Dapagliflozin: FDA Wants More Data for Approval

A drug treatment for Cyctic Fibrosis was approved by FDA. The drug was developed after a gene responsible for causing Cycstic Fibrosis was found. The identification of gene has been acomplished after almost 22 years.

Vertex is producer of the drug named as Kalydeco. Cystic fibrosis is caused because of defective gene responsible for decoding a protein known as Cystic Fibrosis Transmembrane Regulator. It is found that the gene is behind 4% cases of cystic fibrosis.

Approval of Kalydeco is believed to be of great significance as all other available treatments in market are only capable to treat symptoms of disease. A press note has been published by USA FDA regarding the approval.

The treatment is approved for patients of age above six and with confirmed G551D mutation. Vertex is quite please as approval came earlier than expected.

Considering rareness of the disease, producer company is contemplating to initiate programs to make the drug available at affordable cost or may be for free. Current estimation of drug cost is $294,000 per year which is near to the cost of other treatment for same disease.

Kalydeco is expected to generate millions of dollars in US market alone. There are 200,000 patients of Cystic Fibrosis in USA.

Recent amendment in FDA approval policy is the reason that the drug was approved with priority in review.
Clinical trial included 213 patients with G551D defect. The pill was administered twice a day in all participants. During trial Kalydeco showed some side effects such as stomachache, headache, infection in respiratory system and diarrhea.

Cystic Fibrosis is serious disease as it decreases life of patients because of thick mucus accumulated in digest tract and lungs. Patient suffering from CF lives upto 36-38 years.

Gel Treatment to Heal Damaged Heart Cells

Scientists at University of California has conducted a trial on a unique gel which would help to heal damaged heart tissues. The gel is hydrogel and can be injected directly to damaged part.

The gel is in trial and may seek FDA approval soon. It is prepared from tissues known as connective tissues. Connective tissue is one of the four basic types of tissue. The tissues used in gel are derived from Decellularized Ventricular Extracellular Matrix of heart. Derived tissues are then transformed into powder by freezing and drying. The powder along with special liquid, is then used to inject in heart.

Formation of new cells is initiated by connective tissues when the liquid consolidates and becomes partly solid. The overall process triggers formation of new cells at the injected area without disturbing functionalityies of heart. This eventually results in replacement of damaged cells with new cells. Apart from healing, the hydrogel also generates signals to stop further damage of the cells.

Other materials, used to heal damaged cells of heart, experimented on mice are suppose to be delivered by syringe or needle. But, none of them were suitable for delivery through catheter as most of the material blocked catheter because of rapid consolidation.

Scientists found, during experiment on rats, the gel very feasible as it was easily accepted by body at body temperature. Unlike other treatment hydrogel did not show side effects such as abnormal heart beats. That way the hydrogel has been concluded as safer.

Dr Karen Christman is one of the authors involved in trial.

The trial result has been demonstrated in Journal of the American Cardiology.

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.

Zioptan, FDA Approved Treatment for Glaucoma

WHITHOUSE STATION – Merck commonly called a MSD in United States told that Food and Drug Administration has given green signal to ZIOPTAN(TM). ZIOPATAN is used in to deduce the effects of elevated intraocular pressure (IOP) in patients with Ocular hypertension. The FDA approved the medication after there was a two year clinical research of almost 905 subjects. The clinical research it was found that ZIOPTAN has IOP lowering effect. Merck has told that ZIOPTAN will be sold to customers till March.

Information about the ZIOPTAN
ZIOPTAN makes alterations in pigmented tissues. The pigmentation has increased in iris pigmentation, periorbital tissue, and eye lashes. The ZIOPTAN should be used with caution with aphakic patients as high risk is involved in it. The further study needs to be done whether pregnant women should be allowed to take ZIOPTAN. The fetus may in any way be in danger due to the use of ZIOPTAN the researchers are dealing with that issue. The pediatric patients are barred to use ZIOPTAN as there is long term implication associated with that kind of patients.

Recommended Usage of ZIOPTAN
The recommended dosage is one drop of ZIOPTAN in conjunctival sac of eye of patients daily in the evening.

Agreement among Merck and Santen It was on 15, April, 2009 that both the pharmacy company collaborated together for Tafluprost. Merck has commercial rights in North America, South Africa, Western Europe, Middle East, Australia and many more area around the world. The Santen handles the market in places like Germany, countries of Asia Pacific, Northern Europe and many more.

Information regarding Merck and Santen
The Merck is a huge world wide healthcare company. The Merck works with more than 140 countries to give them health solutions. The Santen Is a pharmacy company which has its base in Osaka and works in fields ophthalmic, eyesight, and health.

FDA Approves Once a Week Type 2 Diabetes Drug

An application was filed for approval for its weekly diabetes medicine named as Bydureon, a product of Amylin Pharmaceuticals.

Finally FDA has approved the drug. Bydureon is type 2 Diabetes drug to be taken once a week.

Unlike other diabetes drugs such as generic Actos, generic Amaryl and generic Avandia, Bydureon is in injection diabetes medicine. A manufacturing division located at 8814 Trade Port Drive will be producing these injections.

Amylin announced about the approval given on 27th January by FDA. Company has planned to launch the drug in February 2012. Diabetes patients can expect to see the drug in pharmacies in mid February 2012.

Bydureon (exenatide) is receptor agonist for glucagon-like peptide-1 (GLP-1) which improves glycemic control in type 2 diabetes patients. Efficacy of Bydureon is said to be best when administered with proper diet and exercise. Diabetes Medicines

Amylin first launched its manufacturing plant in 2009 and for Bydureon it received, along with other companies such as Lilly and Alkemes, response letter from FDA on April 23 2010. By the time US FDA approves the drug, Amylin launched the drug in Europe Commission which got approval in 2011. Bydureon is also in approval queue in Asian countries like Japan.

Industry experts are happy that finally long acting diabetes drug will be available to millions of diabetes patients in USA. Eyes are on how the drug is going to perform in market.

Amylin is however is not planning to hire more staff because of approval as current staff unit is already manufacturing Bydureon for European market. As USA approval was soon expected, company employees already had increased production.

According to company current numbers of employees are ample to meet demand and it is prepared to hire new people if demand increases.

Blood Pressure Drugs Reduce PTSD Symptoms

Some blood pressure medicines have been found helpful in treating stress post trauma, says a research study.

PTSD or post-traumatic stress disorder symptoms were reduced when patients took medicines such as cozaar or diovan. Drugs of class Angiotensin 2 Receptor Blockers prevent action of receptors of angiotensin 2 enzyme.

The research outcome is significant one because it paves the way for new path to proceed on to develop treatment for PTSD. This is the first study that has linked blood pressure drug to psychological disorder such as PTSD. Dr Kerry Ressler is the author of the study. Dr Ressler is professor at Emory University School of Medicine in Atlanta, psychiatry department.

Experts caution the result did not demonstrate cause of the effect, rather just establishes link. Also, a clinical trial would require to compare efficacy against placebo. The study has been published on reputed journal, Journal of Clinical Psychiatry.

check the study details here http://www.psychiatrist.com/ppp/login/login_check_1.asp?dest=/privatepdf/2006/v67n08/v67n0810.pdf

5,000 patients participated in study. All the patients had had severe PTSD symptoms because of traumatic incident such as sexual abuse, physical abuse or experiencing violent incidents, when the study was conducted.

500 out 5000 people were subject to one incident that left them traumatized. 180 people met conditions to be diagnosed with PTSD. 26 patients were already taking blood pressure drugs of either class ARB or ACE inhibitors.

Symptoms of PTSD are characterized by behavioral pattern such as avoidance, hyperarousal and intrusive thoughts. Occurrence of these symptoms was recorded to calculate score for PTSD symptom. Higher score indicate higher severity.

The score found reduced by 30% in patients who are on Angiotensin II Receptor Blockers or ACE inhibitors. To be specific, ACE inhibitors and ARB drugs lowered intrusive thoughts and hyperarousal. No change in score was reported for those who were taking other types of antihypertensive drugs.

Taking Aspirin Daily Good for Bowel Cancer Patients

Research study has found reduction in death caused by bowel cancer if patient takes aspirin every day. The study result has been presented at British Journal of Cancer.

The study included examination of 4,500 patients of bowel cancer.

All patients were on aspirin 80mg tablet. Aspirin is analgesic pain killer and is usually prescribed to heart patients for daily use.

Despite positive result of aspirin's effect, experts are not ready to prescribe the drug to bowel cancer patients any time soon.

Plenty of research studies have found aspirin helpful in preventing cancers of initial stage. Recent findings have also backed result of previous studies - Aspirin could work well to prevent spread of cancer if included in cancer therapy.

However, grave side effects of Aspirin - such as internal bleeding and irritation in stomach - undermine its good effects, believes expert.

4,500 bowel cancer patients were inspected for almost 10 years. 25% of the patients were not taking aspirin, 25% patients started taking aspirin after diagnosis of bowel cancer and rest of the patients were on aspirin before and after they were diagnosed with cancer.

Patients were taking aspirin, post cardiovascular event, as a part of the treatment to prevent future heart disease and stroke.

Aspirin found to reduce bowel cancer death by 23% regardless of the time span aspirin was taken. Chances to die from bowel cancer were 30% less for those who took aspirin standard dose for 9 months after cancer diagnosis.

Administration of aspirin only after cancer diagnosis was more effective than taking aspirin before and after diagnosis. The reason assumed for this is that people who took aspirin before bowel cancer diagnosis might had stubborn tumor.

Dr Gerrit-Jan Liefers is lead author of the study. Dr Leifers is a scientist at Leiden University Medical Centre.

check more here. Acid reflux disease

Quick Facts about Aspirin

Aspirin

• Aspirin contains Acetylsalicylic acid as its active ingredient
• Aspirin is most commonly prescribed pain killer drug.
• Aspirin is analgesic i.e. it masks the pain.
• Patients with history of cardiovascular evets are recommended to take aspirin (75mg) daily
• Rare side effect of aspirin is fatal internal bleeding.

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.

What is (DIN) Drug Identification Number by Health Canada?

What is a DIN?

DIN or Drug Identification number is unique number given by Health Canada to any product with therapeutic effects, including vitamins and supplements. The DIN number is 8 digit number generated by computer system. The number is allotted only after health and safety assessment by Health Canada. It can be seen on drug label prescription.

A DIN of each product indentifies six properties of respective drug. Properties are Manufacturer Company, name of active ingredient, name of product, amount of active ingredient (strength), form (liquid or tablet or capsule) and method to take (such as oral or injection)

When is a DIN issued?

Assigning DIN is final step in order to allow product in market. A drug product receives, after authorization, DIN number from Health Canada which is like a license for the drug itself. Review is strict for a drug product which is completely new (i.e. it does not have any earlier market history). Such products require NOC (Notice of Compliance) along with DIN.

What is DIN intended to?

A DIN indicates to consumers that the product has been reviewed and its safety and effectiveness have been assessed by medical experts. Any drug in market without DIN is violation of Canadian law.

From administration point of view, DIN makes it easy to update particular drug or pull the drug from market or inspect.

Is that assigned to Prescription medicines only?

DIN is printed on both OTC (Over the Counter) and prescription medicines.

Does DIN have any secret mean?

No. DIN does not have any secret information or meaning. It is generated randomly by computer system.

Effective Generic Drug To Slow Down Bleeding, Used by UK USA Armies

A general generic version of drug has been saving lives of American soldiers. The generic drug is being given to severely injured soldiers to slow excess bleeding.

The drug is tranexamic acid. Cost of tranexamic acid is very low so much so that physicians were wary to use it. That why this drug took long time to fully recognized it’s potential in emergency units. Every year four thousand american people get into emergency care unit for the treatment of hemorrhage caused by various reasons such as vehicle accidents, shoot out and stabbings.

Because of its extremely low cost, manufacturer companies could not afford to market or advertise the drug.

Usefulness of the drug has sparked discussions amongst experts of many hospitals across the US on whether the drug should be included in pharmacies. The drug is OTC in UK to stop excess bleeding during menstrual cycle. A study, on more than twenty thousand patients who suffered bleeding for various reason, proved the drug as life saving drug treatment when it is about stop bleeding. Taking result of the study into consideration, UK and US military started to use the drug for their soldiers.

Along with military the drug is now being used in ambulances in UK. Around 400,000 patients die every year because of unstoppable bleeding. A research on usefulness of drug demonstrated that tranexamic acid can save 128,000 patients a year. The research has been available on March 1 publication of BMC Emergency Medicine.

Experts held pharmaceutical companies responsible as the companies did not marketed the drug despite its great potential in hemorrhage treatment.

Pfizer, a pharmaceutical giant, funded a study trial named as Crash-2. The trial was conducted by Dr. Ian Roberts in 2010. Dr Roberts is acting as director of clinical trial department of London School of Hygiene and Tropical Medicine.

Prescribed Cannabis World’s first Drug to Hit US Market

Imitated medicines are motivated by the cannabis plant himself finds ways to American Pharmacy’s mantelshelves to conduct landmark for such trails, said a British company.

The firm GW Pharma is seeking approval by the US government that the clinical trails regarding 1st pharmaceutical based raw marijuana than synthetic equivalents- a mouth spray it faithful in market by US as a possibility of positive sign in cancer patients.

The Food and Drug Administration sanctioned the prescribed drug according the main psychoactive ingredient in arijuana.

Delta 9-THC and Cannabidiol are the two very main elements of Sativex, and got approved by Canada, New Zealand and eight European countries for releasing muscle contraction associated with variety of sclerosis.

Vital and Innovative bond with marijuana was uneasy to represent by FDA for approval. Where as many nations like Washington DC already allowed in use legally prescribed recommendation with doctors.

As the organic substance parallel with prescribed drug, it could raise the burden on government returning its status and potential that, other drug industries will follow GW Pharma. The US Drug Enforcement Administration categorises tub as a warning without medical consequences.

A founder of the company GW Pharma’s Dr. Geoffrey Guy got the permit for the growth and development of prescribed drug as marijuana is yet banned in UK.

Dr Guy bring in the idea at a scientific meetings which brought unreliable proof that tub heals to various sclerosis patients, British government allowed it as a conceivable path for drawing straight line in recreational and medicinal usage, urged Mark Rogerson Industries spokesperson.

A study from University of California, Davis the neurologist influenced on how smoking marijuana links to Marinol in noticing dangerous muscle pains. Marijuana is not sponsored by The National Multiple Sclerosis Society.

The biggest doubt is whether they are visibly constructive.

Company is experimenting more with different Cannabis Formulations.

More deep study is required, where as the believer dread that the government would bring into use any new prescribed product in explaining marijuana’s use limit.

Sumagen Canada Inc. awarded $728,000 for their HIV/AIDS

National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP)

awarded Sumagen Canada Inc. a financial contribution of up to $728,000 to support their

human clinical trials for the preventative HIV/AIDS vaccine on Friday (Jan.12).

The tests are based on genetically modified ‘killed whole virus’, called SAV001.United States

Food and Drug Administration (FDA) last December gave approval to Sumagen Canada to

start the first of three phases of clinical trials.

The preliminary studies showed no adverse effects or safety risks, during test it was also

found that the HIV vaccine stimulate strong immune responses, the tests was undertaken at

University of Western Ontario. Canada is one of few countries were the development of such

kind in HIV vaccine has been undertaken.

Sumagen Canada is getting a huge assistance from NRC-IRAP under The Canadian HIV

Technology Development (CHTD) Program and Bill and Melinda Gates foundation to test the

safety of the clinical trail of first of three phases which is going to start in this month.

Canadian HIV Initiative (CHVI) initiates CHTD Program which is a partnership between

Melianda Gates foundation and Government of Canada.

28 million people have been killed due HIV/AIDS virus worldwide, and at present 35 million

people are living with the virus. Pharmaceutical companies and academic institutions all

over the world have made numerous trials since 1983 when the virus was first typified. Till

now no commercialized vaccine has been made.

Till now the vaccines that have been developed focuses on recombinant viruses carrying the

HIV genes or it concentrates on specific elements of HIV.

Damage Of Lungs Due To Blood Pressure Drugs To Smokers

A research from Johns Hopkins says that blood pressure drugs, which is commonly consumed by the patients, can cause lung damages to smokers, with Chronic Obstructive Pulmonary Disease which ranks third in the cause of death, in our nation.

The researchers first tried on mice, next is human. Clinical trails which includes C.O.P.D , chronic emphysema and bronchitis.

The Drug called  Losartan which is also known as Cozaar , has saved lungs from damaged, since two months of damage due to cigarette smoke. It highlights lungs tissue breakdown, airway wall thickening , inflammation and lung over expansion which cause in breathe.

          12 million Americans are suffering from C.O.P.D and there is no cure for lung damage. Only few medical attention has provided to shortness of breath, coughing, and mucus production and surgery.

           Senior investigator Dr. Enid Neptune, a Hopkins pulmonologist and an associate Professor who did research with said " Because these drugs are already approved for use in the United States as safe and effective treatments for hypertension, incorporating them into our treatment regime for C.O.P.D would be quote rapid".

           Treatment for lung damage in smokers will be the achievement, said the study of researchers in Journal of Clinical Investigation. When Hopkins research found out that same drug benefits Marfan Syndrome which cause a genetic mutation and weakness arteries, the investigation started.

Female Sexual Dysfunction Drug Fails to Reach Market

It is a shock for many that the product from BioSante Pharmaceuticals Inc has failed in its final testing. The solution is found to be less arousing than its competitive products and these reports has bought about a huge difference in the company’s market share and seems to have affected the value of its shares. However, the authorities in the firm have ordered to get the complete details for the product and plan to sort the problem as soon as possible. The representative of the company has come out that there is a partial doubt if the product has failed to satisfy the old aged consumers of is it a stress on the entire consuming population.

The product libigel phase 3 is essentially formulated for the ailments such as breast cancer and cardiovascular problems and the experts are finding the best way forward to solve the unexpected failure of the product. The representatives also came out and indicated that the company has been lucky to have maintained a stable balance sheet and it has in no way left a void in planning its experiences and trial runs. There has been a notable amount of huge sums that is spent on these activities is what is bought to the notice. Reviling the balance data of the company it is told that the firm had a cash balance of 69.6 million and it is expected that this healthy amount will clash down to around 56 million by the time the year ends.

It is not that all bad for the firm as it has a royalty deal and a cancer vaccine program with the major medicine producer Teva Pharmaceuticals (TEVA O) that will play the role of savior resource. However, the company’s losses amount to about 80 % from their previous value soon after the declaration and closed at $2.12 on NASDAQ.

Related reading: Labeling for birth control patch

New Drug (Jakafi) Approved by the FDA to Treat Myelofibrosis

No more is Myelofibrosis a threatening disorder. After so many years of research and waiting, the researchers have been able to incept a medication that can treat this rare bone disorder known as Myelofibrosis. The FDA (Food And Drug Administration) has never before approved any medication to treat this disorder. Jakafi (Ruxolitinbin) is the first successful medication that is approved by the necessary standard boards to treat the same.

Jakafi manufactured by Incyte Corporation has to be consumed twice a day. This Incyte Corporation has its partnership with Swiss Drugmaker Novartis. 

Myelofibrosis is this bone disorder where one has scares instead of the marrow that has to be present. This means the body is unable to produce the necessary blood cells. One is prone to problems like anemia and any sort of other infections in the body. One can also suffer from extrameddulary hematopoiesis. Though there is no particular cause of this severe disorder, it can result because of leukemia or lymphoma. 

Richard Pazdur who is the Director of the Office of Hematology and Oncology Products in the FDA Department has been appreciating the process of the invention of this medication where it is based on the process of understanding of disorder and the problems that the sufferer undergoes. generic viagra

This medication was out on a comparative study along with the placebo effect and other sorts of therapy like hydroxyureo. Jakafi however proved to be successful amongst all with patients experiencing 50% better results. Though like every medication, Jakafi can also have its own list of adverse effects including nausea, fatigue and thrombocytopenia. 

HPV Vaccine May Reduce Cervical Cancer Rates in Developing Countries

Human papillomavirus (HPV) is a set of over 150 viruses; know as papilloma viruses, which encourages a certain type of skin growths. Human papilloma viruses (HPV) are often connected to certain kind of cancer, also known as, carcinogenic HPVs or “high-risk," oncogenic.

Out of 150 types of HPV, 40 types of HPV are contagious, and can be transmitted from person to person during sexual interaction. The transmission of HPV can take place by genitals or oral, even if usually HPV’s is passed on sexually. It is studied that several Human papilloma virus (HPV) appear without any indications and goes away without any treatment.

The major cause of cervical cancer is high-risk HVP infection. More or less all the women have HPV infection, at some point of time, but only few develop into cervical cancer. Immune system, nearly in all the women, is suppresses or reduces HPV. Only a persistent HPV infection leads to the development of cervical cancer.

As per a study, giving human papilloma virus (HPV) vaccine dose for a longer period of time may establish an effectual way to formulate the vaccine to be obtainable to more and more women’s in the underprivileged nations.

According to the researcher, different schedules of dosing vaccine where used to conclude the treatment in the developing country.

The WorldHealth Organization (WHO) has accepted this programmatic limitation that should be considered to be initiated in the national Human papilloma virus (HPV) vaccination programs. Neuzil's team has announced that, delivering Human papilloma virus (HPV) vaccine in flexible timetable, will lets countries to  reduces the cost and increase the availability of vaccination  programs.

Natrecor a heart failure drug is found to be ineffective

A latest study published by New England Journal of Medicine says, Natrecor (nesiritide),the heart failure medicine is not effectual and is associated to increasing rates of possibly hazardous low blood pressure.

The heart failure drug Natrecor was approved in 2001 to help patients breathe without difficulty. According to the research, since the medicine had no major consequence on breathing problems or any other disease difficulty may also cause low blood pressure.

The study authors have noted that the research has recognized the possible risk and benefits of the drug in people with heart failure who have serious difficulty in breathing a condition also known as dyspnea as the illness is worsening.

To come up with new drugs, we require adequate plan and must have enough data, to rework the whole process so that the doctors and patients are comfortable. Billions of dollars were spent on Natrecor (nesiritide), where as we could have used Lasix which costs penny for single dose. We need to rethink the entire pharmaceutical industry process.

Even though, there were small non-specific effect on reducing death, re-hospitalization and improve dyspnea with nesiritide use for severely worsening heart failure. This result improves clinicians about the possible danger and benefits of Natrecor (nesiritide) in treating such patients.

In 2001 Food and Drug Administration (FDA), U.S. approved nesiritide, the anxiety were raise which may also be associated with worsening of renal functioning and mortality.

It is said that Nesiritide, shall be not be taken away from the market, as it doesn't harm anyone, just because it doesn't hurt people it doesn't means that it should be made available in the market.