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FDA accepts for filing Cladribine Tablets NDA for MS

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).

28 Jul 2010

Research findings provide new insight into skeletal development

Too little of a protein called neogenin results in a smaller skeleton during development and sets the stage for a more fragile bone framework lifelong, Medical College of Georgia researchers report.

28 Jul 2010

New York Times examines questions left unanswered by microbicide trial

The New York Times examines a set of questions raised by news out of the International AIDS Conference-AIDS 2010 last week that a microbicide gel containing the antiretroviral tenofovir used by women before and after sex helped reduce their risk of HIV infection by 39 percent.

28 Jul 2010

Integral Molecular receives patent for Lipoparticle membrane protein technology

Integral Molecular, Inc. today announced the issuance of a key patent covering its technology for deriving high concentrations of membrane proteins. The patent, issued by the U.S. Patent and Trademark Office, covers the core composition of Integral Molecular's Lipoparticle technology, a novel cell-free format for deriving highly-concentrated membrane proteins for antibody development, drug discovery, and biomedical research.

28 Jul 2010

Genzyme accepts CMS decision for delaying Renvela administration to dialysis patients

Genzyme Corp.today said it welcomed the Centers for Medicare and Medicaid Services' decision not to include oral medications without IV equivalents in Medicare's End Stage Renal Disease patient benefit. According to the final rule, these medications, including Genzyme's Renvela (sevelamer carbonate), will not be included in the bundle until January 1, 2014.

28 Jul 2010

GSK awards NCCN $4 million grant for study of ofatumumab and pazopanib

The National Comprehensive Cancer Network has been awarded two individual $2 million grants from GlaxoSmithKline to support clinical studies of ofatumumab (Arzerra®, GlaxoSmithKline) in the treatment of hematologic malignancies and pazopanib (Votrient®, GlaxoSmithKline) in the treatment of solid tumors.

28 Jul 2010

LLS collaborates with Shape Pharmaceuticals to advance treatment for CTCL

The Leukemia & Lymphoma Society (LLS) and Shape Pharmaceuticals announced today that they have entered into a partnership to advance Shape's novel, topical treatment for cutaneous T-Cell lymphoma (CTCL) into clinical development. The compound, SHP-141, is a first-in-class topical histone deacetylase inhibitor with the potential to treat both early- and late-stage CTCL.

28 Jul 2010

Medicare to bundle payments for end-stage renal care, reward quality

Medicare payment for end-stage renal disease care may soon be tied to performance and quality measures if a new proposed rule issued by the Centers for Medicare and Medicaid Services is finalized. "If the rule is finalized, ESRD providers that do not meet set standards" - two measures for anemia management and one for hemodialysis quality - "could have their Medicare payments lowered by up to 2 percent starting January 2012, the CMS said" (McKinney, 7/26).

28 Jul 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

Report: Generic drugs offer savings for Medicaid

A new report suggests that expanding use of generic drugs could offer significant savings for Medicaid.

28 Jul 2010

Research on method to open blood-brain barrier for safe cancer drug delivery

One of the human body's most powerful defensive tools, the blood-brain barrier is a chemical labyrinth that prevents toxins and viruses in the bloodstream from reaching the brain. This foolproof security system, however, limits the ability of physicians to deliver drugs directly to the brain, making it difficult to treat brain tumors. Researchers at Rensselaer Polytechnic Institute are endeavoring to solve this problem by investigating new methods for bypassing the blood-brain barrier and combating the spread of brain cancer.

28 Jul 2010

MabCure's MAbs 94% accurate in identifying ovarian cancer

Biotechnology company MabCure, Inc. today announced that a confirmatory study demonstrated the company's proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood. MabCure's serum diagnostic test is the first to recognize unique tumor markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers.

28 Jul 2010

Scientists develop novel chemotherapeutic method for anticancer drug delivery

Combining nature and Greek mythology, researchers at the Technion-Israel Institute of Technology have developed a tiny "Trojan Horse" system for delivering cancer-fighting drugs. With this system, the drugs are delivered only once they are inside the cancerous cells, so there is no damage to the healthy cells in the surrounding area.

28 Jul 2010

Attaching transferrin to nanoparticle surface can kill cancer cells

A normally benign protein found in the human body appears to be able - when paired with nanoparticles - to zero in on and kill certain cancer cells, without having to also load those particles with chemotherapy drugs.The finding could lead to a new strategy for targeted cancer therapies, according to the University of North Carolina at Chapel Hill scientists who made the discovery.

28 Jul 2010

Momenta Pharmaceuticals provides update on generic Lovenox ANDA litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today provided an update regarding a lawsuit that Sanofi-Aventis U.S. LLC filed in the United States District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA), Margaret A. Hamburg, Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services.

27 Jul 2010

Progenra receives Official Notice of Allowance for screening platform

Progenra, Inc., announced today their receipt of an Official Notice of Allowance, dated June 15, 2010, of U.S. Patent Application No. 11/156,707, "Diagnostic and Screening Methods and Kits Associated with Proteolytic Activity." IP protection of this technology was also recently granted by the European Union. This technology will enable faster drug discovery by improving the ability to identify more selective drugs that modulate the handling of proteins associated with various disease states.

27 Jul 2010

Thermo Fisher Scientific highlights products, services for clinical research and specialty diagnostics at AACC 2010

Thermo Fisher Scientific Inc., the world leader in serving science, will highlight its innovative offering of products and services for clinical research and specialty diagnostics during the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo held in Anaheim, California, July 25 - 29, 2010.

From Thermo Fisher Scientific Inc. 27 Jul 2010

Studies that compare treatment options for carotid artery disease provide no clear answer, physician reports

A review of scientific studies that compares two treatments for preventing strokes due carotid artery disease provides no clear answer on which treatment is better, a UT Southwestern Medical Center physician reports in an editorial in today's issue of the Archives of Internal Medicine.

27 Jul 2010

Journal of Mental Health features special issue on diagnosing mental illness

This month Journal of Mental Health features a special issue on diagnosing mental illness. The issue - which comes out just weeks after the eagerly-awaited new draft of the Diagnostic and Statistical Manual of Mental Disorders, the global diagnostic 'bible' for the field of mental health medicine - includes a series of articles written by high profile mainstream personalities on what a diagnosis of mental illness has meant to them.

27 Jul 2010

SeeChange Health Insurance to offer value-based HSA products to California employers

SeeChange Health Insurance Company, a provider of value-based health insurance plans to employers, will offer a variety of Health Savings Account products in parts of California beginning August 1, 2010. The product launch will make SeeChange Health the first insurance company to offer value-based HSA products to California employers.

27 Jul 2010