Showing posts with label News. Show all posts
Showing posts with label News. Show all posts

Friday, January 3, 2014

Medical Marijuana Inches Closer to Beat Viagra

Seems like Marijuana is taking a medical form to stock up its sales and popularity. It’s a good way to become legal as well, well atleast for those who want to boost the performance of their senses. So now we guess that Viagra maybe facing some stiff competition from this heady plant medicine.

The fascination for marijuana has grown manifold ever since its medical version was introduced. Now people would get a taste of it legally and because of this fact, its sales have reached a whopping $1.7 billion in no time. Compare this to the annual sales of Viagra which is around $1.9 billion and we have a lip smacking clash of the titans, a battle of the drugs indeed. It has been said that in around 5 years time, the sales of the medical marijuana will reach around $8.9 billion, which is just amazing as this drug has been prescribed for various medical problems in many states of the US.

Although under the federal law, the sale of this medical form is prohibited, it remains to be seen as to what will be the future actions of the federal government regarding this drug. If people are being benefited from it and if its side effects are mild and harmless, then medical marijuana should be legalized in all the states.

Judging by its current sales and popularity, it might be likely that this medicine might just beat the blockbuster drug that is Viagra. Well, only time will tell.

Tuesday, March 5, 2013

Big Pharma Companies, Good and Bad

Big Pharma is both good and evil. Regardless of its motives, Big Pharma has prolonged our lives or kept our lifespan about this same (which is remarkable considering how fat an unhealthy we are). Maybe we all need a wake-up call to realize that a longer life isn't necessarily a better life... I for one would rather die at 70 then to live from 75 - 95 in a nursing home staring at a TV drooling while some nurse changes my poop filled depends twice a day.

If you want to give Big Pharma the proverbial 'middle finger' then put down the fork, the cigs, and get off of your couch and do 30 - 60 minutes of exercising a day (the anti-glutton effect). This will lower your blood pressure (no more ACEs, ARBs, beta blockers, CCBs, alpha antagonists), cholesterol (bye bye statins, niacin, fibrates and zetia), reverse diabetes (no more metformin, TZDs, insuline), and prevent heart attack (adios plavix/effient/brillinta).

Yes, I realize that genetics and other uncontrollable factors cause illness... but many things are preventable by not smoking, eating decent, and exercising. But if you choose to ignore the anti glutton effect fact, then don't you dare b*tch about "Big Pharma" and "Big Medicine."

Generic drugs help defray the cost pharma drugs which I would hope means lower healthcare costs and health insurance premiums. It certainly doesn't address more investment into preventative care. I would agree with many comments that while NIH helps to fund many pharma drug research projects, pharmaceuticals turn around charge health care providers and patients eye-gouging prices that only aid increasing insurance costs. So pharma basically uses the consumer, hospitals and health insurance companies as its piggy bank. Yet, these same companies cannot charge market rate for their drugs in countries with cost controls like Canada. The same Lipitor drug is sold at dramatically different rates. And what is so bizarre is that our government says it's fine to have two different pricing systems for pharma: the US and everyone else. So our government uses our tax money to finance a drug development system that gouges its own citizens. I understand pharmas use clinical developers that fund their own trials and the cost to bring a drug to market can run into the millions. If the government helps, then that cost to consumers should reflect savings proportionate to the aid. Bioethics aside, prevention is preferable to cure.

Friday, February 1, 2013

Does Alternative Medicines Really Work?


Views are little ambivalent when it comes to alternative medicines. Reason for that is alternative medicine is very broad spectrum. Because of half a dozen varieties it is difficult to understand what really defines alternative medicine.

Alternative medicine or alternative treatment includes herbal remedies, acupressure or puncture, homeopathy, chiropractics etc. So experts classify medicine in two categories, one traditional medicine; second rest. Traditional treatment is evidence based with scientific back ground. Alternative medicine falls into 'rest category'.

One would definitely have got question in their mind on why do alternative medicines work? What is the reason of the success where as it does not have scientifically proven method? Some experts answer these questions with 'Placebo effects'. Placebo is treatment which does not have any effects. In clinical trial placebo concept is used to prove effects of real treatment by comparing results of placebo medicine.

People who oppose alternative medicine give example of recent proven-scam of PowerBalance bracelet. The bracelet was claimed to have increased positive strength and brought balance in one's life. The effects were supposedly caused by so called new holographic technology.

But the product eventually found to be not working when tested. Manufacturer company also confessed to falsifying about the effects of bracelet.

While on other hand, alternative medicine like Homeopathy has been found effective in treating many ailments such as hair loss (less effective than Minoxidil). But nobody has been able to explain its working mechanism. Only fact that has been proven about homeopathy is promising result can be obtained when medicine is administered with extremely diluted form. More dilution more powerful result that too with zero side effects.

Thursday, January 10, 2013

Protein Linked to Heart Failure Identified by Bristol Uni Scientists

Heart patients face many risks of life threatening events such as cardiac arrest, stroke, heart attack and cardiac death etc. Calcium plays vital role in monitoring cells responsible for expansion and contraction of heart muscles. A study conducted by scientists has reportedly identified a protein (or a gene) related to heart movement.

Calcium, present in heart cells, enables heart to circulate blood throughout the body. Abnormal release of calcium in heart cells is believed to be responsible for abnormal heart beats. Ryanodine receptor, also known as RyR, controls release of calcium. RyR is a type of calcium channel which maintains selective permeability of calcium ions. This ensures normal and systematic release of calcium. Irregularity in heartbeats is most commonly found in patients of heart disease.

Scientists at Bristol University conducted an experiment with RyR. As a part of the experiment, researchers took out RyR channels from heart cells and planted in artificial membranes. By doing that scientists could measure calcium currents passing through calcium channel.

Experts believe that the finding of the experiment can pave the way for new and promising treatment for heart patients and ward off deaths cause by heart diseases.

During that experiment two genes (FKBP12 and FKBP12.6) were identified which were found to be changing the flow of calcium ions in RyR channels.

Structure of the two proteins was almost similar but their function was quite opposite to each other’s. FKBP12 raised flow of calcium ions in RyR channels and FKBP12.6 protein hampered FKBP12′s effects. Lost balance between the function of the two genes is found in most of the heart patients.

Wednesday, January 9, 2013

Avastin, a drug for Breast Cancer Patients Found Useful but Restricted


Efficacy of a new drug named Avastin to treat tumors from those suffering from breast cancer at their early stages may get revisited. Avastin is found useful in treating breast cancer.

Avastin is found useful in those who were new to cancer, and as doctors expected it has high efficacy of treating breast cancer. Chemotherapy was done in few women with Avastin plus before they go any surgery. Period of surgery arise, doctors didn’t see any sign any of cancer in them. It was a shocking result for everyone as women doing chemotherapy with Avastin plus were safe than those with only chemo alone.

Regular precautions and research are being made as it not stated that Avastin can continue existence. The drug can also cause harm, said experts.

Virginia Commonwealth University, Dr. Harry Bear commented against Avastin as it is not specified yet that it will lead them in success. More researches are going on.

Avastin got sanctioned in the treatment for advanced breast cancer by the United States, in 2008. Researchers found Avastin is helpless in increasing life’s validity, heart problems, bleeding and many other problems can occur. Till November the government retracted the consent.

The California-based Genentech, the Swiss company Roche is the manufacturer of the Avastin. Since in few countries it is not recommended by doctors but in nations like Europe and Japan it is still practiced by the doctors for treating advance breast cancer and the charges is $10,000 a month.

The sponsorships for study included support from drug companies and National Cancer Institute.
Dr. Gary Lyman, who is a researcher at Duke University and one of the members at panel which retracted Avastin, commented on Avastin’s positive side of outcome through study.

Minckwitz suggested in breast cancer patients more important is healing.

Looking at results Lyman stated, it was found nearly 200,000 women in U.S every year detect breast cancer.

Women who underwent with Avastin their sample tissues would be studied for genes bio markers to check which women are positive toward Avastin which will help researchers in finding more improvement in the drug.

Dr. Sandra Horning Global Development Chief of Cancer Drugs for Roche and Genentech said, the company is not planning to alter drug Avastin until more proofs are accessible.

Wednesday, January 2, 2013

Breastfeeding Lowers Risk of Obese Baby

A study revealed the childhood obesity of a child from a diabetic mother that it can be cured when babies are small by breastfeeding them for continuous 6 months.

An experiment was conducted on those 399 of non diabetic and 94 diabetic mothers from the
time they were pregnant, birth and ended at the age of 13 years, said Epidermiologist Tessa Crume, PH.D., MSPH Childhood obesity is analyzed on BMI i.e. body mass index according to the growth of child through breastfeeding.

Dr Crume also highlighted about the time immediately after birth in elaborating the danger of obesity and pregnancy at early stage in toddler life. Women are regularly checked by the doctors, when babies are in mother’s womb the doctors take care of the nutrition level in them and analyze that if it would affect child with obesity.

BMI of infants whose mother is a diabetic patient and fed her child less than six months of time, is BMI recorded slow than those who breast-fed their child full six months.

The Academy of Pediatrics suggested mother’s in order to increase the BMI growth, experts told them to breastfeed their children for regular six months to cut down the chances of childhood obesity and metabolic diseases. Crume explained children who were having chances of getting diabetes or obesity when they were in the womb are more prone to childhood obesity and metabolic disease.

Crume also continued in order to cut down the chances of childhood obesity and to maintain public health Breast-feeding is a must.

The study would encourage the pregnant mother to breastfed their children’s and more importantly to those mother’s who are suffering from diabetes. It is printed in the International Journal of Obesity.
read more at http://www.nature.com/ijo/journal/v28/n10/abs/0802758a.html

Thursday, December 27, 2012

GLP-1R Agonists May Help Weight Loss, New Study Reavels

University of Copenhagen scientists have come up with a study that shows Glucagon-like peptide-1 receptor (GLP-1R) agonists can be used to aid in weight loss.

The study was undertaken by university scientists in that adult participants with BODY MASS INDEX (BMI) of 25 or more and not having diabetes mellitus were examined. They were also exposed to drugs like exenatide twice in day and once in a week. Diabetes drugs such as liraglutide were also given daily at clinically applicable doses for the duration of 20 weeks. These drugs that were given to the participants come under the class of GLP-1R agonists. Oral antidiabetic drugs, placebo and insulin are given to the control group.

The study covered broad range of trials, almost 25 of them. The group which was exposed to GLP-IR agonists saw a huge contrast in their weight as compared to the control set of group. Both diabetic and non-diabetic participants showed this effect. The study came out with the conclusion that GLP-1R agonists helps towards improving diastolic, plasma collections of cholesterol, systolic blood pressure a glycaemic regulation. But does not have any effect on plasma concentrations found in liver enzymes.

Scientists also cautioned that GLP-1R agonists have some side-effects like vomiting, nausea and diarrhea. Drug did not develop hypo-glycaemia. So at last the team concluded that GLP-1R if consumed have great effect in attaining weight loss to obese patients having diabetes or not.
The study is available in BRITISH Medical Journal.

Tuesday, December 25, 2012

For Diet Pills, Drug Companies Want Explicit Approval Rules

Industry experts from U.S see possibility that pharmaceutical companies may halt investing for medicines indicated for the treatment of diseases such as diabetes drugs or weight loss pills.

The reason for that is believed to be lack of precise approval guidelines for medicines. Any product with therapeutic effects has to earn FDA approval before getting in market. Drug manufacturers are confused about how FDA inspects risk factors associated with medicine.

Focus of drug companies is likely to shift to other drugs, such as cancer drugs, where life-saving management is assured in case of severe side effects. The Food and Drug Administration is looking forward to address the concern.

Mr. Christopher Viehbacher, chairman of Pharmaceutical Research and Manufacturers of America (PhRMA), believes that there should be clear methods or guidelines which are being used by FDA so that manufacturer can predict the outcome before investing in production.

Pharma drug companies are preparing strategy for coming Congressional hearing on FDA user fee act. User fee is the fee manufacturer companies pay for faster review of their product by FDA.

Renewal is required from Congress for Prescription Drug User Fee Act (PDUFA) every 5 years. Current fee structure is due to expire on September 2012.

Recently several weight loss pills have been denied approval by Food and Drug Administration. There are many weight loss pills, such as Acomplia. Review panel sensed that obesity drugs by Arena Pharmaceuticals, Orexigen Therapeutics and vivus have approval barrier for diet pills because of safety reasons.

In United States around 70% of the population is over weight and medicines will help weight control along with regime and workouts.

Patient’s well-being and safety are the concern of Food and Drug Department which Mr Viehbacher agrees on.

Tuesday, May 1, 2012

Replacement For Viagra is Stendra, FDA Approves Stendra

FDA has approved new erectile dysfunction drug developed by Vivus. The drug has been named as Stendra.

With this development, Vivus has finally managed to get first approval for its product. The approval came in time when patent of Viagra is about to expire. Stendra is expected to be replacement for Viagra. The drug manufacturer is also hoping approval for its weight loss drug called Qnexa which is in reviewal process.

Stendra is brand name of Avanafil. Earlier we had reported development of Avanafil, and the drug has got approvalfrom FDA. Currently there are three FDA approved erectile dysfunction drug treatments namely, Viagra; Cialis; Levitra. Generic Viagra is most popular drug. Being top popular drug, pharmaceutical companies were competing to take place of Viagra when its patent expires.

What is Erectile Dysfunction?

Erectile Dysfunction is a disorder characterised as a man is unable to get erection or maintain erection or erection is not rigid enough for sexual intercourse. FDA estimates around 30 million suffering by erectile dysfunction caused by various reasons.

How Stendra Works?


Like other drugs, Stendra also works by increasing blood flow in penis which eventually results in erected penis.

How To Take Stendra for Best Effect?


Stendra is recommended to take half an hour before intercourse. Medical experts have seen Stendra producing effect within fifteen minutes. The time of action is maximum and can be less for other patients. Stendra is thus the fastest acting erectile dysfunction drug.

Stendra Side Effects


FDA has strictly advised patients not to take Stendra if patient is taking nitrate drug. Stendra is contraindicated to nitrate drugs and may lower blood pressure. Side effects reported by FDA are vision problem. Since Stendra is also PDE5 inhibitor drug it can cause vision loss in single or both eyes. Hearing problem is another side effect likely to develop in some patients.

Headache, nasal congstion, redness at several parts of body and back pain are common side effects observed by FDA review panel.

Wednesday, April 18, 2012

Erectile Dysfunction Indicates Future Heart Disease

A research study has confirmed Vasculogenic ED as marker for future cardiovascular disease. Presence of Vasculogenic indicates that a person is going to have heart disease.

Many earlier studies have established close link between erectile dysfunction and cardiovascular disease but failed to explain how exactly. The latest one has provided confirm proof that a biological marker is something that is responsible for heart diseases in patients who are suffering from erectile dysfunction.

Lead researcher of the study, Dr Kew Kim Chew says, the study has provided pathological evidence of connection on how atherosclerosis develops from endothelial dysfunction. Dr Chew is physician and senior clinical researcher at Keogh Institute for Medical Research.

Endothelial dysfunction is pathological status of membrane lining inside blood vessels. It is the status basically means imbalance in contraction and widening of blood vessels.

In both erectile dysfunction and cardiovascular disease, dysfunction of endothelium is caused by higher concentration of biomarkers (such as cytokines interleukin-6, interleukin-8 and 18) in plasma. Also high level of C-reactive proteins has also been noticed in both the condictions.

This way erectile dysfunction deomnstrates vascular disease in penile muscles. That is the reason that ED medicines such as viagra helps in heart diseases also.

Although ED may get developed because of psychological (anxiety, stress and depression) and neurological disorders, vascular disorder is more common cause. Vascular cause in more observed in young adults with liklihood of developing heart disease in future.

Thursday, March 29, 2012

Counseling Needed for Women on Fertility After Cancer Treatment Chemotherapy

A research study found that not all young women, who receive cancer treatment, taking precocious measures to preserve fertility. Study found very few women take counseling on presevin fertility after cancer treatment.



Different perceptions were seen in different groups of young women. Some women take measures such as eggs freezing or preserving embryo, says Dr Mitchell Rosen - lead researcher at University of California, San Francisco (UCSF).



Researchers suggest, in a study published in Cancer Journal, to educate reproductive-age-women on various fertility preservation methods.



Number of young women seeking counseling has increased yet, number is still large of women not aware of protecting their fertility during cancer treatment.

Rate of survival of cancer diagnosed women has improved, but quality of life following treatment remains in question. 120,000 women are diagnosed in US every year.



There are many side effects of cancer therapy, particularly chemotherapy. One of the side effects is female patient may lose fertility and reduce chances of getting pregnant again. Change in menopause may also affect fertility.



In order ot be able to have kids later, storing freezed embryo or eggs is best bet for women who have not yet received or started cancer treatment after being diagnosed.

Cancer suffering women of age between 18 to 40, were surveyed to determine which women are utilizing fertility preservation method.

Tuesday, January 31, 2012

Antidepressants risks Pregnancy, serious take

A British Medical journal complained that pregnant women taking paroxetine (Paxil), Fluxetine (Prozac) and sertraline (Zoloft) which are the different forms of serotonin could possibly double the chances of PPHN persistent pulmonary hypertension in the newly born infants.

The search resulted in cautionary advice from FDA in 2006, which actively intellectually advised pregnant women to avoid SSRIs depression medications.

As PPHN effects in right ventricle of heart which helps in pumping the blood can cause in heart failure and heart infirmity.

It is noted that Pulmonary Hypertension is caused in newly born at the rate of 1 in 1,000 by taking antidepressants after women’s half duration of pregnancy.

In the first instance, it is found that not only mothers who took antidepressants themselves are at danger but also mothers who are suffering from other health problems such as asthma, diabetic, obese are also at risks. Mothers undergone with Cesarean section are also at warnings. Mothers undergone with all these are more likely to use antidepressants.

Pulmonary Hypertension could be cause due to intake of antidepressants. The distinctive are reference to warnings.

Looking forward to another study, being medicated psychiatrically former to pregnancy could
proliferate the chances of pulmonary hypertension to newborns, taking antidepressants before
pregnancy it did or did not affected mothers. That risk of depression in mothers causing pulmonary hypertension in infants.

Stopping antidepressants while pregnancy going on, would lead in isolation influences to women and her unborn offspring.

Peace of suggestions given to women such as, avoid using antidepressants, if needed in any case consult a physician or opt. for psychotherapy. Transcranial Magnetic Stimulation (rTMS) helps in treating depression through magnetic pulses carried from head which helps in contraindications in pregnancy.

Stopping antidepressants in between unexpectedly, would result in severe abnormality in fetuses. Concluding it is believed psychiatrists are treating well patients with depression and
wanting to have child.

Tuesday, January 17, 2012

Probiotic Pills Leads May Cure Food Borne Diseases

Purdue University scientists found that Probiotic will lower the risk for Listeria infections to people from vulnerable immune systems. Probiotic have properties to deal with vulnerable immune systems. Reformed Probiotic or beneficial bacteria are popular for the positive effects on digestive system.

Convulsions takes place when listeria reaches the nervous system. Listeria when pass in to bloodstream, small amount of it obviously results in fever, nausea, diarrhea, headaches, confusions, stiff neck and muscles aches. Abortion or stillbirth roots to infections in pregnant women. A study also says that, listeria a
protein helps authorize in circulation of bacteria from intestinal cells to blood, that delay the penetration process combined probiotics.

Professor of Food Science Arun Bhunia allude that it seems to be hopefully an important reduction of listeria infection

Listeria Adhesion Protein when influence with Lactobacillus paracasei, the listeria when attack intestine, it gets reduced by 46%. Tha fall in proportion of bacteria is noted as sufficient, in case of preventing a person from susceptible immunity. When mixture of Probiotic and protein interacts with heat shock protein at surface of intestinal cells due to which the Probiotic gets attached with cells and a mass of listeria breakouts.

The journal, PloS One stated that the increase of pill or Probiotic drink will cause to listeria disorder in patients. Hence, listeria is not attached to a specific place but it did not attack intestinal cells.

Monday, December 26, 2011

Berlin heart pump for weak hearted kids gets FDA nod


It happens more that doctors are unable to find a donor for children suffering from heart ailments and it is tough to pull on in the same manner. However, the million dollar question is it possible that the patients may survive until they get a life saver? In efforts to help kids under such an unfortunate situation the Food and Drug Administration (FDA) department of the USA has approved a new medical device which helps in the proper functioning of the dysfunctional heart. This device is named as EXCOR Pediatric system is a finding of the Berlin Heart in Germany and is a mechanical pulsatile cardiac assisting instrument. The device is usage for all the children falling in various age groups from the newborns to the teenagers.

An expert from the FDA authority said that this is the initial step towards treating the young children as previously it was very tough to use the huge adult mechanisms for the same purpose in case of seriously ill children. Talking of the device the expert further said that it comprises of 1 to 2 blood pumps that work by air from the exteriors along with the many tubes that hook the pump to the heart chambers. The studies conducted had 48 patients who underwent the treatment of the device and results were found to be truly remarkable.

The EXCOR Pediatric system already has the approval from the Humanitarian Device Exemption (HDE) team. The promoters are allowed to promote the health device in the market as it is a complete FDA approved product however; they have to abide by some of the restrictions that have been laid by the former body.

Friday, September 30, 2011

FDA has approved 1st biologic medication for children with ulcerative colitis (UC)

The U.S. Food and Drug Administration (FDA) has approved Remicade (infliximab) to moderately treat the vigorous ulcerative colitis (UC) in patients younger than six years, and have a insufficient reaction to the unconventional therapy.

There are around 1.4 millions of Americans adults and kids living with inflammatory bowel disease (IBD). Its is said that they are split between ulcerative colitis (UC) and Crohn’s disease. Predictably there are 150000 children below the age of 17 who are living with the symptoms of inflammatory bowel disease (IBD).

Ulcerative colitis (UC) is a kind of inflammatory bowel disease (IBD) that distress the inside layer of the large intestine (colon) and rectum and the cause of ulcerative colitis (UC) is still unidentified. Ulcerative colitis (UC) can affect people for all age group, even thought it is high to be affect at the age of 15-30.

Earlier there was no approved therapy for ulcerative colitis (UC) which is a distressing disease and had an insufficient respond to this conventional therapy. Due to this approval, Remicade (infliximab) represents an unconventional treatment in treating children suffering from inflammatory bowel disease (IBD).

Remicade (infliximab) permit is supported by the proof from a sufficient and well controlled study in young ones suffering from ulcerative colitis (UC). Treating ulcerative colitis (UC) with infliximab, strength 5 mg/kg has clinically responded to the patients in 8 weeks and established a safe profile, with a clinical examination carried out in adults as well.

In small kids all the vaccines should be up to date prior to initiating the medication with infliximab and should avoid receive vaccination while treating with infliximab. Few of the most frequent side effects of infliximab is worsening of ulcerative colitis (UC), respiratory infections, and headache.

Wednesday, September 21, 2011

New measures to prevent and cure TB and save HIV patients

Tuberculosis (TB) a contagious disease that spreads from one person to another, while the infectious person cough, spits, or sneeze this caused the germs to spread in air. Only a few inhaled germs of can infect you and attack your lungs. Researcher says antibiotic drugs if taken as schedule could help prevent it completely. Tuberculosis affects millions of people around the world, infected with the bacterium which causes Tuberculosis (TB), particularly those who are already infected by HIV.

Tuberculosis (TB) can be a cause for death amongst the individuals, co-infected with HIV, the AIDS virus. Nearly 400,000 people die every year of HIV-related Tuberculosis (TB), as per the TB Partnership, pointed out some measures to cure and prevent TB that will save the life of millions people suffering with HIV/AIDS globally by 2015.

TB rapidly growing in europe

To provide with an essential TB and HIV care the five new scientific models are introduced. At United Nations Headquarters it was launched to take wise steps to prevent and cure tuberculosis amongst individuals affect with HIV virus globally. The steps will also include testing for TB and HIV in every 3 years. In the case where both the disease is common both the test will be carried out prominently. Further steps will include, ensuring weather both TB and HIV treatments are available and are of excellent quality.

The joint venture of “Stop TB” and “United Nations Programme on HIV/AIDS (UNAIDS)” , in 2010 has set a joint goal to reduce the number of death rates of the people suffering from HIV to half by the end of 2015.

Monday, September 12, 2011

FDA Accord with Drug makers Raises User Fees 6% to Renew Law

Drug manufacturers Pfizer Inc. and Eli Lilly & Co. have agreed with regulators on increasing 6% fees, as a part of their reauthorizing drug-approval process through financial year 2017. This accord has disclosed in parts on September 1st. The law will expire on Sept.30, 2012, so it must be approved before the given date.

The increased fees are likely to put in $40.4 million, revenue for the financial year 2012 and bringing the revenue toward $712.8 million by the year 2013.

The accord should permit more time to access for new safe and effective medicine. According to FDA, the agreement includes extra review time for the organization to fit in the extra meetings, by extending the for reviews after submitting applications to 8-months from 6-months, and 10-months to 12-months.

The FDA and the manufactures have agreed to set up the advisory panels and giving companies the time to collect the required data, in accordance to the agreement.

Agreement will also include a 3rd party review; weather FDA is meeting all the drug-evaluating goals, according to the agreement. In 2007, user fees were reauthorized; Congress gave FDA new responsibilities, which grounds the organization to slow its evaluating process.

The agreement will also help to bring back Food and Drug Administration's review performance.

New York-based Eli Lilly and Pfizer have been discussing with the Food and Drug Administration for a user-fee renewal process ever since July 2010. Medical-device Company New Brunswick based Johnson & Johnson is in different talks on fees that they pay the agency for product reviews. Device industry discarded the agency's proposal for paying more than double fees.

Tuesday, September 6, 2011

Erectile Dysfunction Drugs Safer for Diabetics- Says Report

Erectile dysfunction is a problem that has devastated the conditions of many. The disease is such that there are drugs to fight it (viagra, cialis or Kamagra), but these drugs end up leaving several side effects in the body. There are mild speculations that do the round that erectile dysfunction drugs have ill effects on patients with diabetics. However, a recent study has shown that ED drugs are safe for diabetic patients. This study has been really beneficial for several people with diabetics and for doctors who have been reluctant to prescribe diabetes medicines to patients.

Dr Moshe Vardi, M.D., with the internal medicine division at Lady Davis Carmel Medical Center in Israel said that observation has not come as surprise to them but provides support to the notion that this class of drug is efficient and secure for a specific class of people. The medications that are available are considered the basis of treatment for erectile dysfunction for the general populace. However, patients with diabetes are more likely to variations in the results of these drugs as they have various complications and the process of their erectile dysfunction are multifactorial, thus making their treatment a almost a challenge for physicians and health care professionals.

An international organization called The Cochrane Collaboration conducted a research that included the around 1,700 men who had diabetes. The men varied in age, ethnicity and weight. After the 12 week study it was found that about 30 percent of men were reported with massive improvement in their sex life and no reported were found that had any type of complications related to diabetes.

Wednesday, August 10, 2011

FDA to Cancel License Indication of Bevacizumab

Genentech has a new proposal for keeping its licensed indication for bevacizumab (Avastin) in breast cancer.

Genentech has come up with a proposal to maintain license of its medicine Bevancizumab. Genentech wants FDA to maintain breast cancer as licensed indication of Bevancizumab. The drug is brand named as Avastin and is used in treatment of cancer (Metastatic Colorectal Cancer).

US FDA is mulling to cancel the license of the drug for usage in breast cancer treatment. Commissioner of FDA is yet to confirm it.

Despite manufacturer's efforts to convince review team not to revoke the license, members of drug review panel has voted against use of the drug in breast cancer.

In meeting, company addressed many concerns which were expressed by members of panel. Genentech argued that patients suffering from metastatic disease had fewer approved treatments. Manufacturer claimed, in documentation submitted to FDA, Bevacizumab has been found very effective when administered with paclitaxel in patients who are suffering from severe form of metastatic.

With these facts company advocated fast approval of bevacizumab plus paclitaxel subject to supporting research and change in labeled usage if risk factors are addressed.

Genentech sought revised labeling and change in indication of the drug Bevacizumab. According to new proposal, the drug remains in metastatic breast cancer but its usage would be limited in women with severe type of breast cancer such as severe hormone receptor positive breast cancer or triple negative cancer.

Monday, July 18, 2011

Under Trial Chemotherapy Drug Gets Positive Response by FDA

For a targeted treatment, developed by Seattle Genetics is in trial and the company is seeking for approval with conditions. FDA has asked monitoring committee for more clinical trial data that would back the conditional approval.

FDA on Tuesday issued documents to be considered by advisory committee in the wake of company's conclusion inferred from clinical trials. No major-safety concerns were raised in documents.

The under-trial drug is brentiximab vodotin with given Adcentris as brand name. Brentiximab is indicated to treat lymphom, a type of cancer which has not responded other available treatments. The drug is believed to be effective for treatment of Hodgkin and anaplastic lymphoma by increasing effects minimizing side effects of chemotherapy. It is co-developed with japan's pharmaceutical company.

The proposed cancer treatment drug is being reviewed by cancer drugs panel of FDA. Panel also includes some non-FDA medical personnel. FDA has asked the panel to vote on whether it can approve the drug or not.

Final decision is likely to come out in August. FDA is free to take or not to take advice from the panel.

Effect of positive notion from FDA can directly be seen on stock value of the company. Shares of Seattle Genetics have risen sixty two percent in a year.

Market experts took the released documents positive as no major concerns were there which may prevent the approval. However, company woun't be able to cash in on its product if the drug is approved for Hodgkin lymphoma only.

Estimated annual sales for the drug could be between $450-$500 million.