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Research & Development

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Kadmon’s ROCKstar Is Rising On GvHD Therapy Data

Kadmon’s treatment for graft-versus-host disease, belumosudil continues to perform well in its pivotal ROCKstar study, setting the stage for a US filing under the FDA’s pilot Real-Time Oncology Review program.

Clinical Trials Companies Research & Development

Clinical Trials

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Latest From Clinical Trials

Coronavirus Update: WHO Suspends Hydroxychloroquine Trial, Novavax Launches Phase I/II Vaccine Study

Mounting evidence that President Trump's 'game changer' does more harm than good for COVID-19 patients. Novovax and Medicago among the latest vaccine developers to report progress.

Coronavirus COVID-19 Clinical Trials

Roche Touts Safety Profile For NMOSD Drug Satralizumab

With Alexion's Soliris already approved, and Viela's inebilizumab within touching distance of an FDA green light, Roche is highlighting the safety profile of its investigational neuromyelitis optica spectrum disorder drug satralizumab.

Neurology Rare Diseases

SELECTION Positive For Gilead/Galapagos’s Filgotinib In UC But Will It Be Enough To Compete?

Gilead and Galapagos’s closely watched JAK inhibitor filgotinib has produced some promising Phase IIb/III data in ulcerative colitis. The question now is whether they will be enough to allow the product to put in a strong showing in this competitive market.

Clinical Trials Companies

Kancera Targets COVID-19 With Fractalkine Inhibitor

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

Clinical Trials Companies

A Considerable Setback For Cancer Trials Because Of COVID-19, IQVIA/CRI Survey Finds

Patient enrollment in clinical trials for cancer drugs was "severely" affected by the COVID-19 pandemic, according to a report published in Nature Reviews Drug Discovery

Clinical Trials Coronavirus COVID-19

Vaccine Manufacturing Hub Will Help UK Meet Coronavirus Challenge

Vaccine manufacturing capacity has been lost in the UK in recent decades. Now a new Vaccines Manufacturing Innovation Centre will re-seed that capacity and expertise - and the pandemic is accelerating its arrival.

Companies Clinical Trials
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Approvals

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Latest From Approvals

Pipeline Watch: Phase III Readouts For Cabotegravir, Filgotinib

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

Latecomer Alunbrig Faces Entrenched Rivals After US 1L Approval

First-line lung cancer approval will expand potential market for Takeda's ALK contender but the latecomer is also facing some well-established class competition in the setting.

United States Approvals

Sunovion Plans September Launch For Parkinson’s 'Off' Episode Drug Kynmobi

Kynmobi is an important approval for parent company Sumitomo Dainippon ahead of the loss of exclusivity for Latuda. Sunovion hopes to launch after COVID-19 social distancing requirements ease.

Approvals Neurology

AZ/Merck & Co' s Lynparza Gets US Approval For Prostate Cancer

Lynparza has received the green light from the FDA for advanced prostate cancer, its fourth tumor type, and while it may not be the first PARP inhibitor to be approved for this indication, analysts are expecting the drug to lead the class.

Cancer Approvals

Novartis Targets Quick Launches For Zolgensma in Europe

The Swiss major is offering a ‘Day One’ access program to governments and reimbursement agencies for Zolgensma, which is already available in France and will be shortly in Germany.

Approvals Gene Therapy

New Approvals In Spotlight As China Gears For National Congress

In a sign that attention in China may be shifting back to more routine regulatory work as the local coronavirus outbreak appears to recede, authorities have granted approvals to multiple new drugs for cancer and rare diseases, as the government gears up to hold its delayed annual congress in Beijing.

Approvals China
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