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    Euro Roundup: MHRA misses multiple performance targets due to COVID-19, CAP grandfathering

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed several performance targets last year as it contended with challenges including COVID-19. A target for the production of validation reports for marketing authorization applications was among the missed objectives.   MHRA aims to produce a validation report for a new marketing authorization application within 14 days of case creation 97% of the time. In its 2020 to 2021 fiscal year, MHRA hit that d...
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    FDA Approvals Roundup: Rezurock, Fexinidazole, Bylvay

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rezurock cleared for treating chronic graft-versus-host disease Kadmon’s Rezurock (belumosudil) has been approved for treating chronic graft-versus-host disease (GVHD) in adults and children aged 12 years or older after failure of previous systemic therapy.   Approval of the kinase inhibitor was based on efficacy findings from the randomized...
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    Asia-Pacific Roundup: TGA seeks feedback on classification of devices applied to the skin

    Australia’s Therapeutic Goods Administration (TGA) has begun a consultation on refinements to the regulation of some medical devices. The proposals apply to devices that are substances introduced into the human body via an orifice or applied to the skin.   TGA published the proposals as part of its efforts to reclassify certain categories of medical devices so that they align with the new regulatory framework in the EU. Medical devices that consist of substances introd...
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    Euro Roundup: EU Parliament adopts position on expanded EMA mandate

    The European Parliament has adopted its position on extending the European Medicines Agency’s (EMA) mandate. Parliamentarians voted overwhelmingly in favor of a text that will shape upcoming negotiations with the European Council over the final legislation.   As part of an effort to build a health union, the European Commission adopted a legislative proposal on EMA’s mandate in November. The Commission proposed reinforcing EMA’s mandate to enable the agency to facilita...
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    FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Kerendia cleared for slowing serious kidney, heart complications in type 2 diabetes Bayer’s Kerendia (finerenone tablets) has been approved for reducing the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with typ...
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    Asia-Pacific Roundup: Malaysia publishes guidance on manufacturing cell and gene therapies

    Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance about cell and gene therapy manufacturing facilities. The guidance describes the process for setting up a facility in Malaysia and the local and international regulations and guidelines that cover the production of cell and gene therapies.   NPRA has provided a step-by-step guide to the regulatory side of setting up a facility to manufacture higher-risk cell and gene therapy products in M...
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    Euro Roundup: EDQM says remote inspections could be third pillar for GMP oversight

    Real-time remote inspections piloted during the COVID-19 pandemic could serve as a third pillar for the supervision of active pharmaceutical ingredient (API) manufacturers, the European Directorate for the Quality of Medicines (EDQM) said.   EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections EDQM performs each year happen...
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    FDA Approvals Roundup: Rylaze, Solosec, Keytruda

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rylaze cleared for leukemia and lymphoma in adults and children Jazz Pharmaceuticals’ Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn, intramuscular injection) has been approved as a component of a multiagent chemotherapeutic regimen for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and child...
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    Asia-Pacific Roundup: AstraZeneca fights accusation of Tagrisso overcharging in India

    AstraZeneca has begun a legal challenge against a demand by India's National Pharmaceutical Pricing Authority (NPPA) for payment in relation to alleged overcharging. NPPA has accused AstraZeneca of overcharging for cancer drug Tagrisso by more than $2 million from March 2019 to January 2021.   The root of the dispute dates back to February 2019, when the Indian government capped the trade margins on 42 oncology medicines. Osimertinib, the active ingredient in Tagriss...
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    Euro Roundup: EMA hails doubling of SME’s MAA success rate

    The European Medicines Agency (EMA) has hailed the doubling of the proportion of successful filings for marketing authorization from small and medium-sized enterprises (SMEs) from 2016 to 2020.   Last year, 89% of approval applications from SMEs ended in success, up from 40% in 2016. The new high for the success rate follows several years in which the figure has ticked upward, rising to 57% in 2018 and 67% in 2019. EMA offered no specific explanation for the rise but p...
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    FDA Approvals Roundup: Verkazia

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Verkazia okayed for treating vernal keratoconjunctivitis Santen’s Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops has been approved for treating vernal keratoconjunctivitis (VKC) in children and adults.   VKC is a rare and debilitating allergic inflammation of the eye surface that is most common in children and adolescents. Verkaz...
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    Euro Roundup: European Council, Parliament reach informal deal on contentious HTA regulation

    The European Council and Parliament have reached an informal deal on a planned health technology assessment (HTA) law. European Union officials are working on the HTA law to support cross-border cooperation on the clinical assessment of health technologies.   Full details of the compromise are yet to emerge, but the agreement has already come under attack. Pharma trade group EFPIA said, “The failure to agree on a predictable, efficient and non-duplicative system is a m...