Category: Clinical trials
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STAT+: NIH redefines ‘clinical trials,’ dividing researchers
STAT+: NIH redefines ‘clinical trials,’ dividing researchers In a long-debated move, the National Institutes of Health will no longer characterize basic experimental studies involving humans as clinical trials, a step that was cheered by many researchers, but is also raising transparency concerns because the work will no longer have to be registered with — or…
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The high stakes for Huntington’s patients
The high stakes for Huntington’s patients Biotech company UniQure is set to meet with the Food and Drug Administration to discuss the path forward for its gene therapy for Huntington’s disease, and the outcome could be potentially devastating for patients. That’s what patient advocate Lauren Holder says on the latest episode of “The Readout LOUD,”…
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A new top drug regulator and the future of psychedelics
A new top drug regulator and the future of psychedelics On this week’s episode of “The Readout Loud”: a look at an emerging class of psychedelic drugs that may treat depression, anxiety, and other psychiatric conditions without the hallucinogenic “trip.” Plus, a dash through the week’s biotech news. The turmoil at the Food and Drug…
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NIH funding cuts have affected over 74,000 people enrolled in experiments, a new report says
NIH funding cuts have affected over 74,000 people enrolled in experiments, a new report says NEW YORK — Over 74,000 people enrolled in experiments have been affected by the National Institutes of Health’s funding cuts, according to a new report. Between the end of February and mid-August, funding ceased for 383 studies that were testing treatments for conditions…
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Opinion: Drug developers shouldn’t shortchange the autoimmune community
Opinion: Drug developers shouldn’t shortchange the autoimmune community My teenage years were ravaged by severe autoimmune disease. In that era, the burdens of treatment for Crohn’s disease rivaled the misery of the affliction. My illness brought searing stomach pain, fatigue, and fistulas. The steroids my physician prescribed caused breakouts of cystic acne all over my…
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STAT+: Cytokinetics drug yielded benefits over common therapy in patients with heart condition, study shows
STAT+: Cytokinetics drug yielded benefits over common therapy in patients with heart condition, study shows An experimental medicine from Cytokinetics improved exercise capacity more than a widely prescribed beta blocker in patients newly diagnosed with a common, inherited heart condition, study results reported Saturday showed. The Cytokinetics drug, called aficamten, is currently being reviewed by…
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STAT+: Akeso says its closely watched drug improved patient survival in a lung cancer trial
STAT+: Akeso says its closely watched drug improved patient survival in a lung cancer trial Akeso, a Chinese biotech with a drug positioned to rival Merck’s megablockbuster Keytruda, has reported for the first time that the therapy can improve patient survival. The therapy, ivonescimab, showed a statistically significant survival benefit as a second-line treatment when…
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STAT+: Using mRNA, scientists overcome a key challenge to HIV vaccines
STAT+: Using mRNA, scientists overcome a key challenge to HIV vaccines The decades-long push to develop an HIV vaccine has been riddled with setbacks. But researchers reported on Wednesday that they have managed to circumvent one of the longstanding challenges to developing protective shots against this complex and crafty virus. Scientists used a messenger RNA-based…
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STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight
STAT+: GLP-1 drug helped type 1 diabetes patients keep healthy glucose levels and lose weight Obesity drugs were first approved to treat type 2 diabetes, but there’s a growing movement to test them in type 1 diabetes, too. Research presented Monday at a large diabetes meeting showed some promise for this approach. Patients who took…
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STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing
STAT+: Amgen’s obesity drug led to high discontinuation rates in mid-stage trial, as company plans to adjust dosing CHICAGO — Amgen’s monthly obesity candidate led to substantial weight loss but a high rate of side effects and discontinuations in a mid-stage trial, results that support the company’s decision to use a slower dosing schedule to…
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STAT+: GLP-1 reduced migraine frequency by nearly half, in a pilot study
STAT+: GLP-1 reduced migraine frequency by nearly half, in a pilot study GLP-1 drugs could treat more than just diabetes and obesity. They may also reduce migraine frequency. That is according to the findings of a study presented on Friday at the European Academy of Neurology congress. The pilot study found that GLP-1 agonists reduced…
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STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer
STAT+: Merus drug, with immunotherapy, shows preliminary survival boost for patients with head and neck cancer Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis…
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FDA OKs trial of pig livers as dialysis-like treatment for liver failure
FDA OKs trial of pig livers as dialysis-like treatment for liver failure WASHINGTON — U.S. researchers will soon test whether livers from a gene-edited pig could treat people with sudden liver failure — by temporarily filtering their blood so their own organ can rest and maybe heal. The first-of-its-kind clinical trial has been cleared by the Food…
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STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues
STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by…