United States

Human Longevity, Cleveland Clinic collaborate on human genomics

Monday, May 18, 2015 01:04 PM

Human Longevity (HLI), a San Diego-based, privately held company building a comprehensive database of human genotypes and phenotypes, and the Cleveland Clinic, a nonprofit multispecialty academic medical center, have inked a broad collaboration agreement to first sequence and analyze blood samples from Cleveland Clinic's GeneBank study of de-identified patients.

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OMT Therapeutics, Caltech ink UniRat alliance

Monday, May 18, 2015 01:01 PM

The California Institute of Technology (Caltech) has partnered with OMT Therapeutics, a private, California-based biotech company, to use OMT Therapeutics’ fully human nanobody platform, UniRat, for the generation of nanobodies against HIV-1.

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23andMe launches Lupus research study in collaboration with Pfizer

Thursday, May 14, 2015 10:19 AM

23andMe, a personal genetics company based in Mountain View, Calif., has launched the Lupus Research Study in collaboration with Pfizer. The companies aim to enroll 5,000 individuals with systemic lupus erythematosus, more commonly known as lupus, into the study to help better understand the genetics of lupus. The effort also is in collaboration with the Lupus Research Institute and in concert with Lupus Awareness Month in May.

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FPWR, NORD launch Global Prader-Willi Syndrome Registry

Monday, May 4, 2015 01:23 PM

The Foundation for Prader-Willi Research (FPWR), a nonprofit charitable organization, and National Organization for Rare Disorders (NORD), a nonprofit organization representing all patients and families affected by rare diseases in the U.S., have launched the Global Prader-Willi Syndrome Registry, a new database to accelerate research and cures for the rare disease Prader-Willi Syndrome (PWS).

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FDA approves first generic Abilify to treat mental illnesses

Thursday, April 30, 2015 11:07 AM

Alembic Pharmaceuticals, Hetero LabsTeva Pharmaceuticals and Torrent Pharmaceuticals have received FDA approval to market generic Abilify (aripiprazole) in multiple strengths and dosage forms. Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. 

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NIH names Dr. Eliseo Pérez-Stable director of the NIMHD

Thursday, April 30, 2015 10:47 AM

National Institutes of Health director Francis S. Collins, M.D., Ph.D., has announced the selection of Eliseo J. Pérez-Stable, M.D., as director of the National Institute on Minority Health and Health Disparities (NIMHD). Dr. Pérez-Stable is expected to join NIH in September.

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Takeda appoints new president of U.S. business unit

Thursday, April 16, 2015 03:11 PM

Takeda Pharmaceutical has appointed Ramona Sequeira as president of the U.S. business unit. In this role, Sequeira will lead all business operations for the U.S., and will report to Christophe Weber, the president and CEO of Takeda.

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Reata Pharmaceuticals receives Orphan Drug Designation for Bardoxolone Methyl

Thursday, April 16, 2015 02:42 PM

The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for Reata Pharmaceuticals’ bardoxolone methyl for the treatment of pulmonary arterial hypertension (PAH). PAH is a life-threatening disease involving endothelial dysfunction, pulmonary vasoconstriction, vascular remodeling, pulmonary fibrosis and right ventricular hypertrophy. Additionally, PAH involves skeletal muscle dysfunction that contributes to the exercise intolerance observed in PAH patients. In preclinical studies, bardoxolone methyl has demonstrated potent antioxidant, anti-inflammatory, and bioenergetic properties, which may lead to improved exercise tolerance in patients.

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FDA modifies partial clinical hold on Tekmira's TKM-Ebola IND

Thursday, April 16, 2015 02:33 PM

The FDA has notified Tekmira Pharmaceuticals, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV) headquartered in Vancouver, BC, Canada, that the partial clinical hold on the company's Investigational New Drug application (IND) for TKM-Ebola has been modified to permit repeat dosing of healthy volunteers at a dose of 0.24mg/kg/day. The IND remains on partial clinical hold with regard to doses above 0.24mg/kg/day in healthy volunteers.

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IBM launches Watson Health Cloud, partners with Johnson & Johnson, Medtronic and Apple for personal health

Tuesday, April 14, 2015 11:51 AM

IBM is establishing a Watson Health Cloud that will provide a secure and open platform for physicians, researchers, insurers and companies focused on health and wellness solutions. 

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CWWeekly

July 6

FDA sued by advocacy groups seeking hepatitis C trials data

Google to test health-tracking wristband to collect clinical trial data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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