Approvals
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Pipeline Watch: Phase II Starts In End-Stage Renal Disease, Diabetic Retinopathy
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Pipeline Watch: Multiple Positive Readouts In COVID-19
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
BMS/Bluebird Ready Abecma, First BCMA-Targeting CAR-T, For Initial Patients
Idecabtagene vicleucel for fifth-line multiple myeloma lags GSK’s BCMA-targeting ADC Blenrep, but it is months ahead of J&J/Legend’s CAR-T. Abecma is BMS’s second CAR-T approval this year.
Pipeline Watch: Phase III Readouts In Melanoma, Huntington's Disease, Prostate Cancer
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Poxel/Sumitomo's Novel Diabetes Therapy Imeglimin Nears Japan Market
Poxel’s potential first-in-class diabetes therapy, imeglimin, could be approved in Japan this year, and a new partner is being sought for the EU and US – events that would transform the outlook for the decade-old Merck Serono spin-out.
Zealand Set To Take On Lilly After Zegalogue US Approval
Despite being third to market behind Lilly’s Baqsimi and Xeris’s Gvoke to treat emergency episodes of hypoglycemia, Zealand is confident of a successful US launch for Zegalogue (dasiglucagon).
First EU Nation OKs CanSino's One-Shot COVID Jab
China continues the global push for its domestically-developed COVID-19 vaccines, with a new approval in Eastern Europe and new delivery routes entering clinical trials.
World-First Korean Nod For Hanmi's Neutropenia Contender Rolontis
Hanmi’s novel, long-acting neutropenia drug gets world-first approval in South Korea, setting it up to be the first product using the company's proprietary platform technology to be commercialized. An FDA manufacturing inspection also seems to bode well for the pending US approval.
Pipeline Watch: Phase III Starts In COVID-19, DMD, And IgA Nephropathy
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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