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Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

Discoveries in study and manipulation of human ES cells win first prize in research competition

World-recognized discoveries in the study and manipulation of human embryonic stem cells have won first prize in a prestigious applied research competition for a Hebrew University of Jerusalem researcher.

22 Jun 2010

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

OrbusNeich today announced that six-month clinical follow-up data show the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please®, B.Braun) followed by implantation of the company's Genous Bio-engineered R stent for the percutaneous treatment of coronary artery stenosis.

22 Jun 2010

Four-year clinical study results show sustained effect that Rheos System has on reducing hypertension

CVRx, Inc. announced today the four-year Rheos clinical results from the European study evaluating the Rheos System at the European Society of Hypertension 20th Meeting. The system is the first device designed to treat hypertension (high blood pressure), a leading cause of heart and kidney disease, stroke and death. This device is a future treatment option for the millions of people who cannot control their blood pressure with medications.

22 Jun 2010

Celator announces expansion of research agreement with Cephalon

Celator Pharmaceuticals today announced that it has expanded its research agreement with Cephalon, Inc.. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

22 Jun 2010

Women who experience early menopause may have cardiovascular disease later in life: Study

Women who experience early menopause appear to have more than twice the risk of having a heart attack, stroke or other cardiovascular disease event later in life than do women who do not go through early menopause, a new study indicates. The results will be presented Saturday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

Experimental cure for Type 1 diabetes

Researchers have developed an experimental cure for Type 1 diabetes, a disease that affects about one in every 400 to 600 children and adolescents. They will present their results in a mouse model of Type 1 diabetes on Sunday at The Endocrine Society's 92nd Annual Meeting in San Diego.

21 Jun 2010

Boston Scientific adds 22 new balloon sizes to PolarCath Peripheral Dilatation System

Boston Scientific Corporation today announced that 22 new balloon sizes have been added to the PolarCath® Peripheral Dilatation System, including balloon lengths of 120 and 150 mm. The PolarCath System is used to restore blood flow in patients with critical limb ischemia (severe blockages in the arteries below the knee) and blockages in the femoral and popliteal (behind the knee) arteries. Both conditions result from peripheral artery disease.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

Gamida Cell-Teva Joint Venture's StemEx program receives FDA Fast Track Designation

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.

21 Jun 2010

Positive preclinical data on Aeterna Zentaris' AEZS-130/Ghrelin Receptor Agonist presented at ENDO meeting

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, was presented yesterday at the 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which is held through June 22, 2010 at the San Diego Convention Center in San Diego, California.

21 Jun 2010

Cancer survivor organizes first Chattanooga Oral Cancer Awareness Walk

Recently, oral cancer survivor Jeanna Richelson, organized the first Chattanooga Oral Cancer Awareness Walk, which raised donations for the Oral Cancer Foundation, and much needed awareness of a disease that too few Americans know about. According to the foundation's executive director Brian Hill, "I don't believe there has ever been an oral cancer walk that was this successful in its first year. This was an absolutely amazing effort by Jeanna and those who helped her make this possible."

21 Jun 2010

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

OncoGenex Pharmaceuticals, Inc. announced today the initiation of a Phase 3 registration trial of custirsen sodium (OGX-011/TV-1011), its lead product candidate being developed for the treatment of castrate-resistant prostate cancer (CRPC). This trial, referred to as the Prostate Cancer SATURN Trial, is the first of three Phase 3 trials to be initiated under a global collaboration and license agreement between OncoGenex and Teva Pharmaceutical Industries to develop and commercialize OGX-011/ TV-1011.

21 Jun 2010

FDA accepts ev3's Pipeline Embolization Device PMA for expedited review

ev3 Inc., a global endovascular device company, today announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the Pipeline Embolization Device for treatment of large, giant and wide-necked cerebral aneurysms. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is May 18, 2010, the date the FDA received ev3's PMA submission.

21 Jun 2010

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Stallergenes S.A. announces the results of a phase III clinical trial (VO55.06) conducted in China aimed at assessing the efficacy and safety of sublingual immunotherapy (Staloral(R) mites 300) in adult patients suffering from asthma triggered by house dust mites.

21 Jun 2010

Medco Health Solutions, Celesio join to help relieve financial burden on healthcare payors across Europe

Medco Health Solutions, Inc. and Celesio AG, two of the world's leading pharmacy-driven healthcare companies, today announced a joint venture with a long-term goal of improving patient health and helping to relieve the crushing financial burden on healthcare payors across Europe.

21 Jun 2010

GSK acquires exclusive marketing rights for new topical patch from Labtec GmbH

In a recently finalized license agreement, the Consumer Healthcare division of GlaxoSmithKline acquired the exclusive marketing rights for a new topical patch for the treatment of cold sores from Labtec GmbH, the transdermal and topical patch specialist based in Langenfeld, Germany. The agreement designates Labtec as the exclusive manufacturer.

21 Jun 2010

Zydus Cadila receives DCGI approval to initiate Phase I clinical trial for ZYOG1

Zydus Cadila, a global healthcare provider and one of India's leading healthcare companies has received Phase I clinical trial permission from the DCGI for ZYOG1 - a novel GLP-1 agonist. Designed and developed at the Zydus Research Centre using a unique platform technology, ZYOG1 is a novel, oral, anti-diabetic molecule.

21 Jun 2010

PAS technique to predict how blood platelets respond to complex conditions found during heart attack

A team of bioengineers from the University of Pennsylvania Institute for Medicine and Engineering have trained a computer neural network model to accurately predict how blood platelets would respond to complex conditions found during a heart attack or stroke.

21 Jun 2010

Therapy News and Research

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Discoveries in study and manipulation of human ES cells win first prize in research competition

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

Four-year clinical study results show sustained effect that Rheos System has on reducing hypertension

Celator announces expansion of research agreement with Cephalon

Women who experience early menopause may have cardiovascular disease later in life: Study

Experimental cure for Type 1 diabetes

Boston Scientific adds 22 new balloon sizes to PolarCath Peripheral Dilatation System

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Gamida Cell-Teva Joint Venture's StemEx program receives FDA Fast Track Designation

Positive preclinical data on Aeterna Zentaris' AEZS-130/Ghrelin Receptor Agonist presented at ENDO meeting

Cancer survivor organizes first Chattanooga Oral Cancer Awareness Walk

OncoGenex initiates Phase 3 Prostate Cancer SATURN Trial

FDA accepts ev3's Pipeline Embolization Device PMA for expedited review

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Medco Health Solutions, Celesio join to help relieve financial burden on healthcare payors across Europe

GSK acquires exclusive marketing rights for new topical patch from Labtec GmbH

Zydus Cadila receives DCGI approval to initiate Phase I clinical trial for ZYOG1

PAS technique to predict how blood platelets respond to complex conditions found during heart attack

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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