AliveCor gets FDA breakthrough status for Hyperkalemia diagnosis

Hyperkalemia is defined as the condition where there would be a higher potassium level in blood. The potassium level goes higher due to chronic kidney disease and type 1 diabetes, suffered by millions of people. Irregular heartbeat is the common symptom of hyperkalemia. A blood sample is required to detect the potassium level till date.

But a Silicon Valley start-up company named AliveCor along with the doctors from Mayo Clinic have developed a novel technology, where the blood sample is not required. Just by looking at the electrocardiogram (ECG) pattern which records the electric signals of the heart, the level of potassium can be detected.

Hence, the U.S. Food and Drug Administration had given ‘breakthrough device’ designation on 10^th September 2018 for a novel way of potassium level measurement.

Vic Gundotra, the CEO of AliveCor, said "It was a pie-in-the-sky idea that we could use AI to see something like this in the ECG when no one else could; It's a big milestone for us."

This screening tool would prove beneficial for the patients who stay at home and don’t prefer to visit labs and give the blood sample.

AliveCor team expects that this product would reach the market in a year, after the submission of clinical trial results.

The post AliveCor gets FDA breakthrough status for Hyperkalemia diagnosis appeared first on Drugdu.com

from Drugdu  https://goo.gl/QgQoHk

New drug formulation for opioid addiction approved by FDA

Cassipa, a Teva Phaarmaceuticals manufactured sublingual film containing naloxone and buprenorphine in new dosage amounts, receives FDA approval on the 7^th of September as a continuing therapy for opioid addiction.

In a press release, the FDA announced that the buprenorphine and naloxone sublingual film, formulated in a 16 mg/4 mg dose for Cassipa, is sanctioned not only in its brand version but also in its generic edition. The two drugs in different strength combinations are also approved by the FDA.

A set management protocol including psychotherapy and counseling should comprise of Cassipa post the patient is administered and stabilized with a step-ladder buprenorphine 16 mg dose of another brand. Drug Addiction Treatment Act (DATA) certified professionals only can prescribe these drugs.

“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder ... the FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment,” FDA Commissioner Scott Gottlieb, MD, mentioned in the statement.

Adding that, “individuals who successfully transition onto medication-assisted treatment are not swapping one addiction for another. Opioid replacement therapy can be an important part of effective treatment. Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”

Opioid use disorder patients are recommended to be treated with Medication-assisted treatment (MAT), a methodical way amalgamating counseling, psychotherapy and drug formulae approved by the FDA. 

Suboxone sublingual film’s safety and efficacy testing by the FDA proved beneficial, partly, in getting approval for Cassipa via the abbreviated 505(b)(2) approval pathway.

The post New drug formulation for opioid addiction approved by FDA appeared first on Drugdu.com

from Drugdu  https://goo.gl/QgQoHk

Retention in de-addiction therapy increased on administration of medicines

Medications like buprenorphine, naltrexone, or methadone when added to treatment of opioid use disorder (OUD) youths, resulted in longer adherence to in-care regimen. However, very few receive the medicines, reveals a retrospective cohort study.
The study on 4,837 OUD youths between the age 13-22 years including 2,752 females observed that only 1 out of 4 youths and 1 out of 21 adolescents received medication, as reported by Scott E. Hadland, MD, MPH, MS, of Grayken Center for Addiction and Department of Pediatrics, Boston Medical Center, and coinvestigators.

The results brought greater attention to the need for better management of OUD in young adults and increase their adherence to treatment, noted Dr. Hadland and co-authors in JAMA Pediatrics.

“As deaths from overdose increase among U.S. youths, it is vital that clinicians, researchers, and policy makers ensure that access to evidence-based OUD medications for young people remains a national priority,” they said.

The researchers found that retention in de-addiction centres was higher in youths who were given OUD medications on scheduled time. In care median retention was observed to be 67 days when youths were given only behavioural therapy. However, it jumped to 123 days, 150 days and 324 days on giving buprenorphine, naltrexone, or methadone respectively.  

Dr. Hadland and co-authors feel that staying in care is imperative to ensure effective treatment of OUD, “Even when patients do not reduce their substance use, individuals engaged and retained in care can receive harm-reduction services and treatment of comorbid medical and psychiatric conditions.”

The post Retention in de-addiction therapy increased on administration of medicines appeared first on Drugdu.com

from Drugdu  https://goo.gl/QgQoHk

Highly Resistant Food Poisoning Bug Responds to Antibiotics

Listeriosis is a deadly food-borne infection caused by consuming contaminated food like meats, soft cheese, salads, smoked salmon etc. Listeriosis is more dangerous for immunocompromised people including infants and the elderly. In pregnant women, this infection could even lead to miscarriage. Listeria always reproduces within the body cells and is called a food-poisoning bug but could potentially even affect the brain, for which only a few therapeutic options are available.

Hence a research team from the University of Edinburgh suggested that fosfomycin should be reconsidered. Though Listeria bacteria carry highly resistant genes based on early laboratory tests, they can respond to fosfomycin antibiotics as per further animal studies conducted in a lab. The study team also explained that when a bacteria infects the body, certain genes could be activated, which cancels the effect of a specific gene that destroys the drug effect.

The study was published in the journal PLOS Genetics, which was funded by the Wellcome Trust.

Professor Jose Vazquez-Boland, the lead investigator from the University of Edinburgh's Division of Infection Medicine, said "Our study focused on Listeria, but this important discovery may be relevant for other species of bacteria too. It is encouraging that we may be able to repurpose existing drugs in the race against antibiotic resistance."

The post Highly Resistant Food Poisoning Bug Responds to Antibiotics appeared first on Drugdu.com

from Drugdu  https://goo.gl/QgQoHk

Study Discovers New Mechanism of Immune System to Fight Disease

The disease-fighting capacity of the body depends on the proper functioning of its immune system. Hence, a new discovery revealing new insight into its functioning by University of Queensland (UQ) researchers could reveal new ways to treat diseases like cancer and autoimmune disorders.

A study headed by Kate Schroder, associate professor and Molecular Bioscience researcher at UQ, found a new mechanism by which the immune system fights bacteria. Their study was published in Science Immunology.

"Bacteria are often quickly killed by white blood cells called neutrophils, which are the body's initial line of defense against infection," Dr. Schroder said.

"We discovered an unexpected secondary line of defense that is deployed against bacteria that have evaded the initial immune response and invaded the neutrophil itself. This new immune defense pathway is mediated by an 'executioner' protein called Gasdermin D. This protein drives an unusual form of 'cellular suicide', where the cell expels structures called neutrophil extracellular traps (NETs) to catch the infection and prevent it from spreading."

A supplementary line of defence is offered by NETs which basically are a meshwork of DNA strands containing microbe destructing proteins that halt and destroy bacteria. A relation between NETs and neutrophil destruction was earlier known, however, these findings unearthed a new Gasdermin D and inflammasome (molecules that identify and control infections) based line of defence.

The pathology of certain autoimmune and inflammatory disorders like cancer could also be based on NETs, added to its microbe fighting function, said Dr. Schroder.

"It's important we understand the basic cellular mechanisms of inflammation before we develop treatments for various immune-related diseases," Dr. Schroder added. "Understanding how the Gasdermin D drives neutrophil death and the expulsion of NETs could lead to new therapeutic targets for immune-related diseases, which could in turn lead to more effective treatments and improve quality of life for affected individuals."

The post Study Discovers New Mechanism of Immune System to Fight Disease appeared first on Drugdu.com

from Drugdu  https://goo.gl/QgQoHk

Join Drugdu.com’s Online Medical Devices Exhibition to Discover Global Trading Opportunities

Drugdu.com Online Medical Devices Exhibition

Drugdu.com (Ddu), the leading global pharmaceutical and medical device B2B online platform, is presenting an Online Medical Devices Exhibition from September to December on Ddu’s official website and mobile app.

This expo will include some of the top manufacturers such as X&Y International Corporation and Shenzhen Tianlang Medical Equipment. More than 5,000 medical device suppliers from all over the world have registered as participants to join this online event. The Online Medical Devices Exhibition aims to assist both buyers and suppliers worldwide to seek new business opportunities through Drugdu.com’s online platform.

Expected to exceed 477.5 billion USD by 2020, the increasing speed of the global medical device market is the best evidence that proves the great potential within this field. As a results, the Online Medical Devices Exhibition creates an effective shortcut for buyers to achieve their online business opportunities.

Buyers on Ddu can enjoy a smart and groundbreaking new way of selecting any of over 1,000,000 medical products from more than 100,000 global suppliers with specific classifications. With the assurance and protection of the Ddu Credit Verification system, which is collaboration with Swiss SGS and German TÜV Rheinland, buyers and suppliers are able to establish reliable partnerships across the globe.

Regarding product categories, Drugdu.com (Ddu) has 9 main categories for pharmaceutical drugs and 7 main categories for medical devices according to a product’s functions. The sub-categories further serve as a guide to buyers efficiently search for specific products. With the relevant details listed beside the products, time and costs are greatly reduced amounting only to an Internet connection and a mouse click.

Drugdu.com’s (Ddu) mission is to solve the issue of finding products by matching the information of international supply and demand, offer comprehensive solutions and become the leading information center of the medical industry.

About Drugdu.com (Ddu)  
Drugdu.com (Ddu) is the leading global B2B online platform focused on the cross-border trade of pharmaceuticals and medical devices. As a pioneer in the industry, Ddu's advanced technology and user-centered services is aimed at not only accelerating the circulation of pharmaceuticals and medical devices around the world, but also simplifying industry trading, making it more practical and efficient.

For more information about Drugdu.com (Ddu), visit our website at http://www.drugdu.com or follow us on Facebook, LinkedIn, Twitter, YouTube and Google Plus.

If you are interested in the Drugdu.com (Ddu) Online Medical Device Exhibition, please visit  
https://www.drugdu.com/Online-Medical-Equipments-and-Devices-Exhibition-2018-Expo.html?dtag=10027102310246 
or contact Drugdu.com at marketing@drugdu.com

The post Join Drugdu.com’s Online Medical Devices Exhibition to Discover Global Trading Opportunities appeared first on Drugdu.comfrom Drugdu  https://goo.gl/QgQoHk