Biotech Business

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PROJECT ZERO DELAY ACCELERATES DRUG'S PATH TO CLINICALTRIAL.
A phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial, a milestone that norma . . .

ADVANCED LIFE SCIENCES GETS LETTER FROM FDA FOR RESTANZA.
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for . . .

FDA LIFTS PARTIAL CLINICAL HOLD OF ICA-105665.
Icagen, Inc. (Nasdaq:ICGN), Research Triangle Park, N.C., has reported that the FDA has lifted the partial clinical hold related to the development of ICA-105665, the company's novel orally availabl . . .

FDA APPROVES AVASTIN FOR THE MOST COMMON KIDNEY CANCER.
Genentech, Inc., South San Francisco, Calif., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has announced that the U.S. Food and Drug Administration (FDA) approved Avastin ( . . .

YAUPON ENROLLS PHASE 2 OF CLEARAZIDE FOR T-CELL LYMPHOMA.(Clinical report)
Yaupon Therapeutics, Radnor, Pa., a privately held specialty pharmaceutical company, has completed enrollment for a pivotal Phase 2 clinical trial for Clearazide for the treatment of early-stage cut . . .

JANET DAVIDSON AWARDED GRUBER GENETICS PRIZE.
Janet Davison Rowley, MD, a founder in the field of cancer cytogenetics and a renowned leader in molecular oncology, will receive the 2009 Genetics Prize of The Peter and Patricia Gruber Foundation. . . .

ECI BIOTECH DEVELOPS EXPRESSDETECT FOR PATHOGEN DETECTION.
ECI Biotech of Worcester, MA, a leading edge protein sensor company, has announced that ECI was chosen to present at the 15th Annual Life Sciences Venture Forum in San Jose CA. For over a decade the . . .

CARDIOXYL INITIATES PHASE I/IIA STUDY IN HEART FAILURE.
Cardioxyl Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, has announced the initiation of a Phase I/IIa dose . . .

OSTEOLOGIX GETS PATENT ALLOWANCE FOR OSTEOPOROSIS DRUG.
Osteologix, Inc. (OTCBB:OLGX), has received a Notice of Allowance from the U.S. Patent and Trademark Office for its U.S. Patent Application Number 11/269,289 titled "Water-Soluble Strontium Salts fo . . .

SHORT-COURSE RADIOTHERAPY EFFECTIVE FOR BONE METASTASES.
A single high dose of radiotherapy is as effective in relieving the pain from vertebral bone metastases as ten smaller treatments according to new research from the Radiation Therapy Oncology Group . . .

HPV STATUS PREDICTS SURVIVAL IN OROPHARYNGEAL CANCERS.(Clinical report)
The largest and most definitive study to date has found that patients with stage III or IV oropharyngeal cancer (cancers of the upper throat) whose tumors contained the human papillomavirus (HPV) ha . . .

ALEXION'S SOLIRIS PREVENTS REJECTION IN KIDNEY TRANSPLANTS.(Clinical report)
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), Cheshire, Conn., has announced that researchers presented early clinical and laboratory data on the potential role of terminal complement inhibition wit . . .

SCYNEXIS REPORTS SCY-635 POSITIVE SINGLE AGENT RESULTS.(Financial report)(Clinical report)
Drug discovery company SCYNEXIS, Inc., Research Triangle Park, N,C., has presented positive results from a Phase 1b single-agent, randomized, double- blind, placebo-controlled study of its lead, ora . . .

CHELSEA GETS POSITIVE RESULTS FROM PHASE I CH-4051 TRIAL.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C. has announced positive findings from its Phase I trial of CH-4051, the L-isomer of CH-1504 and second drug candidate from its . . .

ICAGEN COMPLETES ENROLLMENT IN PHASE II ALERGEN ASTHMA TRIAL.(Clinical report)
Icagen, Inc. (Nasdaq:ICGN), Research Triangle Park. N.C. has reported the completion of enrollment in the company's Phase II proof-of-concept study of senicapoc in patients with allergic asthma. Ini . . .

WAFERGEN/DUKE UNIV. TO USE SMARTCHIP FOR SNP VALIDATION.
WaferGen Biosystems, Inc. (OTCBB: WGBS), Fremont, Calif., a leading developer of state-of-the-art genetic analysis systems, has announced the signing of a research collaboration with Duke University . . .

COVANCE ADDS ALZEIMER''S ASSAY TO PORTFOLIO.
Covance, Princeton, N.J., has announced the availability of a new ELISA kit specific for soluble APPbeta, a protein that is the subject of substantial research interest in the Alzheimer''s Disease ( . . .

ATON PHARMA AQUIRES MARKETING RIGHTS TO MERCK'S TIMOPTIC LINE.
Aton Pharma, Inc., Lawrenceville, N.J., a diversified specialty pharmaceutical company, has acquired the U.S. marketing rights to the TIMOPTIC product line from Merck & Co., Inc. TIMOPTIC (timolol m . . .

PDS BIOTECHNOLOGY LICENSES MERCK EPROVA'S DOTAP CHLORIDE.
PDS Biotechnology, Indianapolis, has obtained an exclusive license from Merck Eprova AG to utilize Merck Eprova's proprietary chiral lipid DOTAP Chloride in Versamune(TM)-HPV and other products in d . . .

COMBIMATRIX TO LAUNCH NON-INVASIVE CANCER SCREENING TEST.
CombiMatrix Corporation (Nasdaq:CBMX) Mukilteo, Wash., has announced positive preliminary data on its investigational Comprehensive Cancer Array (CCA) test showing it can non- invasively screen for . . .

CHEMIMAGE OFFERS BIOEQUIVLANCE TECHNOLOGY FOR DRUG MAKERS.
ChemImage (www.chemimage.com), Pittsburgh, one of the world's leading chemical and biological imaging technology solutions companies, is set to help generic drug makers become the first to achieve b . . .

RXI PHARMACEUTICALS/MASS. MEDICAL SCHOOL GET RESEARCH GRANT.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), has announced . . .

CHELSEA THERAPEUTICS INITIATES PHASE II OF DROXIDOPA IN FIBROMYALGIA.(Clinical report)
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C., has initiated a Phase II trial of Droxidopa, a synthetic precursor of norepinephrine, both alone and in combination with carb . . .

U.S. FDA APPROVES ORAQUICK ADVANCER 12-MONTH SHELF LIFE DATING.
OraSure Technologies, Inc. (NASDAQ: OSUR), Bethlehem. Pa., has announced that the United States Food and Drug Administration (FDA) has approved its request for 12-month shelf life from the date of m . . .

RESVERATROL IN DARK CHOCOLATE & COCOA LEADS TO ANTI-AGING.
The new age health obsession with anti-aging medicine and longevity has finally been given a fresh insight with recent scientific evidence proving the anti-aging abilities of a naturally occurring c . . .

ARUNA BIOMEDICAL OFFERS EBRYONIC STEM CELL DERIVED NEURAL CELLS.
ArunA Biomedical, Inc., Athens, Ga., will make its hN2(TM) cells commercially available to the research community in early 2009. The cells, derived from NIH registered human embryonic cell lines, ar . . .

LILLY WITHDRAWS CYMBALTA APPLICATION AND TO RESUBMIT IN 2009.
Eli Lilly and Company (NYSE:LLY), Indianapolis, has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta(R) (duloxetine HCl) for the m . . .

ANGIOGENEX REVIEWS 2008 AND SETS GOALS FOR 2009.
AngioGenex, Inc. (OTC Bulletin Board: AGGX) is a New York- based biotechnology company that leads in targeting Id genes and proteins for the discovery and development of anti- angiogenic drugs to tr . . .

SIGMA-ALDRICH/D-FINITIVE CELL TO DEVELOP REGENERATIVE TOOLS.
Sigma-Aldrich (NASDAQ:SIAL}, St. Louis, has entered into a research collaboration program with D-Finitive Cell Technologies, Inc. This collaboration is expected to support the development and commer . . .

FDA APPROVES PLC SYSTEMS PIVOTAL TRIAL OF RENALGUARD IN U.S.
PLC Systems Inc. (OTC Bulletin Board: PLCSF), Franklin, Mass., has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of th . . .

NON-BRAIN PENETRANT CB1 ANTAGONISTS CAN TREAT DIABETES/OBESITY.
Research shows that proprietary non-brain penetrant cannabinoid subtype 1 (CB1) receptor antagonists developed by Jenrin Discovery are able to produce metabolically favorable effects in peripheral t . . .

TOVAXIN REDUCES DISABILITY FOR MULTIPLE SCELEROSIS.(Clinical report)
Opexa Therapeutics, Inc. (NASDAQ:OPXA), The Woodlands, Texas, a company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple . . .

ORASURE SUBMITS ORAQUICK HCV TEST PMA TO FDA.
OraSure Technologies, Inc. (NASDAQ: OSUR), Bethlehem, Penn., has submitted a pre-market approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for a rapid test for antibodies . . .

ROCKWELL MEDICAL ANNOUNCES UPDATED DSMB RESULTS.(Financial report)
Rockwell Medical Technologies, Inc. (Nasdaq:RMTI), Wixom, Mich., a specialty pharma company focused on drug and device development in the renal market, has reported that the independent Data Safety . . .

NOVAVAX GETS GOOD RESULTS FROM PHASE I/IIA VACCINE STUDY.(Report)
Novavax, Inc. (NASDAQ:NVAX), Rockville, Md., has announced favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine . . .

CHELSEA PATIENT DOSING IN DROXIDOPA PHASE III.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C., announced that it has initiated patient dosing in Study 301, the second of two pivotal Phase III trials designed to demonstra . . .

DISCOVERY AEROSOLIZED KL-4 SURFACTANT SELECTED FOR PHASE 2A.(Clinical report)
Discovery Laboratories, Inc. (Nasdaq:DSCO), Warrington, Pa., announces that its proprietary, aerosolized KL-4 surfactant has been selected for a Phase 2a clinical trial in patients with Cystic Fibro . . .

NIH FUNDS DISCOVERY OF NEW INFLUENZA INHIBITORS.
Integral Molecular, Inc., Philadelphia, initiates a federally-funded program to discover new drugs to combat influenza infection. Sponsored by the National Institute of Allergy and Infectious Diseas . . .

ANTIDEPRESSANTS/COCAINE INTERACT WITH BRAIN CELL TARGETS.
In a first, scientists from Weill Cornell Medical College and Columbia University Medical Center have described the specifics of how brain cells process antidepressant drugs, cocaine and amphetamine . . .

PHARMACOPEIA EARNS MILESTONE PAYMENT FROM WYETH.
Pharmacopeia (Nasdaq:PCOP), Princeton, N.J. an innovator in the discovery and development of novel small molecule therapeutics, has announced that it has received a milestone payment from Wyeth Phar . . .

DISCOVERY LABS KL-4 DATA PUBLISHED IN PEDIATRIC RESEARCH.
Discovery Laboratories, Inc. (Nasdaq:DSCO), Warrington, Pa., has announced the publication in Pediatric Research of data from a pre-clinical research study conducted at the Nemours Research Lung Cen . . .

LEXICON SUCCESSFULLY COMPLETES PAHSE I STUDY OF LX1031.
Lexicon Pharmaceuticals' Drug Candidate for Irritable Bowel Syndrome Completes Phase 1 Clinical Trial Showing Positive Results Phase 2 Proof-of-Concept Clinical Trial in IBS Patients to be Initiat . . .

BAYER EXPANDS HEMOPHILIA PORTFOLIO FEATURING MAXY-VII.(Company overview)
Bayer HealthCare is expanding its commitment to hemophilia with the acquisition of Maxygen's hemophilia program assets, including a next-generation recombinant Factor VIIa protein known as MAXY-VII. . . .

HANA BIOSCIENCES GETS U.S.ORPHAN DRUG DESIGNATION FOR MARQIBO.
Hana Biosciences (Nasdaq:HNAB), South San Francisco, Calif., a biopharmaceutical company focused on strengthening the foundation of cancer care, has announced that the U.S. Food and Drug Administrat . . .

SENESCO CHOOSES VGXI TO PRODUCE FACTOR 5A PLASMID.
Senesco Technologies, Inc., (AMEX:SNT), Brunswwick, N.J., has contracted with VGXI, Inc. (The Woodlands, TX) ("VGXI") to supply the plasmid portion of the company's combination therapy consisting of . . .

REGENERX COMPLETES ENROLLMENT OF PHASE IA FOR HEART DRUG.
RegeneRx Biopharmaceuticals, Bethesda, Md., (AMEX:RGN) has completed enrollment and dosing of 40 healthy subjects for its Phase IA clinical trial testing RGN-352, an injectable formulation of T?4 fo . . .

APP PHARMACEUTICALS GETS APPROVALS FOR ADDITIONAL DOSAGES.
APP Pharmaceuticals, Inc. (Nasdaq:APPX), Schaumburg, Ill., a leading manufacturer of multi-source and branded injectable pharmaceutical products, has received final approvals from the U.S. Food and . . .

MOLECULAR INSIGHT INITIATES PHASE 2A AZEDRA CLINICAL TRIAL.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI), Cambridge, Mass., has initiated a Phase 2a clinical trial of Azedra (Ultratrace(tm) iobenguane I-131 or Ultratrace MIBG) for the treatment of . . .

FDA PROVIDES CLARITY TO ISIS ON MIPOMERSEN REQUIREMENTS.
Isis Pharmaceuticals, Inc. (NASDAQ:ISIS)and Genzyme Corp. (NASDAQ:GENZ) has announced that the FDA has provided guidance regarding approval requirements for mipomersen. The FDA has indicated that re . . .

DUSKA THERAPEUTICS PLANS NDA 505(B)(2) FILING FOR ATPACE.
Duska Therapeutics, Inc. (BULLETIN BOARD: DSKA), La Jolla, Calif., a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor- related technologies, . . .