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Nektar lifted by Merck alliance for bempeg, new trial funding

pharmaphorum

Nektar Therapeutics is waiting on multiple data readouts for its lead drug bempegaldesleukin paired with strategic partner Bristol-Myers Squibb’s checkpoint inhibitor Opdivo, but that hasn’t stopped it signing up to test the drug with rival Keytruda from Merck & Co. .

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STAT+: ‘A blind eye’: NIH fails to ensure clinical trial results are reported and funds researchers who don’t file results

STAT News

National Institutes of Health failed to ensure that results of roughly half of clinical trials funded by the agency — both those conducted by its own scientists and outside researchers — were reported to a federal database during a recent two-year period, a new government review has found.

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STAT+: Pallone pushes NIH and FDA to disclose steps being taken to ensure clinical trial results are reported

STAT News

A Democratic lawmaker is demanding to know what steps the Food and Drug Administration and the National Institutes of Health are taking to ensure that results of clinical trials funded by the government are reported to a federal database. In a letter sent on Thursday, U.S. Frank Pallone (D-N.J.)

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Trial backs Lilly’s Olumiant plus remdesivir as combo COVID-19 therapy

pharmaphorum

Adding Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir reduces recovery time in COVID-19 patients compared to remdesivir alone, says a new trial. ACTT-2 used a 4mg dose of the drug, which wasn’t approved by the FDA on safety grounds.

Trials 111
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Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail

pharmaphorum

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trialfunded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile.

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Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?

Advarra

Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial. Funding, sponsorship, tasks to be conducted, and the legal structures of entities may impact sites and the study overall. Why do Funding and Sponsorship Matter?

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New Hope Against Diseases Marked by Progressive Scarring of Lung Tissue

The Pharma Data

Steven Nathan, senior researcher on the new trial. There are, however, drugs for another form of pulmonary hypertension, known as pulmonary arterial hypertension. Over 16 weeks, patients randomly assigned to use the drug were able to improve their performance on a six-minute treadmill walk.

Doctors 52