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I-SPY 2: The Biomarkers Consortium launches clinical trial for high risk, fast-growing breast cancers

The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), today announced the launch of a highly anticipated clinical trial to help screen promising new drugs being developed for women with high risk, fast-growing breast cancers—women for whom an improvement over standard treatment could dramatically change the odds of survival.

18 Mar 2010

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

Aetna, SBUH announce new agreement for hospital’s participation in Aetna network

Aetna and Stony Brook University Hospital are pleased to announce today a new agreement for the hospital’s participation in the Aetna network. The agreement is effective through April 30, 2011, and will enable Stony Brook physicians currently participating with Aetna to continue their participation uninterrupted.

18 Mar 2010

Cangene receives European Commission approval to market ImmunoGam

Cangene Corporation today reports that it has received European Commission approval to market Cangene's ImmunoGam(TM) (Human Hepatitis B Immunoglobulin), indicated for immunoprophylaxis of hepatitis B.

18 Mar 2010

As Medicare pay shrinks, some California doctors hike patient fees

Kaiser Health News staff writer Christopher Weaver writes about a California cardiology group that has confronted steep Medicare cuts with a tactic that may irk patients who already face soaring health costs.

18 Mar 2010

CytoDyn commences full humanization of Cytolin immune therapy for treating HIV/AIDS

CytoDyn, Inc. has begun full humanization of Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS. Although a murine (mouse) version of Cytolin® was used for previous human experience that included some 200 patients successfully treated for up to two years, as well as an encouraging Phase I(b)/II(a) study, the Company believes that a fully-humanized version is necessary for the clinical trial that is expected to follow the current one (described at http://clinicaltrials.gov) for the reasons explained below.

17 Mar 2010

Obama to appear on Fox News; Heath reform will be high on his topic list

New York Times: President Obama is scheduled to give an interview with Bret Baier of Fox News Wednesday evening. The interview comes "at the height of a week in which Democrats, including Mr. Obama, are pressing allies and lawmakers to push ahead to get the health care bill passed in the House despite solid Republican opposition and the lessening of public support for the legislation." The interview comes after Obama administration aides last year criticized Fox News for its political coverage and commentary (3/16).

17 Mar 2010

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.

17 Mar 2010

Cut looms for Medicare payments to doctors

Marketwatch/The Seattle Times reports on the looming 21 percent cut to physicians' Medicare payments. "The cut was to take effect March 1 until Congress delayed it by 30 days. The Senate then voted last Wednesday to postpone the cut an additional six months as part of a larger bill that extends unemployment benefits. The measure now moves to the House."

17 Mar 2010

Access MediQuip enhances Recall Management Service for implantable devices

Access MediQuip, LLC, the nation's first and largest provider of outsourced implantable medical device management solutions to the healthcare industry, announced today it has enhanced its proprietary Recall Management Service, "RMS," for its customers nationwide. The new release is designed to protect patients, inform and empower surgeons and facilities, and help payers improve quality while managing cost.

17 Mar 2010

AstraZeneca's CRESTOR: Health Canada approves new indication

AstraZeneca announced today that Health Canada has approved CRESTOR (rosuvastatin calcium) to reduce the risk of nonfatal myocardial infarction (heart attack), nonfatal stroke, and coronary artery revascularization in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Coastal Contacts' sales up 15% for first fiscal quarter 2010

Coastal Contacts Inc. today announced its financial results for the three months ended January 31, 2010.

17 Mar 2010

Biomoda enters into agreements with syndicate of institutional investors for up to $2.0M

Cancer diagnostics company Biomoda, Inc. (www.biomoda.com) today announced that it has entered into agreements with a syndicate of institutional investors for up to $2.0 million. LifeTech Capital, a division of Aurora Capital LLC, acted as the exclusive placement agent for the financing.

17 Mar 2010

Industry game changers to watch in healthcare IT

Whatever the outcome of healthcare reform, this much is clear: Information technology will play a critical role in the improvement and delivery of patient outcomes. So, will government contractors — they already are. So, who’s in the lead?

17 Mar 2010

Unigene Laboratories enters into amended and restated financing agreement

Unigene Laboratories, Inc. (http://www.unigene.com) today announced that it has entered into an amended and restated financing agreement for $33 million three-year convertible senior secured term notes.

17 Mar 2010

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Hospitals can save more than $1M annually by implementing Masimo Patient SafetyNet with SET pulse oximetry

Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new cost-effectiveness study shows that implementation of the Masimo Patient SafetyNet remote monitoring and clinician notification system with Masimo SET pulse oximetry saved one hospital $817,000 in its first year.

17 Mar 2010