FDA Approves Clinical Trial for Cancer-Busting Turkey Tail Mushroom

In what may be the most significant health discovery for mycologists and health researchers since the invention of penicillin (which was derived from the fungus Penicillium), research continues to mount as to the amazing healing effects of Turkey Tail mushroom against Breast Cancer.

News about Turkey Tail

The news about Turkey Tail made headlines in 2012 when the FDA approved clinical trials to test the cancer-healing properties of Polysaccharide K (PSK), an extract that comes from Trametes versicolor, or Turkey Tail mushroom. Turkey Tail has been used medicinally all over Asia for thousands of years, usually in tea form. As of 2014, the clinical trial, sponsored by Bastyr University and head researchers Cynthia Wenner PhD and Masa Sasagawa, ND, was in Phase I/II with women who have Stage IV breast cancer.

One of the first study reports that Bastyr University researchers published, along with their partners from the University of Minnesota Medical School, showed that the Turkey Tail extract (PSK) was successful at restoring the immune systems and improving the health of women who had undergone traditional cancer therapy (radiation in particular). The study found that Turkey Tail mushroom extract was able to increase the level and activity of Natural Killer Cells as well as “cytotoxic T-cells.”

The job of NK cells in the body is to hunt down harmful pathogens, especially cancer cells, and destroy them. All the women in this part of the trial had raised lymphocyte as well as NK cell counts after a daily dose of 6 and 9 grams over a period of 4 weeks. Those women who were given the higher amounts (9 grams) showed higher levels of T cells. No negative side effects were discovered with any of the women.

Noted Researchers Speak Out About Turkey Tail

Famed mycologist and author Paul Stamets, whose mother healed from breast cancer with the use of Turkey Tail in 2009, has been one of the main providers of Turkey Tail mushrooms and has also served as director of research for many past studies.

“Cancer is notorious for its ability to evade immune detection,” says Stamets. “One theory is that when patients ingest our Turkey Tail mycelium, the immune system’s increased populations of NK cells and their associated CD8 glycoproteins are better able to discover and bind to receptor sites on the stroma of tumors, thus allowing NK invasion.”

Dr. Wenner of Bastyr University recently spoke about their findings to a group of over 100 clinical oncologists in Tokyo.

“The opportunity to present our findings to an international audience is quite important,” Dr. Wenner said in a statement. “Having worked as an investigator on the study since 2004, it felt like a fitting conclusion to bring back these positive findings to a group that has access to this mushroom extract and can apply our findings to treatment options in their oncology practices and in doing further research.”

FDA Approval Still Stalled

In previous studies, Turkey Tail has also been shown to help with upper respiratory tract infections, pulmonary disease, urinary tract infections, malaise and digestive tract issues. And it has shown to be effective against colorectal cancer and lymphoma.

PSK/ Turkey Tail extract is still not approved for medical use in the U.S. but perhaps the final results of the Bastyr University study, combined with the results of all the other Turkey Tail mushroom studies over the years, will finally push the envelope towards approval soon.

One thing is for sure: the positive evidence demonstrated so far by the Bastyr study as to how Turkey Tail has helped reinvigorate the immune systems of Stage IV Breast Cancer patients proves that with a little help from Nature, the body can– and does– heal from cancer.

Dr. Veronique Desaulniers, better known as Dr. V, is the founder of  The 7 Essentials System ™, a step-by-step guide that teaches you exactly how to prevent and heal Breast Cancer naturally. To get your FREE 7-Day Mini e-Course and to receive her weekly action steps and inspiring articles on the power of Natural Medicine, visit her at BreastCancerConqueror.com

FDA Approves Clinical Trial for Cancer-Busting Turkey Tail Mushroom

UK regulator approves drug that could extend lives of breast cancer patients

Women with later-stage breast cancer may gain up to three months of extra life after health regulators gave the NHS the green light to prescribe the first new drug to treat the disease in almost a decade.

About 1,500 women a year in England who have locally advanced breast cancer, or whose disease has spread despite two rounds of chemotherapy, will be eligible to receive the life-extending drug. On average, they usually only have two years to live after they have been diagnosed.

The National Institute for Health and Care Excellence (Nice) reversed its previous refusal to approve eribulin because new evidence showed that it could result in “substantial” benefits.

Prof Carole Longson, director of Nice’s centre for health technology evaluation, said: “For this appraisal we’ve been able to consider updated results from the trial used in the original guidance that show women taking eribulin lived on average almost three months longer compared with women taking other treatments.”

“The life expectancy of people for whom eribulin is licensed is short, and quality of life is very important.”

Breast cancer charities said the decision to make the drug routinely available in England could make a big difference to women whose breast cancer had proved resistant to other treatments.

Delyth Morgan, chief executive of Breast Cancer Now, said: “This is immensely positive news. Eribulin is the first breast cancer drug in a decade to be approved and this represents real progress for certain patients in England.

“It offers a crucial life-extending alternative for patients whose breast cancer has become resistant to other therapies, and for those with triple negative disease, who desperately lack treatment options”.

Triple negative cancers are those that do not involve the three molecules that are used to classify breast cancers. About 225 of the potential 1,500 recipients have that form of cancer.

Eribulin is the first new drug to be approved for use in patients with metastatic breast cancer since Gemzar, also known as gemcitabine, was given the go-ahead in January 2007.

Danni Manzi, head of policy and campaigns at Breast Cancer Care, said: “This decision could be life-changing for many women living with incurable breast cancer. Access to this life-extending drug eribulin will offer patients precious extra time to spend with their loved ones. For these patients every day counts.”

She hoped that Nice’s decision will lead to other breast cancer drugs being approved. “With so few treatment options available, it is momentous to bring another medicine to the table,” she said.

Breast cancer in women whose disease has spread to other parts of the body is deemed to be incurable. In those women whose cancer has advanced locally, though, it is seen as still potentially curable.

About 4,000 breast cancer patients have already received eribulin, which is also known as Halaven, since it became available in England through the Cancer Drugs Fund, in March 2011. It is one of the medicines the fund has paid for the most often.

Patients in Wales should also be able to receive the drug as the Welsh NHS follows Nice’s rulings on which medicines represent value for money. Scotland’s equivalent, the Scottish Medicines Consortium, approved the drug in March this year.

Dr Mark Harries, a consultant medical oncologist working with the pharmaceutical company Eisai, who make the drug, said: “I am delighted that women in England with locally advanced or metastatic breast cancer will continue to be able to access eribulin and that the future of this treatment within the NHS is secure. Eribulin significantly improves overall survival in women with this disease and it is therefore an important option against breast cancer.”

Breast cancer is the most common form of cancer in women in England. There are about 45,000 new cases a year, with approximately 300 men contracting it. In 2014, some 9,500 women and 60 men died from the disease.

UK regulator approves drug that could extend lives of breast cancer patients

FDA Approves Addyi, But It Is Not The "Female Viagra"

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Will the new drug to &ldquotreat&rdquo lower female sexual want function, or leave a good deal disappointed females in its wake?

FDA Approves Addyi, But It Is Not The "Female Viagra"

FDA approves "female Viagra" pill Flibanserin soon after two rejections

The FDA has ultimately accepted the tiny pink pill to assist females enhance their sex drive.

Flibanserin, to be offered as Addyi, finally received a green light from the US Foods and Drug Administration on Tuesday. This was the third time the agency has regarded approval for the drug, which is intended for ladies diagnosed with hypoactive sexual wish disorder, HSDD.

The drug, while usually referred to as “female Viagra”, is more akin to an antidepressant as it changes brain chemistry related to the way that dopamine and serotonin do. Viagra relaxes muscle tissue and increases blood movement to specific regions of the male body, assisting deal with erectile disfunction. Although the blue pill for men should be taken ahead of engaging in sexual action, girls are to consider the pink pill day-to-day.

“Today’s approval provides women distressed by their lower sexual desire with an authorized therapy choice,” stated Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of females, and we are committed to supporting the development of safe and effective treatment options for female sexual dysfunction.”

But the FDA cautioned that care should be taken for prospective adverse reactions to the pill, like reduced blood strain and loss of consciousness.

“Because of a probably critical interaction with alcohol, treatment method with Addyi will only be offered by means of certified overall health care professionals and licensed pharmacies,” Woodcock mentioned. “Patients and prescribers should entirely understand the dangers connected with the use of Addyi before taking into consideration remedy.”

Connected: ‘Female viagra’: FDA panel backs Flibanserin with security restriction

In June of this 12 months, the pill took the 1st step to making it into US pharmacies. An FDA panel voted 18-6 in favor of approving Flibanserin on the problem that Sprout develops a strategy to restrict safety dangers. The panel had previously rejected the pill twice before.

When the FDA rejected Boehringer Ingelheim’s application for Flibanserin in June of 2010, it ruled that the drug worked no better than a placebo.

“I certainly hope Boehringer does not give up,” Sheryl A Kingsberg, a psychologist and Case Western Reserve University healthcare professor, informed the New York Times at that time. “Flibanserin showed an terrible good deal of guarantee. I’m going to have some quite, really disappointed patients if there’s practically nothing for them.”

However by October of that year, Boehringer did just that, announcing that it was discontinuing advancement of Flibanserin. Months later on, in 2011, the drug was acquired by Sprout. The pharmaceutical company attempted its luck ahead of the FDA in June of 2013, only to be thwarted when the company ruled that the dangers of sleepiness, dizziness, fatigue and nausea outweighed the rewards.

It was at about that time that the conversation about Flibanserin became heated, with opponents lobbying against the drug due to its side results and supporters accusing the FDA of gender bias.

In October of last year, Sprout, along with number of organizations supporting the approval of Flibanserin, launched a campaign referred to as “Even the Score”.

“There are 26 FDA accredited drugs to treat a variety of sexual dysfunctions for males (41 if you count generics!), but nonetheless not a single one for women’s most frequent sexual complaint,” the campaign argues on its site. “Why do we rapidly track the approval of medication like Viagra (1998) for men?”

According to the campaign, intercourse is “a standard human right” and now is the “time to even the score when it comes to treatment of women’s sexual dysfunction”.

But a coalition of organizations led by the National Women’s Overall health Network wrote in a letter to the FDA: “The problem with Flibanserin is not gender bias at the FDA but the drug itself.” The group expressed help of the FDA’s “evidence-primarily based evaluation and decision-making”.

Some healthcare authorities, like Dr Adriane Fugh-Berman, a professor at Georgetown University, fret about how such campaigns might influence the FDA in the potential now that Flibanserin has been approved.

“This may possibly set a precedent of risky medication getting accepted based on public relations campaigns rather than science,” she informed Marketplace.

Relevant: We shouldn’t push dubious ‘pink Viagra’ capsules on girls and contact it emancipation | Barbara Mintzes and Leonore Tiefer

“I believe whether or not or not this is eventually the proper decision for ladies is a story that will be advised in the marketplace,” Cindy Whitehead, the chief executive of Sprout, informed Quickly Business. Whitehead stated that building the drug and receiving it accepted grew to become “a cause” for her.

Ladies struggling from HSDD also argue that it’s up to them to decide if the benefits outweigh the risks. Testifying prior to the FDA in June, a number of them urged the company to approve the drug.

Amanda Parrish was a single of the more than eleven,000 women who have participated in Flibanserin’s trial. Prior to joining the trial, she would attempt to avoid her husband, Ben, come bedtime. Soon after she started taking Flibanserin, she stated she did not come to feel any distinct throughout the day but her evenings turned around.

“What it did do was at the finish of a prolonged day, no matter how tired I was, I desired to initiate and it was not operate to do that,” she told NBC Nightly Information.

“She was flirty once more. She was leaving me notes on my bathroom mirror in the morning,” explained Ben Parrish. “We know that it performs. We experienced it.”

FDA approves "female Viagra" pill Flibanserin soon after two rejections

FDA Approves New Heart Pump From Abiomed

Abiomed has announced that it received FDA approval for its Impella RP System, the initial percutaneous single access heart pump that provides assistance to the appropriate side of the heart. The approval, beneath a Humanitarian Device Exemption (HDE), is primarily based on outcomes of the single arm Recover Right review, in which 30 sufferers were enrolled. The total survival charge was 73% at 30 days.

The gadget is indicated to supply circulatory assistance for as prolonged as 14 days to pediatric or adult patients with acute appropriate heart failure or decompensation following implantation of a LVAD, MI, heart transplant, or open-heart surgical procedure. The Impella RP supplies up to 4 liters per minute of hemodynamic assistance, in accordance to the firm.

Abiomed said the device would undergo a “controlled launch” and would be accessible only soon after websites comprehensive a rigorous coaching program involving the heart staff from each and every institution, such as the interventional cardiologist, cardiac surgeon, heart failure cardiologist and lead nurse.”

The FDA is requiring Abiomed to execute post-approval research in thirty adult individuals and up to 15 pediatric sufferers. The single-arm scientific studies will adhere to individuals at 30 days and 180 days right after gadget explant.

The Boston Globe reported that the business strategies to initiate stick to-up testing that could perhaps significantly expand the patient population eligible to get the device.

FDA Approves New Heart Pump From Abiomed

FDA Approves Second Generation Heart Valve From Edwards Lifesciences

The subsequent phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market place has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had accredited its 2nd generation Sapien XT TAVR device  for the therapy of large-threat and inoperable sufferers struggling from extreme symptomatic aortic stenosis (AS).

The Sapien XT is the successor to the first generation Sapien gadget, which supplied the initial nonsurgical method to aortic valve substitute. A competing gadget, Medtronic’s CoreValve, was approved earlier this year and has acquired significant curiosity. The Sapien XT is expected to be far more aggressive, in portion due to the fact of its reduced-profile and the availability of a 29 mm valve dimension for sufferers with a larger native annulus.

Edwards mentioned the Sapien XT will be immediately obtainable along with its accompanying transfemoral, transapical, and transaortic delivery techniques.

“There is a significant and growing physique of proof that the SAPIEN XT valve advantages both high-threat and inoperable patients, and clinicians have documented these consistently optimistic results in the two randomized studies and European nation registries,” mentioned Martin Leon, the co-principal investigator for the Spouse II Trial which evaluated the SAPIEN XT valve, in a press release. “The final results from the Partner II Trial in treating US inoperable sufferers with the SAPIEN XT valve demonstrated a reduction in issues with the TAVR method, and improved patient outcomes over earlier trials.”

FDA Approves Second Generation Heart Valve From Edwards Lifesciences

FDA Approves Novel Implanted Sensor To Monitor Heart Failure

The FDA announced these days that it had authorized the CardioMEMS Champion HF Technique. The small implantable device offers daily pulmonary artery strain measurements to guidebook doctors in their therapy of  NYHA Class III heart failure individuals who have been hospitalized for heart failure in the preceding 12 months. The program consists of 3 elements: a tiny everlasting sensor implanted in the pulmonary artery, a catheter-based mostly delivery technique, and a method that acquires and processes PA pressure measurements from the implanted keep track of and transfers the information to a secure database.

CardioMems had a rocky street to approval. Two separate instances, in 2011 and in 2013, the FDA’s Circulatory Program Units Panel agreed that the device was safe but that it had not been proven to be powerful or that the positive aspects of the device outweighed the hazards. Most of the discussion revolved all around the pivotal CHAMPION trial which enrolled 550 heart failure sufferers. The FDA explained today that it “believes that there is sensible assurance that the device is safe and successful for heart failure management with the goal of reducing the rate of heart failure-associated hospitalizations in specific sufferers.”

The FDA stated that it would need CardioMems to conduct “a thorough Publish-Approval Examine to continue to learn about the device’s efficiency when used outdoors the context of a clinical research.”

CardioMEMS was founded by cardiologist Jay Yadav, who is also the company’s CEO. The firm is partly owned by St. Jude Healthcare, which has mentioned that it ideas to entirely acquire the company in the first half of 2014.

“Heart failure is one of the most typical causes for hospitalizations for folks aged 65 and older,” mentioned Christy Foreman, director of the Office of Gadget Evaluation in the FDA’s Center for Units and Radiological Health, in an FDA press release. “The goal of this very first-of-its-sort implantable wireless gadget with remote monitoring of pulmonary artery pressure is to lessen heart failure-connected hospitalizations.”

There is widespread agreement that heart failure signify an massive and increasing burden on the well being care program. CardioMems cites American Heart Association estimates that direct and indirect expenses of heart failure in 2012 equalled $ 31 billion. However, it is unclear no matter whether the gadget will be capable to fulfill the high expectations suggested in this statement from a CardioMems representative:

Not only is this FDA approval going to influence the quality of lifestyle for patients, it will also conserve up to 40% in Medicare expenditures related to heart failure, which is the largest part of the Medicare price range.

FDA Approves Novel Implanted Sensor To Monitor Heart Failure

FDA Approves Novel Merck Drug To Stop Heart Attacks And Strokes

The FDA nowadays approved vorapaxar (Zontivity), Merck’s Merck’s after-troubled platelet receptor antagonist, to minimize the danger of myocardial infarction (heart assault), stroke, cardiovascular death, and revascularization procedures. The drug is accepted for use in people with a background of MI or peripheral arterial illness. The approval represents an wonderful turnaround for a drug that had knowledgeable nearly as several ups and downs as an amusement park roller coaster.

Vorapaxar is the 1st in a new drug class recognized as protease-activated receptor-1 (PAR-one) antagonists. By stopping the capability of platelets to stick collectively and kind blood clots, the drug can support prevent MI and stroke. But it also increases the chance of bleeding, which includes daily life-threatening and fatal bleeding. Simply because the threat of significant intracranial bleeding is specially large in individuals who have had a stroke, a transient ischemic assault, or bleeding in the head, use of the drug is contraindicated in these groups. The drug’s label consists of a boxed warning about the chance of bleeding. The FDA stated the drug will be dispensed with a patient Medication Guidebook.

Vorapaxar appeared to be all but dead a number of years in the past following unacceptably substantial significant bleeding costs had been identified in two huge clinical trials. But hopes for the drug resurfaced with a new examination of one of these trials, the TRA2P trial. In a statement to the press, Ellis Unger, director of the FDA’s Workplace of Drug Evaluation I, mentioned that the trial showed that “in sufferers who have had a heart assault or who have peripheral arterial illness, this drug will lower the risk of heart assault, stroke, and cardiovascular death…  Zontivity lowered this danger from 9.five percent to seven.9 % over a three-yr period – about .5 percent per yr.”

In January the FDA’s Cardiovascular and Renal Medication Advisory Committee voted 10-one in favor of approval for vorapaxar.

FDA Approves Novel Merck Drug To Stop Heart Attacks And Strokes

FDA Approves New Omega-3 Supplement

The FDA has authorized a new omega-three supplement for the remedy of grownups with serious hypertriglyceridemia, defined as triglyceride amounts 500 mg/dL or higher. The drug, which will be marketed under the brand identify of Epanova, is produced by AstraZeneca, which acquired the drug when it obtained Omthera Pharmaceuticals in 2013.

AstraZeneca mentioned that Epanova is the very first omega-three formulation approved by the FDA in free fatty acid form. Epanova will be accessible in 1 gram capsules and has been authorized for 2 gram and four gram dosages, which can be taken with or with out food.

There are at the moment two other prescription formulations of omega-3 dietary supplements: Lovaza from GSK and Vascepa from Amarin Pharmaceuticals. All 3 are accepted only for the remedy of serious hypertriglyceridemia. Last yr the FDA turned down a request from Amarin to enable an expanded use of Vascepa in people with a lot more frequent forms of dyslipidemia. The expanded indication for Vascepa is now becoming studied in the ongoing REDUCE-IT trial, which is scheduled to enroll 8,000 individuals.

The use of Epanova in an expanded population will be studied in the 12,000 patient STRENGTH study, headed by  the Cleveland Clinic’s Steve Nissen, Michael Lincoff, and Stephen Nicholls.

FDA Approves New Omega-3 Supplement

FDA Approves New Catheter For Treatment Of Atrial Fibrillation

The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in sufferers with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson &amp Johnson Johnson &amp Johnson firm.

The device, according to the organization, “is the very first therapeutic catheter approved in the U.S. that permits direct and real-time measurement of make contact with force in the course of catheter ablation procedures.”

The new catheter was evaluated in the SMART-AF Trial, which was presented final May possibly at the Heart Rhythm Society meeting (webcast of presentation). At one year there was a 74% all round good results charge in patients treated with the catheter. There were, nonetheless, 4 cases of tamponade among the 160 sufferers who underwent ablation.

“The Thermcool Smarttouch catheter is an important new device that will benefit the electrophysiology neighborhood, as it will enable us to much more precisely handle the amount of make contact with force applied to the heart wall when generating lesions in the course of catheter ablation,” explained Andrea Natale, the Main Investigator of the trial, in a press release. “Data from the Intelligent-AF Trial demonstrated that consistent and stable application of get in touch with force has a important affect on patient outcomes. The use of make contact with force-sensing technological innovation has emerged as a vital instrument in delivering optimal outcomes in the therapy of individuals with atrial fibrillation and represents a significant advancement for the clinical community.”

Other manufacturers of RF ablation devices for AF include Medtronic Medtronic, Boston Scientific Boston Scientific, and St. Jude Medical.

FDA Approves New Catheter For Treatment Of Atrial Fibrillation