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.

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.

FDA Proposes New Rule for Targeted Treatment

As per new policy, targeted therapies seeking for FDA approval would also require approval for devices the therapy is performed with.

Pharma companies are developing more targeted treatments designed according to patients' genetic structure. Manufacturers of such treatments would have to get the device reviewed if the new proposed amendment come into effect.

Before giving approval to the medicine/therapy, FDA wants to test the device used in therapies. With that being said, therapy as well as device both would require clearance certificate from FDA.

Medicines that are targeted for specific patients only, are prescribed after a diagnostic test. Efficacy of the treatment is determined by studying genetic structure of a patient. After a thorough study physicians determine whether the therapy is fit to the patient or not. Such pre-tests are known as companion diagnostics (or targeted medicines).

One such drug in review is lung cancer drug Crizotinib of Pfizer. This drug targets genetic mutaion found in non-smokers with lung cancer of type NSCLC. Pre-test for the drug has been developed by Abbott.

However, new proposed rule has two exceptional situations where a medicine and its companion test can get approval without FDA. Medicine and its diagnostic test may get auto-approval either a disease is life threatening and no other treatment is found or benefits of the treatment is far more than the risk.

Testosterone Gel by Teva Nears Approval

Bio-T-gel is the new gel that claims to treat Hypogonadism and is set on to pass the last stage of clinical trials for the approval of FDA (Food And Drug Administration).

This testosterone gel ash already passed the entire previous test and is supposed to clear the last stage which has to be done before November 2011. Manufactured by BioSante Pharmaceuticals and later passed to Teva pharmaceuticals, it is gearing up for further process. Testosterone is what makes men. It is what offers the men his masculine characteristics. The deepening of voice and the muscles that he flaunts is all because of testosterone. When testosterone is lower than 300 nanograms per deciliter of blood, it is considered to be a sign of low testosterone level in your body. With over 1.2 $ billion of market share in the testosterone industry, it has further scope to grow. Also with around 4-5 million men being affected by low testosterone levels, they surely need more of such treatment. Also Teva is completely confident and optimistic about their results. Stepehn Simes who is the CEO and President of this company has been excited and is working on the further steps. Low testosterone can further lead to other sexual problems like erectile dysfunction, depression, stress etc.

So a new gel in this field can only be considered to be a blessing.

For the first time FDA approves a drug for treating Melanoma

Till this date the pharmacy and medical science have failed in delivering a medication that could cure Melanoma. Whatever drug was presented to treat this disorder, it was seen that they were somewhere below the standards of FDA (Food And Drug Administration). Dr. Richard Pazdur who is the director of the Office of Oncology products for drug evaluation and research in the department of the FDA (Food And Drug Administration). On the other hand, Melanoma is posing an increasing threat. The latest statistics reveal that Melanoma is rising since 2010. Especially in U.S around 8300 men have died due to this disorder. This research was carried out by the National Cancer Institute. Melanoma is fatal and can the last stage of this can be extremely dangerous as there are hardly any medication capable of treating it. By proving to be the first FDA approved drug to treat Melanoma effectively, this medication has truly won hearts of many. Here the melanoma tumors are attacked skillfully. To check its effectiveness, there was an international study conducted where around 676 patients were studied. The conclusion of the research clearly stated that Yervoy could surely postpone the threat caused by Melanoma when taken in combination with other therapy. However there might be adverse effects associated with this disorder that has to be made aware to the patients who might consume this drug. For this purpose, there will be a guide that will talk about all the necessary facts that the consumer has to be made aware of before the ingestion.