• RoundupsRoundups

    Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests

    Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance on advertising the tests and issuing a fine in relation to an allegation of unlawful importation.   The Q&A is focused on point-of-care tests, as opposed to the home-use products that became available in Australia late last year, while...
  • RoundupsRoundups

    Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

    The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.   Companies working with active substances, raw materials, starting materials or excipients that are the subject of a European Pharmacopoeia monograph can request a CEP from EDQM and include the text in their applications instead of cert...
  • RoundupsRoundups

    FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Quviviq nabs go-ahead for insomnia in adults Idorsia’s Quviviq ( daridorexant; tablets ) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.   The approval was based on efficacy findings in two studies ( Study 1 and Study 2 )...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on planned adoption of 19 international guidance documents

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation about plans to adopt 19 international scientific guidelines. TGA wants to know whether stakeholders support the adoption of the European Medicines Agency (EMA) and International Council for Harmonisation (ICH) documents.   As part of its effort to closely align its regulatory approaches with EMA, ICH and the US Food and Drug Administration, TGA has adopted around 370 international scientific g...
  • RoundupsRoundups

    Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.   MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investi...
  • RoundupsRoundups

    FDA Approvals Roundup: Tarpeyo, Dartisla ODT, Yusimry

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Tarpeyo approved for reducing proteinuria in IgA nephropathy Calliditas Therapeutics’ Tarpeyo (budesonide) delayed release capsules were granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, also known as Berger’s disease, who are at risk of rapid disease progression. Approval of Tarpeyo wa...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA asks drugmakers to mitigate cybersecurity weakness amid ‘active malicious exploitation’

    Australia’s Therapeutic Goods Administration (TGA) has asked drugmakers and other stakeholders to detect and mitigate a cybersecurity vulnerability. TGA made the request after learning of “widespread and active malicious exploitation” of the critical vulnerability in an open-source logging library.   Developers across multiple industries use Apache's Log4j to track activity in their software applications and online services. The log serves as a journal of activity that...
  • RoundupsRoundups

    Euro Roundup: Commission acts to stop Brexit from disrupting supply of medicines

    The European Commission has set out how it plans to stop Brexit from disrupting the supply of drugs in certain markets, most notably Northern Ireland. The plan builds on the proposal the Commission made in October as part of the multiple rounds of negotiations with the United Kingdom.   Under parts of the Brexit agreement designed to avoid a hard border on Ireland, Northern Ireland, which is part of the UK, is subject to European Union regulations. The situation has ...
  • RoundupsRoundups

    FDA Approvals Roundup: Apretude, Vyvgart, Tezspire

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals  Apretude cleared for HIV pre-exposure prevention  Viiv’s Apretude (cabotegravir extended-release injectable suspension) has been  approved  for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.  Approval of Apretude was based on safety and efficacy findings from two randomized, dou...
  • RoundupsRoundups

    Asia-Pacific Roundup: New Zealand probes role of Pfizer’s COVID-19 vaccine, myocarditis in three deaths

    Authorities in New Zealand are reviewing whether the Pfizer-BioNTech COVID-19 vaccine played a role in the deaths of three people who died with potential myocarditis in the period following vaccination.   Myocarditis, inflammation of the heart muscle, is a rare reaction to vaccination with Pfizer’s Comirnaty and Moderna’s Spikevax. However, myocarditis can occur in response to viral infection, too, and the New Zealand COVID-19 Vaccine Independent Safety Monitoring Boar...
  • RoundupsRoundups

    FDA Approvals Roundup: Entadfi, Zynrelef, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Entadfi okayed for benign prostatic hyperplasia Veru’s Entadfi (finasteride and tadalafil capsules) has been approved for treating urinary tract symptoms caused by benign prostatic hyperplasia (BPH), or enlarged prostate. The combination has also been shown to have less potential for adverse sexual side effects compared with finasteride mono...
  • RoundupsRoundups

    Euro Roundup: EMA backs mix-and-match approach to COVID-19 vaccine courses and boosters

    The European Medicines Agency (EMA) has backed the use of a mix-and-match approach to COVID-19 vaccine initial courses and booster shots, for example two AstraZeneca jabs followed by a booster dose of the Pfizer-BioNTech vaccine.   Many countries in the European Union and beyond are already allowing people to receive two different COVID-19 vaccines for their first and second doses and, in particular, booster shots that differ from their initial course. The heterologous...