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 ...

Sanofi-Aventis SA (ADR) (NYSE:SNY), France’s biggest pharmaceutical group has accused Hospira Inc and Canada’s Apotex Inc of infringing patents for the cancer drug Taxotere. Sanofi-Aventis has said that both the companies have tried to copy their products. Earlier Sanofi-Aventis have filed separate complaints against Hospira Inc and Apotex Inc that they have violated the patent laws and have attempted to duplicate their top ranging product that is developed and marketed for the treatment of cancer patients. Though the market reacted sharply after the news broke into the market, but there was not much of fluctuation in the shares of Sanofi-Aventis at the end of the day.

Sanofi-Aventis is one of the leading pharmaceutical companies in France and globally as well. The company is into the research, development, manufacturing

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Abbott Labs (ABT) is looking to launch its XIENCE V Everolimus Eluting Coronary Stent System in China in the fourth quarter of 2009. The company recently received approval from the Chinese State Food and Drug Administration (SFDA) for the treatment of coronary artery disease (CAD). In our opinion, the launch of XIENCE V in China should bring in significant incremental revenues for the company’s Vascular Product division, which posted sales of $2.2 billion in 2008. China is the second-largest drug eluting stent market in the Asia-Pacific region after Japan. With the launch in China, XIENCE V will be available in every Asia-Pacific market except Japan, where the product is currently being reviewed by the regulatory authority. XIENCE V’s launch in Japan in early 2010 could potentially add another $500 million market opportunity. CAD is the leading cause of death in China -- according to the China ...

Cepheid, a diagnostics company focused on the biothreat market, last week made a joint announcement with Instrumentation Laboratory (IL), a worldwide developer, manufacturer and distributor of vitro-diagnostics instruments, reporting that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) FII & FV test.

According to the Centers for Disease Control and Prevention (CDCP), between 300,000 and 600,000 people have deep-vein thrombosis, or blood clots; additionally, 5 percent to 8 percent of people have thrombophilia, a condition leading to increased risk of thrombosis. Cepheid’s Xpert HemosIL FII and FB test detects thrombophilia, delivering results in roughly 30 minutes. Cepheid said IL’s experience in the market will allow for time-efficient testing, ultimately benefiting physicians and their patients.

“The Xpert HemosIL FII & FV test is the first product developed in conjunction with our partnering model to be marketed in the U.S.,” John Bishop, Cepheid’s CEO

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Abbott Labs (ABT) presented results on XIENCE V Everolimus Eluting Coronary Stent System from the SPIRIT IV trial yesterday at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. Results showed that XIENCE V achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to Boston Scientific’s (BSX) Taxus Express2 Paclitaxel-Eluting Coronary Stent System at one year. The study was conducted with about 3,690 patients. XIENCE V demonstrated a statistically significant 38% reduction in TLF compared to Taxus. Target lesion failure occurred in 4.2% of the XIENCE V patients compared to 6.8% of the patients in the Taxus arm. XIENCE V also demonstrated a statistically significant 46% reduction in TLR compared to Taxus. Target lesion revascularization occurred in 2.5% of the XIENCE V patients compared to 4.6% of the patients in the Taxus arm....

For Immediate Release

Chicago, IL – September 2, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: International Paper (IP), Mead Westvaco (MWW), Johnson & Johnson (JNJ), Abbott (ABT) and Medtronic (MDT).

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Here are highlights from Tuesday’s Analyst Blog:

PMI Shows Expansion

As recently as May, the employment reading was down at 34.3. Yes, the current reading means that we are still losing manufacturing jobs, but at a vastly slower pace than we were just a few months ago. With new orders and production leaping upwards, the first effect

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Yesterday, Johnson & Johnson (JNJ) announced the initiation of enrollment in the Cypress study (CYPherR for Evaluating Sustained Safety), which is designed to assess clinical outcomes in a wide range of patients suffering from coronary artery disease and taking dual anti-platelet therapy after receiving a Cypher Sirolimus-eluting Coronary Stent. The study, which will enroll approximately 2,000 patients, will be conducted at 200 centers throughout the U.S. Cypress will provide data for the clinical evaluation of the company’s new NEVO Sirolimus-eluting Coronary Stent in the NEVO III trial. NEVO III is a single-arm trial which is expected to serve as the pivotal trial for the pre-market application (PMA) submission in the U.S. NEVO III will be conducted with approximately 1,200 patients in the United States and Canada. The Cypress trial is divided into two phases. In Phase I, patients will receive the Cypher Stent coupled with 12 ...

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 ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Genzyme [GENZ: 59.12, +0.75 (+1.28%)] and Isis Pharma [ISIS: 13.66, +0.53 (+4.04%)] announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL

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What Cangrelor Failure Means To Medicines Co.This morning, 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.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 enrolled approximately 5300 of the 6400 patients, testing Cangrelor plus usual care (clopidogrel) vs. usual care alone in a non-inferiority study looking at all-cause mortality (myocardial infarction or ischemia driven revascularization) in patients undergoing percutaneous coronary intervention (PCI)....