Erivedge Approved to Treat Basal Cell Carinoma

Erivedge(vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday.

The drug was approved for people for whom surgery or radiation aren't options, and for people with basal cell that has spread to other parts of the body, according to an FDA news release. Erivedge was evaluated in clinical studies involving 96 people with basal cell carcinoma. The most common side effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted taste, loss of appetite and constipation.

The drug was approved with an FDA's label warning that pregnant women who take Erivedge could have babies at greater risk of severe birth defects or death. "Pregnancy status must be verified prior to the start of Erivedge treatment," the agency release advised.

Ref : http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13827

Pertuzumab plus trastuzumab and docetaxel has competitive advantages in efficacy over our current proprietary clinical gold-standard treatment...

In continuation of my update docetaxel

"Pertuzumab plus trastuzumab and docetaxel has competitive advantages in efficacy over our current proprietary clinical gold-standard treatment, trastuzumab plus docetaxel," said Decision Resources Analyst Amy Duva"l. 

Decision Resources' analysis of the breast cancer drug market also finds that Roche/Genentech/Chugai's Trastuzumab-DM1 (T-DM1) is likely to initially enter later-lines of treatment before receiving approval for the first-line setting, which means it will gain use across all lines of therapy, fragmenting its patient share across lines of treatment and restricting its uptake in the first-line setting. 

Additionally, according to insights from interviewed thought-leaders, pertuzumab plus trastuzumab and docetaxel and T-DM1 plus pertuzumab have demonstrated the potential to increase patients' overall survival, which has not been improved by drug-treatment since the approval of trastuzumab over a decade ago. 

Findings also reveal that the overall breast cancer drug market declined from $10 billion in 2010 to $9.3 billion in 2011 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Decision Resources forecasts that the market will increase from $9.3 billion in 2011 to $10.8 billion in 2020. Significant declines in sales, due to generic and biosimilar price erosion and a substantial reduction in the prescribing of Roche/Genentech/Chugai's Avastin, particularly in the U.S., will be offset by the launch and uptake of premium-priced emerging therapies, particularly in the metastatic HER2-positive setting. 

Ref : http://decisionresources.com/News-and-Events/Press-Releases/Breast-Cancer-Drug-Market-020212

Clot-Busting Drug, tPA, May Work for Those Who Have Strokes While Asleep

New research suggests that it may be safe to give the clot-busting drug tPA  to people who wake up with stroke symptoms, even though there is a short time window in which to use the treatment and doctors have no idea when these patients first started experiencing their stroke.

The powerful medication can save lives and stave off lasting disability after a stroke, but experts believe it needs to be given within 4.5 hours of the start of symptoms. Almost 25 percent of people who have strokes have them while they are asleep, the study authors noted, and doctors typically err on the side of caution, assume the stroke happened when the patient first went to bed and do not treat with tPA....

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New Anti-Clotting Drug May Cut Brain Bleeding Risk: Study

In continuation of my update on rivaroxaban (Xarelto)

In a new study, researchers led by Dr. Graeme Hankey, a neurologist at the Royal Perth Hospital and University of Western Australia, followed more than 14,000 people who took anti-clotting drugs for a median of two years. Of those patients, 136 had bleeding in the brain.

People who took a new anticoagulant called rivaroxaban (Xarelto) and suffered from the most common type of atrial fibrillation and didn't have heart valve damage were about one-third less likely to experience bleeding in the brain than those who took warfarin, the investigators found...

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Experimental Drug-apixaban (Eliquis) : Might Beat Aspirin in Preventing Repeat Strokes: Study

An investigational drug called apixaban (Eliquis) appears to be better than aspirin at preventing blood clots in certain patients who have already suffered a stroke or so-called "mini-stroke" due to an abnormal heart rhythm, according to the results of a new study.

For patients with the dangerous irregular heart rhythm known as atrial fibrillation who can't tolerate the standard drug treatment, daily apixaban seems to be more effective at warding off a stroke or blood clot than aspirin, the study found.

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FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer

In continuation of my update on imatinib...

FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer: The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in...

FDA Approves Jentadueto ((linagliptin/metformin hydrochloride)).....

In continuation of my update on linagliptin and metformin hydrochloride

U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta (linagliptin) tablets....

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FDA Approves Jentaduet ((sitagliptin and metformin hydrochloride (HCl) )...

In continuation of my update on sitagliptin and metformin hydrochloride (HCl)

U.S. Food and Drug Administration (FDA) approved JANUMET^® XR    ((sitagliptin and metformin hydrochloride (HCl) ) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA^® (sitagliptin), with extended-release metformin. JANUMET XR provides a convenient once-daily treatment option for healthcare providers and patients who need help to control their blood sugar.

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Study shows grape seed extract kills head and neck squamous cell carcinoma cells

A study by researchers lead by Dr.Rajesh Agarwal,  shows that in both cell lines and mouse models, grape seed extract (GSE) kills head and neck squamous cell carcinoma cells, while leaving healthy cells unharmed. "It's a rather dramatic effect," says Rajesh Agarwal, PhD, investigator at the University of Colorado Cancer Center and professor at the Skaggs School of Pharmaceutical Sciences.

Grape seed extract creates these conditions that are unfavorable to growth. Specifically, the paper shows that grape seed extract both damages cancer cells' DNA (via increased reactive oxygen species) and stops the pathways that allow repair (as seen by decreased levels of the DNA repair molecules Brca1 and Rad51 and DNA repair foci).

 "Yet we saw absolutely no toxicity to the mice, themselves," Agarwal says.

Interestingly,  the grape seed extract killed the cancer cells but not the healthy cells. As per the lead reseacher,  the  cancer cells have a lot of defective pathways and they are very vulnerable  and one can  target those pathways. The same is not true of healthy cells," adds Agarwal.

The Agarwal Lab hopes to move in the direction of clinical trials of grape seed extract, potentially as an addition to second-line therapies that target head and neck squamous cell carcinoma that has failed a first treatment.

Ref :  http://carcin.oxfordjournals.org/content/23/11/1869.abstract?sid=90421d40-8cea-478e-8d70-f5a17c4158b7

Tea could help lower high blood pressure: Study

In continuation of my update on tea and its effect....

A new study suggests that taking tea daily could help in lowering blood pressure.The study shows that people who drank three cups of black tea a day were able to lower their blood pressure. This was seen when compared to those who drank a placebo similar in taste and caffeine content. Those who drank the tea saw a slight drop in both systolic and diastolic blood pressure over six months.

Experts however warned that drinking tea is not a substitute for blood pressure-lowering medication, but researchers said the findings show tea could still provide a benefit.

Researchers note that although the study cannot identify specific components of the tea that might lead to a drop in blood pressure, past studies have shown flavonoids, compounds found in many plants such as tea, are good for heart health.

“The message really isn't for an individual to go out and drink a lot of tea,” said Jonathan Hodgson,

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Preliminary findings suggest a drug used to treat   cryopyrin-associated periodic syndromes  disease might also reduce painful flare-ups in gout patients starting new medication regimens.

In a new study, the protein-inhibitor drug rilonacept (Arcalyst) appeared to markedly lower the risk of gout flare-ups during the first few months of treatments aimed at lowering uric acid levels.

"To reduce deposits of crystals in the joints, we advise patients to initiate treatment with medications that lower levels of uric acid in the blood," study author Dr. H. Ralph Schumacher 

The researchers wanted to learn if rilonacept could lower this short-term risk for by neutralizing a specific target protein -- interleukin 1 or IL-1 -- before it initiates inflammation.

They looked at 83 gout patients in 27 U.S. study centers who had a history of gout flare-ups and high levels of uric acid. All were placed on a chronic uric-acid lowering regimen of the standard drug allopurinol.

About half were also given an initial double-dose injection of rilonacept (320 milligrams) followed by a single dose for 16 weeks. The other half received sugar pills.

Rilonacept patients were less likely to have flare-ups, with 15 percent experiencing flare-ups three-months into the study compared with 45 percent among the non-rilonacept group, the researchers found....

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FDA Approves Inlyta for advanced kidney cancer (renal cell carcinoma)

The U.S. FDA,  approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. 

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

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FDA Approves BYDUREON™ -- The First and Only Once-Weekly Treatment for Type 2 Diabetes

In continuation of my up date on Exenatide...

Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon  (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings....

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Drug May Slow Early Prostate Cancer: Study

In continuation of my update on Dutasteride (Avodaart)

New research suggests that Avodart, a drug used to treat an enlarged prostate gland, may help slow the progression of early stage prostate cancer, reducing the need for aggressive treatment in some men. 

Avodart belongs to a class of drugs called 5-alpha reductase inhibitors. These drugs work by interfering with the effects of certain male hormones on the prostate. In the three-year study, prostate cancer progressed in 38 percent of 144 men with early prostate cancer who were treated with Avodart and 48 percent of the 145 men who received a placebo....

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Could 'Magic' Mushrooms Ease Depression?

Psychedelic mushrooms (see above picture) may point to new ways to treat depression, suggest two small brain imaging studies that seem to show how psilocybin (see right structure) the active ingredient in such mushrooms -affects the brain. 

One study included 30 healthy people who had psilocybin inserted into their blood while magnetic resonance imaging (MRI) scanners measured changes in their brain activity. The scans revealed that psilocybin caused decreased activity in what the researchers described as the brain's "hub" regions -- areas especially well-connected with other areas.

The second study included 10 healthy volunteers and found that psilocybin boosted their recall of personal memories and their emotional well-being for up to two weeks. The researchers said this suggests that psilocybin might prove useful as an adjunct to psychotherapy.

"Psychedelics are thought of as 'mind-expanding' drugs, so it has commonly been assumed that they work by increasing brain activity, but surprisingly, we found that psilocybin actually caused activity to decrease in areas that have the densest connections with other areas," Nutt said....

Researchers lead by Dr.David Nutt, add that result is consistent with earlier finding that psilocybin decreases mPFC activity, as many effective depression treatments do. The effects need to be investigated further and this study was only a small study, and  are interested in exploring psilocybin's potential as a therapeutic tool.....