Today an hour before the opening bell, ReGen Biologics announced that the U.S. Food and Drug Administration (FDA) has given the company clearance to market its collagen scaffold device, the Menaflex™ collagen meniscus implant. This device was designed to be used in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus (a band that spans the knee joint).

Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics, stated, “We are extremely pleased that the FDA has considered the recommendations of the Orthopaedic and Rehabilitation Devices Advisory Panel in support of our collagen scaffold 510(k) and that the FDA agreed to enable U.S. marketing for this important product. Today’s announcement represents the culmination of many years of effort on the part of the Company and the invaluable contribution of many supportive investors, advisors and surgeons, as we sought to bring the Menaflex

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Today Amgen Inc. (AMGN) announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its potential next blockbuster drug, denosumab. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase-III trials involving more than 11,000 patients.Denosumab is a fully human monoclonal antibody target receptor activator of nuclear factor kappa B ligand (RANK-L). The clinical data on denosumab, or D-Mab as management calls it, is impressive. In July 2008, Amgen release top-line data from the pivotal trial testing denosumab in 7,800 women with postmenopausal osteoporosis over a 3-year period. Data from the trial showed taking denosumab subcutaneous injections once every six months resulted in statistically ...

Laura Cadden says Aastrom Biosciences, Inc. (NASDAQ:ASTM) is one of the hottest biotech stocks priced under $5. The company hopes to use its proprietary Tissue Repair Cell (TRC) technology to revolutionise treatment for heart disease. And it is making good progress through the trial phases. Laura says Aastrom is poised to make 20% gains in six months

This from Today’s Financial News:

Investors expect President-Elect Obama to make good on his campaign promise to lift restrictions on federally funding human embryonic stem cell research. House Speaker Nancy Pelosi has vowed to introduce legislation for a regulatory framework necessary to enable expanded stem cell research.

Biotechnology experts consider both the regulatory framework (to underpin clinical trials) and the additional funding to be crucial to the future of the American bio-pharma industry. In fact, it could ring in a new era for American stem cell

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Roughly 7 million patients worldwide receive interventional cardiovascular therapeutic and diagnostic imaging procedures each year. Approximately 15 percent to 20 percent of all patients undergoing such procedures are at risk of developing Contrast-Induced Nephropathy (CIN), the third leading cause of in-hospital acute renal failure.

Medical device company PLC Systems Inc. (OTCBB: PLCSF) develops cardiac and vascular technologies primarily in the United States. The company today announced it has received full approval from the U.S. Food and Drug Administration (FDA) regarding the company’s RenalGuard System, which was developed for interventional cardiology and radiology patients to eliminate toxins.

The FDA approved the company’s U.S. pivotal trial to study the effectiveness of the RenalGuard System, as well as associated therapies for the prevention of CIN.

“We remain very confident that RenalGuard is a highly promising therapy addressing a large, unmet market need. We are optimistic that the results from the CCM study will provide

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GenVec, Inc. reported today that the U.S. Food and Drug Administration (FDA) has approved GenVec’s TNFerade™ for Fast Track development in the treatment of locally advanced pancreatic cancer. TNFerade™ is designed to stimulate the production of immune system proteins with anti-cancer properties that are injected into tumors. GenVec is developing TNFerade™ for use in combination with other tools such as radiation and chemotherapy for the treatment of various cancers.

TNFerade™ qualifies for Fast Track status because GenVec provided the FDA with evidence that TNFerade™ may have potential to improve the survival rate of patients suffering from pancreatic cancer. The FDA grants Fast Track designation to drugs that are designed to treat life-threatening conditions and that have a proven potential to address an unmet medical need.

Fast Track designation only applies to situations where a developmental stage drug is used to treat one specific

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Alpharma Inc. published its third quarter results today and those results show the company has advanced towards meeting its goal announced earlier this year of producing positive earnings for the last half of 2008. Alpharma makes and sells specialty pharmaceuticals worldwide for humans and animals. Increases in livestock sales and the resulting need for additional products boosting animal health in the United States helped push Alpharma into the black. Both revenue and operating income increased, leading to higher earnings per share. Alpharma recorded revenue of $175.7 million, a 32% increase in revenue from the third quarter of 2007. Operating income reached $9.7 million after subtracting costs from King Pharmaceuticals, Inc.’s unsolicited takeover bid for all of Alpharma’s common stock. Excluding the extraordinary costs for the takeover bid, operating income was $13.9 million. Earnings per share were $0.10, or $0.16 when the takeover costs

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New Mexico Software produces powerful Business Process Acceleration Systems that turn data into searchable electronic files, applicable to every field of endeavor. Hospitals, nursing homes, and radiology reading centers, to name a few, have the need to search patients’ records for data efficiently. New Mexico Software today obtained 510(k) clearance for its XR-EXpress Picture Archiving and Communication System (PACS) from the U.S. Food and Drug Administration (FDA).

XR-EXpress PACS is a teleradiology system designed to retrieve HIPAA (Health Insurance Portability and Accountability Act) compliant medical images in DICOM (Digital Imaging and Communications in Medicine) format. Also, it generates, organizes and archives textual reports while making them accessible across web networks with customized user interfaces. FDA classified XR-EXpress as a Class II device under Regulation 21 CFR 892.2050 with product code LLZ.

President of the Healthcare division of New Mexico Software, Bruce Stabile said, “FDA clearance is required for nearly all medical devices

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Oxygen Biotherapeutics Inc. (OTCBB: OXBO) engages in marketing innovative pharmaceuticals and medical devices to monitor respiration in patients suffering from or associated with respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes.

The company today announced it will submit an amended test protocol to the U.S. Food and Drug Administration, as well as in Canada, to cover the dose escalation studies of the company’s therapeutic oxygen carrier Oxycyte. The company plans on recruiting 40 traumatic brain injury (TBI) patients in each country to test the safety and efficacy of Oxycyte.

“Personally, I think that the extensive data we will collect in the dose escalation studies should be more than needed for proof-of-concept in both safety and efficacy. The advantage is that we should have the data we need much earlier, after each cohort of 10, rather than after 200 patients as it was previously planned. Another important

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Neurobiological Technologies, Inc. (NASDAQ: NTII) announced that a recent meeting with the U.S. Food and Drug Administration to discuss a Phase 3 Clinical trial for its Viprinex was encouraging.

As a result, the company will consolidate data and patients from its two other trials into a single Phase 3 pivotal trial to be completed by mid-2009. Viprinex is designed to assist with the treatment of acute ischemic stroke. Interim trial results are now expected in January 2009.

“Since the two concurrent Phase 3 studies employ the same protocol and patient entry criteria, the validity of the single merged study remains the same as initially designed for the two individual studies,” a company news release states.

“This is game-changing for us, our shareholders and patients,” said Paul E. Freiman, president and CEO. “… If results are positive, we will be able to move the program forward with much more information and a higher level

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Neurobiological Technologies, Inc. (NASDAQ: NTII) announced that a recent meeting with the U.S. Food and Drug Administration to discuss a Phase 3 Clinical trial for its Viprinex was encouraging.

As a result, the company will consolidate data and patients from its two other trials into a single Phase 3 pivotal trial to be completed by mid-2009. Viprinex is designed to assist with the treatment of acute ischemic stroke. Interim trial results are now expected in January 2009.

“Since the two concurrent Phase 3 studies employ the same protocol and patient entry criteria, the validity of the single merged study remains the same as initially designed for the two individual studies,” a company news release states.

“This is game-changing for us, our shareholders and patients,” said Paul E. Freiman, president and CEO. “… If results are positive, we will be able to move the program forward with much more information and a higher level

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