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BioWorld - Monday, May 11, 2026
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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Kidneys
Nephrology

Jemincare obtains approvals to advance five drugs into clinical trials

Dec. 28, 2023
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
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Photomicrograph of bone marrow aspirate showing myeloblasts of acute myeloid leukemia
Cancer

FDA clears Senti Biosciences’ IND for SENTI-202

Dec. 27, 2023
Senti Biosciences Inc. has received clearance of its IND application from the FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome, while sparing healthy bone marrow cells.
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Endocrine/Metabolic

Olix cleared to conduct phase I study of OLX-75016 in Australia

Dec. 27, 2023
Olix Pharmaceuticals Inc. has received approval from the Alfred Human Research Ethics Committee (HREC) in Australia to conduct a phase I clinical trial of drug candidate OLX-75016 for the treatment of nonalcoholic steatohepatitis (NASH).
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Futuristic medicine research illustration with petri dishes and pipette
Infection

Asieris Pharmaceuticals obtains approval to conduct phase I study of antibacterial drug

Dec. 27, 2023
Asieris Pharmaceuticals Co. Ltd. announced that it has received approval to commence phase I clinical trials in Australia of its novel antibacterial drug, APL-2301 (ASN-1733, MET-102), under development for the treatment of Acinetobacter baumannii infections.
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Nephrology

Arrowhead files to begin phase I/IIa trial of ARO-CFB for complement-mediated renal disease

Dec. 22, 2023
Arrowhead Pharmaceuticals Inc. has filed an application in New Zealand seeking clearance to initiate a phase I/IIa trial of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for complement-mediated renal disease, such as immunoglobulin A nephropathy (IgAN).
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Musculoskeletal

Aurinia submits IND for AUR-200 for autoimmune diseases

Dec. 22, 2023
Aurinia Pharmaceuticals Inc. has submitted an IND application to the FDA for AUR-200, a potential next-generation therapy for B-cell-mediated autoimmune diseases.
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Kidneys
Gastrointestinal

Ocelot's OCE-205 awarded US orphan drug designation for ascites

Dec. 21, 2023
The FDA has awarded orphan drug designation to Ocelot Bio Inc.'s lead candidate OCE-205 for the treatment of ascites due to all etiologies except cancer. Ocelot Bio plans to initiate clinical studies of OCE-205 in refractory ascites next year.
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Colorful brain illustration with binary number background
Neurology/Psychiatric

Iama cleared in Italy to begin first-in-human study of IAMA-6 for autism and epilepsy

Dec. 21, 2023
Iama Therapeutics Srl has obtained clinical trial application (CTA) clearance from the Italian Medicines Agency (AIFA) to initiate a first-in-human phase I study of IAMA-6, an orally administered small-molecule therapeutic targeting NKCC1 for the treatment of autism and epilepsy.
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Cancer cell targeted in crosshairs
Immuno-oncology

Avstera’s AVS-100 cleared to enter clinic for solid tumors

Dec. 19, 2023
Avstera Therapeutics Corp. has received FDA clearance of its IND application for HDAC6 inhibitor AVS-100. Avstera intends to initiate a phase Ia/b trial in the first half of 2024 to evaluate AVS-100 alone and in combination with pembrolizumab in locally advanced or metastatic solid tumors.
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Urinary tract with kidneys, adrenalin glands, ureter and vessels on light blue background
Infection

NRX-101 receives FDA clearance to enter clinic for cUTI

Dec. 19, 2023
Nrx Pharmaceuticals Inc. has announced FDA clearance of its IND application for the use of NRX-101 (lurasidone hydrochloride/D-cycloserine) for the treatment of complicated urinary tract infections (cUTI).
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