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Global

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NGOs Praise C-TAP COVID-19 Deals But Say Much More Needs To Be Done

With efforts continuing to maximize access to medical countermeasures against the pandemic threat, a webinar organized by NGOs looked at progress with and the shortcomings of the WHO’s C-TAP initiative, recent moves by the WHO on access provisions in funding agreements, and plans for a global C-TAP database.

International Spain

Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch

International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.

International Coronavirus COVID-19

Work Presses On To Harmonize Global Expectations On Using Modeling & Simulation

The level at which model-based analyses is integrated into regulatory decision-making can vary between regulatory agencies, from application to application and within agencies for similar submissions, leading to missed opportunities, says the International Council for Harmonisation.

International Regulation

Coronavirus Notebook: Global COVID-19 Summit To Press For More Funding For Vaccines & Treatments, WHO Calls For End To IP Waiver ‘Stalemate’

CEPI has announced funding for a “variant-proof” vaccine being developed by a multidisciplinary consortium. The European Medicines Agency's new committee on drug shortages in health crises has held its first meeting, and the European Parliament’s new COVID-19 committee will quiz the health commissioner on the EU’s vaccines strategy and response to the pandemic.

International Europe

Global Pharma Guidance Tracker – April 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

Australian Regulator On The Highs & Lows Of Project Orbis

The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard. 

International Australia

COVID-19 Products Still Vulnerable To Falsification & Diversion

High demand for genuine COVID-19 products, together with related product shortages, has fueled the proliferation of falsified, substandard and counterfeit vaccines, medicines and diagnostic tests.

International Coronavirus COVID-19

Global COVID-19 Access Program Facing ‘Financial Crisis’

ACT-A, an initiative led by the World Health Organization and involving international health agencies, has significantly improved access to COVID-19 medical countermeasures in lower-income countries. However, further progress could be hindered by a funding shortfall, and ACT-A has urged donors to contribute their fair share.

International Coronavirus COVID-19

What Vexed Top Global Biopharmaceutical Executives About COVID-19 Response

Pfizer, Eli Lilly and Roche bosses say no country was perfect in its response to the coronavirus pandemic and there are lessons to be learnt.

International Coronavirus COVID-19

WHO Backs Pfizer’s Paxlovid For High-Risk COVID-19 Patients

An international group of experts has issued new guidance on the use of therapeutics in patients with non-severe COVID-19.

International Coronavirus COVID-19

Global Biopharma CEOs Frustrated By IP Waiver Talk Amid COVID-19 Vaccine Glut

Top pharma executives claim ongoing vaccine inequity is not due to a lack of supply but to a shortage of sufficient infrastructure in low-and-middle income countries to administer available doses. 

International Coronavirus COVID-19

Global Pharma Guidance Tracker – March 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
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