Mylan announces U.S. launch of Celecoxib Capsules

In continuation of my update celecoxib

Mylan Inc. (Nasdaq: MYL)      announced the U.S. launch of its Celecoxib Capsules,   50 mg,  100 mg,  200 mg, and 400 mg,  one  of the  first  available  generic  versions        of   Pfizer's elebrex®       Capsules,     which    is   indicated for  the  relief  of the  signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.

Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, had U.S. sales of approximately $2.5 billion for the 12 months ending September 30, 2014, according to IMS Health.

Currently, Mylan has 286 ANDAs pending FDA approval representing $111.6 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $29.5 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.

Mylan announces U.S. launch of Celecoxib Capsules

Midazolam drug helps recover full consciousness in traumatic brain injury patient

A patient who had suffered a traumatic brain injury unexpectedly recovered full consciousness after the administration of midazolam, a mild depressant drug of the GABA A agonists family. This resulted in the first recorded case of an "awakening" from a minimally-conscious state (MCS) using this therapy. Although similar awakenings have been reported using other drugs, this dramatic result was unanticipated. It is reported in Restorative Neurology and Neuroscience.

Traumatic brain injuries occur at high rates all over the world, estimated at 150-250 cases per 100,000 population per year. These injuries can result in several outcomes, ranging from vegetative state, minimally conscious state, severe disability to full recovery. In most cases, the outcome will cause catastrophic changes for his/her family and a significant drain on both human and financial resources.

Two years after the injury caused by a motor vehicle accident, the patient was mildly sedated, in order to undergo a CT scan, using midazolam instead of the more commonly used propofol. As the authors described in the article, the patient began to interact with the anesthetist and soon after with his parents. He talked by cellphone with his aunt and congratulated his brother when he was informed of his graduation; he recognized the road leading to his home. When he was asked about his car accident, he did not remember anything and apparently he was not aware of his condition. This clinical status lasted about two hours after drug administration and disappeared quickly thereafter, taking the patient back to the previous condition.

Midazolam drug helps recover full consciousness in traumatic brain injury patient

Scientists zero in on obesity pill 'that could replace the treadmill'

Scientists at Harvard University have created a way of screening potential drugs that turn white fat cells – which are "bad" – into the brown fat cells that are healthier. They have already identified two compounds that work on human cells growing in the laboratory.

Researchers believe it may be possible to lower the levels of white fat, which is linked with diabetes and heart disease, by increasing the proportion of brown fat, which burns off excess energy. It could lead to a “pill that can replace the treadmill” for the control of obesity, they said.

Meanwhile, Imperial College researchers in London have identified an enzyme that drives the craving for sugar in the brain’s hypothalamus, which regulates food intake. The scientists believe the enzyme, called glucokinase, could be a viable target for an anti-obesity drug.

“This is the first time anyone has discovered a system in the brain that responds to a specific nutrient, rather than energy intake in general. It suggests that when you’re thinking about diet, you have to think about different nutrients, not just count calories,” said James Gardiner of Imperial College, who led the study published in the Journal of Clinical Investigation.

Tests on rats showed that boosting the activity of the enzyme within the brain caused the animals to consume more glucose in preference to normal food. A drug targeting glucokinase or its metabolic pathway could potentially prevent obesity by lowering the desire for sugary foods, the scientists suggest.

Scientists zero in on obesity pill 'that could replace the treadmill' - Health News - Health & Families - The Independent

Carboplatin and paclitaxel show promise for advanced thymic carcinoma

In continuation of carboplatin and paclitaxel

A multicentre, phase II study of carboplatin and paclitaxel (CbP) in chemotherapy-naïve patients with advanced thymic carcinoma has shown that the treatment has promising efficacy compared with standard anthracycline-based chemotherapy.

Thymic carcinoma is very rare, and consequently it is hard to investigate it separately from thymoma. Previous studies evaluating chemotherapy regimens have included patients with both types of tumour, explain Takashi Seto (National Kyushu Cancer Center, Fukuoka, Japan) and colleagues.

Forty patients from 21 centres across Japan were enrolled in the current study from May 2008 until November 2010. One patient subsequently dropped out. The sample size was decided on the basis that it was large enough to reject the primary endpoint of an objective response rate (ORR) of 20%.

Carboplatin and paclitaxel show promise for advanced thymic carcinoma

Injectable 3-D vaccines could fight cancer, infectious diseases

One of the reasons cancer is so deadly is that it can evade attack from the body's immune system, which allows tumors to flourish and spread. Scientists can try to induce the immune system, known as immunotherapy, to go into attack mode to fight cancer and to build long lasting immune resistance to cancer cells. Now, researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University and Harvard's School of Engineering and Applied Sciences (SEAS) show a non-surgical injection of programmable biomaterial that spontaneously assemblesin vivo into a 3D structure could fight and even help prevent cancer and also infectious disease such as HIV. Their findings are reported in Nature Biotechnology.

Selenium compounds appear to have beneficial effect on cancer

The immune system is designed to remove things not normally found in the body. Cells undergoing change, e.g. precursors of cancer cells, are therefore normally recognised and removed by the immune system. Unfortunately, the different cancer cells contain mechanisms that block the immune system's ability to recognise them, allowing them to freely continue cancer development.

Certain cancer cells overexpress immunostimulatory molecules in liquid form. Such over-stimulation has a negative impact on the immune system:

"You can say that the stimulating molecules over-activate the immune system and cause it to collapse, and we are, of course, interested in blocking this mechanism. We have now shown that certain selenium compounds, which are naturally found in, e.g., garlic and broccoli, effectively block the special immunostimulatory molecule that plays a serious role for aggressive cancers such as melanoma, prostate cancer and certain types of leukaemia," says Professor Søren Skov, Department of Veterinary Disease Biology, University of Copenhagen.

Study: Selenium compounds appear to have beneficial effect on cancer

FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency

Macimorelin is a drug being developed by Æterna Zentaris for use in the diagnosis of adult growth hormone deficiency. As of January 2014, it is in Phase III clinical trials. 

Macimorelin is a mimic of ghrelin, a growth hormone secretagogue. It binds to the growth hormone secretagogue receptor(GHSR) causing release of growth hormone from the pituitary gland.

Now, Aeterna Zentaris Inc. today announced that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (“AGHD”). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency

BPA Exposure May Change Stem Cells, Lower Sperm Production

BPA (Bisphenol A) and other estrogenic compounds hamper development of the stem cells responsible for producing sperm in mice, which suggests such exposure could contribute to declining sperm counts in men, according to a new study.

The study, published online today in PLoS Genetics, is the first to suggest that low, brief exposures to bisphenol-A, or other estrogens such as those used in birth control but found as water contaminants, early in life can alter the stem cells responsible for producing sperm later in life.

Exposure to estrogens “is not simply affecting sperm being produced now, but impacting the stem cell population, and that will affect sperm produced throughout the lifetime,” said Patricia Hunt, a geneticist at Washington State University who led the study.

BPA is a ubiquitous chemical found in most people and used to make polycarbonate plastic and found in some food cans and paper receipts. People also are exposed to synthetic estrogens used in birth control as they are commonly found contaminating water, even after treatment. 

The U.S. Food and Drug Administration banned BPA from baby bottles in 2012 but maintains that BPA currently used in food containers and packaging is safe. And this week the European Food Safety Authority announced in a new assessment there is “no consumer health risk from bisphenol-A exposure.

”BPA Exposure May Change Stem Cells, Lower Sperm Production  

Study indicates major added benefit of propranolol in some children with haemangioma

The Institute for Quality and Efficiency in Health Care (IQWiG) investigated in a dossier assessment whether propranolol offers an added benefit in comparison with the appropriate comparator therapy in infants with proliferating infantile haemangioma (sometimes called "strawberry mark").

According to the findings, there is an indication of major added benefit of propranolol (structure) in some children, i.e. those with haemangioma with a risk of permanent scars or disfigurement. In contrast, an added benefit is not proven for children with life- or function-threatening haemangioma, or with ulcerated haemangioma with pain or lack of response to simple wound care measures, because informative data are lacking.

Study indicates major added benefit of propranolol in some children with haemangioma

Three-drug combination produces better results in multiple myeloma patients

In continuation of my update on dexamethasone, lenalidomide and  carfilzomib (above respective structures from left to right)....

In the treatment of multiple myeloma, the addition of carfilzomib to a currently accepted two-drug combination produced significantly better results than using the two drugs alone, according to a worldwide research team led by investigators from Mayo Clinic.

Their findings will be reported online Dec. 6 in the New England Journal of Medicine, and presented on Dec. 7 at the annual meeting of the American Society of Hematology (ASH), held in San Francisco.

Interim analysis of the ASPIRE clinical trial, which enrolled 792 patients with relapsed multiple myeloma from 20 countries, found an "unprecedented" prolongation of the time patients were free of disease progression, says the study's lead investigator, Keith Stewart, M.B., Ch.B, a Mayo Clinic oncologist in Arizona. "Patients taking three drugs -- carfilzomib, lenalidomide and dexamethasone -- stayed free of disease progression for 26 months on average," he says. "No one has reported anything like this before for relapsed multiple myeloma."

Researchers found that adding carfilzomib to standard treatment (lenalidomide and dexamethasone) resulted in 8.7 months of longer remission, almost 50 percent longer than the standard two-drug combination (26.3 months versus 17.6 months).

The number of patients who responded to treatment was also significantly improved by adding carfilzomib to standard treatment -- 87.4 percent versus 66.9 percent-- and more than three times more patients had no detectable disease after the three-drug treatment (31.8 percent versus 9.3 percent). Although results were preliminary, there was also a trend toward improved overall survival, Dr. Stewart says. "Importantly, patients on the three-drug cocktail also reported a better quality of life despite a higher intensity of treatment," he says.

These findings highlight increasing success in treating myeloma, the second most common blood cancer, says Dr. Stewart.

"Survival of multiple myeloma has almost doubled over the last decade, and the very positive outcomes from use of the three-drug combination will likely further improve outcomes," he says. "This is a nice story to tell."

Lenalidomide, a potent derivative of thalidomide, affects immune system function. Dexamethasone is a steroid drug. Carfilzomib is a proteasome inhibitor approved for use in 2012 by the U.S. Food and Drug Administration (FDA) for patients with advanced, end-stage multiple myeloma. The drug specifically targets regulation of the proteins that fuel growth of multiple myeloma.

Three-drug combination produces better results in multiple myeloma patients

Cimetidine drug could be one of many common over-the-counter medicines to treat cancer...

   

We know that, Cimetidine is a histamine H₂-receptor antagonist that inhibits stomach acid production. It is largely used in the treatment of heartburn and peptic ulcers. It has been marketed by GlaxoSmithKline (which is selling the brand to Prestige Brands) under the trade name Tagamet (sometimes Tagamet HB or Tagamet HB200). Cimetidine was approved in the UK in 1976 and was approved in the US by the Food and Drug Administration for prescriptions starting January 1, 1979.

Now, it has been concluded that, a popular indigestion medication can increase survival in colorectal cancer, according to research published in ecancermedicalscience. But in fact, scientists have studied this for years - and a group of cancer advocates want to know why this research isn't more widely used.

Phase IIb trial shows platinum-resistant ovarian patients treated with PM1183 live longer

Zeltia announces today that its pharmaceutical division PharmaMar has data from a group of 33 randomized patients with platinum-resistant ovarian cancer demonstrating that PM1183 (see structure) shows a significantly superior median overall survival compared to topotecan. In this multicenter Phase IIb randomized trial, platinum-resistant ovarian patients treated with PM1183 lived longer, with a median overall survival of 18.1 months, compared to topotecan, which only achieves 8.5 months. PharmaMar will launch a pivotal Phase III trial to confirm the efficacy of PM1183 in a larger population, and that is expected to be the final step before registration of PM1183 for platinum-resistant ovarian cancer. "The pivotal trial planned for next year will hopefully confirm the effects in survival that we observe in these patients, who are in need of drugs that will reduce the risk of death and extend their lives, without posing major side effects", says Arturo Soto, Director of Clinical Development, PharmaMar.

The Phase IIb trial consisted of a first stage, single arm approach to assess efficacy of PM1183 in platinum-resistant ovarian cancer patients, followed by a second stage, in which patients were randomized to be treated with PM01183 or topotecan as control group.

Results presented at the American Society of Clinical Oncology (ASCO) earlier this year showed a significant improvement in the other secondary endpoint, progression-free survival, as well as in the overall response rate, which was the primary endpoint1. The results found now for the overall survival of patients with platinum-resistant ovarian cancer treated with PM1183 add to the clinical benefit, measured as 70% of overall responses and stable disease, previously observed. The manageable safety profile previously described for these patients has not changed.

Phase IIb trial shows platinum-resistant ovarian patients treated with PM1183 live longer

Resveratrol in red wine inhibits formation of inflammatory factors that activate cardiovascular diseases

In continuation of my update on resveratrol 

A natural substance present in red wine, resveratrol, inhibits the formation of inflammatory factors that trigger cardiovascular diseases. This has been established by a research team at the Department of Pharmacology of the University Medical Center of Johannes Gutenberg University of Mainz (JGU) working in collaboration with researchers of the Friedrich Schiller University in Jena and the University of Vienna. Their results have recently been published in the scientific journal Nucleic Acids Research.

Despite the fact that they eat more fatty foods, the French tend to less frequently develop cardiac diseases than Germans. This so-called French Paradox is attributed to the higher consumption of red wine in France and it has already been the subject of various studies in the past. A number of research projects have actually demonstrated that the natural product resveratrol, present in red wine, has a protective effect against cardiovascular diseases. But what exactly is the reason for this? It seems that at least part of the protective effect can be explained by the fact that resveratrol inhibits the formation of inflammatory factors, a conclusion reached by the research team of Junior Professor Andrea Pautz and Professor Hartmut Kleinert of the Mainz University Medical Center following collaboration in a joint project with Professor Oliver Werz of the Friedrich Schiller University in Jena and Professor Verena Dirsch of the University of Vienna. In fact, the researchers discovered that the natural substance binds to the regulator protein KSRP and activates it. KSRP reduces the stability of messenger RNA (mRNA) in connection with a number of inflammatory mediators and thus inhibits their synthesis.

Resveratrol in red wine inhibits formation of inflammatory factors that activate cardiovascular diseases

New drug offers hope for victims of spinal cord injury

New drug offers hope for victims of spinal cord injury

Antacid medicines improve overall survival in patients with head and neck cancer

Patients with head and neck cancer who used antacid medicines to control acid reflux had better overall survival, according to a new study from the University of Michigan Comprehensive Cancer Center.

-Prevacid  Nexium

 Prilosec 

Reflux can be a common side effect of chemotherapy or radiation treatment for head and neck cancer. Doctors at the University of Michigan frequently prescribe two types of antacids - proton pump inhibitors or histamine 2 blockers - to help treat this side effect.

The researchers looked at 596 patients who were treated for head and neck cancer. More than two-thirds of the patients took one or both types of antacid medication after their diagnosis.

Patients who were taking antacids had significantly better overall survival than those who did not take them. Proton pump inhibitors, which include drugs such as Prilosec, Nexium and Prevacid, had the biggest effect: a 45 percent decreased risk of death, compared to patients who did not take antacids. Patients taking histamine 2 blockers, such as Tagamet, Zantac or Pepcid, saw a 33 percent decreased risk of death.

"We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better," says lead study author Silvana Papagerakis, M.D., Ph.D., research assistant professor of otolaryngology--head and neck surgery at the University of Michigan Medical School and an adjunct clinical assistant professor at the U-M School of Dentistry.

Results of the study are published in the December issue of Cancer Prevention Research.

The researchers are not clear why these medications affect the cancer, although they have begun additional work to understand the mechanisms involved.

Antacid medicines improve overall survival in patients with head and neck cancer