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Home » Topics » Regulatory

Regulatory
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FDA Approved seal

Mite as well: Tarsus receives approval for Demodex blepharitis treatment

July 25, 2023
By Lee Landenberger
The U.S. FDA has approved the first treatment directly targeting the mites that cause Demodex blepharitis, an eye disease shared by about 25 million people in the U.S. and now a huge market opportunity for the developer.
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Leqembi launched and PDUFA near, ‘fit-for-growth’ Biogen gets leaner

July 25, 2023
By Randy Osborne
With the launch of intravenous Leqembi (lecanemab-irmb) for Alzheimer’s disease (AD) underway, Priya Singhal, Biogen Inc.’s head of development and interim head of research, said the firm, along with partner Eisai Co. Ltd., aims to “address the long-term duration question” with a subcutaneous version, recently touted at the Alzheimer's Association International Conference.
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Musculoskeletal

Epibone’s IND for allogenic osteochondral graft receives FDA clearance

July 25, 2023
Epibone Inc. has received IND clearance from the FDA to begin testing its engineered allogenic osteochondral graft in humans. Clinical trials are set to open patient recruitment as soon as early next year.
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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.
Read More
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