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Oculus Innovative Sciences, Inc. Receives First FDA Clearance for Microcyn(R)-Based HydroGel for Dermatology Market PDF Print E-mail
Friday, 12 March 2010 15:22
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS - News), a commercial medical technology company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, today announced that it has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new dermatology indications for Microcyn® Skin and Wound HydroGel.
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FDA Advisory Committee Recommends Approval of InterMune, Inc.'s Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis PDF Print E-mail
Friday, 12 March 2010 13:17
InterMune, Inc. (Nasdaq:ITMN - News) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.
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Ark Therapeutics Pulls Drug Application, Weighs Sale of Company PDF Print E-mail
Thursday, 11 March 2010 14:49
The Board of Ark Therapeutics Group plc ("Ark" or "the Company") today announces an update relating to the Marketing Authorisation Application ("MAA") for its brain cancer treatment, Cerepro®. Following a presentation to the EMEA's Scientific Advisory Group on Oncology ("SAG-O") as part of the re-examination procedure, the SAG-O did not consider that the current study provides sufficiently reliable evidence of clinical benefit.
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Luminetx® Signs National Distribution Agreement with Alliance Medical PDF Print E-mail
Wednesday, 10 March 2010 13:09

Luminetx®, a division of Christie Medical Holdings, Inc. and recently acquired by Christie Digital Systems USA, Inc., has signed an exclusive national sales distribution agreement with New Alliance of Independent Medical Distributors, Inc., DBA Alliance Medical.

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GeneGo Releases Content And Tools From Industry-FDA Driven MetaTox Partnership Via ToxHunter? PDF Print E-mail
Wednesday, 10 March 2010 12:04
GeneGo announces the release of the first set of tools and content to come out of its industry-FDA MetaTox? partnership program. The MetaTox partnership is developing a unique comprehensive systems toxicology suite designed for compound safety assessment in chemical and pharmaceutical R&D.
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Merck & Co., Inc. Sues Teva Pharmaceutical Industries Limited to Block Generic Vytorin PDF Print E-mail
Tuesday, 09 March 2010 13:56
Merck & Co. and its Schering unit is suing Teva Pharmaceutical Industries Ltd. to prevent it from selling a generic version of the cholesterol drug Vytorin in the United States until 2017.
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InterMune Shares Soar Despite U.S. FDA Concerns PDF Print E-mail
Monday, 08 March 2010 16:35

U.S. health regulatory staff are concerned about unclear trial results and possible side effects with InterMune Inc's (ITMN.O) drug for lung scarring, but investors who were braced for a more negative analysis sent the company's shares soaring.

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XenoPort, Inc. Restructures to Focus on Key Programs; Includes An Overall Reduction of 50% of XenoPort's Workforce PDF Print E-mail
Monday, 08 March 2010 12:26
XenoPort, Inc. (Nasdaq:XNPT) announced today a restructuring that includes an overall reduction in its workforce of approximately 50%. The restructuring is designed to focus the Company’s resources on advancement of its later-stage product candidates.
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Biomoda and Amigenics Announce Collaboration PDF Print E-mail
Saturday, 06 March 2010 15:08
Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) and Advanced Medical Imaging and Genetics (Amigenics) (www.amigenics.com), an innovative medical clinic specializing in prevention and early detection of disease, announced their intent to collaborate on a variety of projects to advance technology for the early detection of lung and other cancer.
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Novo Nordisk Receives FDA Approval for Norditropin(R) FlexPro(R) for Growth Hormone Treatment PDF Print E-mail
Friday, 05 March 2010 17:59

Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Norditropin(R) FlexPro(R) (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children and adults with growth hormone disorders. It will be available in the second quarter.

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Allergan Inc.'s BOTOX(R) (OnabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults PDF Print E-mail
Friday, 12 March 2010 14:20
Allergan, Inc. (NYSE: AGN - News) today announced that the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.
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AutoImmune, Inc. Announces Board Approval of Plan of Complete Liquidation and Dissolution PDF Print E-mail
Thursday, 11 March 2010 16:53
AutoImmune Inc. (OTC Bulletin Board: AIMM) today announced that its Board of Directors has determined, after consideration of potential strategic alternatives, that it is in the best interests of the Company and its stockholders to liquidate the Company's assets and to dissolve the Company.
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Exelixis, Inc. Announces Restructuring; Reduces Workforce by Approximately 40%, or 270 Employees PDF Print E-mail
Thursday, 11 March 2010 13:46
Exelixis, Inc. (Nasdaq:EXEL) today announced a restructuring as a consequence of its continued strategy to focus resources on the development of its key late-stage compounds. As its first priority, the company will aggressively advance XL184, XL147 and XL765, each of which is the subject of a large clinical development program.
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Olink Bioscience And Multisciences Biotec Sign Distributorship Agreement For The Chinese Market PDF Print E-mail
Wednesday, 10 March 2010 12:59

Olink Bioscience has signed a distributorship agreement with the Chinese distributor Multisciences Biotech Co., Ltd for distribution of the Duolink® product line in China.

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Intomics Enters Collaboration with LEO Pharma PDF Print E-mail
Tuesday, 09 March 2010 14:59

Intomics A/S and LEO Pharma A/S announced a collaboration under which LEO Pharma gains access to Intomics’ unique biological data analysis expertises. The recently founded spin-off company from The Danish Technical University, Intomics, has methods and tools for use in LEO Pharma’s early drug discovery.

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VGXI, Inc. Expands Manufacturing Facility, Adds Key Personnel PDF Print E-mail
Tuesday, 09 March 2010 12:53
VGXI, Inc., a leading provider of DNA plasmid manufacturing and development services, announced today at the 2010 DNA Vaccines Conference the expansion of its state-of-the-art cGMP plasmid manufacturing facility in The Woodlands, TX.
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Adamis and La Jolla Pharmaceutical Company Kill Merger Deal PDF Print E-mail
Monday, 08 March 2010 13:33
La Jolla Pharmaceutical Company (Pink Sheets: LJPC) today announced that La Jolla and Adamis Pharmaceuticals Corporation /quotes/comstock/11k!admp (ADMP 0.29, -0.01, -3.33%) have agreed to terminate their merger agreement relating to the proposed merger of the two companies.
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Merck Reports Results of Phase III Study of Investigational Oral Allergy Immunotherapy Tablet (AIT) in Patients Ages 5-17 with Grass Pollen Allergy PDF Print E-mail
Saturday, 06 March 2010 17:14
In new data from a Phase III study in 345 children and adolescents (ages 5-17 years), patients with grass pollen allergic rhinoconjunctivitis treated with Merck's investigational sublingual grass (Phleum Pratense) allergy immunotherapy tablet (AIT) showed a 26 percent greater improvement in the total combined score (daily symptom score and daily medication score), compared to patients receiving placebo (p=0.001).
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Ranbaxy Laboratories Unable to Launch New Generic, Flomax; Shares Fall PDF Print E-mail
Saturday, 06 March 2010 13:01

Ranbaxy Laboratories (RANB.BO) said on Wednesday it would not be able to launch a generic urinary drug as per schedule in the absence of a final regulatory approval, sending its shares down more than 6 percent.

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PTC Therapeutics, Inc. and Genzyme Corporation (GENZ) Announce Preliminary Results from the Phase 2b Clinical Trial of Ataluren PDF Print E-mail
Friday, 05 March 2010 16:54
PTC Therapeutics, Inc. and Genzyme Corporation /quotes/comstock/15*!genz/quotes/nls/genz (GENZ 57.23, +0.41, +0.72%) today announced preliminary results from the Phase 2b clinical trial of ataluren, an investigational new drug, in patients with nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD).
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