Tag Archives: type-industry & policy

FDA Approves Orgenesis IDE for Pilot Clinical Trial of its Tissue Genesis Icellator2® to Treat ARDS Resulting from COVID-19 Infection

Orgenesis, Inc. announced it has been granted Investigational Device Exemption (IDE) approval by the FDA to conduct a first-in-human feasibility study of the Tissue Genesis Icellator2® to treat Acute Respiratory Distress Syndrome (ARDS) resulting from COVID-19 infection.
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Chiesi Global Rare Diseases Announces FDA Approval of FERRIPROX® (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease

Chiesi Global Rare Diseases announced that the U.S FDA has approved FERRIPROX® for the treatment of transfusional iron overload due to sickle cell disease or other anemias in adult and pediatric patients 3 years of age and older.
[Chiesi Global Rare Diseases]
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AbCellera Partners with Angios to Develop Therapeutics to Combat Blindness Caused by Diabetic Retinopathy

AbCellera and Angios GmbH announced that they have entered into a multi-year, multi-target collaboration to facilitate the discovery of monoclonal and bispecific antibodies for vascular diseases of the eye.
[AbCellera (BusinessWire, Inc)]
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In Shock Move, US Backs Waiving Patents on COVID Vaccines

In a historic move, the US government has today announced its support for waiving patent protections for COVID-19 vaccines, a measure aimed at boosting supplies so that people around the world can get the shots.
[Nature News]
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$8M Grant Aims to Better Understand Disease Mechanisms of Schizophrenia

A research team from the Duke Center for Genomic and Computational Biology have teamed up with scientists at UNC-Chapel Hill and Flora Vaccarino at Yale University to narrow down areas of the genome previously marked relevant to schizophrenia risk.
[Mirage News]
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GE Healthcare Acquires Zionexa; Molecular Imaging Agent Aims to Enable More Targeted Treatment for Metastatic Breast Cancer Patients

GE Healthcare announced the acquisition of Zionexa. The company aims to develop and bring to market Zionexa’s pipeline biomarkers, as well as the recently FDA-approved PET imaging agent, Cerianna™ , which is used as an adjunct to biopsy for the detection of estrogen receptor positive lesions to help inform treatment selection for patients with recurrent or metastatic breast cancer.
[GE Healthcare]
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The FDA Expands Collaboration with CN Bio to Investigate Lung-on-a-Chip Model for Inhaled Drug Evaluation Applications

CN Bio, announced the US FDA has extended their research collaboration, for a further three years.
[CN Bio, Inc (Business Wire, Inc.)]
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ImmunoMet Therapeutics Granted Fast Track Designation by U.S. FDA for IM156 in Idiopathic Pulmonary Fibrosis

ImmunoMet Therapeutics, Inc., announced that the US FDA has granted Fast Track designation for its lead compound IM156, an investigational Protein Complex 1 inhibitor, being evaluated for idiopathic pulmonary fibrosis.
[ImmunoMet Therapeutics, Inc. (Business Wire, Inc.)]
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‘There Are So Many Hurdles.’ Indian Scientists Plead with Government to Unlock COVID-19 Data

Indian researchers say they urgently need better access to data collected by government agencies to help them understand and fight the country’s devastating second pandemic wave. An open letter published on 29 April that has 740 signatories so far asks the government for access to databases on COVID-19 testing and genomic sequencing and urges it to remove other obstacles to research.
[ScienceInsider]
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French National Cancer Institute and XBiotech Join forces to Conduct Innovative Phase II/III Adaptive Multicenter Clinical Study for XBiotech’s New Cancer Drug for Colorectal Cancer

XBiotech announced that it had reached an agreement to supply its new cancer drug XB20-01 to INSERM, and its Federation of Digestive Oncology group.
[XBiotech (GlobeNewswire, Inc.)]
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Hoth Therapeutics Announces Development of HT-KIT to Treat Multiple Orphan Diseases, Including Rare Cancers

Hoth Therapeutics, Inc. announced it intends to pursue development of its HT-KIT mRNA Frame Shifting Therapeutic for multiple orphan diseases, which are rare diseases that affect less than 200,000 people in the US. HT-KIT targets a shared cell signaling pathway that may have therapeutic potential for multiple rare cancers.
[Hoth Therapeutics, Inc.]
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