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Home » Topics » Regulatory

Regulatory
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Acute myeloid leukemia
Immuno-oncology

Avencell’s CRISPR-engineered switchable allogeneic CAR T AVC-201 receives European trial clearance

July 25, 2023
Avencell Therapeutics Inc. has received approval from the EMA for its clinical trial application (CTA) for AVC-201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and other selected hematologic malignancies positive for CD123. A phase I study will be conducted in Germany.
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Regulatory actions for July 24, 2023

July 24, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nesa Medtech.
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Flag of Australia, sky background

TGA eyes revamp of regulations for devices with biological tissues

July 24, 2023
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) is reconsidering its approach to regulating devices that bear materials of animal, microbial or recombinant origin, a broad class of products that includes transcatheter aortic valve replacement (TAVR) devices.
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U.S. FDA headquarters

Spring-loaded: BD poised to jump on pent up demand for updated Alaris following long-awaited FDA clearance

July 24, 2023
By Annette Boyle
A more than three-year commercial hold built up an estimated $1 billion in demand for Becton, Dickinson and Co.’s (BD) Alaris infusion system and BD has every intention of meeting that demand as quickly as possible now that it has FDA clearance for the updated device. The clearance allows the company to resume commercial sales and undertake remediation of its installed base of point-of-care units with enhanced features for its pumps and monitoring systems as well as new software and upgraded cybersecurity and interoperability.
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Regulatory actions for July 24, 2023

July 24, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Beigene, BMS, Daiichi Sankyo, Emergent Biosolutions, GC, Genentech, Hansoh, Ipsen, Janssen, Jazz, Menarini, Merck, Mirati, Pfizer, Scynexis, SN, Stemline.
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Ycanth

Verrica perseveres as FDA approves skin lesion treatment

July 24, 2023
By Lee Landenberger
Fourth time’s a charm for Verrica Pharmaceuticals Inc. as the U.S. FDA has approved Ycanth (cantharidin) to treat molluscum contagiosum in those ages 2 and older. Three complete response letters (CRL) have stood in the treatment’s way for the past three years, blocking approval of the U.S.’s first approved treatment.
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3D rendering of antibody drug conjugated with cytotoxic payload
Immuno-oncology

Mabwell's antibody-drug conjugate 7MW-3711 cleared to enter clinic in China for solid tumors

July 24, 2023
Mabwell (Shanghai) Bioscience Co. has received approval from China's National Medical Products Administration (NMPA) for its clinical trial application for 7MW-3711 for advanced malignant solid tumors.
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Kissei withdraws NDA for rovatirelin for spinocerebellar degeneration in Japan

July 21, 2023
By Tamra Sami
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
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Green approved stamp
Biopharma regulatory actions and approvals June 2023

US FDA approvals up, with two treatments for generalized myasthenia gravis among 18 approvals in June

July 21, 2023
By Amanda Lanier
U.S. FDA drug approvals increased 19.18% compared to the first six months of last year, with June approvals up to 18 from the previous five months’ average of 14. Worldwide approvals are down 16.8% from the first half of 2022, but up 1.43% compared to the previous seven years’ average.
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Drug vials

Korea’s FTC slams GSK, domestic vaccine makers with $32M for price-fixing

July 21, 2023
By Marian (YoonJee) Chu
South Korea’s antitrust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down on 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program.
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