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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 Approvals

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.

Pipeline Watch Approvals

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.

Launches Approvals

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.

Pipeline Watch Approvals

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.

Metabolic Disorders Approvals

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).

Metabolic Disorders Approvals

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. 

China Coronavirus COVID-19

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.

South Korea Approvals

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.

Pipeline Watch Approvals
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