IgA Antibodies Influence Friendly Gut Bacteria

Japanese Scientists unravel a molecular apparatus via which antibodies control gut bacteria to conserve health. They observed that immunoglobulin A (IgA) antibodies released by the intestines can influence how bacteria express their genes.

Senior study author Dr. Keiichiro Suzuki, of the RIKEN Center for Integrative Medical Sciences in Japan, commented that they already "knew that [IgA] contributed in some way to gut health."

However, they were thrilled to find that the "new mechanism" that they discovered "actually promotes symbiosis among the bacteria that inhabit the mucus membrane of the gut." Our guts harbour labyrinthine and varied communities of bacteria and microorganisms that carry out vital functions in health and disease, together called the gut microbiota. They noted that a common species of human gut bacteria called Bacteroides thetaiotaomicron "was specifically vulnerable to coating by IgA."

In this study, the scientists explored the molecular foundation of this process. The results suggested that IgA influences gene expression in B. theta. These proteins were called "mucus-associated functional factors” (MAFFs) by Dr. Suzuki and team, and they discovered that they appeared to promote friendly gut bacteria in two ways.

The MAFFs appeared to help B. theta multiply in the mucosa of the gut simultaneously stimulating it to release molecules that promote the growth of Clostridiales and other good bacteria. The researchers validated this favorable effect of MAFFs in mice. They injected the mice with B. theta that were unable to produce plenty of MAFFs. The mice's gut bacteria transformed and the animals became susceptible to colitis.

The team expects that the results will ultimately give way to newer treatments for inflammatory bowel disease.

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Siemens gets FDA Clearance for Troponin Assay

Siemens Health received US-FDA (US-Food and Drug Administration) clearance for two highly sensitive troponin assays, which detect protein levels released into the bloodstream during a heart attack allowing them to be made available in the U.S.

Siemens Health confirmed that these two assays can detect lower levels of troponin in serum or plasma with 99 percentile precision compared to traditional assays. It can also detect smaller changes in a patient’s troponin level over time.

The troponin I assays were cleared for usage with the Siemens Atellica IM and ADVIA Centaur XP/XPT in vitro laboratory analyzers. Siemens Healthineers is a separately managed healthcare business of Siemens AG.

Due to an increased number of chest pain complaints, there occur more than 8 million emergency room visits in a year. Only around 5 percent were related to myocardial infarctions.

Within 60 minutes after the heart attack, the presence of troponin in the bloodstream precisely indicates heart muscle damage. Hence by determining the slight changes of troponin levels in the blood over time, the physicians could effectively proceed with relevant treatment of these life-threatening conditions or discharge the patients.

These assays which meet the European Society of Cardiology guidelines have been made available in Europe since May 2017.

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Updated HIV Guidelines Recommend Immediate Treatment, Three-Drug Therapy

The 2018 Recommendations of the International Antiviral Society-USA (IAS-USA) suggests that early treatment in adult HIV patients brings about rapid and more definite decrease in viral load and better care of the patient.

The updated guidelines, written by Michael S. Saag, MD of the University of Alabama at Birmingham and his co-authors, have also revised the drug selection from the previous single-tablet combination to include a three-drug therapy and two-drug switch therapy.  Additionally, cash incentives for treatment have been strongly discouraged. The guidelines were published in JAMA.

A number of studies were conducted to validate the importance of early antiretroviral therapy (ART) ever since the earlier IAS-USA guidelines were published in 2016. The majority of them concluded that immediate medication leads to quick viral suppression. Consequently, the updated guidelines recommended that ART should be started early on (even in the absence of supporting laboratory results), exempting those who are reluctant to start treatment and who are at risk for immune reconstitution syndrome.

Three-drug therapy is recommended for initial treatment selection, which includes a single-strand transfer inhibitor (InSTI) with 2 nucleoside reverse transcriptase inhibitors. Single-tablet combinations are effective, well endured, and encourage medication obedience. Dolutegravir is contraindicated in pregnant women or those who may get pregnant as it may raise the risk of neural tube defects. Two-drug regimens may be thought of as switch therapy to reduce expenditure and complications for initial therapy.

The 2018 guidelines dispirited cash incentives for ART compliance on account of being unproductive while noting that noncash incentives could prove to be favorable. Additional recommendations were extensive and included detection of food shortage or psychiatric disorders among patients. 

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Discovery of Novel Target in Multiple Sclerosis

Multiple sclerosis is a neurological disease affecting the myelin sheath that surrounds nerve fibers in the central nervous system, composed of the brain, spinal cord, and optic nerve. Since myelin is destroyed, it creates lesions which leads to an interruption in communication between the brain cells. The symptoms of multiple sclerosis include weak and stiff muscles, tingling in the limbs, pain in the eye, difficulty in balance and bladder issues. These symptoms might fluctuate and vary from person to person.

The degradation of myelin alone does not lead to multiple sclerosis, failure of repair the damage also plays a significant role. Considering this aspect as a major factor, scientists from the University of Buffalo in New York found that the receptor muscarinic type 3 (M3R) is a "key regulator" of remyelination, where the lost myelin is replenished. Blocking M3R could increase the remyelination process. M3R is found on the surface of precursors named oligodendrocyte progenitor cell (OPC), which makes up myelin. This study was published in The Journal of Neuroscience.

Fraser J. Sim, senior study author and an associate professor of pharmacology and toxicology had suggested that their novel findings might help in conducting clinical trials of drugs which targets M3R in MS cases. He said, "This work establishes that M3R has a functional role and if blocked, could improve myelin repair."

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Valsartan Based Drugs Recalled by FDA

At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.

Multiple companies such as Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., are withdrawing their drugs containing valsartan. The FDA reported, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”

These affected drugs were generic versions of Diovan, made by Novartis International AG. But the generic versions made by other companies were not included in this recall list.

Dr. Victoria Shin, a cardiologist from Torrance Memorial Medical Center in California said, “It’s not the drug valsartan that’s the problem. It’s a contaminant that was included in the manufacturing process that’s the problem. Patients shouldn’t lose faith in the drug itself.”

CNN reported that the external supplier associated with the NDMA impurity in the recalled products had also stopped distributing valsartan.

The FDA provided instructions issued by the companies regarding how to return or dispose of the affected medicines. Patients should look at the drug name and the listed company on the prescription label to check if their medication has been recalled.

Dr. Victoria Shin said, “patients should not stop their medication on their own without consulting a physician; This can cause elevated and uncontrolled blood pressure which can potentially have severe health consequences.”

The definite level of NDMA which might increases the risk of cancer is still unknown.

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Europe Approves InPen; Makes Insulin Injections Easier

San Diego based Companion Medical got its InPen insulin management system certified with the European CE Mark of approval.

Also readily available in the United States, the InPen not only functions as a regular insulin pen but also synchronizes the user data with a paired smartphone with the help of the Insights app. It utilizes the information to facilitate evaluation of next insulin dosage suggestions, thereby updating the user’s physician on the patient’s obedience to the regimen, and to help modify treatment if required.

The user has to physically feed the data on the pen before taking the injections even though the Insights app suggests the quantity of dose to be taken. This permits the patient to use the InPen even in the absence of the paired smartphone. This presents as a key safety attribute of the pen.

A report on the aggregated glucose, insulin, and meal data is generated by the app every day. Getting all the relevant information collectively at a single portal makes it easier to detect any probable causes for anomalous glucose levels that keep fluctuating due to unknown reasons. 

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Bayer Announces the end of Essure Sales in the US

Bayer announced on last Friday that it would stop the sales of its Essure birth control system in the United States by the end of this year due to a steady decline in its sales making the product no longer justifiable. Bayer insisted that its decision to discontinue Essure sales is only for business reasons and not for any safety or efficacy concerns.

Jeremy Schulman, the husband of one patient advocate tweeted, "So proud of my wife and the work the Essure Problems teams has done over the many years to stop Bayer from selling this harmful product. Mission accomplished." 

The FDA was emphasizing that the women who were considering this implantable contraceptive device should be adequately informed about its risks. The patients must be given a chance to sign an acceptance of risk, which should be further signed by the physician who implants the device. The FDA passed the rule to Bayer to implement the restrictions at once and ensure that this process results in healthcare provider compliance with the sales restriction.

But some women never received this information before having Essure implanted. Further actions were taken by the FDA to address the medical device reports of serious side effects associated with the device. At last, FDA Commissioner Scott Gottlieb acknowledged Bayer's decision to stop Essure sales.

Scott Gottlieb said, "For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.”

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New Simplified Formula Tested for Assessment of MRI in Crohn’s Disease

A Spanish research team who gained fame for introducing the MRI-based formula that grades the activity of luminal Crohn’s disease in 2011, recently developed and tested a fresh, easier adaptation of their MRI score that leads to a swifter assessment.

“The simplified version of the MaRIA [Magnetic Resonance Index of Activity] score allows a faster and easier assessment of inflammation and quantification of severity in Crohn’s disease by keeping high accuracy for diagnosis and therapeutic response,” Ingrid Ordás, MD, said at the annual Digestive Disease Week. She pointed the chief benefit of the simplified MaRIA to be a “less time-consuming calculation that is not confounded by missing segments.”

The derivation results were included in the data reported by Dr. Ordás, comprising of 98 patients enrolled in two different prospective studies, and another prospective validation cohort of 37 patients.  The totalities of patients were assessed by clinicians at the Hospital Clinic of Barcelona, and therefore additional validation with patients registered at other sites is required, Dr. Ordás commented in an interview.

More data on the increased sensitivity and specificity of Crohn’s disease assessment with the simplified MaRIA could make it a contender to replace endoscopy as the model tool for evaluating disease process and severity in luminal Crohn’s disease patients.                    The post New Simplified Formula Tested for Assessment of MRI in Crohn’s Disease appeared first on Drugdu.com

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Mersana’s Lead Cancer ADC Held Up by FDA for Patient’s Death

The FDA held up Mersana’s top antibody-drug conjugate (ADC), XMT-1522 over safety issues following a patient’s death in phase 1 trial, causing a descent in the company’s shares.

No new subjects are being allowed to register for the study on HER2-positive breast, lung and gastric tumors. However, those already taking the drug are permitted to continue doing so, as reported by the Cambridge, Massachusetts based Biotech Company.

Mersana will try for a release from the clinical hold, it said, by working with the FDA and the site inspector, who found the drug to be the probable cause of the death. It emphasized that the second phase 1 ADC contender, XMT-1536 for NaPi2b-expressing tumors remains unaffected. Nonetheless, Mersana’s stock price plummeted by one-third of its previous rate on Thursday and persisted to fall after few hours.

XMT-1522 is administered in an escalating dose as an intravenous infusion once every three weeks to spot the highest tolerated dose and pick the dose for phase 2 testing. Well tolerated, the ADC dose continues until the disease progresses. ADCs can cause side effects if the dosage is given before the stipulated time.

It would be too early for Mersana to speculate the probable reasons for the patient’s death. But it can bring XMT-1522 in race with Kadcyla, which sought $1 billion in revenue in last year if it manages to get the trial running by lifting the clinical hold.

Mersana CEO Anna Protopapas said, “Patient safety is our utmost concern. Based on the totality of the data we have for XMT-1522, we believe that it continues to be a promising drug candidate in the solid tumor setting and we will be initiating the proper steps with the objective of resuming enrollment.”

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Fatty Liver Recovers Speedily After Hepatitis C Cure

A report in Alimentary Pharmacology and Therapeutics revealed that Liver stiffness and liver fat (steatosis) in chronic hepatitis C virus (HCV) infected patients improved considerably post-treatment with direct-acting antivirals (DAAs) resulting in sustained virological response (SVR). A fall in ALT levels and a rise in platelet count was observed six months after SVR.

It is still ambiguous whether SVR following HCV therapy with DAAs is related to improvements in steatosis.

About half of hepatitis C positive patients suffer from steatosis and it is more rampant in people with hepatitis C genotype 3 infection. Few studies show that in untreated people with hepatitis C genotype 3, steatosis progresses into more aggressive fibrosis. In genotype 1 infection, steatosis will mostly result in metabolic problems such as diabetes.

Although it is observed that liver fibrosis begins to recover after the hepatitis C infection is removed, it is less obvious that steatosis diminishes after DAA treatment.

A prospective study involving 198 people was designed by investigators from Japan with SVR after DAA therapy. The participants were treated between 2015 and 2016. Of the participants, 58% of them were women and the average age was 72 years. All the participants had HCV monoinfection with genotypes 1 or 2.

MRI imaging (proton density fat fraction – PDFF – for steatosis) was used to evaluate liver stiffness and steatosis at baseline and repeated 24 weeks after SVR. Blood values, including ALT and platelet count, were also supervised at the same time intervals.

For comparison, the investigators also evaluated liver stiffness and steatosis values in nine people without SVR after DAA therapy. There were no marked changes in either of the measures between baseline and 24SVR.

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Physiotherapy can Improve QoL of Cerebral Palsy Patients

Cerebral palsy is a neurological disorder diagnosed during early childhood when a child is having problems with posture, gait and muscle tone. Cerebral palsy occurs due to damage to the cerebral portion of the brain that controls muscle tone and movements. Various causes include genetic disorders, infections, injuries, hemorrhages, asphyxia (lack of oxygen supply to the brain tissues), etc.

Though cerebral palsy is non-treatable, physiotherapy can help in keeping the affected individual healthy. When an individual with cerebral palsy does not receive any physical therapy, it leads to muscular atrophy, loss of joint movement, contracture of muscle and joint pain.

Role of physiotherapy:

Physiotherapy prevents further damage to the skeletal muscles by enhancing muscle strength, improving the blood supply and preserving the nerve control. The physiotherapist will prescribe the following exercises, which can be done by the patient himself/herself with the help of a caregiver.

1. Weight training is done to improve the muscle tone and endurance.

2. Heat packs help in preserving the blood circulation.

3. Ultrasound therapy conditions the muscle fibers and the nerves.

4. Treatment measures may also include the use of exercise machines, game activities and stretching.

Various studies have shown significant improvement in the quality of life of individuals who successfully followed physiotherapy, compared to those who do not.

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