FDA Review: ClearPoint Neuro, Oncopeptides, Iterative Scoping, and More

FDA_Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

the US Food and Drug Administration He had a busy week with a variety of drug approvals, advisory committee meetings and classification announcements. Here’s a look.

September 23

oncopeptides reported the FDA’s Advisory Committee on Oncology Drugs voted 14-2 against the company’s Pepaxto with dexamethasone for relapsed or refractory multiple myeloma.

September 22

Clear Point Neuroswedish partner of Clinical Laserthermy Systems, He received 510(k) clearance for its ClearPoint Prism neurolaser therapy system to necrotize or coagulate soft tissue via interstitial irradiation or thermal therapy under 3.0T MRI guidance.

Iterative scopes Y Test Announced SKOUT has received 510(k) clearance for adults undergoing colorectal cancer surveillance or screening.

QT images He received 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV), which can be used to help assess breast cancer risk.

perkinelmerThe T-Cell Select Reagent Kit for automation of your T-SPOT TB test workflow for in vitro diagnostic use was passed by the FDA.

Fennec’ Pharmaceuticals pedmark was passed for chemotherapy-induced hearing loss in patients with localized non-metastatic solid tumors treated with cisplatin.

Spectrum Pharmaceuticals faced the brunt of the FDA’s largely negative briefing papers a day before the September 21-22 FDA advisory meeting on the NDA for poziotinib, considered for non-small cell lung cancer (NSCLC).

September 21st

Immunity Therapeutics He received the green light to start a phase I trial of IMT-009, a monoclonal antibody against CD161 in immuno-oncology.

Cellenko’s He received the go-ahead for a Phase I and Phase Ib trial of CK0803, allogeneic neurotrophic Treg cells, in amyotrophic lateral sclerosis.

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Kinnate Biopharmacy I was granted Fast Track designation for KIN-2787 for patients with stage IIb to IV malignant melanoma with positive BRAF Class II or III alteration and/or positive NRAS mutation that is metastatic or unresectable.

Eli Lilly Retevmo (selpercatinib) for adults with locally advanced or metastatic solid tumors with a rearranged gene during transfection (RET) fusion was passed by the FDA.

September 20

avrobius‘s AVR-RD-04, an investigational gene therapy for cystinosis, He received Rare Pediatric Disease Designation.

Therapeutics of alterity He received the go-ahead for a phase II trial of ATH434 in multiple system atrophy (MSA), a parkinsonian disorder.

predictions PredicineCARE cfDNA Assay for cancer testing He received Innovative device designation.

Xpira Pharmaceuticals He received the green light for a Phase IIa trial of psilocybin-assisted therapeutic protocols in patients with anorexia nervosa.

Therapeutic Verismo He received authorization for a phase I trial of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma.

Stryker He received 510(k) clearance for your OptaBlate bone tumor ablation system.

Artiva Biotherapeutics He received FDA clearance for a clinical trial of AB-201, a HER2-directed allogeneic CAR-NK cell therapy for solid tumors in the outpatient setting.

September 19th

WuXi Biological Products two pharmaceutical substance facilities and one pharmaceutical facility located in the city of Wuxi He received FDA and European Medicines Agency (EMA) approval.

rheonix He received Expanded Emergency Use Authorization (EUA) for your COVID-19 MDx assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit.

XORTX Therapeutics Announced completion of its Pre-phase III Type B meeting with the FDA to advance its XRx-008 program for autosomal dominant polycystic kidney disease.

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Seagen Announced The FDA accepted for priority review its sNDA for the accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for adults with HER2-positive colorectal cancer who have received at least one prior treatment.

Advanced nanotherapies He received FDA breakthrough designation for its SirPlux Duo drug-coated balloon (DCB) for coronary artery disease in vessels smaller than 3.0 mm.

alligator bioscience Y Aptevo Therapeutics obtained FDA approval to launch a Phase I trial of ALG.APV-527 for tumor antigens expressing 5T4 in multiple types of solid tumors.

Antengene Corporation ATG-101, a PD-L1/4-1BB bispecific antibody, was granted Orphan drug designation for the treatment of pancreatic cancer.

Seagen Announced The FDA accepted for priority review its supplemental NDA for Tukysa (tucatinib) in combination with trastuzumab for adults with HER2+ colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease.

September, 17th

Bluebird biographies Skysona (eli-cel) was passed by the FDA for early active cerebral adrenoleukodystrophy (CALD).

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