Tag Archives: type-industry &amp; policy

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Agilent PD-L1 IHC 22C3 pharmDx Expands CE-IVD Mark in Non-small Cell Lung Cancer (NSCLC)

Agilent Technologies Inc. announced that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union.

[Agilent Technologies Inc.]

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Omniscient Neurotechnology Launches Quicktome^™ Brain Mapping Platform for Neurosurgery after Regulatory Clearance in United States, Canada and Australia

Omniscient Neurotechnology, Inc. announced that it has received US FDA 510(k) clearance for Quicktome^™, a digital brain mapping platform that allows neurosurgeons to visualize and understand a patient’s brain networks prior to performing life-changing brain surgery.

[Omniscient Neurotechnology, Inc. (BusinessWire, Inc.)]

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Oblato Announces That It Has Received a Positive Response from the FDA for the Use of OKN-007 for Patients with High-grade Gliomas in an Expanded Access Program

Oblato, Inc. announced that it has received an agreement from the FDA for its plan to submit an intermediate size expanded access protocol for use of OKN-007 in patients with high-grade gliomas.

[Oblato, Inc.]

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Xeris Pharmaceuticals Enters into an Exclusive License and Supply Agreement with Tetris Pharma Limited to Commercialize Ogluo^® in Europe

Xeris Pharmaceuticals, Inc. announced an exclusive agreement with Tetris Pharma Limited for the commercialization of Ogluo^® in the European Economic Area, United Kingdom, and Switzerland for the treatment of severe hypoglycaemia in adults, adolescents, and children aged two years and over with diabetes mellitus.

[Xeris Pharmaceuticals, Inc.]

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OSE Immunotherapeutics Announces Voluntary Pause of Enrollment in the CoVepiT Phase 1 Study

OSE Immunotherapeutics SA announced a voluntary and temporary pause of enrollment and dosing in its ongoing Phase I clinical trial for CoVepiT, the company’s investigational prophylactic COVID-19 vaccine candidate.

[OSE Immunotherapeutics SA (GlobeNewswire, Inc.)]

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Enzo Biochem Receives FDA Emergency Use Authorization for Rapid Extraction Method on Proprietary Test System for Detection of Coronavirus SARS-CoV-2

Enzo Biochem, Inc. announced that it has received an expansion of its FDA Emergency Use Authorization for the Company’s rapid extraction method on its proprietary test system for the detection of coronavirus SARS-CoV-2 including the genetic variants that are now proliferating globally.

[Enzo Biochem, Inc. (GlobeNewswire, Inc.)]

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Japan Becomes First Country to Approve Ronapreve (Casirivimab and Imdevimab) for the Treatment of Mild to Moderate COVID-19

Roche announced that Japan’s Ministry of Health, Labour and Welfare has approved Ronapreve™, for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.

[Roche (GlobeNewswire, Inc.)]

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Brooklyn ImmunoTherapeutics Completes Acquisition of Novellus Therapeutics

Brooklyn ImmunoTherapeutics, Inc. has announced that it had completed its acquisition of Novellus Therapeutics Limited. Novellus is developing next‑generation engineered MSC therapies using extensively patented mRNA-based cell reprogramming and gene editing technologies.

[Brooklyn ImmunoTherapeutics, Inc.]

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GC LabCell and GC Cell to Merge, Creating a Premier Cell Therapy Company

GC LabCell and GC Cell announced that they have entered into a definitive merger agreement to combine in an all-stock transaction.

[GC LabCell (BusinessWire, Inc.)]

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Imbria Pharmaceuticals Announces Initiation of Enrollment in IMPROVE-HCM, a Phase II Study Investigating the Safety, Tolerability, and Efficacy of IMB-1018972 (IMB-101) in Patients with Non-obstructive Hypertrophic Cardiomyopathy

Imbria Pharmaceuticals announced that the Hypertrophic Cardiomyopathy Center at Boston-based Tufts Medical Center has randomized the first patient in the IMPROVE-HCM study, a Phase II study of the safety, tolerability, and efficacy of IMB-101 in patients with non-obstructive hypertrophic cardiomyopathy.

[Imbria Pharmaceuticals]