May 17, 2020

Teva Pharma under investigation for U.S. anti-bribery law

U.S. anti-bribery law
global generic drug maker
Tel-Aviv-b
Admin
1 min
Teva Pharma under investigation for U.S. anti-bribery law
Teva Pharmaceutical Industries is being investigated by the U.S. securities regulator on violations of a U.S. anti-bribery law, the news reports said...

Teva Pharmaceutical Industries is being investigated by the U.S. securities regulator on violations of a U.S. anti-bribery law, the news reports said.

The global generic drug maker said in a filing with U.S. Securities and Exchange Commission that in July it has secured a subpoena from SEC regulator asking to produce documents pertaining to allegations on bribing officials in Latin America.  

The Tel-Aviv-based company said, “These matters are in their early stages and no conclusion can be drawn at this time as to any likely outcomes.”   It also said besides cooperating with US government on the probe, it has also hired an independent counsel to assist in its own internal investigation into its certain business practice in Latin America. 

Teva is the latest drug maker that has come under the scanner of the U.S. regulators, who have since past three years conducting an investigation in the pharmaceutical industry practices of offering bribes to doctors in state-run hospitals to buy their brand of drugs, the reports said.  

Teva Pharmaceuticals is the global pharma company based in Israel. The company specializes in active pharmaceutical ingredients and in generic and proprietary pharmaceuticals. It is the largest generic drug maker having 15 largest pharmaceutical companies world over.

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Jun 15, 2021

 NHS trials test that predicts sepsis 3 days in advance 

sepsis
MachineLearning
clinicaltrial
blooddisorder
2 min
Queen Alexandra Hospital is trialling a new sepsis test by Presymptom Health that uses machine learning to detect the onset of the disease

A new test that can predict sepsis before the patient develops symptoms is being trialled at a National Health Service (NHS) hospital in the south of England. 

Clinicians at Portsmouth’s Queen Alexandra Hospital are leading medical trials of the blood test, which they hope will help them save thousands of lives a year. 

The test is being developed by government spin-out company Presymptom Health, but the research began over 10 years ago at the Defence Science and Technology Laboratory (Dstl). This included a study of 4,385 patients and more than 70,000 samples, the largest study of its kind at the time. 

From the samples taken, a clinical biobank and database were generated and then mined using machine learning to identify biomarker signatures that could predict the onset of sepsis. The researchers found they were able to provide an early warning of sepsis up to three days ahead of illness with an accuracy of up to 90%.

Unlike most other tests, Presymptom Health identifies the patient’s response to the disease as opposed to detecting the pathogen. This is an important differentiator, as sepsis occurs as a result of the patient's immune system’s overreaction to an infection or injury, which can then cause life-threatening organ dysfunction. 

Worldwide, an estimated 49 million people a year contract sepsis, while in the UK almost two million patients admitted to hospital each year are thought to be at risk of developing the condition. If Presymptom's test is effective, it could save billions of pounds globally and improve clinical outcomes for millions of sepsis patients.

The initial trials at Queen Alexandra Hospital will last 12 months, with two other sites planned to go live this summer. Up to 600 patients admitted to hospital with respiratory tract infections will be given the option to participate in the trial. The data collected will be independently assessed and used to refine and validate the test, which could be available for broader NHS use within two years. 

If successful, this test could also identify sepsis arising from other infections before symptoms appear, which could potentially include future waves of COVID-19 and other pandemics.

Dr Roman Lukaszewski, the lead Dstl scientist behind the innovation, said: “It is incredible to see this test, which we had originally begun to develop to help service personnel survive injury and infection on the front line, is now being used for the wider UK population, including those fighting COVID-19.”

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