Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS crisis and public furor over drug tampering, said his son, Jonathan Young, co-founder and chief operating officer of South San Francisco-based Akero Therapeutics Inc. Post-FDA, Frank Young would help grapple with the opioid epidemic as well – a scourge that began with the passage of the Compassionate Pain Relief Act (CPRA), passed the year he was appointed. Young, 88, died Nov. 24 of B-cell lymphoma.
One necessary step to fend off a dystopian future of medical care without antibiotics is the development of new antibiotics. Another is improved deployment of existing ones, a feat which will take, among other things, better antibiotic susceptibility testing (AST). “I’m astounded that we can get men to the moon, and we are using practices [dating] almost back to the age of Robert Koch to identify bacteria,” Deborah Hung told BioWorld MedTech. “The standard practice takes amazingly long.”
Less than two weeks after giving the go-ahead to Novartis AG for Adakveo (crizanlizumab) to reduce the frequency of vaso-occlusive crises (VOCs) in adult and pediatric patients ages 16 and older with sickle cell disease (SCD), the FDA cleared – well ahead of its Feb. 26, 2020, PDUFA date – Oxbryta (voxelotor), from Global Blood Therapeutics Inc. (GBT), for SCD in adults and pediatric patients ages 12 and up.
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide.
Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.
Hafnium nanoparticles that home onto microfractures in bone make the tiny cracks visible in spectral or color computed tomography (CT) imaging. Researchers at the University of Illinois at Urbana-Champaign and the University of Maryland created the nanotechnology to work in conjunction with spectral molecular imaging developed by New Zealand-based MARS Bioimaging Ltd. (MBI). The research appeared in Advanced Functional Materials.
The case of Arthrex v. Smith & Nephew, Inc., has raised a host of questions about the appointment of judges to the Patent Trial and Appeal Board (PTAB), and witnesses at a congressional hearing said a Supreme Court review might be two years in coming. Any such resolution might not clear out the thicket of underlying legal questions, however, and thus the witnesses urged Congress to take action quickly even as the Federal Circuit considers an en banc hearing of the matter.
Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
A team led by researchers at Washington State University (WSU) has developed a nanoparticle technology to deliver cell-killing drugs to shut down the overactive immune response that can cause damage or death in diseases like stroke and sepsis without affecting other cell types or compromising the immune system.
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