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FDA approves Xiaflex drug for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration (FDA) has approved Xiaflex, a new drug to treat Dupuytren's contracture (or disease) that was discovered and developed by Marie A. Badalamente, Ph.D., and Lawrence C. Hurst, M.D., in the Department of Orthopaedics at Stony Brook University Medical Center.

4 Feb 2010

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Seattle Genetics, Inc. and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma.

4 Feb 2010

National consensus reached on Joint Technical Statement for drug products

A pan-Canadian initiative was announced today that will ultimately have a major impact on patient safety by reducing preventable medication errors.

4 Feb 2010

Repligen receives USPTO Notice of Allowance for patent covering a recombinant form of Protein A

Repligen Corporation announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities.

4 Feb 2010

UBC announces the opening of new global office in Tokyo, Japan

nited BioSource Corporation (UBC) today announced the opening of its newest global office in Tokyo, Japan. The UBC office will be led by Kumpei Kobayashi, PharmD, a biopharmaceutical industry veteran with over 20 years of product development experience throughout the Asia-Pacific region.

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

Drug company CEOs under pressure

Dow Jones Newswires/The Wall Street Journal on Severin Schwan, chief executive of Swiss pharmaceutical company Roche Holding AG: "'It is difficult to gauge the impact of the planned U.S. healthcare reform on the pharmaceutical industry,' Schwan told reporters at a media conference to detail 2009 earnings. 'On the one hand, more U.S. citizens will be getting access to healthcare, which is positive. At the same time, pressure on drug prices will certainly increase,' he added." The wire service adds that he also said "decisions on generic biosimilars will be key" (Greil, 2/3).

3 Feb 2010

DLA stocks USNS Comfort with medical supplies for Haiti in a day's notice

Getting the USNS Comfort stocked with needed supplies before it steamed out of the Baltimore harbor and headed for earthquake-stricken Haiti was a high priority for logisticians and acquisition specialists at the Defense Logistics Agency's supply center in Philadelphia.

3 Feb 2010

Ambassadors of Purple selected to help promote Purple Day for Epilepsy

As the third annual, worldwide Purple Day for Epilepsy approaches on March 26, 2010, organizers in Canada and in 15 other participating countries around the globe are looking for volunteers to promote epilepsy awareness in local communities.

3 Feb 2010

Home Diagnostics signs definitive merger agreement with Nipro

Home Diagnostics, Inc., a leading manufacturer and marketer of diabetes testing supplies, announced today that it signed a definitive merger agreement with Nipro Corporation (Tokyo Stock Exchange and Osaka Stock Exchange Ticker Code 8086), a global manufacturer and distributor of medical devices, pharmaceutical products and medical and glass products headquartered in Osaka, Japan, under which Nipro will acquire all outstanding shares of Home Diagnostics’ common stock, $.01 par value, for a cash purchase price of $11.50 per share (or aggregate consideration of approximately $215 million).

3 Feb 2010

Report: California biomedical industry faces unprecedented challenges

The biomedical industry is one of the most recession-resilient sectors in California's hard-hit economy and a critical driver of innovation, job growth and revenue that will help lead the state to economic recovery, according to a report released today by the California Healthcare Institute (CHI) and PricewaterhouseCoopers LLP (PwC).

3 Feb 2010

SNM Clinical Trials Network Workshop: Experts to discuss usage of molecular imaging

On Feb. 2, the final day of the second annual SNM Clinical Trials Network Workshop, experts working in various facets of the molecular imaging community met in Albuquerque, N.M., to discuss the nuts and bolts of using imaging in clinical trials and the challenges and opportunities ahead in the regulatory landscape.

3 Feb 2010

Pall launches PallSep Biotech filtration system

Pall Corporation, a global leader in filtration, separation and purification, has introduced the PallSep Biotech system for the gentle separation of target molecules from complex biotechnology process fluids.

From Pall Corporation 3 Feb 2010

New resources to support Teva Pharmaceutical Industries' Tjet injector system now available

Teva Pharmaceutical Industries Ltd. announced today the availability of new resources to support the recently introduced Tjet® injector system, a needle-free device designed to deliver Teva’s TEV-TROPIN® [somatropin (rDNA origin) for injection] brand human growth hormone (hGH) to children who have growth failure due to inadequate secretion of normal endogenous growth hormone.

3 Feb 2010

Hundred millions for biotech-licence

Apeiron Biologics AG (Apeiron) today announced the signing of an agreement granting GlaxoSmithKline (GSK) exclusive rights to APN01 (recombinant human Angiotensin Converting Enzyme 2, rhACE2), an enzyme biotherapeutic currently in Phase 1 development for the treatment of the Acute Respiratory Distress Syndrome (ARDS).

3 Feb 2010

GE Healthcare expands ecomagination product portfolio, adds Centricity Enterprise EMR solution

GE Healthcare, a unit of General Electric Company, today announced that it has expanded its portfolio of ecomagination products aimed at helping healthcare companies and hospitals reduce cost and waste while positively impacting the environment. The GE ecomagination portfolio of more than 85 products now includes two new healthcare products and three product categories, including the Centricity Enterprise Electronic Medical Record (EMR) solution.

3 Feb 2010

Hypertension drug market to decrease through 2013 due to generic erosion and few emerging therapies

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in addition to extensive generic erosion, the hypertension drug market will be constrained through 2018 by a pipeline containing very few emerging therapies with novel mechanisms of action. Gilead's darusentan was positioned to be the next emerging therapy with a novel mechanism of action to reach the hypertension market. However, following darusentan's failure to meet its primary endpoint in the recent DORADO-AC Phase III clinical trial, further development of the agent has been terminated.

3 Feb 2010

BioSpecifics Technologies' XIAFLEX receives FDA approval

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.

3 Feb 2010

Celsis IVT alleges patent infringement, files lawsuit against Sekisui Chemical and subsidiaries

Celsis In Vitro, Inc. announced today that it has filed a patent infringement lawsuit against XenoTech LLC, Sekisui Chemical Co. Ltd., and Sekisui Medical Co. Ltd. in the United States District Court for the Northern District of Illinois in Chicago. XenoTech and Sekisui Medical are wholly-owned subsidiaries of Sekisui Chemical.

3 Feb 2010

Entelos awarded U.S. patent for apparatus and methods of assessing metabolic substrate utilization

Entelos, Inc., a simulation and modeling company focused on human health, announced today that the U.S. Patent and Trademark Office has granted U.S. Patent No. 7,654,955 entitled “Apparatus and Methods for Assessing Metabolic Substrate Utilization” to the Company. These methods further strengthen the Entelos® Metabolism PhysioLab® platform and leverage insights about human physiology that can lead to improved diagnosis, clinical testing, and personalized treatment across a highly variable patient population.

2 Feb 2010

Pharmaceuticals News and Research

FDA approves Xiaflex drug for treatment of Dupuytren's contracture

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

National consensus reached on Joint Technical Statement for drug products

Repligen receives USPTO Notice of Allowance for patent covering a recombinant form of Protein A

UBC announces the opening of new global office in Tokyo, Japan

Phase 2a clinical trial results of VX-809 in patients with CF announced

Drug company CEOs under pressure

DLA stocks USNS Comfort with medical supplies for Haiti in a day's notice

Ambassadors of Purple selected to help promote Purple Day for Epilepsy

Home Diagnostics signs definitive merger agreement with Nipro

Report: California biomedical industry faces unprecedented challenges

SNM Clinical Trials Network Workshop: Experts to discuss usage of molecular imaging

Pall launches PallSep Biotech filtration system

New resources to support Teva Pharmaceutical Industries' Tjet injector system now available

Hundred millions for biotech-licence

GE Healthcare expands ecomagination product portfolio, adds Centricity Enterprise EMR solution

Hypertension drug market to decrease through 2013 due to generic erosion and few emerging therapies

BioSpecifics Technologies' XIAFLEX receives FDA approval

Celsis IVT alleges patent infringement, files lawsuit against Sekisui Chemical and subsidiaries

Entelos awarded U.S. patent for apparatus and methods of assessing metabolic substrate utilization

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