FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

High-dose fluticasone effective against eosinophilic esophagitis, study shows...

I continuation of y update on Fluticasone..

Results from a clinical trial show that high doses of the corticosteroid fluticasone propionate safely and effectively induce remission in many people with eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus characterized by high levels of white blood cells called eosinophils. However, some trial participants did not respond to fluticasone even after six months of high-dose treatments, providing evidence that certain people with EoE are steroid-resistant. By analyzing gene expression -- the degree to which certain genes are turned on or off -- in esophageal tissues, the scientists identified a cluster of genes that may help predict steroid responsiveness.

Ref :Read more

High-dose fluticasone effective against eosinophilic esophagitis, study shows

Bowel cancer breakthrough may benefit thousands of patients

Researchers at Queen's University have made a significant breakthrough that may benefit
patients with bowel cancer. 

Dr Sandra van Schaeybroeck and her team have discovered how two genes cause bowel cancer cells to become resistant to treatments used against the disease. The research, which was funded by Cancer Research UK, was published this month in the international journal CellReports.

The activity of the two genes, called MEK and MET, was uncovered when the researchers looked at all the different pathways and interactions taking place in bowel cancer cells.

Dr van Schaeybroeck and her group found that these bowel cancers switch on a survival mechanism when they are treated with drugs that target faulty MEK genes. But when the researchers added drugs that also block the MET gene, the bowel cancer cells died.

The team are now testing a new approach to target these two genes in the most aggressive forms of bowel cancer in a European Commission funded clinical trial that is being led by Dr van Schaeybroeck.

Bowel cancer breakthrough may benefit thousands of patients

Zydelig Approved for Three Types of Blood Cancer

 Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL), the FDA said Wednesday in a news release.

The approval for the three forms of blood cancer covers instances when the cancer returns despite treatment with at least one other therapy, the agency said.

The drug's label will include a boxed warning that the medication could cause liver toxicity, diarrhea, high blood sugar, elevated liver enzymes, high blood triglycerides [a blood fat] and inflammation of the colon (colitis). Other side effects noted during clinical testing included fever, fatigue, nausea, cough, pneumonia, abdominal pain, chills and rash.

Zydelig is marketed by Gilead Sciences, based in Foster City, Calif.

Zydelig Approved for Three Types of Blood Cancer 

New combination drug controls tumor growth, metastasis in mice...

Researchers at UC Davis, University of      Massachusetts  and Harvard  Medical  School  have
created a combination drug that controls both tumor growth and metastasis. By combining a COX-2 inhibitor, similar to Celebrex, and an epoxide hydrolase (sEH) inhibitor, the drug controls angiogenesis (blood vessel formation), limiting a tumor's ability to grow and spread. The study appears today in the journal Proceedings of the National Academy of Sciences.

"We've   been   studying  the  effects of  COX  and  sEH  inhibitors, both    by themselves  and in combination, for several years," said senior author and UC Davis Distinguished Professor Bruce Hammock. "We were surprised to find that the dual inhibitor was more active than higher doses of each compound, either individually or together. By combining the two molecules into one we got much greater potency against several diseases and completely unique effects in terms of blocking tumor growth and metastasis."

Both COX and sEH enzymes control lipid signaling, which has long been associated with inflammation, cell migration, proliferation, hypertension and other processes. COX inhibitors block production of inflammatory and pain-inducing lipids, while sEH inhibitors preserve anti-hypertensive, anti-inflammatory and analgesic compounds. Separate COX and sEH inhibitors were previously found to work together in reducing inflammation and neuropathic pain.

After testing individual COX-2 and sEH inhibitors, the team synthesized the drug (PTUTB), the first combined COX-2/sEH inhibitor. They then tested the dual inhibitor against human lung and breast tumors, both in vitro and in mice. They found that PTUTB blocked angiogenesis, inhibiting the proliferation of endothelial cells, which are critical to blood vessel formation. This in turn limited tumor growth and metastasis, reducing lung and breast tumor growth by 70 to 83 percent. 

In breast and lung cancers, the dual inhibitor blocked angiogenesis, which blocked the growth of solid tumors," said Hammock. "This represents a new mechanism to control blood vessel and tumor growth."

Robert Weiss, a co-author and professor of nephrology at UC Davis, added that the combination drug achieved the results with minimal side effects and no cardiovascular or gastrointestinal effects.

"This is particularly important when administering COX-2 inhibitors, which have well-known cardiovascular risks," he said. "However, the added sEH  inhibitor appears to block COX-2's side effects."

The research was initiated by first author Guodong Zhang when he was a postdoctoral fellow in the Hammock laboratory. Zhang previously demonstrated that sEH inhibitors improve the power of omega-3 fatty acid (fish oil) diets to reduce tumor growth and metastasis, and implicated epoxides of the dietary supplement DHA as the causative agent.

New combination drug controls tumor growth, metastasis in mice  

Liver Cancer Drug Fails to Live Up to Early Promise...

In continuation of my update on everolimus

Although it looked promising in early studies, the drug everolimus didn't improve survival for people with advanced liver cancer in its latest trial, a new study found.

The findings from the phase 3 clinical trial are disappointing because earlier research suggested that everolimus (Afinitor) prevented tumor progression and improved survival for in advanced liver cancer. Normally, these patients can expect a median overall survival of less than one year.

The only drug currently shown to significantly improve survival of advanced liver cancer patients is sorafenib (Nexavar). But that drug's benefits are temporary and the cancer eventually progresses, according to background information in the new study.

The current study included 546 adults with advanced liver cancer whose disease progressed during or after treatment with sorafenib, or who could not take sorafenib. The patients were divided into two groups, with 362 given everolimus and 184 given a placebo.

Liver Cancer Drug Fails to Live Up to Early Promise 

New Inhaled Drug Shows Promise Against Asthma, Allergies...........

A new inhaled medication has the potential to treat mild asthma and allergies by interrupting the production of an immune system protein that triggers allergic reactions, a new study reports.

The drug, quilizumab, targets the blood cells that produce a protein called immunoglobulin type E (IgE), that serves a key role in allergies.

Quilizumab lowered total levels of IgE in the blood of people with allergies and mild asthma, and kept them low for a month, researchers report in the July 2 issue of the journal Science Translational Medicine.

"The subjects who received the drug not only had a reduction in their total IgE level, it also seemed to block production of new IgE in response to the allergen they inhaled," said study co-author Dr. Jeffrey Harris, principal medical director of immunology, tissue growth and repair for the drug manufacturer Genentech, which produces quilizumab and funded the study.

However, one expert noted that the drug has yet to prove itself against moderate to severe asthma.

New Inhaled Drug Shows Promise Against Asthma, Allergies  

New Inhaled Drug Shows Promise Against Asthma, Allergies - Drugs.com MedNews

A new inhaled medication has the potential to treat mild asthma and allergies by interrupting the production of an immune system protein that triggers allergic reactions, a new study reports.

The drug, quilizumab, targets the blood cells that produce a protein called immunoglobulin type E (IgE), that serves a key role in allergies.

Quilizumab lowered total levels of IgE in the blood of people with allergies and mild asthma, and kept them low for a month, researchers report in the July 2 issue of the journal Science Translational Medicine.

"The subjects who received the drug not only had a reduction in their total IgE level, it also seemed to block production of new IgE in response to the allergen they inhaled," said study co-author Dr. Jeffrey Harris, principal medical director of immunology, tissue growth and repair for the drug manufacturer Genentech, which produces quilizumab and funded the study.

However, one expert noted that the drug has yet to prove itself against moderate to severe asthma.

New Inhaled Drug Shows Promise Against Asthma, Allergies  

Breast Cancer Drug May Help Women Fight a Leading Cause of Infertility: Study

Women with polycystic ovary syndrome have a better chance of getting pregnant if they take a breast cancer drug instead of the currently preferred medication, a new study suggests.

Polycystic ovary syndrome -- the most common cause of female infertility in the United States -- causes higher than normal levels of the male hormone androgen, infrequent periods and small cysts on the ovaries. It affects 5 to 10 percent of reproductive-age women, according to background information in the study.

Currently, doctors typically prescribe clomiphine (Clomid) to boost fertility for women with polycystic ovary syndrome. However, this new study suggests the drug letrozole (Femara) results in better ovulation, conception and birth rates.

"We found a simple and comparatively safe and vastly more effective treatment for [polycystic ovary syndrome]," said lead researcher Dr. Richard Legro, a professor of obstetrics and gynecology at Penn State University's College of Medicine in Hershey, Penn.

Clomiphine, which works by stimulating ovulation, has been the standard treatment for years, but has a high rate of multiple births, Legro said.

Letrozole, a treatment for breast cancer in postmenopausal women, works by blocking estrogen production, tricking the ovaries into producing more of the hormone, he explained.

The new study, funded by the U.S. National Institutes of Health, was published July 10 in the New England Journal of Medicine.

Breast Cancer Drug May Help Women Fight a Leading Cause of Infertility: Study - Drugs.com MedNews

First drug candidate from NIH program acquired by biopharmaceutical company

A drug candidate developed by researchers at the NIH’s National Center for Advancing Translational Sciences (NCATS) and its collaborators to treat sickle cell disease has been acquired by Baxter International’s BioScience business. The drug candidate, Aes-103, is the first specifically developed to target the underlying molecular mechanism of sickle cell disease. Baxter now will advance the clinical development activities required for regulatory approval and commercialization.

Sickle cell disease is a genetic blood disorder that affects millions worldwide, including approximately 100,000 people in the United States — among them, 1 in 500 African-Americans.

This is the first time a company has acquired a drug candidate developed with NCATS’ Therapeutics for Rare and Neglected Diseases (TRND) program resources. Baxter International recently acquired AesRx, LLC, Newton, Massachusetts — the TRND program collaborator — including Aes-103. TRND and AesRx researchers worked together to develop Aes-103 through a Phase II clinical trial to evaluate safety and effectiveness. The trial data indicated that Aes-103 significantly reduced patients’ pain. 

“This is a wonderful example of why NCATS was created,” said NIH Director Francis S. Collins, M.D., Ph.D. “The progress made thus far in the development of Aes-103 demonstrates NCATS’ catalytic role in bringing together the necessary players, whether academic, nonprofit or industry, to overcome obstacles to translation and advance badly needed treatments to patients.”

First drug candidate from NIH program acquired by biopharmaceutical company

New Amyloid Reducing Compound Could Be a Preventive Measure Against Alzheimer’s | Neuroscience News Research Articles | Neuroscience Social Network

New Amyloid Reducing Compound Could Be a Preventive Measure Against Alzheimer’s | Neuroscience News Research Articles | Neuroscience Social Network



Ref : http://onlinelibrary.wiley.com/doi/10.1002/ana.24149/abstract;jsessionid=9F003DBC49DC78B99E15FC97CC073CFA.f01t03

New Drug May Boost Survival for Advanced Prostate Cancer Patients: Study - Drugs.com MedNews

A pill that blocks male hormone activity can improve survival and delay the need for chemotherapy in men with advanced prostate cancer, a new clinical trial has found.

Men who took a daily dose of the drug enzalutamide started chemotherapy nearly a year and a half later than men who received a placebo, even though their prostate cancer had spread to other parts of their bodies, said senior study author Dr. Tomasz Beer, deputy director of the Knight Cancer Center at Oregon Health and Science University.

New Drug May Boost Survival for Advanced Prostate Cancer Patients: Study

New Drug May Treat Constipation Caused by Strong Painkillers - Drugs.com MedNews

A new drug holds promise as a safe and effective treatment for constipation caused by prescription narcotic painkillers, new research states.

Constipation is a common side effect experienced by patients taking these powerful medications for chronic pain. When laxatives failed to provide relief, two phase 3 trials found the once-daily drug naloxegol could help.

"The studies showed rapid and sustained improvement for these patients, without compromising their pain management," study author Dr. William Chey, a gastroenterologist and professor of internal medicine at the University of Michigan Health System, said in a university news release.

The U.S. Food and Drug Administration, as well as health agencies in Canada and Europe, are reviewing the drug for possible approval.

Naloxegol (structure) was specifically designed to treat constipation caused by the narcotic painkillers that are often used to treat chronic health issues, such as osteoarthritis and back pain. These medications ease patients' pain by binding to certain receptors in the brain, but they also bind to receptors in the bowel, which raises the risk of constipation.

Naloxegol works by preventing the painkillers from binding to receptors in the bowel, but not the brain, according to the news release.

One of the new studies involved 652 people. The other study included 700 participants. The patients were randomly assigned to receive one 12.5 milligram (mg) or one 25 mg dose of naloxegol daily, or an inactive placebo.

New Drug May Treat Constipation Caused by Strong Painkillers 

Green tea could reduce pancreatic cancer risk: Study explains how

A study recently published online by the journal, Metabolomics, offers an explanation that researchers say could open a new area of cancer-fighting research. The study reports that EGCG, the active biologic constituent in green tea, changed the metabolism of pancreatic cancer cells by suppressing the expression of an enzyme associated with cancer, LDHA.

The researchers also found an enzyme inhibitor, oxamate, which is known to reduce LDHA activity, operated in the same manner: It also disrupted the pancreatic cancer cells metabolic system.

"Scientists had believed they needed a molecular mechanism to treat cancer, but this study shows that they can change the metabolic system and have an impact on cancer," said Wai-Nang Lee, MD, corresponding author of the study and a Los Angeles Biomedical Research Institute (LA BioMed) lead researcher. "By explaining how green tea's active component could prevent cancer, this study will open the door to a whole new area of cancer research and help us understand how other foods can prevent cancer or slow the growth of cancerous
cells."

Using sophisticated metabolic profiling methods, the researchers found EGCG disrupted the balance of "flux" throughout the cellular metabolic network. Flux is the rate of turnover of molecules through a metabolic pathway. The researchers found the EGCG disrupted this balance in the same manner that oxamate, a known LDHA inhibitor, did.

Based on this finding, they concluded that both EGCG and oxamate reduced the risk of cancer by suppressing the activity of LDHA, a critical enzyme in cancer metabolism, thereby disrupting the balance in the cancer cells metabolic functions.

Green teacould reduce pancreatic cancer risk: Study explains how  

New drug for non-Hodgkin lymphoma, chronic lymphocytic leukemia passes early test

The drug,
alisertib or MLN8237, inhibits the enzyme aurora A kinase, which is known to be
very active during cell division. The present study, published in the journalInvestigational
New Drugs, looks at the safety, tolerability, and preliminary success of
alisertib in treating non-Hodgkin lymphoma (NHL) and chronic lymphocytic
leukemia (CLL).

"An advantage with this drug is it is oral and very effective in a significant number of patients with aggressive lymphoma when used at that dose for 7  days out a 21 day cycle," said hematologist Swaminathan Iyer, M.D., who led the multi-site study. 

Drugs commonly used to treat NHL and CLL are chemotherapeutic drugs and some biological targeted agents such as the monoclonal antibodies rituximab, ofatumumab and obinutuzumab with varying degrees of success.

Although about 1/2 of patients participating in the phase I study experienced side effects most of which were manageable events, Iyer said that is not unusual for such
biologic (non chemotherapy) drugs.

"The side effects were fairly tolerable in this study," Iyer said. "We would like to see more information from a larger group of patients to fully understand the drug's safety and tolerability for those experiencing the middle-to-later stages of these diseases."

Iyer and his group recommend 50 mg, twice-daily doses of alisertib for the advanced phase trials of the drug, which Iyer says has begun enrollment. Alisertib is not yet approved for general medical use by the FDA. Its impact on T cell lymphoma is being investigated in a separate, phase III trial for a specific type of  lymphoma called the T cell lymphomas. Houston Methodist is a participating study site for that project. Initial phase II reports in these T cell lymphomas showed a 57% response, the highest ever noted for any single agent in this disease entity.

New drug
for non-Hodgkin lymphoma, chronic lymphocytic leukemia passes early test