: iStockAnalyst.com Symbols Feed

BioMed News Bytes: Merck KGaA, BioMarin, Cytori, Theravance

Mon, 30 Nov 2009 21:55:06 GMT

On 11/27/09, Theravance (NASDAQ: THRX) announced that it received a Complete Response Letter (CRL) from the FDA for the telavancin New Drug Application (NDA) for the treatment of nosocomial pneumonia (NP). VIBATIV (telavancin) is approved in the US/Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria.[More...]

Investing In The Biotech Sector: Here’s An Easy Way To Profit From Biotech Stocks

Wed, 11 Nov 2009 14:39:06 GMT

Investing in the Biotech Sector: Here’s An Easy Way to Profit from Biotech Stocks by Marc Lichtenfeld, Healthcare Expert Wednesday, November 11, 2009: Issue #1135 Investing in the biotech sector can be risky – no doubt about that.[More...]

Seven Potential Short Stocks In Healthcare

Mon, 26 Oct 2009 13:45:00 GMT

On October 12, I wrote an article on seven bull stocks to know in healthcare (medical) sector. In the present article, I will be taking you through the seven stocks that you could profit by shorting.[More...]

The Next Big Thing In Health Care: How To Profit From Immunotherapy & Regenerative Medicine

Wed, 07 Oct 2009 19:22:50 GMT

The procedure has been called "one of the most barbaric mistakes ever perpetrated by mainstream medicine." Back when medicine was highly primitive, the process involved shoving an ice pick-like instrument between the upper eyelid and the eye in hopes of severing certain nerves of the frontal lobe.[More...]

Bullish Sentiment High In Overbought Market

Tue, 04 Aug 2009 16:34:23 GMT

As the market hits new highs, bullish sentiment is reaching extreme levels. A quick look at the SPX bullish percent index shows us to be significantly overbought. We have a lot of economic reporting this week, particularly relating to employment and manufacturing, along with the continuation of earnings[More...]

Bullish Picks for Next Week

Sat, 01 Aug 2009 16:59:14 GMT

Taking a look at stock market action last week, we see price consolidating after breaking to new highs. Stocks are being bought even after rather poor earnings reports, and meanwhile there are a good number of stocks reporting legitimately positive quarters. Money is flowing into equities, and traders have a large number of earnings winners from which to choose. Looking at the SPY chart, price made a major move to new highs on 7/23, and then broke out again on 7/30. The last two days of the week saw some end-of-day weakness, which provides some reason for short-term caution. In any case, this is a bullish chart. [More...]

FDA Calendar Updates: ABII, BMRN, JNJ, OSIP, Roche

Mon, 13 Jul 2009 19:24:05 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 254 entries as of 7/13/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete respo (...)[More...]

Spectrum Pharma (NASDAQ:SPPI): Undervalued Based On Late-Stage Pipeline

Fri, 19 Jun 2009 16:45:08 GMT

With two potential approvals coming up in the next 120 days, Spectrum Pharmaceuticals (Nasdaq: SPPI) still remains a hidden gem. Investor's Business Daily bases its rankings on the relationship that one company has with other companies within the same industry. In my June 12 article, I indicated the company could likely generate $280 million in annual revenue within the next 12-18 months upon approval of both the company's cancer drugs Zevalin and Fusilev. The table below is a lis (...)[More...]

Not Even Government Interference Will Damage These Three Stocks

Wed, 10 Jun 2009 23:34:59 GMT

Not Even Government Interference Will Damage These Three Stocks by Marc Lichtenfeld, Senior Analyst, Smart Profits Report It’s bold. It’s ambitious. And if it works, it should make America a healthier nation. Reform plans are a dime a dozen in Washington - many of which get stuck in political gridlock without ever reaching a satisfactory resolution. And healthcare reform is no different, with multiple presidents trying - and failing - to pass a plan that would see every American covered by healthcare insurance. The Obama administration is the latest to step up to the plate and take a swing. And with Congress currently chewing over the details of its plan, it has healthcare investors shaking in the knees, wondering how an overhaul of the system[More...]

More Cash, Less Debt = Stock Market Gains?

Thu, 23 Apr 2009 13:41:32 GMT

Today there were a couple of posts about how tech stocks are currently especially attractive because they hold plenty of cash and tend to have little debt. Paul Kedrosky initially caught my eye with his post "Tech Cash is King" which in turn pointed me to a story on Bloomberg by Eric Martin. I ran a screen tonight that looked at both cash and debt. Specifically, I screened for a Price-to-Cash ratio under three, a Debt-to-Equity ratio under three and a Market Cap greater than $2.5 million. Based on these criteria, I obtained a list of 136 stocks. Judging from our list, it is absolutely true that many tech stocks do seem to have lots of cash and little debt. What also became apparent as I went through the list is that there[More...]

Kuvan and Naglazyme Data to Be Presented at the 11th Annual ICIEM Meeting

Wed, 19 Aug 2009 12:56:00 GMT

BioMarin Pharmaceutical Inc. announced today that data from clinical studies of Kuvan and Naglazyme will be presented at the 11th Annual Meeting of the International Congress of Inborn Errors of Metabolism in San Diego, California, August 29 through September 2, 2009.[More...]

BioMarin Announces Second Quarter 2009 Financial Results

Thu, 30 Jul 2009 20:01:00 GMT

BioMarin Announces Second Quarter 2009 Financial Results[More...]

Patient Enrollment Complete for Phase I/II Clinical Trial for GALNS for Morquio A Syndrome

Mon, 13 Jul 2009 12:57:00 GMT

BioMarin Pharmaceutical Inc. announced today that patient enrollment has been completed for the Phase I/II clinical trial for BMN-110 or N-acetylgalactosamine 6-sulfatase , intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA , or Morquio A Syndrome. The company expects to report initial results in the first half of 2010. 'The efficient enrollment of twenty patients is a critical milestone for the MPS IVA program and demonstrates both our commitment to this program and the support and enthusiasm of the MPS IVA patient community. Data generated from this study will be valuable in demonstrating safety and could be instrumental in designing a successful Phase III trial. Assessments from the Phase I/II study such as plasma and urine keratan sulfate levels, pulmonary function and walk tests will be helpful in determining optimal Phase III endpoints," said Henry Fuchs, M.D., Chief Medical Officer of BioMarin. 'We appreciate the collaboration of the Morquio community in this important effort, and we hope to develop this new treatment as expeditiously as possible.'Christian Hendriksz, MBChB, MSc, FRCPCH, MRCP, Consultant in Metabolic Disorders, Birmingham Children's Hospital, UK, added, 'Morquio is a serious and debilitating disease in which accumulation of keratan sulfate results in impaired breathing and walking, recurrent infections, impaired bone and joint function, dysmorphology and an overall impaired quality of life. The rapid accrual of patients for the Phase I/II study speaks to the magnitude of the unmet need for this disease.'The Phase I/II study is designed as an open-label, within-patient dose escalation trial in 20 patients followed by a treatment continuation period. During the dose escalation phase of the study, subjects will receive weekly intravenous infusions of BMN-110 in three consecutive 12-week dosing intervals. The objectives of the Phase I/II study will be to evaluate safety, pharmacokinetics, pharmacodynamics and to identify the optimal dose of GALNS for future studies. BioMarin plans to provide an extension study in which all patients in the Phase I/II study will be eligible to participate. BioMarin has developed and manufactures two FDA-approved enzyme replacement therapies, one for the treatment of MPS I and one for the treatment of MPS VI. Naglazyme for MPS VI is wholly developed and commercialized by BioMarin. Aldurazyme for MPS I is manufactured by BioMarin and marketed by Genzyme Corporation.About MPS IVAMucopolysaccharidosis IVA is a disorder characterized by deficient activity of N-acetylgalactosamine 6-sulfatase causing excessive lysosomal storage of keratan sulfate . This excessive storage causes a systemic skeletal dysplasia, short stature, and joint abnormalities, which limit mobility and endurance. Malformation of the thorax as well as macrophage dysfunction in the lung likely impairs respiratory function and contributes to sinopulmonary infections. Odontoid dysplasia and ligamentous laxity can commonly cause cervical spinal instability and potentially spinal cord compression. Other symptoms may include recurrent infections, hearing loss, corneal clouding, and heart valvular disease. Initial symptoms often become evident in the first five years of life. Depending on severity of the disorder, age of diagnosis will vary. Many patients become wheelchair dependent in their second decade of life and undergo numerous surgeries to alleviate life-threatening conditions caused by the underlying enzyme deficiency.The incidence estimates for MPS IVA vary widely, between one in 200,000 live births to one in 300,000 live births. Approximately 400 patients worldwide have been identified and tracked through the International Morquio Organization survey. There are already more MPS IVA patients identified through this registry than there are MPS VI patients being treated with Naglazyme worldwide. Based on the number of identified patients to date, the prevalence of patients with MPS IVA appears similar to that with MPS I. About BioMarinBioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme for mucopolysaccharidosis VI , a product wholly developed and commercialized by BioMarin; Aldurazyme for mucopolysaccharidosis I , a product that was developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan Tablets, a product for the treatment of phenylketonuria , developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include PEG-PAL , which is currently in Phase I clinical development for the treatment of PKU. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.Forward-Looking StatementThis press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of its program for MPS IVA, and particularly the timing and conduct of clinical trials related thereto, and expectations regarding filings with regulatory agencies. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results of current and planned clinical and pre-clinical trials related to the enzyme replacement therapy for MPS IVA; the content and timing of decisions by the U.S. Food and Drug Administration, EMEA and other regulatory agencies, particularly with respect to the enzyme replacement therapy for MPS IVA, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2008 Annual Report on Form 10-K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.BioMarin, Naglazyme and Kuvan are registered trademarks of BioMarin Pharmaceutical Inc.Aldurazyme is a registered trademark of BioMarin/Genzyme LLC. Contacts:[More...]

BioMarin to Host Second Quarter 2009 Financial Results Conference Call and Webcast on Thursday, July 30 at 5:00 p.m. ET (23:00 CET)

Wed, 01 Jul 2009 12:57:00 GMT

BioMarin Pharmaceutical Inc. today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, July 30, at 5:00 p.m. ET to discuss second quarter 2009 financial results.[More...]

Richard A. Meier Appointed to STAAR Surgical Board of Directors

Thu, 25 Jun 2009 09:56:00 GMT

Former President and COO of Advanced Medical Optics Brings Significant Industry Background to STAAR's Board[More...]

Kuvan Receives Priority Review Status From Health Canada

Wed, 10 Jun 2009 12:57:00 GMT

BioMarin Pharmaceutical Inc. announced today that it has received notice of priority review status for Kuvan as an oral treatment for patients with phenylketonuria from Health Canada. Priority review provides for a shortened submission review of 180 days versus the standard twelve months. BioMarin plans to file a marketing application for Kuvan in Canada in the third quarter of 2009, and with priority review status, a decision for marketing approval is expected in the first half of 2010.[More...]

BioMarin to Present at the Jefferies Healthcare Conference

Wed, 10 Jun 2009 12:56:00 GMT

BioMarin Pharmaceutical Inc. today announced that Steve Aselage, Senior Vice President and Chief Business Officer of BioMarin, will present a company update at the Jefferies Healthcare Conference in New York City on Wednesday, June 17, 2009 at 8:30 a.m. ET.[More...]

Results From Phase 1 Clinical Study of PEG-PAL in PKU and Update on Phase 2 Clinical Study

Tue, 09 Jun 2009 12:58:00 GMT

BioMarin Pharmaceutical Inc. today announced results from the Phase 1 clinical study of PEG-PAL for the treatment of phenylketonuria . The company expects to initiate the Phase 2 clinical study in late June or early July, pending institutional review board approval from the clinical trial sites. The U.S. Food and Drug Administration has reviewed the Phase II clinical trial protocol.[More...]

BioMarin to Present at the William Blair Growth Stock Conference

Wed, 03 Jun 2009 12:55:00 GMT

BioMarin Pharmaceutical Inc. today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will present a company update at the William Blair Growth Stock Conference in Chicago on Wednesday, June 10, 2009 at 12:00 p.m. CT.[More...]

BioMarin to Present at the Goldman Sachs Healthcare Conference

Tue, 02 Jun 2009 13:00:00 GMT

BioMarin Pharmaceutical Inc. today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will present a company update at the Goldman Sachs 30th Annual Global Healthcare Conference in New York City on Tuesday, June 9, 2009 at 9:00 a.m. ET.[More...]