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Research & Development

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Merck & Co.’s Keytruda Stakes Another Adjuvant Flag, In RCC

Adjuvant renal cell carcinoma is a potentially lucrative indication for any checkpoint inhibitor; Merck & Co. flagship Keytruda is the first to demonstrate benefit in a Phase III study, although rivals are in pursuit.

Clinical Trials Life Cycle Management Business Strategies

Clinical Trials

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Latest From Clinical Trials

AZ’s ‘Long Shot’ COVID-19 Trial Of Diabetes Drug Farxiga Fails

The failure of the SGLT2 inhibitor is not unexpected, but allays any concerns that it could have worsened outcomes for patients with hypertension or heart disease.

Companies Commercial

AI And Tackling Challenges In Clinical Medicine

ISCR conference hears how artificial intelligence and machine learning can address challenges in clinical medicine, especially for cancer, and also optimize clinical trials.

Research & Development Artificial Intelligence

Roxadustat CKD Doubts Fanned By FibroGen Data Blunder

AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

Clinical Trials Companies

Five Phase III Data Readouts To Look Out For In Q2

Phase III trials of a number of late-stage investigational therapies are expected to read out during the second quarter of 2021, according to new analysis from Informa Pharma’s product pipeline database Biomedtracker. Some of the Phase III data could be transforming for a few of the less grand players in the pharma sector and here Scrip picks out some of the highlights to look out for in the months ahead.

Clinical Trials Companies

AbiVax Poised For 'Transformational' Q2

Q2 promises to be ‘transformational’ for AbiVax, propelled by key readouts for investigational anti-inflammatory, ABX464, and cancer agent, ABX196, but more funds will be needed by year end.

Clinical Trials Commercial

AriBio Progresses Novel Alzheimer's Contender Despite Mixed Phase II

Korea's AriBio is poised to file for US Phase III trial approval this year for its novel Alzheimer's candidate and lead asset AR1001, which showed an improvement in cognitive function from baseline at Phase II. But will the benefits over existing therapies be enough to carve a position in the challenging field?

Neurology Clinical Trials
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Approvals

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Latest From Approvals

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
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