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Coronavirus Notebook: EU & Australia Assessing Comirnaty In 5-11 Year Olds, Aviptadil shows Promise In Critical COVID-19 Patients
The European Medicines Agency has OKd new manufacturing sites and a ready-to-use formulation for Comirnaty, while Australia has provisionally approved Ronapreve for treatment and post-exposure prophylaxis. The UK has secured supplies of two investigational antiviral products from Pfizer and MSD.
As China's regulators renew moves to encourage the development of pediatric medicines, indication expansion may give health players a new growth engine, despite remaining policy challenges and lingering market uncertainties.
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.
The inaugural Informa Pharma Intelligence Awards Japan will be held in Tokyo on 12 May 2022 to recognize and reward the very best innovations and achievements in pharma and biotech, highlighting Japan’s integral role in the global healthcare market.
Australian off-patent industry association GBMA and brand body Medicines Australia can continue to collaborate closely as part of work to mitigate shortages in the context of the COVID-19 pandemic, the Australian Competition and Consumer Commission has decided, extending an existing authorization by a further year.
China's Center for Drug Evaluation has issued fresh warnings that it will tighten reviews of anti-tumor drugs on the grounds that “redundant” development activities waste clinical resources.
South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.
Any delays caused by unpredictable regulatory reviews related to the export of genetic materials threaten to derail the inclusion of China in international clinical trials, caution two trade groups representing the pharma industry in the country.
As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.
Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.
A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.
Hot on the heels of Australia’s plan to overhaul the National Medicines Policy comes a new deal with the pharmaceutical industry to make new drugs available as soon as possible after approval and get patients more closely involved in reimbursement processes.
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