World Cancer Day 4th February

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World Cancer Day 4th February

Posted on: February 4th, 2015 by BIOPharma-MEA No Comments

World Cancer Day – February 4, is a key date every year for all of the international cancer communities.

Globally, more people die from cancer than from AIDS, malaria, and tuberculosis combined. Each year, 14.1 million people learn they have cancer, and 8.2 million people die from the disease worldwide.

The World Health Organization (WHO) projects that without immediate action, the global number of deaths from cancer will increase by nearly 80% by 2030, with most occurring in low- and middle-income countries. Research suggests that one-third of cancer deaths can be avoided through education, the dispelling of myths and misconceptions and addressing the known modifiable risk factors, which are known to cause cancers.

BIOPharma-MEA is committed to raise the awareness of cancer within our communities by disseminating information about cancer inside and outside our business. 

Chronic Lymphocytic Leukemia “ CLL” is slow-growing disease and tends to grow more slowly. It is usually not curable with standard treatments, but depending on the stage and growth rate of the disease. Sometimes, these slow-growing lymphomas turn into a more aggressive type.

Follicular lymphomas “FL” are hard to cure. These lymphomas may not require treatment when they are first diagnosed. Instead, treatment may be delayed until the lymphoma is causing problems. Over time, about 1 in 3 follicular lymphomas turns into a fast-growing diffuse B-cell lymphoma. About 1 out of 5 lymphomas in the United States is follicular lymphoma.

BIOPharma-MEA is immensely proud of approaching CLL and FL patients by offering them new hope and better quality of life with Zydelig.

BIOPharma-MEA is mapping the next stages of its engagement in this therapeutic area through different aspects and strategies putting patients in heart of things. 

2015 Biopharma-MEA annual Kickoff Meeting

Posted on: January 10th, 2015 by BIOPharma-MEA No Comments

 

 

 

 

 

 

 

The 2015 Biopharma-MEA Annual Takeoff Meeting took place this year in Singapore. The slogan of “BPROUD” standing for “Biopharma People Outreaching Ultimate Dreams”, has been selected for this year meeting reflecting the high level of energy, enthusiasm, and ambitious of the Biopharma-MEA team.

This year’s meeting is taking place in The Mandarin Hotel, Singapore during the period of 4th- 9th January 2015, containing the company annual briefing meeting for the first couple of days then followed by the second phase of the Sales delegate and management academy that conducted in collaboration with TTM Associates, the Cyprus based management and training consultancy firm.

The meeting is coming this year with the company remarkable achievements with the introduction of the new all-oral therapies of Hepatitis-C Virus, the first-to-market Cystic Fibrosis therapy, and the new FL& CLL oncology therapy. This is in addition to the success of maintaining the company leadership of its targeted markets of Infertility, metabolism, HIV, and systemic Anti-Fungal therapies.

Biopharma MEA, Win the “2014, Distributor of The Year Award” from Gilead Sciences

Posted on: October 15th, 2014 by BIOPharma-MEA No Comments

Athens, Oct,15, 2014

Biopharma Middle East& Africa proudly received today the “2014, Distributor of The Year Award” from Gilead Sciences.

This award is coming in recognition for the efforts and achievements that Biopharma MEA made. The company has been very successful in achieving its planned milestones, building access to many institutions to new innovative therapies, and indeed, with Lord’s blessings, transforming the lives of many patients suffering serious diseases.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions.

Biopharma Middle East& Africa is Dubai based company, developed to partner with niche and biotech multinational pharmaceutical companies, with objective to introduce their innovative therapies to the Middle East markets, to allow patients to benefits from the merits of these therapies.

FDA approves first combination pill to treat hepatitis C

Posted on: October 10th, 2014 by BIOPharma-MEA No Comments

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm

BIOPharma-MEA Leadership Academy

Posted on: September 10th, 2014 by BIOPharma-MEA No Comments
 
 
 
 
 
 
 
 
 
 
 
Learning development never looked so good!
“Inspiring Autonomous Manager” programme takes a break!
 
The training is a start of another journey to sharpen the managerial skills for Biopharma-MEA management team. 
 

BioMarin Announces FDA Approval for VIMIZIM(TM) (elosulfase alfa) for the Treatment of Patients With Morquio A Syndrome

Posted on: February 17th, 2014 by BIOPharma-MEA 12 Comments

FDA approves Vimizim to treat rare congenital enzyme disorder 

First drug to receive Rare Pediatric Disease Priority Review Voucher

The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States.

Vimizim was granted priority review. An FDA priority review provides for an expedited review of drugs for serious diseases or conditions that may offer major advances in treatment. Vimizim is also the first drug to receive the Rare Pediatric Disease Priority Review Voucher - a provision that aims to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

The safety and effectiveness of Vimizim were established in a clinical trial involving 176 participants with Morquio A syndrome, ranging in age from 5 to 57 years. Participants treated with Vimizim showed greater improvement in a 6-minute walk test than participants treated with placebo. On average, patients treated with Vimizim in the trial walked 22.5 meters farther in 6 minutes compared to the patients who received placebo.
 
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386008.htm
 

http://investors.bmrn.com/releasedetail.cfm?ReleaseID=825970

FDA APPROVES SOVALDI

Posted on: December 8th, 2013 by BIOPharma-MEA 1 Comment

FDA approves Sovaldi for chronic hepatitis C

Drug is third with breakthrough therapy designation to receive FDA approval
 
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
 
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
 
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).
 
For more info:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm

ELITE meeting

Posted on: November 20th, 2013 by BIOPharma-MEA No Comments

With the outstanding success of Elite I meeting in Hamburg held in November  2013, BIOPharma-MEA is thankful for Medac sponsoring this standalone meeting that was really a great event.  

Successful BOARD IV meeting

Posted on: October 20th, 2013 by BIOPharma-MEA No Comments

LG life sciences sponsors the forth BOARD meeting for IVF specialists in the region at Gold Coast – Australia 4th – 8th October 2013