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BioWorld - Wednesday, February 1, 2023
Home » Topics » Regulatory

Regulatory
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Lung cancer illustration

Cstone scores approval for Blueprint Medicines’ Gavreto in China

March 26, 2021
By Elise Mak
No Comments
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
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Regulatory actions for March 26, 2021

March 26, 2021
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airway, Astellas, Biontech, Camurus, Diurnal, Gilead, Glaxosmithkline, Idorsia, J&J, Pfizer, Roche, Seagen, Takeda, Vertex, Vir.
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FDA approves Myrbetriq tablets and granules for neurogenic detrusor overactivity in children

March 26, 2021
No Comments
FDA icons

FDA recommends vision check before applying dermal fillers

March 25, 2021
By Mark McCarty
No Comments
The use of dermal fillers has spiked in recent years for a number of reasons, but so have the associated adverse events. An FDA advisory committee made several associated recommendations, including that a patient’s vision be prospectively evaluated prior to any peri-ocular treatment with fillers, but this could be a simple count-the-fingers check, something that should not appreciably increase procedure times or affect the volume of procedures.
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Fluxergy products

Fluxergy corrals CE mark for 1-hour COVID-19 test

March 25, 2021
By Meg Bryant
No Comments
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
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Regulatory front for March 25, 2021

March 25, 2021
By Mark McCarty
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
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Regulatory actions for March 25, 2021

March 25, 2021
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine, Fluxergy, Rapid Medical, Tiger Tech.
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Proposed REMS not enough to mitigate tanezumab risk

March 25, 2021
By Mari Serebrov
No Comments
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
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Regulatory actions for March 25, 2021

March 25, 2021
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anaveon, Vertex.
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Regulatory front

Senators eye patent examiner practice for Section 101 problem

March 25, 2021
By Mari Serebrov
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
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