The Moon Phase

[PoemStone]

Bio updates big board. StocksDiva.
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Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that it has received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs).

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended September 30, 2012 of $69.2 million, or $0.58 per diluted share, compared to net income of $51.6 million, or $0.43 per diluted share, for the same period in 2011.

Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced they received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending approval of Amyvid (Florbetapir F 18) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive impairment.

Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that investigators will present data from over 80 studies that provide new information about the benefits of using Given Imaging's products to detect, monitor and measure a range of gastrointestinal conditions at the upcoming American College of Gastroenterology (ACG) 2012 Annual Meeting taking place October 19-24, 2012 in Las Vegas, and the 20th United European Gastroenterology Week taking place October 20-24, 2012 in Amsterdam, The Netherlands.

Trius Therapeutics (NASDAQ: TSRX): Tedizolid safety data presented at IDWeek; data from Phase 3 trial indicate low incidence of adverse platelet outcomes 5.71 -0.07 : Co announced that two studies of its lead drug candidate, tedizolid phosphate, are being presented at IDWeek 2012. The first report, "A Comparative Evaluation of Adverse Platelet Outcomes among Patients with Acute Bacterial Skin and Skin Structure Infections Receiving Tedizolid Phosphate and Linezolid," summarizes the hematological results from Trius' first Phase 3 trial, ESTABLISH-1 (TR-701-112). It shows that the incidence of platelet counts below the lower limit of normal was significantly lower in patients receiving tedizolid than those treated with linezolid. Thrombocytopenia is a well-recognized toxicity signal associated with Zyvox, so this safety profile information is of particular importance for tedizolid. The second tedizolid-related report, "Population Pharmacokinetics (PK) of Oral and Intravenously Administered Tedizolid Phosphate in Adolescent Patients," evaluated the pharmacokinetics of tedizolid in adolescents. Tedizolid's high potency allows it to be administered once daily as a 200 mg oral tablet or via 200 mg IV infusion. The report concludes that the proposed adult dose of 200 mg produces tedizolid exposure in adolescents similar to healthy adults in both routes of administration.

Ziopharm Oncology (NASDAQ: ZIOP) issues statement regarding misleading blog; states 'statements made in Mr. Pearson's blog entry are misleading and wrong' 4.29 -0.33 : Co issued the following statement regarding a blog entry posted by Richard Pearson, Contributor, on Forbes.com: "The statements made in Mr. Pearson's blog entry are misleading and wrong and, given his disclosed investment position, we call into question the entire credibility of this piece. The Form 483 was issued directly to the independent investigator, not to ZIOPHARM, and had nothing to do with any outcome measures of the Phase 2 PICASSO study. All regulatory matters raised in Mr. Pearson's blog entry were resolved by the investigator in full in 2010, and had no impact on the Company's transition from Phase 2 to Phase 3. Further, the Company has no issues with drug stability. We stand by the clinical data generated at this investigator's site. Consistent with best practices, all data from ZIOPHARM's Phase 2 PICASSO study at this site were reviewed by an independent, former FDA good clinical practice auditor, and the auditor concluded that the study site's violations had no impact on the PICASSO study or the quality of data."

Savient Pharma (NASDAQ: SVNT) confirms it received a positive CHMP opinion for KRYSTEXXA approval in the EU 2.14 +0.00 : Co confirmed that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. This opinion will be transmitted to the European Commission, which has the authority for granting marketing authorisations in the EU. If such marketing authorization is granted, KRYSTEXXA will address a significant unmet medical need for certain patients with refractory chronic gout (RCG) in the European Union.

Cleveland Biolabs (NASDAQ: CBLI) priced offering of 7.5 mln units at $2.00 per unit 2.48 : Each unit consists of one share of common stock and one warrant to purchase 0.5 shares of common stock at an exercise price of $3.00 per whole share.


BioTime (NYSE: BTX) subsidiary, LifeMap, provides update on product portfolio development; co expects to launch or upgrade its four database products during final quarter of calendar 2012 3.97 : LifeMap Sciences announced progress on key development initiatives. During the final quarter of the calendar year 2012, the company expects to launch or upgrade its four database products: GeneCards, MalaCards, PanDaTox, and LifeMap Discovery. In addition, LifeMap Sciences will launch the marketing and sales of BioTime's proprietary research product lines, including PureStem human progenitor and human embryonic stem cell lines via the company's LifeMap BioReagents portal. Another major LifeMap Sciences initiative is its therapeutic discovery collaboration with BioTime, which utilizes the LifeMap Discovery platform and leverages the LifeMap Sciences scientific team to research and identify those progenitor cell lines that are most likely to be useful in developing cell-based regenerative medicine therapies for a wide range of diseases. Once identified, selected cell lines will be marketed by LifeMap Sciences for research purposes via the LifeMap BioReagents portal and may be advanced into therapeutic development by BioTime and/or LifeMap Sciences

Novo Nordisk (NYSE: NVO) A/S: Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) receive positive opinions from the European regulatory authorities 167.31 : Co announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency (EMA) adopted positive opinions, recommending marketing authorisations, for Tresiba and Ryzodeg for the treatment of diabetes mellitus in adults.

Tresiba, the intended brand name for insulin degludec, is a new generation of once-daily basal insulin. In 'treat-to-target' studies supporting the new drug application, where Tresiba was compared to insulin glargine, Tresiba demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c. Further, with a duration of action beyond 42 hours, Tresiba is the first basal insulin to offer patients the possibility of adjusting the time of injection, when needed.

Nabi Biopharmaceuticals (NASDAQ: NABI) announces exchange ratio for proposed business combination transaction with Biota Holdings Limited 1.80 : Co announced that, if the proposed business combination transaction between Nabi Biopharmaceuticals (NABI) and Biota Holdings Limited (ASX:BTA.AX) is completed, each ordinary share of Biota capital stock will be transferred to Nabi in exchange for 0.749778075 of a share of Nabi common stock, subject to the adjustment described below if the proposed reverse stock split becomes effective. If the proposed reverse stock split is approved by Nabi stockholders at the reconvened special meeting of stockholders to be held Oct 22, 2012, depending on the ratio for the reverse stock split determined by Nabi's board of directors, four, five, six, seven or eight shares of existing Nabi common stock will be combined into one new share of Nabi common stock.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced it has received approval from the US FDA to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve. Previously, SAPIEN was approved in the U.S. only for the treatment of inoperable patients via the transfemoral approach.

"We are thankful to the multidisciplinary Heart Teams who worked diligently throughout The PARTNER Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy."

About Transcatheter Aortic Valve Replacement (TAVR) In performing the TAVR procedure, the valve is crimped onto the catheter-based delivery system and inserted into the body in one of two ways: transfemorally or transapically. Once delivered to the site of the patient's diseased valve, the SAPIEN valve is expanded with a balloon and immediately functions in place of the patient's native aortic valve.

The Edwards SAPIEN valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a Heart Team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing co-morbidities would not preclude the expected benefit from the procedure. The previous FDA approval for the treatment of inoperable patients was granted on Nov. 2, 2011.

Abbott (NYSE: ABT) announced the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for HUMIRA® (adalimumab) for the treatment of pediatric patients aged six to 17 years with severely active Crohn's disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next several weeks. Upon final decision, HUMIRA will be the only biologic in the European Union (EU) for the treatment of pediatric CD offering at-home administration.

Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide(i,ii) CD most commonly involves the end of the small intestine and the beginning of the large intestine.(iii) In addition to symptoms such as chronic abdominal pain, weight loss and loose stools(i) pediatric CD can affect children in several ways, including potentially contributing to malnutrition, failure to grow and/or delayed puberty.(i,iv)