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clinical development

Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder. NBI-1070770 is a novel,…

Marengo Therapeutics Announces First Drug Candidate Nomination from Oncology Collaboration with Ipsen

Marengo Therapeutics, Inc, a clinical-stage biotech company pioneering a new way to activate T cells that target the Vβ chain of the T cell receptor (TCR) and select the right T cell subsets against cancer, today announced that Ipsen (Euronext:…

Galimedix Therapeutics presents new scientific data showing promising neuroprotective effects of GAL-201 for the treatment of Alzheimer’s disease at AD/PD™ 2024

Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, announces encouraging data with orally available small molecule GAL-201, showing…

Innovent Announces First Participant Dosed in a Phase I Study of IBI3002 (an anti-IL-4Rα/TSLP bispecific antibody) in Australia 

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been dosed in Australia in a first-in-human (FIH) phase…

Brii Biosciences Announces Agreement to Acquire VBI’s IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies

Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that it has entered into agreements with VBI Vaccines, Inc….

Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global…

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that the first subject has been dosed in the NORSE EIGHT clinical…

Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)

Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the…

Lynk Pharmaceuticals Announced First Rheumatoid Arthritis Patient Dosed in Phase Ⅲ Clinical Study of LNK01001 

Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as ‘Lynk Pharmaceuticals’), an innovative clinical stage company, announced that it has dosed the first patient with Rheumatoid Arthritis (RA) in a Phase Ⅲ clinical trial of its highly selective JAK1 inhibitor LNK01001….

Ascletis Announces Initiation of Phase III Clinical Trial of ASC40 (Denifanstat) for Treatment of Acne

Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces initiation of the Phase III clinical trial of fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) for treatment of moderate to severe acne vulgaris. This Phase III clinical trial is a randomized, double-blind,…