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Amarantus BioSciences Licenses Parkinson's Disease Diagnostic Biomarker Test from Power3 Medical Products

noemail@biohouston.org — Mon, 23 Jan 2012 16:00:00 GMT

SUNNYVALE, CA and THE WOODLANDS, TX - January 23, 2012- Amarantus BioSciences, Inc. (OTCBB: AMBS), a biotechnology company developing MANF, a first-in-class disease-modifying therapeutic protein being developed for the treatment of Parkinson's Disease, today announced an exclusive worldwide license agreement with Power3 Medical Products, Inc. (OTCBB: PWRM) for the NuroPro Blood Test as it relates to Parkinson's disease diagnosis. Concurrent with the license, Amarantus has raised $100,000 from a private, foreign investor introduced to the Company by www.tomorrowsbluechips.com. The NuroPro Blood Test is Power3's diagnostic platform for the early detection of neurodegenerative diseases. It is being developed as a tool to assist physicians to more accurately diagnose disease and monitor progression. The platform involves monitoring the concentration of 57 protein markers in blood serum identified to be linked to neurodegeneration in order to accurately detect and distinguish between...

Pernix Therapeutics Announces Agreement to License a New FDA-Approved Product to Treat Gastroenterology Disease

noemail@biohouston.org — Mon, 23 Jan 2012 14:00:00 GMT

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced it has entered into a license and supply agreement with a private company for a new FDA-approved prescription product to treat gastroenterology disease. Under the terms of the agreement, Pernix obtained exclusive marketing rights to this gastroenterology product in the United States. Cooper Collins, President and Chief Executive Officer of Pernix, said, Our agreement to license a gastroenterology product represents an important milestone for the Company as we continue to execute on our business strategy focused on expanding our branded product portfolio into specialty areas beyond pediatrics. Prior to launching the product, we plan to establish a sales force of up to 30 representatives dedicated to gastroenterology. We expect to invest in the recruiting and...

LX4211 Enhances Effects of DPP-4 Inhibition in Patients with Type 2 Diabetes

noemail@biohouston.org — Mon, 09 Jan 2012 14:00:00 GMT

Combination of LX4211 and DPP-4 Inhibitor Reduces Blood Sugar After Meals and Increases GLP-1 in Type 2 Diabetic Patients More than DPP-4 Inhibitor Alone The Woodlands, Texas, January 9, 2012 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today top-line results from the first clinical study testing the combined effects of LX4211, a novel sodium glucose transporter 1 and 2 (SGLT1 and SGLT2) inhibitor, with the dipeptidyl peptidase 4 (DPP-4) inhibitor, sitagliptin (Januvia), one of the most widely prescribed diabetes drugs. The results of this study are important given that combination therapy is the mainstay of current diabetes treatment, said Dr. Pablo Lapuerta, senior vice president of clinical development and chief medical officer at Lexicon. Alone, LX4211 produces rapid improvement in postprandial blood glucose by delaying intestinal glucose absorption and increasing urinary glucose excretion. When combined, the two agents produce enhanced benefits on blood...

New Biotech Cluster in the U.S. Are Scrambling to Challenge Established Regions

noemail@biohouston.org — Tue, 03 Jan 2012 14:00:00 GMT

Jan. 3, 2012 -- The weak economy of the past four years combined with cutbacks due to mergers and acquisitions have helped consolidate U.S. biopharma activity further within the nation's largest life sciences clusters. Yet that has not stopped several other U.S. regions from trying to carve out their own piece of the life science pie. The real estate firm Jones Lang LaSalle (JLL) highlighted nine examples of what it called emerging bioclusters. The regions in descending order as ranked by JLL are Minneapolis, Raleigh-Durham, Seattle, Chicago, Denver, Houston, Florida, Atlanta, and Indianapolis. Arguably, though, the first three clusters on their list are far past that status. Minneapolis' cluster has long been focused on medical device manufacturers anchored by the Mayo Clinic. Research Triangle Park, which includes the cities of Raleigh and Durham, has attracted several biopharma giants including Biogen Idec and GlaxoSmithKline. Seattle has a growing research...

Cyberonics Announces FDA Approval of Re-Designed AspireHC Generator for VNS Therapy

noemail@biohouston.org — Tue, 03 Jan 2012 14:00:00 GMT

HOUSTON, Jan. 3, 2012 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced that the United States Food and Drug Administration(FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011. We are pleased that the FDA was able to complete its review in approximately 60 days, enabling us to resume our limited commercial release of the AspireHC generator in the United States, said Dan Moore, Cyberonics' President and Chief Executive Officer. With the CE Mark approval announced in December and a recently obtained Canadian approval, we will also resume the limited commercial release in Europe and initiate a limited commercial release in Canada. The AspireHC generator addresses a need among some patients for a device with a higher capacity battery and also provides a platform for the AspireSR™ seizure response generator, which is the subject of our E-36 clinical trial in Europe. We...

Lonza Launches Novel Plasmid (pDNA) Production Platform for Microbial Derived Biopharmaceuticals

noemail@biohouston.org — Tue, 20 Dec 2011 14:00:00 GMT

•The new pDNA platform results in reduced development time, higher product yields, improved purity and shorter processing time •The process is compatible with a variety of E.coli hosts, providing the flexibility of using either a client's strain or a Lonza developed strain •The microbial-based platform is available for process development projects in either Lonza's Hopkinton, MA (USA) or Visp (CH) development and manufacturing facilities Basel, Switzerland, 20 December 2011 - Lonza, a world leader in biopharmaceutical development and production, announced today the launch of a new microbial-based platform for the production of high-quality plasmid DNA vaccines & therapeutics. This novel pDNA production platform consists of three harmonized processes: fermentation, primary recovery, and purification. Use of this platform process reduces development time required for custom pDNA products compared to existing systems. ...

Abbott pays out $400 million for access to more Reata compounds

noemail@biohouston.org — Mon, 12 Dec 2011 14:00:00 GMT

Abbott Laboratories has signed another deal with partner Reata Pharmaceuticals which will boost the latter's bank balance by a further $400 million. The companies will jointly develop Reata's portfolio of second-generation oral antioxidant inflammation modulators (AIMs). The agreement is in addition to the partnership they announced in September 2010 in which Abbott paid some $450 million to get certain rights to bardoxolone, an AIM compound which is in Phase III for chronic kidney disease. The latest deal covers a large number of molecules in a broad range of therapeutic areas, including pulmonary, central nervous system disorders and immunology. Abbott and Reata will equally share costs and profits for all new AIMs in all indications except for rheumatoid arthritis and select other autoimmune diseases, in which Abbott will be responsible for 70% of costs and profits. Related Links Abbott gets rights to Reata kidney drug for 450 millionInvestors do...

Opexa Announces Publication in Multiple Sclerosis Journal of Tovaxin Phase IIb Clinical Trial Results

noemail@biohouston.org — Mon, 14 Nov 2011 14:00:00 GMT

THE WOODLANDS, Texas (November 14, 2011) - Opexa Therapeutics, Inc. (NASDAQ: OPXA), developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today announced that results of the Company's prior Phase IIb clinical trial of Tovaxin have been published in a leading peer-reviewed publication, Multiple Sclerosis Journal. The Phase IIb placebo-controlled study [Tovaxin for Early Relapsing Multiple Sclerosis (TERMS)] was conducted in 150 patients, evaluating safety and efficacy of Tovaxin in relapsing-remitting MS patients (RRMS) and those with clinically isolated syndrome. The TERMS study, first reported in 2008, showed that Tovaxin was well-tolerated, with no serious adverse events, and demonstrated encouraging clinical results in the reduction of the annualized relapse rate (ARR) and improvement in disease progression. The TERMS trial was a landmark study in that it was the first time that a personalized...

Lexicon Announces Plans for Rights Offering to Stockholders

noemail@biohouston.org — Fri, 11 Nov 2011 14:00:00 GMT

THE WOODLANDS, Texas, Nov. 11, 2011 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced plans for a rights offering pursuant to an effective shelf registration statement in which its stockholders will receive non-transferable subscription rights to purchase up to 144,247,800 shares of its common stock in the aggregate. In the rights offering, stockholders will receive one non-transferable subscription right for every share of common stock owned as of November 21, 2011, which is the record date for the rights offering. Each subscription right will entitle stockholders to purchase a pro rata number of shares of common stock at a subscription price of $1.13 per share. Stockholders who exercise their basic subscription privilege in full may also exercise an over-subscription privilege to purchase additional shares that remain unsubscribed at the expiration of the rights offering, subject to availability. If the rights offering is fully subscribed,...

Mystic Pharmaceuticals Receives U.S. Patent for Innovative Unit Dose Packaging and Delivery Technology for Drugs and Biologics

noemail@biohouston.org — Wed, 09 Nov 2011 15:00:00 GMT

AUSTIN, TX - November 9, 2011 (Business Wire) -- Mystic Pharmaceuticals, Inc. announces today that it has been granted U.S. Patent No. 8,047,204, Combination Unit Dose Dispensing Containers I for a novel unit dose blister packaging technology. This packaging technology is a key element of the company's VersiDoserTM and VRx2TM drug and biologic delivery systems. Mystic's delivery platforms provide preservative free unit dose packaging and devices for precision delivery of drugs and biologics. President and CEO of Mystic, Timothy Sullivan states that, We continue to expand the breadth and depth of our delivery platform technologies with this latest advance. Our novel unit dose blister packaging combined with patient friendly delivery systems enable manufacturers to extend product life for branded products beyond patent expiry and retain market exclusivity. With Mystic's VersiDoserTM and VRx2TM delivery systems patients can precisely and consistently self-administer medications to...

Opexa's Tovaxin for the Treatment of Multiple Sclerosis Granted Fast Track Designation by FDA

noemail@biohouston.org — Tue, 08 Nov 2011 15:00:00 GMT

THE WOODLANDS, Texas--(November 8, 2011)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), announced today that its lead drug candidate Tovaxin has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS). The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. According to the FDA, products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review. Additionally, as per the FDA, Fast Track priority review products are more likely to be approved on the first review cycle than those without the designation. Fast Track also entitles Opexa to more frequent interactions...

Lonza Viral's Production Capacity Expansion: Update

noemail@biohouston.org — Wed, 02 Nov 2011 14:00:00 GMT

Lonza’s Viral-based Therapeutics business is pleased to update you on the status of our new GMP clean suite. We continue to remain on target for completion of construction and validation of this suite by end of Q1 2012.

Notably, we recently held our Type C meeting with FDA. This meeting was to review the new suite’s design with regards to personnel, materials and air flow, cleaning protocols, and other critical components of constructing, commissioning, validating and operating a facility for GMP manufacture of viral products. We are pleased to report that the meeting went extremely well, with no modifications to our design or approach required.

David Enloe, Head of Lonza’s Viral-based Therapeutics unit, stated, “While we were confident going into this important meeting with FDA, we were very pleased to confirm that the Agency’s current thinking with regards to approaches to key facility design and operation issues is consistent with our own. We are excited to complete this facility and begin serving client needs which require higher working volume batches. I’m particularly pleased that we remain proactive with regards to both of our suites being EU-compliant. Our recently upgraded, higher volume, EU-compliant fill/finish unit is now operational and available for upcoming engagements. Our recently installed autoclave is the first one put into operation in the US by our global autoclave supplier which meets new EU standards. Our new vaporized hydrogen peroxide (VHP) decontamination unit will provide further assurance to clients that cross-contamination events will be avoided. We remain on time and within budget for the new GMP suite, and look forward to the growth we are projecting in the viral business segment.”

If you would like to learn more about this or anything else about our activities please let us know and we would be happy to contact you. We may be reached via email at xin.swanson@lonza.com or by phone at 713.568.6180, extension 4059.

Opexa Elects Gail Maderis to Board of Directors

noemail@biohouston.org — Wed, 02 Nov 2011 14:00:00 GMT

Industry Expert Brings Significant Expertise to Tovaxin Clinical Development Program THE WOODLANDS, TX (November 2, 2011) - Opexa Therapeutics, Inc. (NASDAQ: OPXA) today announced the election of Gail J. Maderis to its Board of Directors at its annual meeting of shareholders held on October 27, 2011. Ms. Maderis will Chair the Board's nominating and corporate governance committee, as well as serve on the Board's compensation committee. We are very pleased to welcome Gail to the Board as she brings a wealth of experience in the healthcare industry as a former senior executive in Genzyme and past CEO of Five Prime Therapeutics, commented Neil K. Warma, President and Chief Executive Officer of Opexa. Gail's successful leadership in these companies, including her accomplishments in corporate partnerships and clinical development, will greatly enhance our capabilities at the Board level. Along with her industry knowledge, Gail has acquired an extensive network of contacts...

Opexa Elects Gail Maderis to Board of Directors

noemail@biohouston.org — Wed, 02 Nov 2011 14:00:00 GMT

Arrowhead Research Appoints Bruce Given M.D. Chief Operating Officer

noemail@biohouston.org — Thu, 27 Oct 2011 21:00:00 GMT

PASADENA, Calif. - October 27, 2011 - Arrowhead Research Corporation (NASDAQ: ARWR) today announced that it has appointed Bruce Given, M.D. to the position of Chief Operating Officer of the Company effective October 26, 2011. Since February 1, 2010, Dr. Given has served as Chief Executive Officer of Leonardo Biosystems, Inc., a company in which Arrowhead maintains a minority equity interest, and he also has served as a director of Calando Pharmaceuticals, Inc., a subsidiary of Arrowhead, since October 1, 2009. Additionally, Dr. Given has served on the Board of Directors of ICON, plc since 2004 and was elected Chairman in 2010. For more than 20 years, Bruce has provided sound operational counsel and exceptional leadership in his positions in the biotechnology and pharmaceuticals industries, said Dr. Christopher Anzalone, President and Chief Executive Officer of Arrowhead. He has led the strategic development efforts of numerous drug candidates, including non-clinical studies,...

Cormedics Completes Pre-Submission Financing & Signs Development Agreement With J&J Unit

noemail@biohouston.org — Mon, 19 Sep 2011 19:00:00 GMT

HOUSTON, September 19, 2011 - Cormedics Corp. has received new financing to support refinement of the company's intrapericardial access device for its submission to the Food and Drug Administration, and has signed a development agreement with a Johnson & Johnson affiliate company, Biosense Webster. The new investment, by Palo Alto medical technology investor Patrick Rivelli, is in addition to $750,000 in two previous awards from the Texas Emerging Technology Fund, bringing total investment in the start-up company to more than $1 million. Our development agreement with Biosense Webster will capitalize on Cormedics' patented technologies for accessing the heart via the pericardial space to pursue a variety ofemerging opportunities in epicardial access, said James Meador, Cormedics' Chief Executive Officer. About Whole-Heart Therapeutics The therapies potentially available with Cormedics' novel technology range from emergency heart...

Lexicon Presents LX4211 Clinical Data at European Association for the Study of Diabetes Annual Meeting

noemail@biohouston.org — Tue, 13 Sep 2011 13:00:00 GMT

THE WOODLANDS, Texas, Sept. 13, 2011 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that the company is presenting clinical data this week at the European Association for the Study of Diabetes (EASD) annual meeting in Lisbon, Portugal. Data from the mechanistic study being presented at the EASD meeting demonstrated that a single dose of LX4211 significantly increased circulating levels of GLP-1 (active and total) and PYY, important regulators of glycemic and appetite control. For more information on this program or to download a copy of the presentation from the EASD meeting, please visit www.lexpharma.com. About Lexicon Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has four drug programs in mid-stage development for diabetes, irritable bowel syndrome,...

LX4211 for Diabetes Shown to Reduce Fasting and Post-Prandial Blood Sugar in Healthy Subjects

noemail@biohouston.org — Tue, 13 Sep 2011 13:00:00 GMT

THE WOODLANDS, Texas, Sept. 13, 2011 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, reported positive data from a recently completed clinical trial and mechanistic study of LX4211, a dual inhibitor of the sodium glucose transporters 1 and 2 (SGLT1 and SGLT2). The favorable safety profile and effects on multiple parameters of glycemic control and cardiovascular health in healthy normal subjects support the broad potential of LX4211 in the treatment of diabetes and associated metabolic conditions. Newly observed in this study were the effects of LX4211, in healthy volunteers, of decreasing postprandial glucose levels without hypoglycemia and substantially reducing triglycerides, said Brian Zambrowicz, Ph.D., executive vice president and chief scientific officer. Notably, the magnitudes of the reductions in triglycerides were similar to current standard of care...

Dr. Mark Freedman to Join Opexa's Scientific Advisory Board

noemail@biohouston.org — Mon, 12 Sep 2011 13:00:00 GMT

THE WOODLANDS, Texas (September 12, 2011) - Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today announced it has recently added a key international opinion leader to its Scientific Advisory Board. Mark Freedman, M.D., is a professor of medicine in the field of neurology at the University of Ottawa, and director of the Multiple Sclerosis Research Unit at the Ottawa Hospital, General Campus. He will be joining other colleagues of high regard on Opexa's Scientific Advisory Board: Dawn McGuire, M.D. (Chair), Doug Arnold, M.D., Edward Fox, M.D., Ph.D., Hans-Peter Hartung, M.D., Clyde Markowitz, M.D., Paul O'Connor, M.D., and Arthur Vandenbark, Ph.D. It is a distinct pleasure to welcome Dr. Freedman to Opexa's Scientific Advisory Board, stated Dr. McGuire, Chair of the SAB. Dr. Freedman is internationally renowned for his expertise in MS translational research and has been involved in numerous clinical...

Arcos, Inc. adds Chief Medical Officer

noemail@biohouston.org — Wed, 31 Aug 2011 20:00:00 GMT

HOUSTON, Aug 30, 2011 -- Arcos, Inc. announced today that Stephan Wexler, MD, MBA, JD has joined Arcos as its Chief Medical Officer. Dr. Wexler has 20 years experience in plastic surgery and is familiar with many aspects of sepsis, burn, and trauma critical care. We are delighted to have Dr. Wexler join Arcos, said Chris Meador, CEO of Arcos. In addition to providing important 'voice of the customer' input for new product development, Dr. Wexler will communicate the clinical results and value of Arcos' products at conferences and seminars across the country. Dr. Wexler's clinical understanding and leadership will propel us toward our vision of improving complex care with easy-to-use, proven software tools. Stephan Wexler added, Arcos' products have already improved critical care. The world needs these products. I look forward to working with Arcos to improve care at the bedside. About Arcos Arcos, Inc. is a Houston,...