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    FDA Approvals Roundup: Tavneos, Verzenio, Dextenza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tavneos okayed for ANCA-associated vasculitis ChemoCentryx’s Tavneos (avacopan) has been approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.   ANCA-associated vasculitis is a group of thr...
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    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
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    Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

    The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started reviewing the risk of tumors linked to women’s health products that contain nomegestrol or chlormadinone. PRAC opened the review in response to cases of non-malignant tumors of the brain and spinal cord.   Nomegestrol or chlormadinone are used in products that treat gynecological disorders, such as uterine bleeding, and as hormone replacement therapies or contraceptives...
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    FDA Approvals Roundup: Livmarli and Tecartus

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Livmarli approved for cholestatic pruritus in children with Alagille syndrome Mirum’s Livmarli (maralixibat oral solution) has been approved for treating cholestatic pruritus in patients aged 1 year or older who have Alagille syndrome (ALGS).   ALGS is a rare genetic disorder caused by abnormalities in bile ducts that can lead to progressive ...
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    Asia-Pacific Roundup: China’s NMPA applies for pre-accession to PIC/S

    China’s National Medical Products Administration (NMPA) has applied for “pre-accession” to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The voluntary step is intended to identify gaps between PIC/S membership requirements and the system used by the regulatory agency.   PIC/S held a bilateral meeting with NMPA late in 2019 to discuss issues raised by the Chinese drug regulatory agency in relation to a possible future application or pre-application. Almos...
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    Euro Roundup: Commission seeks feedback on pharmaceutical legislation reform

    The European Commission is seeking feedback on planned reforms intended to address problems such as the “inefficiency and administrative burden of regulatory procedures.”   It’s been 20 years since the European Union held its last comprehensive review of general pharmaceutical legislation. The consultation, which grew out of a strategy adopted late last year, is part of a push to reform pharmaceutical legislation in light of changes to society and science and lessons...
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    FDA Approvals Roundup: Qulipta, Repatha, Erbitux

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Qulipta approved as preventive treatment of migraine AbbVie’s Qulipta (atogepant tablets) has been approved for the preventive treatment of episodic migraine in adults .   The approval of Qulipta was based on findings from the Phase 3 ADVANCE study, a Phase 2/3 efficacy, safety, and tolerability study, and a Phase 3 long-term safety s...
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    Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices

    Australia’s Therapeutic Goods Administration (TGA) has released guidance to help manufacturers of spinal implants and medical devices that come into direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) to transition to new regulatory requirements.   Currently, TGA treats spinal implants as Class IIb medical devices. Products in direct contact with the heart, CCS or CNS are in Class IIa. In 2019, TGA proposed moving some sp...
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    Euro Roundup: CHMP recommends drugs from Biogen and Roche, knocks back Pfizer filing

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines including Biogen’s Vumerity (diroximel fumarate) and Roche’s Gavreto (pralsetinib) for approval.   CHMP voiced support for the approval of RET receptor tyrosine kinase inhibitor Gavreto in non-small cell lung cancer on the strength of data from a Phase I/II clinical trial. Biogen received the backing of the committee for its multiple sclerosis drug...
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    FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Exkivity okayed as oral therapy for advanced NSCLC with certain mutations Takeda’s Exkivity (mobocertinib capsules) has been granted accelerated approval as an oral treatment for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as d...
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    Asia-Pacific Roundup: TGA creates regulatory requirements for COVID-19 testing software

     Australia’s Therapeutic Goods Administration (TGA) has published the regulatory requirements for software used with COVID-19 rapid antigen self-tests. The document is part of a series of actions to prepare Australia for the lifting of the ban on self-testing for the pandemic coronavirus.   TGA has created the guidance to help test developers understand if it regulates their software and, if so, what requirements they need to meet. If the software analyzes or enables i...
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    Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

    MedTech Europe has estimated as few as one-quarter of currently available in vitro diagnostics (IVDs) will be certified under the incoming regulations by the time they take effect next year. The trade group based its forecast on a survey of IVD manufacturers.   Many IVDs will need to be certified by notified bodies for the first time under the new regulations. With a small pool of notified bodies available to do the work, MedTech Europe has repeatedly raised concerns t...