Tag Archives: type-industry & policy

Pfizer’s Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis

Pfizer, Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis in adults who are candidates for systemic therapy.
[Pfizer, Inc.]
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Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (Ozanimod) as a Treatment for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Zeposia for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
[Bristol Myers Squibb]
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Tricol Biomedical Receives NIH Phase IIB Grant to Continue Development of its Hemostatic Device for the Prostate

Tricol Biomedical, Inc. has received an $853,585 grant from the National Institute Of Diabetes And Digestive And Kidney Diseases. This Phase IIB grant will support final development of Tricol’s proprietary hemostatic device to address bleeding in prostate-related procedures for treatment of both benign and malignant prostate conditions.
[Tricol Biomedical, Inc. (GlobeNewswire, Inc.)]
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Krystal Biotech and GeneDx Announce Collaboration to Provide No-Charge Genetic Testing for Patients with Suspected Dystrophic Epidermolysis Bullosa (DEB)

Krystal Biotech, Inc. and GeneDx, Inc. announced a collaboration offering no-charge genetic testing for all types of Epidermolysis Bullosa.
[Krystal Biotech, Inc.]
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Lava Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

LAVA Therapeutics N.V. announced that the US FDA has granted orphan drug designation for the company’s CD1d targeted GammabodyTM, LAVA-051, for the treatment of chronic lymphocytic leukemia.
[LAVA Therapeutics N.V.]
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First Wave BioPharma Announces Dosing of First Patient in Phase IIb Clinical Trial Evaluating Topical Niclosamide in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis

First Wave BioPharma, Inc. announced that it has dosed the first patient in a Phase IIb clinical trial investigating a topical formulation of niclosamide as a potential treatment for patients with ulcerative proctitis and ulcerative proctosigmoiditis.
[First Wave BioPharma, Inc.]
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Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Advanced Solid Tumors

Immune-Onc Therapeutics, Inc. announced that the first patient has been dosed in the company’s first-in-human clinical trial of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) for the treatment of solid tumors.
[Immune-Onc Therapeutics, Inc.]
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Algernon Pharmaceuticals Files US FDA Pre-IND Meeting Request for Ifenprodil Chronic Cough Phase II Study

Algernon Pharmaceuticals Inc. announced that it has filed a pre-IND meeting request with the US FDA for its investigation of NP-120 for a planned Phase II study for the treatment of refractory chronic cough.
[Algernon Pharmaceuticals Inc.]
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Smart Immune Receives IRB Approval for Phase I/II Clinical Trial of Proprietary Allogeneic T-Cell Product Smart-101 (ProTcell™) for AML and ALL

Smart Immune SAS, a T cell medicine company utilizing its proprietary ex vivo biomimetic “thymus in a dish” technology to develop allogeneic T-cell progenitors Smart101 for rapid immune reconstitution, announced that the institutional review board (IRB) of the Memorial Sloan Kettering Cancer Center has approved the commencement of the company’s Phase I/II clinical trial.
[Smart Immune SAS]
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Rhizen Pharmaceuticals AG Announces First Patient Dosing in a Phase II Study of Tenalisib (RP6530) in Locally Advanced or Metastatic Breast Cancer Patients

Rhizen Pharmaceuticals AG announced that it has commenced dosing in a Phase II trial to evaluate Tenalisib in patients with locally advanced or metastatic breast cancer.
[Rhizen Pharmaceuticals (BusinessNewsWire, Inc.)]
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Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer

Agilent Technologies Inc announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer at high risk of disease recurrence.
[Agilent Technologies, Inc.]
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