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USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo® tablets.

1 Oct 2010

AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

AcelRx Pharmaceuticals, Inc. today announced that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for ARX-02, a proprietary Sufentanil NanoTab™ Breakthrough Pain Management System for the treatment of cancer breakthrough pain in opioid-tolerant patients. FDA reviewed a package based on the previously announced positive Phase 2 clinical study results to date for ARX-02 and provided AcelRx with guidance on the Phase 3 program design and NDA requirements.

1 Oct 2010

CVS/pharmacy's fundraising campaign raises $4.1 million for ALS research

In just 21 days, CVS/pharmacy's ninth annual in-store fundraising campaign to support the fight against amyotrophic lateral sclerosis (ALS) brought in $4.1 million. The funds raised by the campaign will be donated to the Boston-based ALS Therapy Alliance (ATA) to support the funding of new clinical research aimed at developing new therapies for ALS patients and focused on the ultimate goal of finding a cure for ALS.

1 Oct 2010

MedQuist enters into definitive agreements for $310 million financing

MedQuist Inc., a leading provider of integrated clinical documentation solutions for the U.S. healthcare industry, announced today that it has entered into definitive agreements relating to a $310 million financing consisting of a $225 million senior secured credit facility and the issuance of $85 million of senior subordinated notes.

1 Oct 2010

Benicar better than Cozaar in reducing blood pressure: Study

New study results show that patients treated with Benicar® (olmesartan medoxomil) 40 mg once daily had significantly greater reductions in blood pressure and higher rates of goal attainment than patients receiving Cozaar® (losartan potassium) 100 mg once daily at week 8, according to findings of a new head-to-head study presented today at the late breaker session at the 23rd Scientific Meeting of the International Society of Hypertension (ISH) in Vancouver, Canada.

1 Oct 2010

Cortex regains global rights to AMPAKINE compounds for treatment of schizophrenia and depression

Cortex Pharmaceuticals, Inc. announced that it has regained worldwide rights to develop and commercialize its AMPAKINE® compounds for the treatment of schizophrenia and depression.

1 Oct 2010

Chelsea prices common stock public offering

Chelsea Therapeutics International, Ltd. announced today that it has priced a public offering of approximately 7.14 million shares of its common stock at a price of $4.90 per share which will result in gross proceeds of $35 million. Net proceeds to the company, after underwriting discounts and commissions and expenses, will be approximately $32.8 million.

1 Oct 2010

IASIS Healthcare completes acquisition of Brim

IASIS Healthcare today announced the completion of its acquisition of Brim Holdings, Inc..

1 Oct 2010

K2M launches VIKOS Cervical Allograft System

K2M, Inc., the spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced the launch of its first product in the spinal biologics market, the VIKOS™ Cervical Allograft System. K2M worked with LifeNet Health™, a leading allograft bio-implant and regenerative medicine company, to combine quality machined allograft implants with precision instrumentation.

1 Oct 2010

BUSM to create Center for Health Insurance Reform, Cardiovascular Outcomes and Disparities

Boston Medical Center (BMC) has been awarded a four year, $5.7 million grant from the National Heart, Lung and Blood Institute (NHLBI) for investigators from Boston University School of Medicine (BUSM) to create the Center for Health Insurance Reform, Cardiovascular Outcomes and Disparities.

1 Oct 2010

Increase in levels of P450 protein creates EET molecules that lower blood pressure

If you are one of the millions of Americans with high blood pressure, more help is on the way. That's because a new research study published in the October 2010 print issue of The FASEB Journal shows that a protein, called P450, metabolizes arachidonic acid in our blood vessel walls to create a tiny molecule with a big name-epoxyeicosatrienoic acid (EET)-which in mice, turns off genes responsible for vascular inflammation and ultimately relaxes blood vessels to lower blood pressure. This protein and genes are also present in humans.

1 Oct 2010

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

Intra-Cellular Therapies, Inc. today announced results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), the Company's novel and selective phosphodiesterase type I (PDE1) inhibitor.

1 Oct 2010

GSA urges treatment of sepsis as a medical emergency

The Global Sepsis Alliance (GSA) is urging healthcare providers, patients and policymakers worldwide to treat sepsis as a medical emergency. "Tens of millions of people die from sepsis each year, making it the likely leading cause of death worldwide. Sepsis kills regardless of age, ethnicity, location and access to care," said Konrad Reinhart, M.D., Chairman of the GSA and director of the Department of Anesthesiology and Intensive Care Medicine, University Hospital of the Friedrich Schiller, University of Jena, Germany.

1 Oct 2010

Healthy respect for flu this season

Flu season officially begins Friday, Oct. 1, and unlike last year's season when shortages lead to rationing, there will be plenty of vaccine on hand for everyone who wants a flu shot.

1 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

CDC awards ACS and GWCI $4.25 million to establish National Cancer Survivorship Resource Center

The American Cancer Society (ACS) and the GW Cancer Institute (GWCI) were recently awarded $4.25 million by the Centers for Disease Control (CDC) to establish a National Cancer Survivorship Resource Center. Work on the project will begin on September 30.

1 Oct 2010

Mylan subsidiary launches Bupropion Hydrochloride Extended-release Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bupropion Hydrochloride Extended-release Tablets USP, (XL), 150 mg and 300 mg (Once-Daily), the generic version of GlaxoSmithKline's antidepressant Wellbutrin XL®.

1 Oct 2010

iMedX acquires FORE Transcriptions USA

iMedX Inc., a leading healthcare software and services company, announced today that it has acquired FORE Transcriptions USA Inc., along with its Indian operations, FORE Transcriptions Pvt. Ltd. With this acquisition, iMedX adds FORE's many clinics and solo practitioners in Southwestern Texas to its customer base and significantly enhances its global transcription production capacity in one of India's prime technology hubs.

1 Oct 2010

New co-branded Medicare Part D prescription drug plan from Humana and Walmart

Today, Humana Inc. announced an innovative Medicare Part D prescription drug plan, co-branded with Wal-Mart Stores, Inc., that can provide significant savings on monthly plan premiums and prescription medicine copayments and cost-shares for Medicare beneficiaries, including seniors and people with disabilities.

1 Oct 2010

DaVita announces $1.45 billion Senior Notes offering

DaVita Inc. announced today that it intends to offer, subject to market and other conditions, $1.45 billion principal amount of senior notes (the "Senior Notes").

1 Oct 2010

Medical News

USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

CVS/pharmacy's fundraising campaign raises $4.1 million for ALS research

MedQuist enters into definitive agreements for $310 million financing

Benicar better than Cozaar in reducing blood pressure: Study

Cortex regains global rights to AMPAKINE compounds for treatment of schizophrenia and depression

Chelsea prices common stock public offering

IASIS Healthcare completes acquisition of Brim

K2M launches VIKOS Cervical Allograft System

BUSM to create Center for Health Insurance Reform, Cardiovascular Outcomes and Disparities

Increase in levels of P450 protein creates EET molecules that lower blood pressure

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

GSA urges treatment of sepsis as a medical emergency

Healthy respect for flu this season

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

CDC awards ACS and GWCI $4.25 million to establish National Cancer Survivorship Resource Center

Mylan subsidiary launches Bupropion Hydrochloride Extended-release Tablets

iMedX acquires FORE Transcriptions USA

New co-branded Medicare Part D prescription drug plan from Humana and Walmart

DaVita announces $1.45 billion Senior Notes offering

How real-time off-gas analysis improves fermentation process control

Advancing Drug Safety Assessment With AI, Predictive Modeling, and Human-Relevant Data

AI-powered analytics and experimental validation

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