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 clarifies label flexibility for COVID vaccines

    COVID-19 vaccines may be distributed in English-language only  packaging in Europe under temporary measures designed to ensure speedy deployment of vaccines against the coronavirus, according to a question-and answer-document published by the European Medicines Agency (EMA).   Based on principles set out in a statement from the European Commission, EMA will permit manufacturers to provide COVID-19 vaccines with outer and immediate packaging that only carries text in ...
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    FDA Approvals Roundup: Imcivree, Danyelza, Ga 68 PSMA-11

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Imcivree okayed as first therapy for managing obesity in some rare genetic conditions Rhythm Pharmaceutical’s Imcivree (setmelanotide) has been approved for chronic weight management in patients aged 6 years or older with obesity related to three rare genetic conditions.   Imcivree is the first treatment approved for pro-opiomelanocortin...
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    Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals

    The head of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined plans to get patients and the public more involved in product development. Chief executive Fujiwara Yasuhiro framed the initiative as part of an effort to increase the number of products that come to market in Japan before being authorized overseas.   Yasuhiro took over as chief executive of PMDA in April 2019. The following month, PMDA established the Patient Centricity Working Group to...
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    FDA Approvals Roundup: Zokinvy, Oxlumo, Xofluza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Zokinvy okayed as first therapy for rare premature aging diseases Eiger BioPharmaceuticals’ Zokinvy (lonafarnib capsules) has been approved for reducing the risk of death from Hutchinson-Gilford progeria syndrome and treating certain processing-deficient progeroid laminopathies in patients aged 1 year or older. The rare genetic diseases cause pre...
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    Asia-Pacific Roundup: India clarifies ‘Make in India’ medical device order

    Guidance from the Indian Department of Pharmaceuticals clarifies how companies can take advantage of an order intended to encourage the use of local suppliers of medical devices. The order , published in September, created two groups of local suppliers that will be eligible to bid on many contract, Class I and Class II.  Class I suppliers will win the full quantity of any contract for which they are the lowest bidder, while Class II or non-local suppliers who submit the...
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    Euro Roundup: EDQM posts batch control guidelines for COVID vaccines

    The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released guidelines on the tests that laboratories need to perform as part of the independent control of COVID-19 vaccines.   Official Medicines Control Laboratories (OMCLs) will test the potency and other characteristics of COVID-19 vaccines distributed in the European Union and review batch release protocols from the manufacturers. The work, which the laboratories will undertake as part of ...
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    FDA Approvals Roundup: Sutab, Keytruda, Vimpat

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Sutab approved as tablet-form prep for colonoscopy Sebela’s Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) has been approved as a tablet-form preparation for colonoscopy, providing patients with an alternative to liquid-based preparations.   Colonoscopy is considered the gold standard of screening for colorectal cancer. Ade...
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    Asia-Pacific Roundup: Quality concerns drive TGA face mask review

    Australia’s Therapeutic Goods Administration (TGA) has begun a postmarket review of face masks amid concerns some do not perform as intended or meet the requirements for inclusion in the Australian Register of Therapeutic Goods (ARTG).   The review will assess if face masks in the ARTG, including devices in the National Medical Stockpile, meet the regulatory requirements and perform as intended. TGA is assessing compliance with the standards for Exhalation Resistance, ...
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    Euro Roundup: Swissmedic allows remote source data verification

    Pandemic-related remote source data verification for clinical trials should focus on critical data, such as the primary efficacy endpoint and key safety measures, according to updated guidance from the Swiss Agency for Therapeutic Products (Swissmedic).   Early in the pandemic, the European Commission began allowing clinical trials of COVID-19 products and pivotal studies of treatments for serious or life-threatening conditions to use remote source data verification (S...
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    FDA Approvals Roundup: Totect, Brilinta, Sesquient

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications and formulation Totect nabs expanded indication for doxorubicin-related cardiomyopathy Clinigen’s Totect (dexrazoxane injection) has been granted an expanded indication for reducing the incidence and severity of doxorubicin-induced cardiomyopathy in women with metastatic breast cancer receiving cumulative and maintenance doxorubicin therapy fo...
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    Asia-Pacific Roundup: Japan’s PMDA asks physicians to cooperate with adverse event relief system

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has called for physicians to cooperate with its Relief System for Adverse Drug Reactions. The system, which was set up in 1980, is designed to ensure prompt relief for people who suffer adverse health effects due to properly used drugs.   Over its first 39 years in use, the system granted relief to almost 25,000 cases using contributions that marketing authorization holders provided to fulfill some of their soci...
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    Euro Roundup: EDQM advises on COVID viral vectored vaccines

    The European Directorate for the Quality of Medicines (EDQM) has published advice on developing COVID-19 vaccines using viral vector platforms. The text covers analytical strategies for recombinant viral vectored vaccines such as AstraZeneca’s AZD1222 and Johnson & Johnson’s JNJ-78436735 (also known as Ad26.COV2.S).   Viral vectored vaccines are a relatively unproven and untested modality. Yet, the need to act quickly in response to the coronavirus outbreak means viral...