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.