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Scientific advances at Scripps Research lay foundation for new lupus drug Benlysta

Scientific advances at The Scripps Research Institute were key to laying the foundation for the new drug Benlysta® (belimumab), approved today by the U.S. Food and Drug Administration. Benlysta®, which treats the most common type of lupus, is the first in a new class of pharmaceuticals that prevents the body from attacking its own critical tissues.

11 Mar 2011

Simcere files IND with SFDA of China for APX003 to treat cancer

Apexigen, Inc., an emerging biopharmaceutical company focusing on the development of monoclonal antibody therapeutics, announced today that its partner, Simcere Pharmaceutical Group, a leading pharmaceutical company in China, filed an Investigational New Drug application with the State Food and Drug Administration of China to evaluate APX003 as a potential cancer therapy.

11 Mar 2011

PNP reaches several major objectives in cancer therapeutic product development

PNP Therapeutics, Inc. — an early-stage Birmingham-based biopharmaceutical company created from research conducted at Southern Research Institute and The University of Alabama at Birmingham — today announced that several major objectives have been reached in the development of its therapeutic technology platform and proprietary products for the treatment of cancer.

11 Mar 2011

FDA announces consent decree of permanent injunction against McNeil-PPC

The U.S. Food and Drug Administration announced today that a consent decree of permanent injunction has been filed against McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.

11 Mar 2011

FDA holds Senesco's SNS01-T clinical study due to delay of supplier's DMF updation

Senesco Technologies, Inc., announced today that the U.S. Food and Drug Administration has informed the Company that its planned study in multiple myeloma is on hold until the Drug Master File of one of its suppliers is updated.

11 Mar 2011

OncoVista plans to advance reduced-toxicity targeted cancer treatments

OncoVista Innovative Therapies, Inc., reported in a letter to shareholders that it is moving forward on its business plan to develop targeted, safer and more efficacious cancer treatments with reduced or no toxicity.

11 Mar 2011

Canadian House of Commons passes bill that could ease access to generic drugs in developing countries

Canadian lawmakers in the country's House of Commons on Wednesday "approved a bill aiming to ease the process that lets generic drug manufacturers produce patented medicines for export to poor nations at cheaper prices in a move the pharmaceutical industry says could undermine intellectual property rights," Bloomberg reports.

11 Mar 2011

Researchers concerned about use of mercury-based compound in inactivated flu vaccines

As the United Nations, the European Commission, and the United States Food and Drug Administration evaluate the health and environmental risks associated with mercury, a known neurotoxin, carcinogen, mutagen, teratogen, and immune-system disruptor, new research continues to fuel concerns about Thimerosal, a mercury-based compound used as a preservative in inactivated flu vaccines.

11 Mar 2011

Murad launches new powerhouse anti-aging treatment product

Murad, Inc. has announced the launch of Complete Reform with Glyco Firming Complex, the latest powerhouse anti-aging treatment product in the company's award-winning Age Reform line.

11 Mar 2011

SAMHSA study finds 51.5% drug-related hospital visits by older patients

Adults aged 50 and older comprise 51.5 percent of all emergency department visits each year related to adverse reactions to medications, according to a study by the Substance Abuse and Mental Health Services Administration.

11 Mar 2011

Infant formulas with fluoridated water increase risk of discolored teeth: HHS

All infant formulas, either concentrated or ready-to-feed, already contain some fluoride and, when routinely mixed with fluoridated water, increase the risk of dental fluorosis, according to Dr. Howard Koh, Assistant Secretary for Health, U.S. Department of Health and Human Services in a video commentary published on Medscape.com, March 8, 2011.

11 Mar 2011

Eisai, Epizyme partner to develop and commercialize EZH2 epigenetic enzyme

Epizyme, Inc. announced today a worldwide partnership with Eisai Co., Ltd., Tokyo, Japan to discover, develop and commercialize therapeutics targeting EZH2, an epigenetic enzyme, for the treatment of lymphoma and other cancers in genetically-defined patients.

11 Mar 2011

FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

Novartis new MS treatment receives Notice of Compliance in Canada

Novartis Pharmaceuticals Canada Inc. announced today that its new MS treatment, Gilenya, has received Notice of Compliance in Canada.

10 Mar 2011

FDA approves Covidien's LEU-based Mo-99 medical isotope

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration has approved the use of molybdenum-99 derived from low-enriched uranium (LEU) in the production of technetium-99m generators.

10 Mar 2011

Medtronic resolves FDA warning letters over Mounds View, Juncos facilities

Medtronic, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the company that issues noted in two warning letters -- one from November 2009 regarding the company's Mounds View, Minnesota facility and another from June 2009 regarding the company's manufacturing facility in Juncos, Puerto Rico -- have been resolved.

10 Mar 2011

Despite aspirin therapy, specific inflammatory pathways may influence risk of colorectal cancer

The reduced risk of colorectal cancer associated with taking aspirin or other nonsteroidal anti-inflammatory drugs may be confined to individuals already at risk because of elevations in a particular inflammatory factor in the blood.

10 Mar 2011

Pepscan signs Research and License Agreement with Crucell to devlop novel vaccines

Pepscan Therapeutics, the Dutch biotechnology firm focusing on protein mimicry technology, today announces that it has signed a Research and License Agreement with Crucell Holland B.V. the Dutch developer of vaccines and antibodies.

10 Mar 2011

Scientists identify chemical compound that may lead to cancer-fighting drugs

Researchers at UT Southwestern Medical Center have identified a chemical compound that may eventually lead to a drug that fights cancers that are dependent on a particular anti-viral enzyme for growth.

10 Mar 2011

AHF unveils new national advertising campaign about AIDS drugs

AIDS Healthcare Foundation today unveiled a new national advertising campaign headlined, "There Is No Magic Pill," an advocacy and awareness campaign to educate and prompt discussion among gay men and others regarding Gilead Sciences and its likely plans to seek Food and Drug Administration approval for use of its blockbuster AIDS drug Truvada as a form a 'pre-exposure prophylaxis' to prevent HIV transmission.

10 Mar 2011