OPP said it won the FDA approval for its product Neomycin, paving the way for its sale in the US. The development follows the successful audit of OPP’s manufacturing [...]]]>

Oman Pharmaceutical Products Company, OPP, belonging to the Al Bahja Group announced that it has won its first product approval from the US Federal Drug Administration (FDA).

OPP said it won the FDA approval for its product Neomycin, paving the way for its sale in the US. The development follows the successful audit of OPP’s manufacturing facility by FDA officials recently.

Al Bahja Group Managing Director Sujay Hamlai, said “We are extremely delighted with this approval. It validates our commitment to provide quality medicines at affordable prices.”

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Dr. Amin Al Amiri, Executive Director for Medical Practices and Licenses at the UAE Ministry of Health the decision, explained that all the above mentioned [...]]]>

UAE Ministry of Health stated that all pharmaceuticals and medicine companies registered at the Registration and Pharmaceutical Drugs Department will be required to appoint a pharmaceutical vigilance officer in their organizations.

Dr. Amin Al Amiri, Executive Director for Medical Practices and Licenses at the UAE Ministry of Health the decision, explained that all the above mentioned companies are requested to appoint a pharmaceutical vigilance officer who must be a doctor, pharmacist, drugs specialist or toxicologist. This officer must have a practical experience in monitoring and following up the reports of drugs side effects, clinical studies and clinical pharmacology.

Dr. Al Amiri said: “All candidates must provide their approved documents including qualifications, experiences, contact information, fax, mobile, phone and email addresses. We addressed all pharmaceutical manufacturers and medical companies to provide their pharmaceutical vigilance and risk management plans at the time of registration or renewal.

The plans include medical products, pharmaceuticals, innovative pharmaceutical products containing active substances registered for the first time, medium or high risk products in addition to other products that have been included in previous circulars by the Ministry of Health or international drugs control association in terms of their safety and side effects”. Dr. Al Amiri explained that the decision demanded all the companies to provide the ministry with an updated safety list of their pharmaceutical and medical products. Such reports must include a yearly detailed report of the medical products that have been registered between 6 months-1 year, an annual record of the products that have been registered between 1-3 years and a progress report every 3 years for the products that have been registered for more than 3 years.

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Hemophilia affects only males but “there are many other bleeding disorders that affect both males and females,” said LAH president Solange Sakr. A [...]]]>

The Lebanese Association for Hemophilia (LAH) and international pharmaceutical company Novo Nordisk held a conference to shed light on blood disorders, as well as mark World Hemophilia Day, celebrated annually on April 17

Hemophilia affects only males but “there are many other bleeding disorders that affect both males and females,” said LAH president Solange Sakr. A number of women remain unaware of a bleeding disorder until they experience complications during childbirth, she said.

LAH is currently the only NGO in the country providing a comprehensive range of diagnostic and treatment services for hemophilia patients. In December last year, LAH launched a screening campaign for bleeding disorders in Zahle, Sakr said.

“Our aim is to improve the lives of people with bleeding disorders through our global research and local partnerships, as we work to change the fact that most of those afflicted do not have access to adequate diagnosis and treatment,” said Rita Sfeir, Lebanon general manager of Novo Nordisk. The firm runs the “Changing Possibilities in Hemophilia” project in Lebanon, organizing awareness activities about the disorder.

Hemophilia, von Willebrand disease, and other factor deficiencies are lifelong bleeding disorders that prevent blood from clotting properly, LAH explained. People with bleeding disorders do not have enough of a particular clotting factor, a protein in blood that controls bleeding, or it does not work properly. The severity of a person’s bleeding disorder usually depends on the amount of clotting factor that is missing or not working.

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The 3rd BE Conference invited representatives from health authorities in charge of BE studies in the region to [...]]]>

Jordanian Association of Pharmaceutical Manufacturers and Medical Appliances (JAPM) in collaboration with Jordan Food and Drugs Association (JFDA) and with the support of USAID Jordan Economic Development Program (SABEQ) held this month the “3rd Middle East Bioequivalence Conference”.

The 3rd BE Conference invited representatives from health authorities in charge of BE studies in the region to address these issues and constraints, aiming for better harmony amongst different regulations, and improving acceptance rate of BE studies in these countries, in line with international regulations and in a bid to simplify the procedures.

“This conference is a discussion platform on BE studies, and aims to bridge gaps between industry, CROs and regulators in the Middle East. The Conference further harmonizes different national regulations and raises them to international standards, minimize debates, increase acceptance level and avoid potential losses due to rejections of bio studies. It also saves efforts and resources of all stakeholders,” said Ms Hanan Sboul, Secretary General, JAPM.

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The agreement is meant to unify efforts and build bridges for the development and transfer of state-of-the-art technology.

In terms of the agreement the research centers at Ainyia, Khafji and [...]]]>

The King Abdul Aziz City for Science and Technology (KAACST) and the Ministry of Health signed a strategic agreement to boost the pharmaceutical sector in the Kingdom.

The agreement is meant to unify efforts and build bridges for the development and transfer of state-of-the-art technology.

In terms of the agreement the research centers at Ainyia, Khafji and Qassim, affiliated to KAACST, would be transferred to a specialist technical zone specializing in bio-pharmaceutical industries.

Meanwhile Dr. Abdullah Al-Othman, President of King Saud University (KSU) in Riyadh, said the university has launched a package of electronic services. A new company specializing in the software industries, emanating from the Wadi Al-Riyadh Company for Technology, has been created.

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The move is part of the Health Ministry’s efforts to provide better, but low-priced, medical services for Kuwaiti citizens and expatriates, he said. The reduction will involve as many as 5,000 types of medicines, the minister told [...]]]>

Minister of Health Hilal Al-Sayer said that prices of medicines and pharmaceutical formulas would be slashed by five percent.

The move is part of the Health Ministry’s efforts to provide better, but low-priced, medical services for Kuwaiti citizens and expatriates, he said. The reduction will involve as many as 5,000 types of medicines, the minister told KUNA. “The reduction of medicine prices will contribute to cutting medical treatment costs for citizens and expatriates,” he said.

Further, Assistant Undersecretary of the Ministry of Health for Medicines and Medical Preparations Omar Al-Sayed Omar said the medicine quotation committee had been reshaped. He added that prices of medicines and food supplements would be reconsidered every six months.

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Fatima, a diabetic patient, had voiced apprehensions about the tablet, Glucophage XR (500mg), saying it had shown up virtually unchanged [...]]]>

Dubai A pharmaceutical company has sought to allay fears of some diabetes patients who came forward with complaints that a pill they are taking is not fully assimilated by the body and could be a fake.

Fatima, a diabetic patient, had voiced apprehensions about the tablet, Glucophage XR (500mg), saying it had shown up virtually unchanged in her stool. She said some other patients who were taking the tablet had failed to notice this until she pointed it out to them.

Fatima said she worried about what would happen if the tablet were to remain inside the body and how it would affect internal organs.

Pharmaceutical company Merck Serono said in a statement that Glucophage XR is an advanced formulation of the oral anti-diabetic agent Metformin.

“When the tablet is swallowed, it absorbs water, swells and remains for a longer period of time in the stomach, releasing Metformin slowly into the upper part of the intestine. This is sufficient to allow for once daily dosage rather than 2 to 3 times daily intakes required for the immediate release [of] formulations of Metformin, making it more convenient for the patients,” it said. “With this advanced tablet technology, it is normal that remains of the tablet can show up in the patients’ stool the morning after the ingestion of the tablet and therefore patients and medical practitioners should be reassured.”

In clinical trials with more than 1,200 patients, Glucophage XR was shown to be comparable to Glucophage in lowering patients’ blood sugar levels. The Food and Drug Administration (FDA) of the US also approved Glucophage XR for use by patients who require combination therapy with Sulfonylureas or insulin, it said.

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MenaITech’s CEO Dr. Bashar Hawamdeh said, “MenaITechMenaITech Al Mouthla Programming Services Company’s four main modules; our human [...]]]>

AMMAN – Hikma Pharmaceuticals, a multinational pharmaceutical group based in Jordan, has selected Middle East & North Africa Internet Technologies’ Human Resources Management System (MenaITech) in order to automate its human capital functions throughout its branches in the MENA region.

MenaITech’s CEO Dr. Bashar Hawamdeh said, “MenaITechMenaITech
Al Mouthla Programming Services Company’s four main modules; our human capital management module MenaHR, our payroll & personnel system MenaPay, our self services module MenaME, our business intelligence tool MenaExplorer and our cell phone notification module MenaSMS have been selected for deployment across Hikma’s branches in Jordan, KSA, Egypt & Algeria. The plan is to get the system up and running for all those entities by the end of 2011 which we are confident we will successfully achieve.”

He added, “We have also launched our French version for the Algeria market that will facilitate implementation of our application in the North African region.”

Hikma’s VP of Corporate HR, Ms. Majda Labadi said, “The selection of a reliable, Arabized and qualified HRMS vendor was no easy task for us. We went through a heavy selection process by assessing companies based on regional expertise, international standards and localized functions that would meet our country-specific needs.”

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Sculptra is an injectable treatment that consists of poly-L-lactic acid sterile suspension that is biocompatible and biodegradable making it easy for the body to absorb. In addition, Sculptra stimulates the natural production of collagen in [...]]]>

Sanofi-aventis pharmaceuticals launched its highly anticipated anti-ageing drug, Sculptra in UAE following its recent approval from the UAE Ministry of Health.

Sculptra is an injectable treatment that consists of poly-L-lactic acid sterile suspension that is biocompatible and biodegradable making it easy for the body to absorb. In addition, Sculptra stimulates the natural production of collagen in the skin.

“The extent of the changes in facial ageing requires a global approach rather than a correction of a few individual lines,” said, Dr. Danny Vleggaar, Head of Dermal Rejuvenation & Substitution Therapy, Esthetic & Reconstructive Surgery, Centre Dermato-Esthetiques, Geneva, Switzerland, “Sculptra is not a dermal filler and it should not be used like one.”

Dr. Ali Al-Numairy, Consultant Plastic & Aesthetic Surgery said, “It can be used to correct facial wrinkles, build up any sunken areas of the face and reduce skin indentations. We are confident that the treatment will be well received in this region as it is a minimally invasive procedure that is effective, well tolerated and has long lasting benefits such as a more natural and youthful appearance.

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