Found "Early HTA": 408 results
FDA rejects expanded use of Regeneron drug for gout
The rejection follows a unanimous vote against the drug’s approval in early May by advisors to the U.S. Food and Drug Administration, with panel members expressing concern that the company had only done a 16-week study.The agency has requested additional clinical data, including chemistry, manufactu
Achillion hepatitis C drug shows promise in mid-stage study
The company said the drug sovaprevir, when given along with the standard therapy of pegylated interferon and ribavirin, showed no detectable virus level in a majority of patients four weeks after the end of the treatment period.Of the 39 patients who received 12 weeks of additional standard therapy
U.S. health panel likely to make HIV tests routine
(Reuters) – A U.S. health panel may soon make HIV testing as standard a practice as checking cholesterol levels, a move that would fundamentally change how the virus is detected and treated.The U.S. Preventive Services Task force, a government-backed group of clinicians and scientists, is expected t
New Novartis drug shows potential in heart failure
(Reuters) – An experimental drug from Novartis may help up to half of heart failure patients for whom no effective treatment is available, although the evidence so far is indirect.Results of a mid-stage clinical trial of the drug known as LCZ696, unveiled on Sunday, gauged its effectiveness by measu
FDA warns Hospira over Costa Rica infusion pump plant
The warning, stemming from an April inspection by U.S. regulators, does not restrict production or product shipments from the plant in La Aurora de Heredia, Costa Rica, Hospira said on Tuesday in a regulatory filing with the U.S. Securities and Exchange Commission.Among the issues cited by the FDA w
Call for debate on freezing IVF embryos
Fertility doctors have called for a debate around whether freezing embryos should become the main option for IVF treatment in the future.An analysis of 13,000 IVF pregnancies suggested the freezing process might be better for the mother and the baby’s health.However, some fertility specialists argue
Knocking on doors to end HIV in Philadelphia
Philadelphia (CNN) — Beth Rutstein rolls up the sleeves of her T-shirt, juggles a stack of fliers and knocks on the door of a stranger’s home. She’s on a mission to save lives.After wiping sweat from her face beneath the sweltering afternoon sun on a recent Thursday, she ascends another set of stair
Breast cancer screening does ‘more good than harm’
Breast cancer screening saves the lives of two women for every one patient who receives unnecessary treatment, according to a major European review.There has been a fierce debate about the use of screening, and policy is being reviewed in England.The latest study, published in the Journal of Medical
Britain asks: Should 3-parent IVF be allowed to avoid disease?
(Reuters) – Britain launched a public consultation on Monday to ask whether controversial “three-parent” fertility treatments should be available to families hoping to avoid passing on incurable diseases.The potential treatments, currently only at research stage in laboratories in Britain and the Un
Scientists grow drug for rare disease in corn
(Reuters) – Scientists have grown a drug to treat a rare genetic disease inside corn plants, potentially offering a cheaper way to manufacture a treatment that currently costs hundreds of thousands of dollars a year for each patient.The move marks an advance for the emerging field of molecular farmi
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