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    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
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    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
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    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
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    Euro Roundup: EU committee publishes pharmaceutical strategy draft

    A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms.   Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The report stresses the need to cut national approval times and align them with European Medicines Agency (EMA) workflows. ENVI als...
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    FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Higher-dose Kloxxado nasal spray cleared for countering opioid overdose Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose. Its indicated dose of 8 mg is notably higher than the previously approved doses of 2 and 4 mg for other naloxone nasal spray products.   Kloxxado was approved thro...
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    Asia-Pacific Roundup: New Zealand bans unapproved COVID vaccines

    The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective.   Only Comirnaty (Pfizer/BioNTech) is approved for use in New Zealand; vaccines from AstraZeneca and Johnson & Johnson currently are under rolling review. The ban on the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved C...
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    Euro Roundup: UK says local plasma is acceptably safe in immunoglobulin medicines

    Plasma obtained from UK patients is “acceptably safe” for use in immunoglobulin products, if certain risk mitigation measures are implemented, according to the UK Commission on Human Medicines.   Manufacturers have been unable to use UK plasma to make immunoglobulin medicines since 1999, when it was its use banned due to the potential for iatrogenic transmission of the prions that cause variant Creutzfeldt–Jakob disease (vCJD). Since then, plasma for immunoglobulin and...
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    FDA Approvals Roundup: Jemperli and Zynlonta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Jemperli nabs approval for advanced endometrial cancer with specific biomarker GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has been granted accelerated approval for treating adults with recurrent or advanced endometrial cancer whose tumors are mismatch repair deficient (dMMR) and in whom disease has progressed despite previous treatmen...
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    Asia-Pacific Roundup: TGA new drug approval times hold steady despite pandemic pressures

    Australian approval times for new drugs and other filings held steady in the second half of 2020 despite the pressures COVID-19 put on regulatory officials, according to a TGA report.   The median approval time for new chemical entities, new biological entities and biosimilars over the back half of last year was 196 days, compared to 198 days in 2019 and a legislated timeframe of 255 days. TGA median approval times for major variations and new generic medicines fell 4%...
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    Euro Roundup: UK’s NICE launches five-year strategy

    The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.   “The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.   The strategy is built...
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    FDA Approvals Roundup: Nextstellis, Ragwitek, Opdivo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nextstellis cleared as first new oral contraceptive in over 50 years Mayne’s Nextstellis (drospirenone and estetrol [E4] tablet) has been approved for the prevention of pregnancy in individuals of reproductive potential.   Nextstellis was approved based on efficacy findings from the year-long phase 3, prospective, multicenter, open-label, s...
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    Asia-Pacific Roundup: TGA investigating death linked to AstraZeneca vaccine

    Australia’s Therapeutic Goods Administration (TGA)’s Vaccine Safety Investigation Group (VSIG) announced that a 48-year-old woman who was vaccinated in New South Wales and admitted to the hospital died four days after receiving the vaccine.   The patient died of thrombosis with thrombocytopenia syndrome (TTS), or blood clots in the arteries and veins, that may be linked to the AstraZeneca vaccine. Officials says this is the third Australian report of a case of TTS foll...