RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
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    Euro Roundup: EMA publishes work plan for Big Data Steering Group

    The European Medicines Agency (EMA) has published the work plan for its Big Data Steering Group, listing the actions the group will take to fulfill its mission to advise EMA and the Heads of Medicines Agencies (HMA) about how to implement 10 priority recommendations.   EMA and HMA established the steering group in February. The group first met in May and has now shared an overview of the tasks that will occupy it through to early 2022.   The work plan is broken up ...
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    FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Detectnet okayed for locating neuroendocrine tumors during PET RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.   Approval for the radioactive diagnostic agent was sup...
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    Asia-Pacific Roundup: Australia to permit some self-test IVDs after industry calls for change

    The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline and other organizations used a consultation to voice their dissatisfaction with the current system.   Home-use tests for serious diseases have been banned in Australia for the past decade. TGA made an exception for HIV tests in 2014 but has otherwise maintained the position...
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    Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects

    Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their products, a senior official at the Directorate-General for Health and Food Safety (DG SANTE) has vowed.   Last month, Reuters reported that differing opinions over the level of legal protection that should be afforded to developers of COVID-19 vaccines were hampering efforts to strike deals for the products needed to protect ...
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    FDA Approvals Roundup: Gavreto and Trulicity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approval Gavreto approved for metastatic lung cancer with RET gene fusions Blueprint Medicines’ Gavreto (pralsetinib capsules) has been granted accelerated approval for treating adults with metastatic non‒small cell lung cancer (NSCLC) whose tumors test positive for rearranged during transfection (RET) fusion in an accompanying biomarker assay.   The ass...
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    Asia-Pacific Roundup: Face masks deregistered amid TGA postmarket review

    Almost 400 sponsors have pulled their face mask from the Australian Register of Therapeutic Goods (ARTG) amid a postmarket review undertaken by the Therapeutic Goods Administration (TGA) amid concerns that some recent listings triggered by COVID-19 fail to meet the legislative or performance requirements.   To date, 384 sponsors have voluntarily cancelled their ARTG listings. TGA noted that these devices have not been recalled as the agency has received no evidence in ...
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    Euro Roundup: Swissmedic resumes on-site inspections

    The Swiss Agency for Therapeutic Products (Swissmedic) has resumed regular on-site inspections amid an easing of COVID-19 restrictions in Switzerland.   The agency is taking precautions to mitigate the risks created by in-person interactions between its inspectors and the employees of the companies they visit. Inspections are only taking place if Swissmedic staff and targeted companies can adhere to measures related to distancing, hygiene and the tracing of coronavirus...
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    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...
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    Asia-Pacific Roundup: TGA advises on Consumer Medicine Information summaries

    Templates for preparing summary pages for Consumer Medicine Information (CMI) documents cover six questions intended to help consumers understand how and why they are taking a medicine, according to new guidance from Australia’s Therapeutic Goods Administration (TGA).   The guidance anticipates new TGA requirements for CMI documents for newly registered prescription and some non-prescription medicines that go into effect in January 2021. Sponsors of medicines that come...
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    Euro Roundup: Denmark relaxes face mask label rules

    The Danish Medicines Agency (DKMA) is temporarily allowing companies to sell face masks that have English, Norwegian or Swedish instructions and labelling in an effort to boost the supply of CE-marked surgical face masks for consumer use.   Last weekend, Denmark mandated the use of face masks on public transport, significantly expanding the contexts in which Danes are expected to wear face masks. DKMA changed its position on the instructions and labelling of masks shor...
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    FDA Roundup: Kyprolis, Kesimpta, Cystadrops

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Kyprolis in triple combo approved for previously treated multiple myeloma Amgen’s Kyprolis (carfilzomib) has received an expanded indication as a once- or twice-weekly combination with Janssen’s Darzalex (daratumumab) and dexamethasone for relapsed or refractory multiple myeloma in patients previously treated with immunomodulatory drug based (...
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    Asia-Pacific Roundup: Philippine FDA scales back as COVID cases spike

    An “alarming” rise in new cases of COVID-19 has led the Philippine Food and Drug Administration (FDA) to  ban face-to-face interactions with customers and set up drop boxes for depositing documents to help curb the spread of the virus in the country.   The rolling seven-day average of new COVID-19 cases in the Philippines passed 4,000 on 5 August, up dramatically from an average of less than 2,000 per day a week earlier. The surge led the Philippine government to reimp...