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BioWorld - Saturday, June 28, 2025
Home » Topics » Regulatory

Regulatory
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Singapore’s Tessa gains U.S. RMAT designation for CD30 CAR T, expands manufacturing efforts

Feb. 28, 2020
By David Ho
HONG KONG – Singapore-based Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy (RMAT) designation by the U.S. FDA based on data from two independent phase I/II trials in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
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Regulatory front for Feb. 28, 2020

Feb. 28, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Costa Rican flag, economy/growth puzzle pieces

Costa Rica designs tailor-made programs to train manpower for the med-tech sector

Feb. 28, 2020
By Sergio Held
SAN JOSE, Costa Rica – Two decades ago, the Costa Rican economy was basically an agriculture-based economy. Since then, the tiny Central American country has emerged as the second-largest med-tech exporter in the region as well as an eager partner and supplier of skilled manpower.
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Regulatory front for Feb. 27, 2020

Feb. 27, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: King Systems.
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FDA icons

FDA wraps up CLIA-related guidances for 510(k) diagnostics

Feb. 27, 2020
By Mark McCarty
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
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Regulatory front for Feb. 27, 2020

Feb. 27, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Celgene, Roche.
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FDA Approved stamp

Acacia’s Barhemsys clears FDA hurdles, wins nod in PONV

Feb. 27, 2020
By Nuala Moran
LONDON – It was third time lucky for Acacia Pharma Group plc, as the FDA finally gave approval to Barhemsys (amisulpride) as a rescue treatment for surgical patients suffering postoperative nausea and vomiting (PONV), despite standard-of-care treatment.
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2-26-Butterfly-Network-iQ-ultrasound.png

Speakers make case for home-use ultrasound with help of AI

Feb. 26, 2020
By Mark McCarty
The second day of the FDA workshop on artificial intelligence (AI) in health care featured several interesting proposals, including that AI will be used in health care without the aid of a health care professional. John Martin, chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.
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Thumbs down

Too bad for Tookad: FDA adcom votes against Steba’s prostate cancer treatment

Feb. 26, 2020
By Lee Landenberger
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
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Regulatory front for Feb. 26, 2020

Feb. 26, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Livanova.
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