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.

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.

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.

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.

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.

Senators Seek Change in FDA's Interest Conflict Rule

A vital amendment is on way. US senators are about to bring change in rule for advisers involve in reviewing new drug approvals. This is because there were lots of cases when FDA could not find experts because of conflicts of interest.

Lawmakers want FDA to loose regulations according to which advisers are not allowed to review new drug application if the respective person is financially associated with manufacturers. Current regulation makes it hard to find experts to be hired on review panel.

FDA is largely funded by fees taken from manufacturer of drug who are seeking FDA approval to make drug available in market. Hence, FDA's funding bill is a way to make major changes in the way FDA work.

Issue was raised by Mike Enzi and Al Franken, senators from Republican and Democratic party respectively.

FDA has to postpone meeting of drug-review committee while finding adviser without any conflicts. Expert doctors are already recruited by manufacturers as consultant and rule prevents FDA to hire same doctor in advisory panel.

FDA in May reported 23% vacant position in advisory panel.

Although FDA is free to avoid recommendations from advisor, it usually follows.

In the wake of Vioxx pain drug controversy, FDA made regulatory changes which restricted appointment of a person with financial ties fearing impact on one's view.

There are currently 10 panelists in FDA advisory panel who were also consulted by drug manufacturers. 9 panelists recommended bringing a drug in market which was called back in 2004.

Hamburg, FDA Commissioner, is also in favour of relaxed rule.

Double Diabetes

What is Double Diabetes?

Recently a report is on rife about a study shows that more and more people are developing signs of double diabetes. Double diabetes is more complicated and difficult to handle than its both predecessors. Patient with symptoms of both type 1 and type 2 diabetes is known as patient of double diabetes.

Type 1 diabetes

Type 1 diabetes occurs when body cannot produce enough insulin. Since insulin is important protein which helps body cells to utilize glucose, lack of insulin causes high sugar level. Patient is needed to gain insulin by injection so that glucose (sugar) can be utilized properly. Some symptoms of type 1 diabetes include extreme thirst, weight loss and more frequent urination than usual. Double diabetes was usually seen in children and young adults, but now it is found in adults also.

Type 2 diabetes

A person with type 2 diabetes may feel tired all the time and lack of energy. This is because human body cells are not able to use the energy of glucose in body. This is called insulin resistance. Type 2 diabetes tends to run in families. Some of the symptoms of diabetes type 2 include urination at unusual intervals, being hungry more often, unusual lose/gain weight, frequent headaches. Diabetes type 2 if left untreated can lead to other problems of kidneys, eyes, heart, nerves and may give you a higher risk of heart attack or stroke within a year or two. Research has shown that when a person with diabetes type 1 gains weight is more likely to develop diabetes type 2. This put that pateint into the category of double diabetes.

Treating Double Diabetes

Double diabetes treatment is complicated as a patient have to deal with issues of type 1 and type 2 diabetes at the same time. Researchers believe that if weight-gain is brought under control, teatment of double diabets becomes much more easy. Until now, treatments include dietary change to one that includes less carbohydrate and more vegetables and nuts containing good fats that your body needs to be healthy.
Along with good diet a person is recommended to use medicinal treatment, insulin injection or generic pill of Glucophage diabetes medication to enable body to use insulin, is by far the best known treatment to cure diabetes type 1 and double diabetes. At this juncture, double diabetes is quiet new to medical world. Researchers assumes that double diabetes will be a great medical challenge in upcoming years, same time human body is highly vulnerable against double diabetes. Double diabetes can occur at any age, to look for signs in children and in adults.