Depomed May Lose Exclusive Rigths on Gralise

Actavis Group has notified Depomed Inc regarding approval from FDA to market generic version of Gralise. Depomed has confirmed the notification. Gralise is once a day pain reliever rx medicine. Depomed possesses exclusive patent rights for Gralise. Approval of Gralise generic version may be trouble for Depomed.

Stock price of Depomed reacted with sharp 3.5% down, though, daily stock price were up by 22%.

However, chief executive of company is confident to retain exclusive marketing rights of popular orphan drug.

As per the law, Depomed now has 45 days to object approval for generic of Gralise. Company can prevent FDA to approve generic version for another 30 months if approval is in violation of patent law.

The company rejected some of the claims by Actavis as invalid or unenforceable when it is about infringement of Gralise patent.

Gralise is pain killer medicine to treat long-lasting pain such as postherpetic neuralgia. Other pain reliever medicine like generic Celebrex can treat short term pain. It works with unique delivery system which relieves pain for longer duration.

Another drug for which Depomed enjoys exclusive rights is Glumetza. It is type 2 diabetes medicine.

Human Clinical Trails To Bears With Omni Bio

Omni Bio Pharmaceutical Inc. a clinical-stage biopharmaceutical company, declared the idea of commencing new human clinical trails to test the ability of Alpha-1 antitrypsin (AAT) for the medication of Type 1 diabetes and Graft Versus Host Disease (GVHD).

Experiment at Omni Bio aimed at placebo-controlled Type 1 diabetes in anticipating clinical trial to analyze on young subjects. The company intends the principle human clinical trail as the treatment of lethal impediment of bone marrow transplantation, which is also called as GVHD. To fund these trails the company will have to arrange funds but it is not guaranteed that it will be successful in case to raise investments.

Barbara Davis Center for Childhood Diabetes concluded with a new Type 1 diabetes trail that builds on initial research from latest full proof of principle Type 1 diabetes was successful, said Dr. James Crapo, Omni Bio’s Chief Executive Officer.

Preventing of GVHD has associated with the treatment of Type 1 diabetes as both are safe disease. AAT treatment GVHD assured in animal models.

Study: Drugs from Credentialed Online Pharmacy are of Good Quality

Wall Street Journal has reviewed several documents which indicted two canadian citizens involved in importing fake breast cancer drug in U.S. This event has sparked debate on authenticity of generic drug bought from online pharmacies. Millions of Americans buy prescription generic drugs online to cut drug cost.

A latest research study by Roger Bate concluded that generics from internet pharmacies are of good quality if purchased from credentialed pharmacies. Mr Bate is lead author of the study who also happens to be influential expert on pharmaceutical counterfeiting at American Enterprise Institute.

A research study of 370 brand drugs ordered from online pharmacies concluded that Viagra purchased by Americans were not real Viagra, however, medicines were found to be authentic when credentialed by several organizations.

This led to author believed that such websites are sometimes, if not all the time, selling medicines of good quality.

FDA and pharmaceutical gianst are increasingly concerned on counterfeit drugs, they have warned againts purchasing poor quality drugs from online pharmacy saying that may put one's health at risk. The study result contradicts their concerns.

Groups who oppose online pharmacies cite several reasons to convince consumers not to order from online pharmacies. Some of the reasons are; pharmacies get away with your credit card details, buying without prescription is illegal, they don't ask for prescriptions.

Another study conducted in 2007 found only 6 percent patients buy medicines with prescriptions. But that seems to be another point that patients go for internet pharmacies.

Higher Drug Cost for Residents of Newfoundland and Labrador

New change in drug policy in one of the Canadian provinces is likely to cause trouble for both consumers and pharmacies. Prescription drug cost would increase for patients who rely on drug program by government. On the other hand pharmacies would earn less, according to proposed amendment in Pharmaceutical Services Act of Newfoundland.

Government is considering bringing changes in an act of drug price policy.

Former health minister of the province had assured, in a press note released by government in july of 2011, new changes would bring down the generic drug cost and no changes in drug price policy which eventually raise cost of medicines.

Patients who are on government's drug plan would have to pay the difference between the cost of brand drug and generic drug; if new the act is amended with proposed changes.

Consumers and Pharmacy Store Owners Concerned

Pharmacy and chemist shop owner are not happy with new amendment as it would significantly affect their revenue.

Policy makers argue that saving millions of dollars annually is the only intention of government. The act with changes would enable government to pay reasonable price for generic equivalent drugs.

Wade Locke, an economist at Memorial University, has been hired by independent pharmacists to study and figure out how exactly the amended act going to affect all the involved parties i.e. gov, pharmacies and patients.

Merck's New Anti-Platelet Drug Produce Mixed Result

A new antiplatelet drug has shown significant ability to prevent blood clots. However, the drug also caused abnormal bleeding in clinical trial. Merck & Co is testing the drug in a trial which is believed to be largest drug trial conducted for any heart medicine so far.

The manufacturer company is seeking approval for Vorapaxar drug since last year. But the approval is denied because of bleeding caused by the drug in patients with history of stroke. Submitted data of the study included 26,449 participants.

Merck has been asked to stop the trial on patients who had stroke in recent past and, allowed to continue trial on heart attack patients who are in stable condition at present. Vorapaxar is currently being tested on patients who have recently been diagnosed with clogged leg arteries.

Latest trial data published by drug maker last month showed significant reduction in forming of blood clots, while on the other hand, it caused excessive bleeding. Experts are inconclusive whether the company would apply for approval. A trial named TRACER for same drug had failed too. It is also not clear whether Merck would conduct another trial on heart attack patients only.

Despite drug maker is quite happy with trial result, experts see very less possibility for approval. Drug usage will be limited to small group even if Vorapaxar succeeds to get approval.

BEST FOR HEART ATTACK PATIENTS

Researchers involved in trial claimed that after 30 months administered Vorapaxar met goal when it's effects were compared with other popular antiplatelet drug such as Plavix and Aspirin. In fact Vorapaxar reduced the risk of stroke, heart attack and cardiovascular diseases by 13% when compared with its other counterparts in market.


In past several decades Vorapaxar is first new antiplatelet drug which provides long time protection for to patients with history of heart attack, says Dr. David Morrow - lead researcher of the trial.

Teva Loses Battle to Pfizer, Succeed Patent Challenge

Teva Pharmaceutical Industries gave a tough fight to protect the patent of the best- sold drug in the market. Teva Pharmaceutical Industries has lost the challenge, as they are not permitted to market the generic version of the Viagra.

As Pfizer Pharma has won the legal battle, and can retain the patent rights of the most blockbuster drug, that cures male impotent, called as Viagra. The major drug used for the preparation of Viagra is Slidenafil Citrate. Teva Pharmaceutical Industries will not be allowed to market the generic version of this medicine till October, 2019, by order.

As Pfizer Pharma, continues to carry on with the exclusive right into producing and marketing Viagra. The management of Pfizer Pharma is extremely content about the fact that the court has understood the necessity and the effectiveness of this drug which is used to treat erectile dysfunction (ED) or male impotent. Pfizer Pharma, also says that court has not only protected their intellectual property rights; but has also protected their patent rights from getting violated in the market.

Teva Pharmaceutical Industries builds a victorious generics industry, standing to test the patents exclusively for the owned drugs. Teva is now finding itself to the other side where they have secured its own owned products. Teva Pharmaceutical Industries has declared that even they are satisfied with the court’s result and are waiting to begin an experiment on September 7, 2011’.

Research based on Generic Drugs, the formation and Key analysis

In Russia and Ukraine, there has been a new study with an objective of researching and analysis information about the Generic Drugs. As they are considered to be a great innovation it is felt there is a need to study and concentrate on this subject.

This new Research named Generic and Innovative Drug Market in Russia and Ukraine 2011 will concentrate on the study and the assessment of the comparative analysis of both Generic and Innovative drugs trends and developments that have been happening in the past few years. Here there is a mutual comparison carried on where their varied attributes are associated and evaluated.

There were varied topics discussed upon. However the significant subjects include identifying the best drugs in the pharmacy industry of Russia and Ukraine, identifying the counterfeit and the fake drugs that are sold as Generics, the name of the key manufacturers over there. The reimbursement and the pricing policies of the generics and the innovative medications will be discussed too. Besides this they would also have to work on their methodology in which the report will be conducted and the synopsis of this study.

The short synopsis included this chief features that includes giving a brief idea about the data and the statistics of the research, the predictions of the future years regarding this industry, policies and programs etc. also there is a need to illustrate the significant points regarding the leading pharmacy industry.

Basically this study might give an enlightening idea about the future prospects of this pharmacy industry.