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Research & Development

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Toripalimab Set For ASCO Buzz With New Nasopharyngeal Data

Junshi and Coherus's PD-1 was already gaining attention for a particularly difficult cancer type even before the meeting, but new data add to its luster ahead of a potential US approval. 

Cancer Clinical Trials Research & Development

Clinical Trials

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Latest From Clinical Trials

Biogen Gives Up On Gosuranemab After No Benefit Seen In Alzheimer's Study

Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.

Clinical Trials Neurology

BIO 2021 Notebook: Biogen CEO On Corporate Responsibility

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains. 

Clinical Trials Companies

Can JAK Inhibitors Save Lives From COVID-19? Pfizer Might Let RECOVERY Answer The Question

Pfizer has unveiled promising results from a study of Xeljanz but needs a bigger trial. Given RECOVERY’s track record, the pharma company may opt to wait for its results.

Commercial Clinical Trials

Blow For CureVac As COVID-19 Vaccine Hits 47% Efficacy

CureVac is not throwing in the towel just yet, but the odds are stacked against a successful end result.

Coronavirus COVID-19 Research & Development

BIO Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

Pivotal Data Boost Omeros’ Stem Cell Transplant Product After FDA Delay

Promising pivotal data boost chances for Omeros’ narsoplimab to become a highly needed, first-to-market drug for the treatment of a deadly complication of stem cell transplants.

Clinical Trials Companies
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Approvals

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Latest From Approvals

Blueprint Prepares To Take On Novartis In Advanced Systemic Mastocytosis

The company’s rollout plans for Ayvakit appear similar to its approach when it marketed the drug for GIST, with an education plan to help boost sales.

Advertising, Marketing & Sales Business Strategies

BIO 2021 Notebook: A Breakthrough Year For Emerging Companies?

News and views from day two of the BIO Digital annual meeting include the increasing number of small companies driving US product approvals, the US FDA's Patrizia Cavazzoni on science vs. emotion at advisory committees and Merck & Co.'s Julie Gerberding on the need for continued HIV/AIDS research.

Advisory Committees Real-World Evidence

Pioneering Japan Approval For Daiichi’s Oncolytic Virus In Glioma

Japan grants ground-breaking approval for Daiichi oncolytic virus in brain cancer on condition of additional data. The nod marks another step forward in the firm's strategic global pivot to oncology. 

Japan Approvals

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

Clinical Trials Approvals

Pipeline Watch: The Bumper ASCO Edition

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

China’s First ADC Secures Domestic Approval

RemeGen’s second approval after a green light for its lupus drug signals accelerating approvals for domestically-developed antibodies in China.

China Approvals
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