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Archive for the 'Pharma Industry' Category

Brazilian Organization Files Opposition To Gilead’s Antiretroviral Patent Application In India

The Brazilian group Interdisciplinary AIDS Association, or ABIA, has joined Indian patient advocacy groups to oppose a patent application for Gilead Science’s antiretroviral drug Tenofovir, saying that the patent would have a direct impact on Brazil’s ability to produce and access affordable generic versions of the drug, India’s

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Praxis’ Patient Recruitment Campaign Saves 380 Days Off Enrollment For Women’s Health Study

Praxis, a company specializing in centralized patient recruitment for clinical research studies, recently provided patient recruitment services to a major pharmaceutical company for a study to test an investigational medication for a women’s health indication. The recruitment program saved over 13 months off the enrollment period and delivered a 370% return on investment for the sponsor. Praxis’ centralized recruitment program directly delivered 58% of all patients randomized into the study.

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New EFPIA Code Of Practice On Relationships With Patient Organisations Effective In 31 Countries

On 1 July 2008, a new Code of Practice comes into effect across Europe to ensure relationships between the pharmaceutical industry and patient organisations are transparent and ethical. The “Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations”, adopted in October 2007, applies to the 2,200 companies that the European Pharmaceutical Industry Association EFPIA represents directly and indirectly in 31 European countries.

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GE Healthcare’s Omnipaque Helpful As Oral Contrast Agent, Technical Note Reports

Low-osmolar contrast media, such as GE Healthcare’s Omnipaque (Iohexol), make effective oral contrast agents for abdominal CT scans concluded a technical note written by a team of physicians from Johns Hopkins Medical and published in the March/April 2008 edition of the Journal of Computed Assisted Tomography. “It [Low-osmolar contrast media] is relatively non-absorbable and of low risk to the patient if aspirated,” according to the technical note.

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Pharmaceutical Companies Say New Approach By FDA Has Led To Decrease In Approvals Of New Medications

An “intensifying focus on safety and a diminished tolerance for side effects” by FDA have “dramatically lowered” the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports.

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Teva Receives First U.S. Approval For Generic Risperdal(R) Tablets; Commences Commercial Launch

Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Janssen’s antipsychotic agent Risperdal® (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has commenced.

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BIO Applauds U.S. Adoption For GE Corn, Cotton, Soybeans

American farmers have adopted genetically engineered (GE) crops widely since their introduction in 1996, especially corn, cotton and soybean varieties, according to a new USDA report. USDA’s Economic Research Service (ERS) report, Adoption of Genetically Engineered Crops in the U.S. was released July 2, 2008. Key findings include: - Adoption of GE soybeans with HT (herbicide-tolerant) traits reached 92 percent in 2008.

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Clinical Data Secures EU Patent For MDR1 - A Key Multi-Drug Resistance Gene

Clinical Data, Inc. (NASDAQ: CLDA), a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced today that the European Patent Office has granted Patent No. 1232260 to Bernried, Germany-based Epidauros Biotechnologie AG, a wholly-owned subsidiary of Clinical Data, relating to the use of a genetic variant, or biomarker, of the gene MDR1 (also known as ABCB1), which encodes P-glycoprotein (PGP).

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FDA Expands Cooperative Research And Development Study (CRADA) With Conformia

Conformia, the market leader of product and process lifecycle management (PPLM) solutions for life sciences, announced the U.S. Food and Drug Administration’s (FDA) Office of Pharmaceutical Sciences (OPS) has asked the Company to expand its Cooperative Research and Development Study (CRADA) focusing on process and product development to 25 companies.

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Canadian Business Groups Applaud Bold, Competitive Vision Set Out By Competition Policy Review Panel

A broad coalition of Canadian business groups welcomes the bold vision and ambitious scope of the final report of the Competition Policy Review Panel and calls on the federal government to secure the economic future of all Canadians by acting quickly on the report’s recommendations.

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