast-moving regulatory systems and scalable manufacturing platforms will be key in preparing for future pandemics, according to vaccine and immunology experts including the CEOs of CEPI and Gavi.

BioPharmaceutical International

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

BioPharmaceutical Neurology

ICH Cuts Burden Of Assessing Drug-Drug Interactions; Argentina Gains Membership

New guidance from the International Council for Harmonisation is designed to tackle problems companies face by having to meet different requirements around the world when evaluating the potential of DDIs for their investigational products.

International Drug Safety

Global Pharma Guidance Tracker – May 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

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe

Amended International Health Regulations Give Fresh Momentum To Pandemic Treaty Talks

The amendments agreed by the World Health Assembly include a definition of a pandemic emergency as well as ways to help improve access to health products.

International Coronavirus COVID-19

Pandemic Treaty Talks Flounder But WHO Still Holds Out Hope For Eventual Agreement

At this week’s World Health Assembly, a working group will be set up to discuss the next steps for talks on a global pandemic treaty and try to reach a final agreement on amendments to the International Health Regulations.

International Coronavirus COVID-19

International Health Regulation Changes Focus On Equitable Access And Production Capacity

The final version of amendments to the IHR is due to be discussed at this week’s World Health Assembly, alongside the way forward for the proposed global pandemic treaty.

International Coronavirus COVID-19

Novel Antimicrobials: Firms Urged To Draw Up Access & Stewardship Plans For Lower-Income Countries

Pharma firms have a set of tools and strategies at their disposal to ensure access to new antimicrobials while safeguarding their effectiveness, but companies developing some of the most promising drug candidates are not making the most of these tools, according to a new report.

International Research & Development

Deadline Nears For Comments On WHO’s Proposed Requirements For MAbs Targeting RSV

The World Health Organization has developed a draft addendum to its 2023 guideline on the evaluation of mAbs intended for the prevention or treatment of infectious diseases, focusing on supplementary aspects specific to respiratory syncytial virus disease.

International Biologics

Major Boost For WHO-Listed Authority Scheme As US & EU Regulators Designated

The US Food and Drug Administration and the European medicines regulatory network, which includes the European Commission, the European Medicines Agency and 30 national agencies, are now WHO-Listed Authorities under a framework launched in 2022.

BioPharmaceutical Europe

UK Subscription Contracts Will Target Antimicrobials Against ‘Critical’ Pathogens

Pharma companies seeking a subscription-style contract for new antimicrobials will need to meet a number of requirements, such as guaranteeing surety of supply, meeting key performance measures and complying with specified manufacturing standards.

International Innovation

Value Of Vaccines ‘Underestimated’ By Policymakers, Economic Researchers Find

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

International Europe

Pandemic Treaty Negotiators Plan Five More Days Of Talks On ‘Critical’ Issues

A co-chair of the Intergovernmental Negotiating Body says that whatever happens over the coming fortnight, a report on the outcome of the talks will be delivered to the World Health Assembly at the end of this month.

International Coronavirus COVID-19

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

Pandemic Treaty Talks Go Up To The Wire

The talks are still tough, with the Pathogen Access and Benefit Sharing proposal proving the most difficult aspect of the treaty, but there is cautious optimism that some form of agreement may be reached this week.

International Coronavirus COVID-19
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