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Global

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Novel Vaccines Among Wide-Ranging EU Plans To Boost Health Threat Preparedness

Two documents published by the European Commission outline proposals to prepare for future health emergencies such as pandemics and the impact of antimicrobial resistance, with next-generation vaccines and novel or repurposed therapeutics high on the agenda.

Europe International

Pharma Firms Must Act On Biodiversity Footprinting To Avoid Business Risks

Biodiversity footprinting may still be a new concept for pharmaceutical companies, but they need to put a clear supply chain strategy in place now, particularly as the COP 15 conference in December is expected to discuss mandatory reporting of biodiversity risks, says Luka Brown.

International Business Strategies

Stakeholders Gather To Discuss Pandemic Response And Next Steps

As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.

Europe International

WHO Gives Strong Backing To Antimalarial Combo As New Resistance Strategy Kicks Off

Hot on the heels of its new antimalarial strategy, the World Health Organization has given a “strong” recommendation for the use of a fixed-dose artemisinin combination therapy from Shin Poong and the Medicines for Malaria Venture that should see it being more widely used in disease-endemic countries.

International Middle East and Africa

EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems

The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.

Europe International

WHO’s Draft Pandemic Treaty Calls For More Regulatory Harmonization

Regulatory convergence and the sharing of dossiers, together with the timely and equitable sharing of pathogens, could help to speed up access to medicines, vaccines and diagnostics in pandemic situations, according to the first draft of the World Health Organization’s proposed pandemic treaty.

International Coronavirus COVID-19

First Draft Of WHO’s Pandemic Treaty: IP Waivers, Tech Transfer & Price Transparency

A World Health Organization negotiating body will shortly examine the “zero draft” of a proposed pandemic treaty aimed at better preparing the world for future health crises. But the international pharmaceutical industry claims the draft as currently worded could actually undermine equitable access to pandemic countermeasures.

International Coronavirus COVID-19

Regulatory Reliance Key To Cancer Drug Access in Lower-Income Countries

Regulatory reliance will be vital in improving access to oncology medicines in low- and lower-middle income countries, delegates at a recent regulatory conference were told.

International Approvals

Coronavirus Notebook: Moderna’s New Boosters More Effective Against Omicron BA.4/BA.5, Inotrem Reports Good Results For Nangibotide In Severe COVID-19

The European Medicines Agency has recommended updating the vaccine product information to include heavy menstrual bleeding with both Spikevax and Comirnaty, and urticaria with Spikevax. The World Health Organization says that the Omicron BA.5 strain and all its descendent lineages continue to be dominant at global level.

Europe International

International Regulators Address Questions On Leveraging Each Other’s Decisions

Initiatives from regulators around the world seek to promote regulatory reliance at global level.

Regulation International

Regulators Back More Reliance On GMP Inspection Results

As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.

International Compliance

Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access Looks Safe, Effective

Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.

Prescription To OTC Switch Drug Approval Standards
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