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Roche Diagnostics' CoaguChek XS Plus system granted CLIA-waived status

Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing.

From Roche Sequencing and Life Science 31 Mar 2010

Eisai seeks simultaneous approval of eribulin mesylate in U.S., EU and Japan

Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union (EU). Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai.

31 Mar 2010

USPTO issues Notice of Allowance for menadione to prevent skin rash in patients taking EGFR inhibitors

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor inhibitors, such as Erbitux® and Tarceva®, for anti-cancer therapy.

31 Mar 2010

EvoLife Laboratories introduces cancer care products in USA

EvoLife Laboratories, a world leader in the development of products for skin, oral, nail, hair, hygiene care specifically designed for cancer patients undergoing chemotherapy and radiotherapy, announced the launch of its products in USA.

31 Mar 2010

Rebooting and reprogramming the brain

Does the brain you were born with have to be the brain you end up with? If you can improve the function of every major organ in the body, why can't you upgrade the function of your brain? Those fundamental questions were the motivation that led Kelly Howell to create Brain Sync.

31 Mar 2010

FDA accepts filing of Lux Biosciences' NDA for Luveniq and grants application priority review

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration has accepted the filing of the company's New Drug Application for Luveniq™ (oral voclosporin) and has granted the application priority review.

31 Mar 2010

Daily Nation examines fundraising efforts in Kenya to support patients living with HIV/AIDS

The Daily Nation examines efforts underway in Kenya to raise money for patients living with HIV/AIDS who are in need antiretroviral (ARV) therapy.

31 Mar 2010

CVS Caremark awarded Specialty Pharmacy accreditation from URAC

CVS Caremark announced today that it has been awarded Specialty Pharmacy accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry.

31 Mar 2010

Devicor offers to acquire EES Breast Care business

Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson company, today announced it has received an irrevocable, unconditional offer from Devicor Medical Products (Devicor), a portfolio company of GTCR Golder Rauner, LLC, (GTCR), to acquire its Breast Care business. The EES Breast Care business sells products designed to help doctors diagnose breast cancer at early stages, while minimizing patient discomfort. Financial terms of the offer are not being disclosed.

31 Mar 2010

Beta-blockers can reduce cancer spread in patients with breast tumours

The risk of cancer spreading in patients with breast tumours can be lowered with the use of beta-blockers, research presented at the European Breast Cancer Conference in Barcelona suggests.

31 Mar 2010

NMS Labs launches test to evaluate the efficacy of Milnacipran

NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy, the potential for physicians to establish therapeutic drug monitoring of individual patients, and the assessment of drug diversion of a new pain management drug therapy.

31 Mar 2010

FDA grants priority review status for Isotechnika Pharma's voclosporin

Isotechnika Pharma Inc. today announced that the New Drug Application (NDA) for the Company's next generation calcineurin inhibitor, voclosporin, has been accepted for priority review as filed by the U.S. Food and Drug Administration (FDA). The application was submitted by Isotechnika's partner, Lux Biosciences, Inc.

31 Mar 2010

Study indicates estrogenic drug could help treat schizophrenia

An estrogenic drug that influences neurotransmitter and neuronal systems in the brain is showing promise as an effective therapy for women who suffer from schizophrenia.

31 Mar 2010

Study evaluates OCP treatment to prevent endometrioma recurrence

Ovarian endometriomas, better known as ovarian 'chocolate' cysts for the brown liquid they contain, can be easily removed by surgery. However, recurrence is common, which can cause ongoing pain and complications. A study evaluated for Faculty of 1000 suggests a simple and effective remedy - the oral contraceptive pill.

31 Mar 2010

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced the initiation of a randomized, placebo and active controlled, multi-center Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This confirmatory Phase 3 study will be conducted at approximately 23 sites in the United States and randomize approximately 250 patients into three arms: Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).

31 Mar 2010

CTRC initiates patient enrolment in U.S. Phase 2 clinical trial of REOLYSIN

Oncolytics Biotech Inc. announced today that the Cancer Therapy & Research Center at the University of Texas Health Science Center has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs.

30 Mar 2010

Savient Pharmaceuticals' resubmission of BLA for KRYSTEXXA accepted for FDA review

Savient Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application for KRYSTEXXA™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy.

30 Mar 2010

Virginia Tech professor receives NSF CAREER award for research on cancer therapies using nanotechnology

Preliminary research on cancer treatments using nanotechnology and laser therapy has led to a National Science Foundation (NSF) Faculty Early Career Development (CAREER) award for Marissa Nichole Rylander, Virginia Tech assistant professor jointly appointed in the Department of Mechanical Engineering and Virginia Tech - Wake Forest University School of Biomedical Engineering and Sciences (SBES).

30 Mar 2010

Study suggests two distinct versions of multiple sclerosis

There may be two distinct versions of multiple sclerosis, a study in both animal models and human blood samples suggests. What's more, a patient's responsiveness to the most popular first-line drug for this episodic and all-too-often recurring autoimmune condition seems to depend on which version that patient has.

30 Mar 2010

Gout incidence lower in women than men: Study

Researchers from Boston University School of Medicine found that women with serum uric acid levels over 5 mg/dl had a significantly lower risk of developing gout than men. This study, the first to examine the relationship between uric acid levels and gout risk in women, also evaluated purported risk factors for gout and found that increasing age, obesity, hypertension, alcohol use, and diuretic use to be among leading contributors for women.

30 Mar 2010