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India, EU trade agreement will not restrict ability for India's pharmaceutical firms to export generic drugs, official says

"India and the European Union (EU) have agreed that the comprehensive bilateral trade agreement being negotiated by the two will not result in an intellectual property regime that restricts the ability of Indian pharmaceutical firms to export generic or off-patent drugs by being far more stringent than the TRIPS [Trade-Related Aspects of International Property Rights] regime of the World Trade Organization," LiveMint.com reports in an article that describes recent debates over the agreement.

9 Dec 2010

Three drug companies to pay $421 million in fraud settlement

Los Angeles Times: Three pharmaceutical firms — Roxane, Abbott Laboratories and B. Braun Medical — "agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid — the latest in a string of large healthcare fraud settlements announced by the Justice Department. The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing healthcare providers, authorities said" (Zajac, 12/8).

9 Dec 2010

Smoking cessation products available on PBS

Australia’s federal government has announced that it will subsidize the cost of nicotine patches to help smokers quit. The announcement was made by Health Minister Nicola Roxon on Thursday who said that concession card holders would be able to access Nicorette, Nicabate P and Nicotinell under the Pharmaceutical Benefits Scheme (PBS) from February 1, 2011. She said, “Cancer scars the lives of too many Australians and we know that reducing the smoking rate is one of the most effective ways to reduce the rate of death from this terrible disease.” Anti-smoking drug Varenicline (Champix) would also be available for willing quitters.

8 Dec 2010

TOS, OAC call on FDA to address urgent need for obesity treatments

The Obesity Society (TOS) and the Obesity Action Coalition (OAC) today called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity.

8 Dec 2010

UBC's new formulation of Amphotericin B for Visceral Leishmaniasis remains stable in tropical climates

A new formulation of Amphotericin B (AmB) developed by University of British Columbia researchers has been shown to be stable in tropical climates and effective in treating Visceral Leishmaniasis (VL) in mouse models.

8 Dec 2010

Golden Living establishes in-house consulting pharmacy company

Golden Living has established a new, in-house consulting pharmacy company that will focus on improving medication safety and patient outcomes. Golden Clinical Rx Services is based on an innovative clinical pharmacist model that will make certified geriatric pharmacists (CGPs) part of the interdisciplinary clinical teams that care for Golden LivingCenter patients and will leverage technology to improve patient outcomes.

8 Dec 2010

European Commission must stop attacking generic medicines, says ITPC

On International Human Rights Day, as the European Commission (EC) and the Government of India meet in Brussels to finalise a European Union (EU)-India free trade agreement, the International Treatment Preparedness Coalition (ITPC) calls on Indian negotiators to put the right to health of its citizens and of the fifteen million HIV-positive people worldwide needing treatment above the pharmaceutical companies' interests and profits.

8 Dec 2010

Financial Times contrasts 'bottom up' and 'top down' approaches to developing country drugs

The Financial Times contrasts the model of drug development for developing countries being used by non-profit groups like the Meningitis Vaccine Project (MVP), which recently rolled out the MenAfriVac, to that of some pharmaceutical companies.

8 Dec 2010

CML patients treated with dasatinib associated with better treatment adherence, lower health costs: Study

Patients with chronic myeloid leukemia who were treated with nilotinib are found to be associated with better treatment adherence, less hospitalizations, and lower total health care costs than patients treated with dasatinib, according to a new study released by Analysis Group Inc., a leading provider of health care research and economic consulting.

8 Dec 2010

Cardinal Health continues agreement with Walgreens to supply pharmaceuticals

Cardinal Health today announced the early renewal of its distribution agreement with Walgreens to supply pharmaceuticals to its national network of retail pharmacies. The new agreement extends into 2013.

8 Dec 2010

FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

The Obesity Action Coalition, The Obesity Society and the American Society for Metabolic and Bariatric Surgery found encouragement in the outcome of today's advisory committee hearing, favoring approval for the first new obesity treatment in more than 10 years.

8 Dec 2010

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Cephalon, Inc. and Mesoblast Limited, today announced they have entered into a strategic alliance to develop and commercialize novel adult Mesenchymal Precursor Stem Cell therapeutics for degenerative conditions of the cardiovascular and central nervous systems.

8 Dec 2010

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Alexza Pharmaceuticals, Inc. announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration in December to discuss the Complete Response Letter regarding the Company's New Drug Application for AZ-004 (Staccato loxapine).

8 Dec 2010

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

What do some pesticides and "electronic cigarettes" have in common? According to a new report published in the American Journal of Public Health, the answer is unregulated concentrations of nicotine that may pose unknown risks to consumers who are exposed to them.

8 Dec 2010

Contrave, new weight loss pill gets FDA panel nod

A Food and Drug Administration (FDA) panel yesterday recommended the approval of Orexigen Therapeutics’ weight loss drug Contrave. This is the first time a weight loss drug has received the nod. The vote went 13 to 7 for Contrave’s approval and 11 to 8, with an abstention that additional studies be conducted on heart risks. Although experts agree to risks they believe the benefits outweigh the risks. Although the FDA is not compelled to go with the panel’s recommendation, it more often than not does. The FDA will deliver its verdict by Jan. 31 2011.

7 Dec 2010

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

Orthovita, Inc. , an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.

7 Dec 2010

Inergetics, Muscle Maker Grill sign Product Development Agreement

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has entered into a Product Development Agreement with Muscle Maker Grill, one of the country's fastest growing health-food franchises, to be the exclusive provider of "Muscle Maker Ultra Pro, powered by Inergetics," a powdered proprietary nutritional product to be used in various platforms in Muscle Maker Grill restaurants.

7 Dec 2010

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system by the Danish Medicines Agency of Denmark.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

OXIS introduces ErgoFlex for relief of joint pain

OXIS International, Inc. announces the market launch of ErgoFlex™, a unique new dietary supplement for the relief of joint pain. It is the first in a series of commercial products planned by OXIS. ErgoFlex is the only joint health complex containing the powerful antioxidant Ergothioneine (ERGO), and is specifically formulated to help the body fight the pain of joint inflammation and maintain optimal joint health.

7 Dec 2010

Pharmaceutical News

India, EU trade agreement will not restrict ability for India's pharmaceutical firms to export generic drugs, official says

Three drug companies to pay $421 million in fraud settlement

Smoking cessation products available on PBS

TOS, OAC call on FDA to address urgent need for obesity treatments

UBC's new formulation of Amphotericin B for Visceral Leishmaniasis remains stable in tropical climates

Golden Living establishes in-house consulting pharmacy company

European Commission must stop attacking generic medicines, says ITPC

Financial Times contrasts 'bottom up' and 'top down' approaches to developing country drugs

CML patients treated with dasatinib associated with better treatment adherence, lower health costs: Study

Cardinal Health continues agreement with Walgreens to supply pharmaceuticals

FDA advisory committee's approval of Contrave for obesity encourages OAC, TOS, ASMBS

Cephalon, Mesoblast to develop, commercialize novel adult MPC therapeutics

Alexza Pharmaceuticals to meet with FDA to discuss CRL regarding its NDA for AZ-004

Concentrated nicotine in E-cigarattes poses unknown risks to consumers

Contrave, new weight loss pill gets FDA panel nod

Orthovita granted FDA marketing clearance for Vitoss Bioactive Foam-2X Bone Graft Substitute

Inergetics, Muscle Maker Grill sign Product Development Agreement

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

OXIS introduces ErgoFlex for relief of joint pain

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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