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Home » Topics » Regulatory

Regulatory
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1-27-GT-Medical-Gammatile.png

Gt Medical gains expanded indication in the U.S. for Gammatile therapy

Jan. 27, 2020
By Liz Hollis
Tempe, Ariz.-based Gt Medical Technologies Inc. has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy. Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. Previously, the therapy was available for individuals with recurrent brain tumors.
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Regulatory front for Jan. 27, 2020

Jan. 27, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Emmaus Life Sciences Inc., Global Blood Therapeutics Inc., Novartis AG and Vyera Pharmaceuticals LLC
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U.S. Capitol building

MDMA’s Leahey: ACA supporters saw device tax as ‘a spreadsheet exercise’

Jan. 24, 2020
By Mark McCarty
The 2.3% tax on medical devices is a thing of the past. Now, Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), has revealed to BioWorld that the supporters of the Affordable Care Act (ACA) saw the tax as little more than “a spreadsheet exercise” in financing the more costly elements of the legislation.
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1-24-Abbott-Infinity-DBS-hero.png

Abbott gets FDA nod for Infinity DBS in Parkinson’s disease, unveils positive data on Proclaim XR

Jan. 24, 2020
By Meg Bryant
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain.
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Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, First Coast Services Options, Livanova, Medline Industries, National Institute for Health and Care Excellence, Novitas Solutions
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FDA Approved stamp

Tazemeto, stat: Accelerated win for Epizyme in ES could ‘reFLect’ well in bigger indication

Jan. 24, 2020
By Randy Osborne
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
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Blocks with upward arrows

Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 24, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.
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Regulatory front for Jan. 24, 2020

Jan. 24, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sage Therapeutics
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Anerem approved in Japan for general anesthesia

Jan. 24, 2020

Japanese approval for Corectim ointment for atopic dermatitis

Jan. 24, 2020
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