Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.  In September 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US ...

Vertex Pharmaceuticals (VRTX) posted a loss of 83 cents per share in the third quarter, 3 cents wider than the Zacks Consensus Estimate of a loss of 80 cents. The company posted a loss of 92 cents per share in the year ago period. The wider than expected loss was mainly due to a significant increase in costs and lower revenues.

Revenues declined to $24.9 million in the reported quarter from $31.6 million in the year ago period. Revenues consist of royalty revenues and collaborative and other research and development revenues. Lower revenues were primarily due to a decrease in collaborative revenues.

Expenses increased mainly due to the increased size of the company’s workforce, increased spending on late-stage clinical programs and increased stock-based compensation expenses. Research and development (R&D) expenses increased to $132.1 million, up from $131.7 million in the year-ago period, mainly due to investments supporting the company’s hepatitis C virus

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ALR Technologies, Inc.’s stock is currently trading at $0.21, up 425%, on massive volume of 3.3+ million traded shares. Earlier this month, QualityStocks highlighted the company in its daily newsletter when the stock was trading for only $0.04 and largely ignored by the investment community. To sign up for the newsletter, visit www.signup.qualitystocks.net.

Today, ALR Technologies announced that the US Patent and Trademark Office has approved its patent application regarding patient compliance and remote monitoring of patient’s use of nebulizer compressors. This approval protects the company’s Health-E-Connect health management communications system and, more importantly, grants ALRT the exclusive ability to remotely monitor the use of nebulizer compressors in the delivery of medications to patients with COPD, chronic asthma and cystic fibrosis.

With more than 750,000 investors signed up for the QualityStocks Daily Newsletter, it is no wonder that highly successful stock picks are made regularly. Using a proprietary data management system,

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On Friday, the U.S. Food and Drug Administration (FDA) approved Eurand N.V.'s (EURX) New Drug Application for its pancreatic enzyme product (PEP) Zenpep. The product targets a condition where insufficient secretion of enzymes by the pancreas hampers digestion of food. This phenomenon, known as exocrine pancreatic insufficiency (EPI), causes malnutrition, impaired growth in children, compromised immune response and shortened life expectancy.   EPI is very common in cystic fibrosis patients. Cystic fibrosis causes life-threatening lung infections and serious digestive complications. Zenpep, which improves digestion and absorption by replacing the missing enzymes, is the only FDA-approved PEP to be tested in adults and children below 12 years of age. The approval of Zenpep is a major milestone for EPI patients. The drug would enable doctors to fine tune treatment regimens to achieve optimal symptom control with improved dosing precision thereby reducing pill burden.   Previously, PEPs were not regulated and

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DrStockPick.com Stock Report!

Friday August 28, 2009

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Muscle Flex Inc. (PINKSHEETS: MFLI) announced today that Danny Alex, CEO of Muscle Flex Inc. (www.MuscleFlexInc.com), has been exclusively invited to the WWDMAGIC (www.MagicOnline.com) fashion tradeshow in Las Vegas by Houston PAD (www.HoustonProjects.com), Master Distributor of VATA Brasil Active Wear (www.VataBrasil.com). The invitation to attend WWDMAGIC comes as Muscle Flex Inc. is preparing to add its Muscle Flex® sports and active wear product line as one of its flagship products. Additional details are expected in the coming days.

Legend International Holdings, Inc (OTCBB:LGDI) is pleased to announce that the Queensland Government has granted the Exploration Permit for Paradise

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Headquartered in Hayward, California, Aradigm Corp. engages in developing inhalation drug products that enhance the quality of life of patients with severe pulmonary disease. Founded in 1991, the company has a team of scientists, engineers, and clinical experts who have been at the forefront of development of advanced inhalation delivery products.

Aradigm Corp.’s team pioneered the AERx® iDMS pulmonary delivery of insulin used in Phase 3 clinical trials conducted by their partner Novo Nordisk. Today, with experience and expertise in inhalation delivery, Aradigm is positioning their company to develop a portfolio of their own products to treat patients with severe respiratory diseases. The company’s current pipeline includes products undergoing development by Aradigm, or in partnerships with others, for the treatment of cystic fibrosis, inhalation anthrax, and pulmonary arterial hypertension. Aradigm Corp. is also investigating the use of their technology for tobacco smoking cessation therapy.

Aradigm’s AERx pulmonary drug delivery platform demonstrated

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Aradigm Corporation

(Public, OTC:ARDM)

Aradigm is a company with a lot of potential positive long-term gains, especially with regards to its product pipeline involving the inhaled Cipro product (ILCH) for BE and CF, however the short-term play is a very different story. This company lacks visibility and the ability to fully utilize press release syndication to maximize potential reach for investors, and also engages in massive dilution in order to maintain ongoing operations. Moreover, the financial position also suffers as the company is enduring a heavy amount of cash burn every year with zero revenues as of Q1 (Mar’09). There is also a big question mark when it comes to partnerships — who will step up to the plate and infuse the cash which is so badly sought after?

About

Aradigm Corporation is a specialty pharmaceutical company focused

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With the Verigene System and 2 currently approved assays not receiving approval until late-2007, Nanosphere Inc. (NSPH) currently generates little in the way of revenue relative to their cost base. We expect the company to generate negative operating income for the foreseeable future as SG&A and R&D expenses remain elevated to support newly-approved products and the company's pipeline.

Manufacturing efficiency programs and economies of scale through higher production volumes should benefit gross margins and help offset increased operating expenses. Grants and government contracts, which had provided 25% of revenue in 2008, will likely be immaterial in 2009 and beyond.

We expect the cystic fibrosis, HFE, Cardiac Troponin and next-generation RVP assays along with the Verigene SP system to receive FDA approval and launch in the second half of 2009. This should help drive significant revenue growth in 2009.

Longer-term growth expectations could significantly increase depending on the success

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Aradigm Corp (ARDM). is a difficult company to value. We like the product pipeline, specifically the inhaled Cipro product (ILCH) for BE and CF, but more visibility is needed before we can recommend investment in the name.Plus, Aradigm continues to post operating losses and unless the company can sign a development and commercialization partner for ILCH in 2010, the company is going to have to raise additional cash. We already witnessed an 82% dilutive offering in February 2009. At this point we think that management is going to have to raise as much as $30 - 40 million over the next 3+ years in order to get to cash flow positive operations and positive EPS in 2013.Hopefully the bulk of this will come in the form of an upfront payment on ARD-3100/3150. Other potential non-dilutive cash raising opportunities exists from Zogenix, the ...

Gilead's Strong Fundamentals Should ContinueBusiness continues to look strong for Gilead Sciences (GILD). The company's tenofovir-based HIV products (Viread, Truvada and Atripla) are number one and widening their lead. The clinical data continues to support the switching of patients from older generation molecules such as abacavir and lamivudine to Gilead's franchise. Also driving impressive trends are revised HIV treatment guidelines from the U.S. Department of Health and Human Services recommending only Truvada (and Atripla) as the backbone of choice in naïve patients.These new guidelines, put into place in November 2008, downgraded Epzicom to an alternative medication based on cardiovascular risk and high rates of virologic failure. Finally, the new FDA chief, Margaret Hamburg, a former New York City Health Commissioner, has significant experience in combating infectious disease, such as HIV/AIDS, and we believe that this type of focused leadership only further adds to the ...