Latest Clinical - Approvals News

New Wellness Team Approach Improves Diabetes Outcomes while Lowering Medication Costs An integrated wellness team approach to diabetes care is helping patients lower their prescription costs and improve their condition, according to research presented today at the American Association of Clinical Endocrinologists’ (AACE) 21st Annual Scientific & Clinical Congress

Regular Aerobic Exercise Improves Vascular Reactivity for Patients at Risk of Developing DiabetesPre-diabetic patients who engage in regular aerobic exercise improve their vascular reactivity to nearly normal levels, even if no weight loss is achieved, according to research presented today at the American Association of Clinical Endocrinologists (AACE) 21st Annual Meeting & Clinica

Sanofi to Start China Clinical Trial of Cancer Drug In-licensed from SIBSSanofi hopes to begin a Phase I clinical trial in China next year of a novel drug that targets liver cancer. The molecule inhibits the slit-robo signaling path that controls tumor vasculature and tumor growth, a discovery made by researchers at th...

News digest – clinical trials, bowel cancer screening, coffee and cancer, and moreSunday was International Clinical Trials Day. To mark the occasion, Gareth Griffiths, Scientific Director of our Wales Cancer Trials Unit, wrote us an article about the world-class clinical trials being carried out there. Nearly one in five cancer pa...

Clinical Support Services Develops MTM Program Assessment GuideCMS has strengthened MTM program rules and regulations, so Medicare plans are urged to take a hard look at their offerings to ensure their compliance and success. Buffalo, NY (PRWEB) May 26, 2012 New Medication Therapy Management (MTM) program requirements outlined by the Centers for Medicare & Medicaid Services (CMS) will make delivering a successful and compliant MTM program more challengin...

Bayer seeks US FDA approval for regorafenib to treat metastatic colorectal cancerBayer HealthCare,, the US─based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the oral multi─kinase inhibit...

Apollo Group's White Dental Clinic offers high end clinical─cosmetic procedures to save natural teethWhite Dental Clinic, an Apollo Group initiative, is offering Micro Dentistry and Snap─on─Smile which would prove to be economical in the long run for patients.

[Articles] Magnesium for aneurysmal subarachnoid haemorrhage (MASH-2): a randomised placebo-controlled trialIntravenous magnesium sulphate does not improve clinical outcome after aneurysmal subarachnoid haemorrhage, therefore routine administration of magnesium cannot be recommended.

Breast Cancer Risk Associated With Sex Hormones Reduced By Losing WeightThe Journal of Clinical Oncology has published a study online which reveals that even a moderate amount of weight loss can considerably decrease levels of circulating estrogens that are linked to a higher risk of breast cancer. Anne McTiernan, M.D.,...

City of Hope Receives $5 Million Grant to Develop T Cell Treatment Targeting Brain Tumor Stem CellsCity of Hope was granted a $5,217,004 early translational research award by the California Institute for Regenerative Medicine (CIRM) to support the development of a T cell-based immunotherapy that re-directs a patient’s own immune response against glioma stem cells. City of Hope has been awarded more than $49.7 million in grant support from CIRM since a...

InVivo Therapeutics Announces Webcast for Annual Shareholders Meeting to Be Held on May 30thInVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that the Company will be conducting a webcast of the Annual Shareholders Meeting scheduled for Wednesday, May 30, 2012 at 9:00 a.m. Eastern Daylight Time at One Broadway, 5th Floor, Cambridge, MA 021...

Cannabis Science Gets Set to Release “Phytiva” Its Newest Brand of Over-the-Counter Skin and Nutraceutical Product Lines Through its Newest Venture Phytiva Pharmaceuticals Inc.Cannabis Science, Inc. (OTCBB: CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to provide insight on the upcoming release of its’ new over-the-counter skin and nutraceutical product line to be branded “Phytiva” through its newest venture Phytiva Pharmaceuticals Inc. The Company is working as...

Clinilabs Opens Phase I Unit in New JerseyClinilabs, an early phase and specialty CRO that provides clinical drug development services to the pharmaceutical industry, announced Thursday that they have opened a second Phase I unit in Southern New Jersey.

Chugai seeks Japanese approval for pertuzumabChugai Pharmaceutical Co. Ltd. (Tokyo:4519) said it submitted an NDA to the Japanese Ministry of Health, Labor and Welfare (MHLW) for pertuzumab to treat HER2-positive metastatic or recurrent breast cancer. Chugai, which is majority owned by Roche (S...

CHMP recommends perampanel, aclidinium bromideEMA's CHMP issued several positive opinions on Friday, including one backing approval of Fycompa perampanel from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) to treat partial-onset seizures in epilepsy patients. The committee also supported approval of Br...

EMA committee backs approval of KalydecoEMA's CHMP issued a positive opinion recommending approval of Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis in patients ages six years and older who have at least one copy of the G551D mutation in the cyst...

Short Course of Drug Fails in Vent-Associated Pneumonia (CME/CE)SAN FRANCISCO (MedPage Today) -- A short course of high-dose doripenem (Doribax) for ventilator-associated pneumonia did more harm than good, and a clinical trial testing the approach was stopped early, a researcher said here.

CHMP recommends Medac's generic Zometa, clears infected MabThera, seeks harmonyThe EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended for approval German firm Medac's generic version of Novartis' Zometa (Zoledronic acid). The product, Zoledronic acid medac, is a concentrate solution for.....

Center for Ambulatory Surgery Selects ProVation® Medical Software for Gastroenterology Procedure Documentation and CodingWolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today that the Center for Ambulatory Surgery has selected its ProVation® Medical Software for gastroenterology procedure documentation and coding. Located in West Seneca, NY, the Center for Ambulatory Surgery provides outpat...

Advanced Biological Laboratories' DeepChek® and ViroScore® Suite Clinical Genotyping Solutions For Personalized Treatment of HIV Receive CE Mark for In Vitro Diagnostic UseAdvanced Biological Laboratories (ABL) announced today that DeepChek® and ViroScore® Suite clinical genotyping solutions are now CE-IVD (In Vitro Diagnostics) approved for commercial use in Europe and other countries that recognise CE certification. This approval is further validating the use of our next generation sequencing (NGS) downstream an...

The Law Office of Ronald A. Marron, APLC and Patton Boggs LLP Announce Preliminary Approval of Class Action SettlementSAN DIEGO, May 25, 2012 /PRNewswire/ -- The following notice is being issued pursuant to an order of the United States District Court, Southern District of California: If you purchased a product manufactured by Boiron such as Oscillococcinum, Children's Oscillococcinum, Arnicare, Quietude, Camilia or Coldcalm between January 1, 2000 and the present, your rights may be affected by a proposed...

Postprostatectomy Test Predicts Risk for Clinical RecurrenceAn ultrasensitive immuno-PCR assay provides prognostic data after radical prostatectomy. Medscape Medical News

FDA clears Medigus SRS endoscopic systemThe US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system.

True Diagnostics wins CE mark approval for TrueDX Platform,TSH testTrue Diagnostics has obtained CE mark approval for its TrueDX Platform and thyroid stimulating hormone (TSH) test.

Drugmakers pledge transparency to tackle credibility problem in journalsEight leading pharmaceutical companies have approved 10 recommendations aimed at improving transparency to address what they call a “credibility gap” that faces industry-funded clinical research. (American Medical News)

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