NEW YORK – The Association for Diagnostics & Laboratory Medicine (ADLM), along with the National Independent Laboratory Association, the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America, has filed an amicus brief this week in the American Clinical Laboratory Association’s (ACLA) suit against the US Food and Drug Administration (FDA) and its final rule on laboratory-developed tests. The brief supports ACLA’s position that the FDA rule exceeds the agency’s statutory authority and asks the court to strike it down.
Verismo Therapeutics this week said it has initiated the Phase I CELESTIAL-301 clinical trial of its CAR T-cell therapy SynKIR-310 at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute. The trial will evaluate safety, tolerability, and preliminary efficacy of the product in patients with B-cell non-Hodgkin lymphomas who have previously received CAR T-cell therapy but have since relapsed or become refractory to it as well as those who have never received CAR T-cell therapy.
Philadelphia-based Gemma Biotherapeutics, a biotech company that launched in August, this week said it inked a deal with the Oswaldo Cruz Foundation, also known as Fiocruz, a public health research institution that's part of the Ministry of Health of Brazil and the agency's main supplier of immunobiologics, biopharmaceuticals, and diagnostics. As part of the agreement, GemmaBio will sponsor clinical research and manufacturing work and hopefully secure approval for rare disease gene therapies at an affordable cost for patients in Brazil. Fiocruz will fund up to $100 million for this work. The agreement funds six clinical development programs, which Fiocruz will be able to license to supply within Brazil's publicly funded healthcare system.
Denovo Biopharma this week said the US Food and Drug Administration granted it fast-track designation for liafensine, a drug candidate that the company is developing for patients with treatment-resistant depression and a specific genetic biomarker that it refers to as DGM4. Denovo, which launched in 2012, acquires drugs that have failed late-stage clinical trials in all-comer populations and assesses their activity in biomarker-targeted patient subsets. The company licensed the triple reuptake inhibitor liafensine, which targets transporters for dopamine, serotonin, and norepinephrine, from Curia.
Flatiron Health and Lifebit Biotech said this week that they are expanding their collaboration to allow researchers in Japan access to Flatiron's database of real-world data. Lifebit's federated trusted research environment (TRE) technology will allow authorized researchers access to and use of Flatiron's data without removing data from the TRE to protect the privacy and security of sensitive clinical and genomic data.
Foresight Diagnostics filed a motion this week to dismiss the trade secret lawsuit brought against the company by Roche. In the motion, Foresight said that Roche failed to show any plausible trade secrets related to the case and failed to provide plausible factual allegations that the alleged trade secrets have independent economic value. It also said that the trade secret claims against Foresight should be dismissed because Roche has failed to allege any acts of misappropriation by Foresight.
Naveris this week said Blue Shield of California began providing coverage for the NavDx test for tumor tissue modified viral HPV DNA as of July 2, 2024. Naveris markets NavDx as a test for detecting HPV-driven cancers before treatment, during treatment, and after treatment.
Telix Pharmaceuticals said this week that Health Canada has approved the gallium 68-labeled PET imaging agent Illuccix (Ga-68 PSMA-11) as a diagnostic to select metastatic castration-resistant prostate cancer patients eligible for treatment with Novartis' Pluvicto (lutetium vipivotide tetraxetan). Illuccix was already approved in Canada as a tool to stage and restage intermediate and high-risk prostate cancers and to localize tumor tissue in recurrent prostate cancer.
China's National Medical Products Administration (NMPA) has approved Biogen's Qalsody (tofersen) under the conditional approval pathway as a treatment for a rare genetic form of amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene, a Biogen spokesperson confirmed to Precision Medicine Online this week. SOD1-ALS affects about 1,000 people in China, he said. Qalsody already has marketing approvals in the US and the EU.
Carsgen Therapeutics said this week that it has submitted complete response letters to the US Food and Drug Administration requesting the agency lift the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel, and CT071 after a positive follow-up inspection of its manufacturing facility by the FDA. The clinical hold on these three trials was issued in late 2023 and based on inspection findings at the facility in Durham, North Carolina. Carsgen said it expects the FDA to respond to its complete response letters within 30 days.
Allarity Therapeutics said this week that it has officially regained compliance with the minimum Nasdaq bid price requirement. The firm received a notice from the Nasdaq Stock Market confirming that Allarity has maintained a closing bid price of at least $1.00 for 20 trading days in a row, meaning it can remain listed on the market. Although the firm announced that it had regained compliance in March, the letter from Nasdaq marks the official notice.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.