Disease categories and therapies

Opportunities for IVD, vaccine makers in US vector-borne disease plan

Wed, 07 Feb 2024 11:00:00 -0500

The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.

Genotyping technology can detect COVID variants quicker

Mon, 22 Jan 2024 11:00:00 -0500

Genotype assay testing can detect new variants of the COVID-19 virus six days faster than whole genome sequencing (WGS), with results returned in just three days — compared to nine for WGS — according to a study published in the Lancet Microbe.

UW spinout Ubidx Inc. develops home test for infectious diseases

Tue, 02 Jan 2024 11:00:00 -0500

Ubidx Inc. has designed a diagnostic system comprised of a fluidic single-use disposable and a base. While the fluidic single-use disposable or cartridge is generally described as being suitable for testing a single sample, the base or hub may be used numerous times to perform numerous tests using numerous fluidic single-use disposables or cartridges.

US FDA’s updated guidance for susceptibility tests incorporates change control plans

Fri, 06 Oct 2023 12:00:00 -0400

The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.

Setpoint resets gut response with VNS in Crohn’s disease

Tue, 03 Oct 2023 12:00:00 -0400

Neuroimmune modulation using vagus nerve stimulation (VNS) reduced Crohn’s disease symptoms and improved patient quality of life, a study published in the Journal of Crohn’s and Colitis found. The research by Setpoint Medical Corp. could provide a better option for patients with the autoimmune disorder than biologics, which often fail to work over time and can cause significant adverse effects.

Hansoh and Olix ink $450M+ liver-focused siRNA therapeutics deal for greater China

Tue, 19 Oct 2021 12:00:00 -0400

In a deal that could be worth more than $450 million, Olix Pharmaceuticals Inc. and Hansoh Pharmaceutical Group Co. Ltd. have agreed to discover, develop, and commercialize siRNA therapeutics for various liver-based targets implicated in cardiovascular, metabolic, and other indications.

Hansoh and Olix ink $450M+ liver-focused siRNA therapeutics deal for greater China

Wed, 13 Oct 2021 12:00:00 -0400

Single-cell resolution reveals cell type, targets for neuroblastoma

Mon, 08 Feb 2021 00:00:00 -0500

The largest single cell transcriptomics study of neuroblastoma to date has discovered that this childhood cancer arises from a single type of embryonic cell, the sympathoblast.

Gene therapy offers potential but poses logistical challenges

Mon, 14 Oct 2019 00:00:00 -0400

The mantra for a while has been that it's not good enough to get your drug approved, you've got to get it payed for, too. For gene therapy treatments, the payment is more complex, and you can add manufacturing and supply chain logistics to the list of challenges.

Three late-stage drugs look to battle in Cushing's syndrome market

Mon, 30 Sep 2019 00:00:00 -0400

The Cushing's syndrome market is heating up with three second-generation drugs in late-stage development to join the two approved medications, Signifor (pasireotide, Recordati SpA) and Korlym (mifepristone, Corcept Therapeutics Inc.), as well as a couple of off-label options.

Pipeline is expanding to meet the need for epilepsy treatments

Mon, 30 Sep 2019 00:00:00 -0400

According to the U.S. Epilepsy Foundation, one in 26 people in the country will develop epilepsy at some point in their lives and the condition is the fourth most common neurological disease that affects people of all ages. That is why the current anti-epilepsy drug therapy market is large and estimated to be worth more than $8.5 billion currently, rising to in excess of $9.5 billion in five years.

More 'Incyte' into GVHD nixes continuum theory, weighing chronic/acute

Fri, 26 Jul 2019 00:00:00 -0400

With Incyte Corp. expecting data from a trio of phase III trials across chronic and acute graft-vs.-host disease (GVHD) and the indication's treatment paradigm continuing to evolve, investors have begun paying more heed to clinical efforts underway by firms trying varied approaches.