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.

Rivaroxaben approved by the FDA as the new anticoagulant medication

With the inception of Rivaroxaban, there are surely more hopes for an effectual medication to treat Atrial Fibrillation. While there are not many heart medications other than Coumadin, this oral medication is being welcomed by one and all. Infact, National Blood Clot Alliance (NBCA) is also pleased and is looking forward for the response of the people.

The abnormal rhythm of the heartbeat is Atrial Fibrillation where the two upper chambers of the heart contract and start beating. This irregular heartbeat can make one prone to severe problems without undergoing treatment. One must immediately opt for some sort of medication to take care of the same.

Like every other anticoagulant, Rivaroxaben is also known to cause this adverse effect of making one prone to bleeding. However the other good aspect that we have to consider is that one has less chances of being susceptible to bleeding in the brain as compared to the other medications like Coumadin. This can surely gain this medication the inclination from the consumer’s side.

With around 2.6 million people in USA alone are reported to be suffering from AFib, we surely need a skilled medication to treat the same as soon as possible. Besides, this rate is going to rise higher is what the health experts say. Around 2050, there might be around 12 million people suffering from the same which is many times higher. In the last two years, Rivoroxaben remains the second anticoagulant to be accepted and approved by the FDA (Food And Drug Administration).

Besides there is still loads of studies and researches that are being carried out for blood thinners that can treat these blood clot problems in one’s leg and lungs.

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.