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    Asia-Pacific Roundup: Australia, Japan authorize COVID vaccines

    Australia and Japan have granted emergency authorizations to COVID-19 vaccines. The Australian Therapeutic Goods Administration (TGA) cleared AstraZeneca’s vaccine, while its Japanese counterpart gave the green light to Comirnaty, the vaccine from Pfizer/BioNTech.   The TGA decision authorizes the  COVID-19 Vaccine AstraZeneca for use in Australia for the next two years. In that time, TGA expects AstraZeneca to provide it with longer-term safety and efficacy data from ...
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    Euro Roundup: MHRA advises on non-COVID trials amid vaccine rollout

    New guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) advises sponsors of ongoing non-COVID-19 trials to conduct risk assessments for how public vaccination efforts will impact their efforts and tells sponsors of new studies to factor vaccination into the protocol to avoid substantial amendments later.   If the sponsor deems the COVID-19 vaccine to be “a simple concomitant medication with no interaction that requires advice on timing of th...
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    FDA Approvals Roundup: Evkeeza, Cosela, Entresto

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Evkeeza gets thumbs up as add-on therapy for inherited severely high cholesterol Regeneron’s Evkeeza (evinacumab-dgnb injection) has been approved as an add-on therapy for homozygous familial hypercholesterolemia (HoFH) in patients aged 12 years or older.   HoFH is a genetic condition that causes life-threatening, severely high levels of low...
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    Asia-Pacific Roundup: TGA publishes COVID vaccine safety monitoring plan

    Australia’s Therapeutic Goods Administration (TGA) has published a five-point plan detailing the enhanced measures it will put in place to ensure the timely identification and mitigation of safety issues during the roll out of COVID-19 vaccines.   The agency aims to “strengthen the existing vaccine vigilance system for early detection and investigation of suspected side effects,” thereby enabling it to manage emerging safety issues and maintain public confidence.   ...
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    Euro Roundup: NICE seeks feedback on how it develops health technology guidance

    The UK National Institute for Health and Care Excellence (NICE) is seeking feedback on its proposals to create a simplified, single process for all technology evaluations and gain the flexibility to assess new and emerging health technologies. Feedback is being accepted until 15 April.   “To continue to support the needs and aspirations of all parts of the healthcare and life sciences ecosystem, NICE must ensure that its processes of health technology evaluation mainta...
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    FDA Approvals Roundup: Breyanzi, Ukoniq, Libtayo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Breyanzi okayed for relapsed/refractory large B-cell lymphoma Juno’s Breyanzi (lisocabtagene maraleucel) has been approved for previously treated adults with relapsed or refractory large B-cell lymphoma ( LBCL ), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular ...
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    Asia-Pacific Roundup: India rejects Comirnaty EUA

    Pfizer has withdrawn its application for emergency use authorization (EUA) in India for Comirnaty, its COVID-19 vaccine with partner BioNTech, after the country’s COVID-19 Subject Expert Committee (SEC) recommended against its authorization.   After reviewing data presented by Pfizer at an SEC meeting on 3 February, the committee did not recommend that an EUA be granted, citing serious adverse events including anaphylaxis and palsy as well as the companies’ lack of saf...
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    Euro Roundup: EC seeks input on health emergency authority

    The European Commission is seeking feedback on plans to create a Health Emergency Preparedness and Response Authority (HERA) to address shortcomings exposed by the COVID-19 pandemic.   EU efforts to coordinate the response to the pandemic at times have been in tension with member states’ desires to protect their own populations. Late last year the Commission published plans to strengthen the European Medicines Agency’s (EMA) ability to coordinate the development and ...
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    Asia-Pacific Roundup: TGA ends COVID exemptions for ventilators, PPE

    Australia’s Therapeutic Goods Administration (TGA) has let the emergency measures imposed to help the supply of medical devices during the pandemic lapse. The change means products will need to be included in the Australian Register of Therapeutic Goods (ARTG) to be supplied in the country.   In March and April 2020, Australia responded to worries about the availability of personal protective equipment (PPE) and ventilators by enacting emergency exemptions. The ventila...
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    Euro Roundup: EMA targets Friday decision on AstraZeneca COVID vaccine

    The European Medicines Agency (EMA) aims to decide on approval of COVID-19 Vaccine AstraZeneca on Friday, 29 January. Amid concerns about the lack of clinical data in seniors, EMA may impose a label that restricts use of the vaccine to younger populations.   Emer Cooke, EMA executive director, fielded a series of questions about the AstraZeneca vaccine at a meeting of the Committee on Environment, Public Health and Food Safety (ENVI) on Tuesday. In her introductory rem...
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    Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

    The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published its procedure for conducting remote compliance inspections related to drugs and regenerative medical products.   PMDA set out its approach to remote inspections late last year, before going on to post an English translation of the document last week. The document details the different steps of the remote inspection process and what applicants can do to prepare.   PMDA will inform an applic...
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    Euro Roundup: EC asks EMA to accelerate approval of vaccine facilities

    The European Commission has called on the European Medicines Agency (EMA) to “speed up the approval process for new production facilities” to increase access to COVID-19 vaccines as part of its has set out its strategy for beating COVID-19.   Manufacturers are scaling up their operations to meet high demand for COVID-19 vaccines but will need regulatory approval to bring capacity online. The EC wants to ensure that happens as quickly as possible, leading it to outline ...