Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

Osiris Therapeutics (OSIR) reported a net loss of 21 cents per share in the third quarter of 2009, well above the Zacks Consensus Estimate of a net income of 6 cents. However, net loss in the year ago period was higher at 63 cents, mainly due to lower revenues.  Revenues in the reported quarter increased to $10.6 million compared to $0.995 million for the same period of the prior year. Osiris generates revenues from collaborative agreements, research licenses, and government contracts.  Revenues in the reported quarter included the recognition of $10 million in revenue under the company’s agreement with Genzyme Corporation (GENZ) for the development and commercialization of Prochymal and Chondrogen.  Osiris earned $0.4 million from its collaborative agreement with the Juvenile Diabetes Research Foundation (JDRF) for the development of Prochymal for type I diabetes, $0.1 million from its contract with the Department of ...

We are initiating coverage of Oxygen Biotherapeutics, Inc. (OXBO) with an ‘Outperform’ rating. Despite what has been a tumultuous past for the company and a abysmal fate for competitors attempting to develop similar products, the potential upside that Oxycyte offers is too significant to ignore.  Does Oxycyte do what management says it does? (Key Efficacy Question) In theory, Oxycyte has the potential to be a wonder drug -- a sort of WD-40 of medicine. Preclinical data suggests that Oxycyte has astounding potential for the treatment of traumatic brain injury (TBI), decompression sickness, carbon monoxide poisoning, sickle cell crisis, organ preservation and as a neuroprotectant in patients with myocardial infarction or stroke. The effects in TBI were clearly evident in the phase I program conducted by Oxygen Bio in 2006. Initial phase II data from STOP-TBI will become available in 2010. However, data from small ...

Oxygen Biotherapeutics now has a clinical development pipeline which includes seven indications for Oxycyte(TM) emulsion. Oxycyte is the Company’s perfluorocarbon (PFC) therapeutic oxygen carrier. The new Oxycyte pipeline includes: Traumatic Brain Injury, Carbon Monoxide Poisoning, Surgical Iatrogenic Air Embolism, Spinal Cord Injury, Organ Preservation, Decompression Sickness, and Sickle Cell Crisis.

The company has also reported that its topical pipeline includes six additional indications in development for the Oxycyte Gel. The first use of the Dermacyte Gel is for a cosmetic line that is now available for pre-orders via the BuyDermacyte.com website, with product shipment expected in about four weeks. Other uses include treatment for Wounds, Burns, Acne, Rosacea, Cell Treatment after Radiation Therapy, and Erectile Dysfunction. Oxygen Biotherapeudics is also working on two additional uses for Oxycyte Compounds, including a ventilation device called VitaVent and a Deep Immersion Fluorocarbon Treatment for severe burns.

Oxygen Biotherapeutics CEO Chris Stern commented on the

...

St. Jude Medical Inc. (STJ) announced the first use of its PressureWire Aeris technology, an interventional tool that measures the severity of blood flow blockages in the arteries using the Fractional Flow Reserve (FFR) methodology. This helps interventional cardiologists to determine the ideal treatment option for their patients during coronary interventions.  The PressureWire Aeris is a wireless FFR system that requires no additional equipment or cabling in the cardiac catheterization laboratory. FFR is an index that specifically identifies the coronary responsible for obstructing the blood flow to a patients’ heart muscle.  The PressureWire Aeris system displays, measures and saves FFR data in real time, thereby making it the only available system in the market that documents the severity of coronary lesions. The system is easier to use and reduces material costs while improving patient outcomes.  Findings in the landmark FAMA (Fractional flow reserve vs. Angiography ...

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CSCO, PWRM, CVAT, CSRH, PER, ABT

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CSCO, Cisco Systems, Inc.

CSCO designs, manufactures, and sells Internet Protocol (IP)-based networking and other products to the communications and IT industry worldwide.

Pelco by Schneider Electric, and CSCO today announced a strategic technology agreement to pursue the joint development of new high-definition (HD) Internet Protocol (IP) video security cameras built upon Pelco’s award-winning Sarix(TM) technology platform. The new co-branded video security cameras will bring together Pelco’s leadership in imaging with Cisco’s IP networking expertise to deliver the next generation of high-definition IP video security cameras. These cameras

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We are disappointed with the failure of Osiris Therapeutics’ (OSIR) Prochymal, a drug derived from human stem cell for the treatment of graft-versus-host disease (GvHD), the most common complication of bone marrow transplants. Currently, there is no approved treatment available for this life-threatening disease.

Based on the preliminary results of two phase III trials conducted by the company, Prochymal was found to be ineffective compared to placebo. Following the setback, Osiris shares fell by 34% to $8.03, their greatest single day decline since August 2006.

In the first trial, where the drug was used along with steroids, 45% of patients responded to the combination compared to 46% who responded to steroid along with a placebo. In the second trial, when Prochymal was used on patients not benefiting from steroids, it did not show statistically significant improvement. However, the drug did have a positive impact on patients with GvHD-affected

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Boston Scientific Corporation (BSX) recently came out with its two-year SYNTAX clinical data that do not typify any statistically significant difference between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. The PCI was performed using the company’s TAXUS Express Paclitaxel-Eluting Coronary Stent System.

The composite safety endpoint consisting of different parameters like all-cause death, stroke, and myocardial infarction (MI) demonstrated no significant difference between PCI and CABG. 

Results in the SYNTAX study were as follows:  

The combined rate of all-cause death, stroke and MI was 10.8% for PCI, compared to 9.6% for CABG. On an individual parameter basis, the rate of stroke was 1.4% for PCI, compared to 2.8% for CABG. MI was 5.9% for PCI and 3.3% for CABG. All-cause death was 6.2% for PCI versus 4.9% for CABG. Positive results from the SYNTAX trial bring an alternative treatment option, ...

In mid-May 2009, The Medicines Company (MDCO) announced that an interim analysis review committee (IARC), along with the data safety monitoring board (DSMB), after conducting a review of the ongoing CHAMPION phase III program with Cangrelor, notified the company that the ongoing CHAMPION-PLATFORM program would not meet the primary endpoint of a persuasive evidence of clinical effectiveness that could serve as the basis for regulatory approval.The IARC DSMB noted that the phase III CHAMPION-PCI program, a nearly fully enrolled 9000 patient program testing Cangrelor vs. Plavix (clopidogrel) in a non-inferiority, all-cause mortality (MI or IDR) study in patients undergoing PCI would also fail to show a meaning clinical difference. Management noted that the bleeding risk seen in the CHAMPION program was similar between Cangrelor and clopidogrel, so the trials were not stopped due to safety concerns.The CHAMPION-PLATFORM program, initiated in October 2006, had ...

Surge of CTIC on PIX301 Trial Data: Sustainable?Pixantrone is more efficacious than comparators but with safety concernsYesterday afternoon (June 1), Cell Therapeutics, Inc. (CTIC) presented updated final results of its pivotal phase III EXTEND (PIX301) trial of Pixantrone in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting held in Orlando, Florida.The PIX 301 EXTEND trial was a phase III single-agent trial of Pixantrone for patients with relapsed or refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either Pixantrone (N=70) or another single-agent drug (N=70) currently used for the treatment of this patient population and selected by the physician.Efficacy data encouragingThe efficacy data were encouraging. Patients treated with ...