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Three West African countries set to roll out new meningitis vaccine

A new vaccine for meningitis, MenAfriVac, offers hope of an escape from one of the world's deadliest, most disabling and infectious diseases, the BBC writes. The vaccine was developed by non-governmental organization PATH in partnership with the WHO and created specifically for Africa.

18 Oct 2010

FDA plans to revoke knee implant approval following intense political pressure for its approval

The Food and Drug Administration on Thursday said it planned to revoke a medical-device company's right to sell a knee implant called Menaflex after an unprecedented yearlong review concluded the agency erred in allowing it on the market

18 Oct 2010

FDA approves ISTA's sNDA for BROMDAY ophthalmic anti-inflammatory drug

ISTA Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for BROMDAY (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

18 Oct 2010

FDA approves BOTOX as prophylactic treatment for Chronic Migraine

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved BOTOX(onabotulinumtoxinA) for the prophylactic (preventive) treatment of headaches in adults with Chronic Migraine.

18 Oct 2010

MasterCard, Interpol partner to prevent online supply of illegal and counterfeit drugs, medicines

MasterCard Worldwide recently partnered with Interpol to support the global police organization's efforts to prevent websites from supplying illegal and counterfeit prescription drugs and medicines to consumers. Named "Operation Pangea III," the week-long effort covered 45 participating countries and resulted in 76 arrests to date. Additionally, 290 websites have been shut down and nearly 11,000 packages of contraband have been seized or detained.

15 Oct 2010

Oragenics to feature ProBiora3 oral care probiotic ingredient at Supply Side West

Florida-based biopharmaceutical company Oragenics, Inc. announced that it will feature the company's ProBiora3® oral care probiotic ingredient at Supply Side West, October 19 - 23, 2010 in Las Vegas, NV.

15 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010

Access receives first MuGard prescriptions and reimbursement

Access Pharmaceuticals, Inc., a biopharmaceutical company specializing in products for cancer and supportive care, announced today it has received initial prescriptions for its lead product, MuGard – an FDA-approved, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of radiotherapy and/or chemotherapy.

15 Oct 2010

Watson Laboratories receives FDA approval for Amlodipine capsules

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules, the generic equivalent to Novartis' Lotrel capsules.

15 Oct 2010

Bristol-Myers, Otsuka launch My SPRYCEL Support program to assist patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced the launch of My SPRYCEL (dasatinib) Support, a useful resource to assist adult patients with chronic myeloid leukemia (CML) who are taking SPRYCEL.

15 Oct 2010

CVS Caremark to present client experiences on innovative approaches at AMCP Conference

CVS Caremark is presenting data at the Academy of Managed Care Pharmacy (AMCP) 2010 Educational Conference illustrating how innovative approaches to traditional plan designs can help clients reduce drug spend, improve generic dispensing rates (GDR) and minimize member disruption.

15 Oct 2010

Mylan granted FDA approvals for generic Hyzaar and Cozaar ANDAs

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for the generic versions of Hyzaar® Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar® Tablets, 25 mg, 50 mg and 100 mg, both antihypertensives.

15 Oct 2010

FDA warns companies over unsubstantiated claims of 'chelation' products

The Food and Drug Administration says there's no proof that nonprescription 'chelation' products—which claim to treat everything from autism to Alzheimer's disease—can rid the body of toxic metals.

15 Oct 2010

A new therapeutic approach for cancer

Trials are being organized for a new therapeutic approach to treating cancer, under exclusive license by Viral Genetics, Inc. According to Scott & White Healthcare Senior Vice President for Research Richard E. Beswick, M.D., who is also assistant dean of research at the Texas A&M Health Science Center College of Medicine, the trials will be conducted at the Glenda Tanner Vasicek Cancer Treatment Center, located at Scott & White in Temple, Texas.

15 Oct 2010

Visa supports global law enforcement action against online sale of counterfeit, illegal medicines

Visa Inc. and Visa Europe today announced support for "Operation Pangea III," a global law enforcement action coordinated by INTERPOL targeting the online sale of counterfeit and illegal medicines resulting in arrests across the globe and the seizure of thousands of potentially harmful medicines.

15 Oct 2010

Scientists to monitor effectiveness of Streptococcus vaccine

Respiratory infections and diarrhoeal diseases kill approximately four million children each year, with most deaths occurring in developing countries. New vaccines for Streptococcus pneumoniae, a bacterium that causes pneumonia, and rotavirus, the most common cause of severe diarrhoea, have proved successful in preventing the development of the diseases in clinical trials, but have yet to be used routinely in many parts of Africa.

15 Oct 2010

Startech, STRCIC invest $2.5 million in ViroXis Corporation

Startech and the South Texas Regional Center of Innovation and Commercialization (STRCIC) today announced the investment of $2.5 million in San Antonio-based ViroXis Corporation by the Texas Emerging Technology Fund (TETF).

15 Oct 2010

GfK HealthCare: RRMS patients anticipate availability of new oral therapies

Relapsing-Remitting Multiple Sclerosis (RRMS) patients have been anticipating the availability of new oral therapies being developed to treat their specific condition. Among the string of oral therapies entering the market is Novartis' Gilenya, which recently became available for use following receipt of FDA approval in late September. One-third of MS patients are aware the new oral agents are under development and there is substantial interest within this group to seek further information through physicians and other sources, according to new research by GfK HealthCare.

15 Oct 2010

CVS/pharmacy agrees to pay civil penalties for excessive sales of PSE

CVS/pharmacy today announced agreements with the U.S. Drug Enforcement Administration (DEA) and the U.S. Attorneys' Offices for the Central District of California and the District of Nevada to settle allegations that in 2007 and 2008 certain CVS/pharmacy stores in California and Nevada engaged in unlawful sales of pseudoephedrine (PSE), an ingredient found in popular over-the-counter cold and cough medicines.

15 Oct 2010

Delcath executes melphalan supply agreement with Synerx and Bioniche Teoranta

Delcath Systems, Inc. announced today that it has executed a multi-year supply agreement with Synerx Pharma, LLC and Bioniche Teoranta, an affiliate of Mylan, Inc., for the supply of Delcath's branded melphalan hydrochloride for injection ("melphalan"). Melphalan is the chemotherapeutic drug used with Delcath's Chemosaturation system in its Phase III clinical study for the treatment of patients with hepatic metastases from ocular or cutaneous melanoma.

15 Oct 2010

Pharmaceutical News

Three West African countries set to roll out new meningitis vaccine

FDA plans to revoke knee implant approval following intense political pressure for its approval

FDA approves ISTA's sNDA for BROMDAY ophthalmic anti-inflammatory drug

FDA approves BOTOX as prophylactic treatment for Chronic Migraine

MasterCard, Interpol partner to prevent online supply of illegal and counterfeit drugs, medicines

Oragenics to feature ProBiora3 oral care probiotic ingredient at Supply Side West

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Access receives first MuGard prescriptions and reimbursement

Watson Laboratories receives FDA approval for Amlodipine capsules

Bristol-Myers, Otsuka launch My SPRYCEL Support program to assist patients with CML

CVS Caremark to present client experiences on innovative approaches at AMCP Conference

Mylan granted FDA approvals for generic Hyzaar and Cozaar ANDAs

FDA warns companies over unsubstantiated claims of 'chelation' products

A new therapeutic approach for cancer

Visa supports global law enforcement action against online sale of counterfeit, illegal medicines

Scientists to monitor effectiveness of Streptococcus vaccine

Startech, STRCIC invest $2.5 million in ViroXis Corporation

GfK HealthCare: RRMS patients anticipate availability of new oral therapies

CVS/pharmacy agrees to pay civil penalties for excessive sales of PSE

Delcath executes melphalan supply agreement with Synerx and Bioniche Teoranta

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