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Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse

Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation. ....

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The need for principle-based regulatory practice

DEALING with government agencies is one of the pain points that many Filipinos struggle with because of the historical difficulty (and for some notoriety) of government offices. It is nothing new for Filipinos to see long lines (actual or virtual), slow or delayed processing, repetitive or redundant requirements, and condescending government employees at times. ....

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Finmin, RBI to look at ownership change in fintech cos for compliance

The finance ministry and RBI will focus on ownership change of listed fintech companies to ensure regulatory compliance. Virtual meetings, workshops, ....

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Teva, Alvotech land approval with edge in Humira biosimilar race

Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23. ....

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Virtual Incision's miniature robotic surgery device gets FDA nod

The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics. ....

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