|The Medicines Company Stops Phase 2b Trial of MDCO-2010; XenoPort Reports Favorable Metabolism and Pharmacokinetics of XP23829|
|By Staff and Wire Reports|
|Thursday, 04 October 2012 20:46|
The Medicines Company (NASDAQ: MDCO) announced it has voluntarily discontinued its Phase 2b dose-ranging study of MDCO-2010, a serine protease inhibitor which was being developed to reduce blood loss during surgery.
This action was taken in response to serious unexpected patient safety issues encountered during the trial, which had so far recruited 44 of a planned 90 patients in the first stage of the study.
XenoPort, Inc. (Nasdaq: XNPT) announced favorable preliminary results from a Phase 1 clinical trial in healthy adults designed to assess the pharmacokinetics (PK), safety and tolerability of single doses of four different oral formulations of XP23829, a novel fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF).
XP23829 is being developed for the potential treatment of relapsing-remitting multiple sclerosis (RRMS) and/or psoriasis. The trial demonstrated that administration of XP23829 resulted in the expected levels of MMF in the blood. As anticipated, the four formulations produced different PK profiles of MMF, including one formulation that could potentially be dosed two or three times a day and at least one formulation that may be suitable for once-a-day dosing. XP23829 was generally well-tolerated in the trial.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the U.S. District Court of the District of Massachusetts has ruled in favor of Alnylam and has denied Tekmira Pharmaceuticals Corporation’s motion to dismiss certain claims and motion to disqualify Alnylam’s counsel in an infringement suit filed in January 2012.
Andain Inc. (OTCBB: ANDN), a company engaged in the commercialization of novel technologies in the biotech & medical fields, announced today that they have engaged American Capital Ventures ("ACV"), a leading provider of comprehensive investor relations services to companies in the micro- and small-cap market.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today the publication of results from the Phase II EAGLE clinical trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, showing that BL-1020 is safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with this condition.
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical drug development company, announced today that it has signed a purchase agreement for the sale, from time to time, of up to $15 million of its American Depositary Shares (“ADSs”) with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. announced today that they have entered into a definitive merger agreement by which the companies will merge in an all-stock transaction, with BioSante as the surviving company.
Can-Fite BioPharma (TASE: CFBI, OTC: CANFY), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases,announced today that it has listed and begun trading of its American Depository Receipts (ADRs).
Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced positive top-line data showing that solithromycin cleared infections in patients with uncomplicated urogenital gonorrhea.
Corgenix Medical Corporation (OTCBB: CONX.OB), a worldwide developer and marketer of diagnostic test kits, today filed its fiscal year Form 10-K and reported financial results.
CorMedix Inc. (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, held the initial financial closing on September 20, 2012, of its private placement of Units consisting of (i) a one-year $1,000 aggregate principal amount 9% Senior Convertible Note, convertible into shares of common stock, par value $0.001 per share, at a conversion price of $0.35 per Note, and (ii) a five-year redeemable Warrant, to purchase 2,500 shares of Common Stock, to certain accredited investors pursuant to a Subscription Agreement.
CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report third quarter 2012 financial results before the market opens on Thursday, October 25, 2012, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.
Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced U.S. Food and Drug Administration 510(k) clearance and European Economic Area (EEA) CE Mark approval for the Covidien Nellcor™ Bedside Respiratory Patient Monitoring system.
Bend Research Inc., a leading independent drug-formulation development and manufacturing company and The Dow Chemical Company (NYSE:DOW), a global leader in designing, manufacturing, and supplying polymeric excipients for enabling drug-delivery systems, have formed an exclusive collaboration to provide science-based spray-dried dispersion (SDD) solutions and select enabling new polymers for poorly soluble oral drugs.
EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("EasyMed" or the "Company") announces the signing of Pakistani cricket superstar Wasim Akram as the face of its Middle Eastern and Asian operations.
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, has acquired from Escalon Medical Corp. its Clinical Diagnostics Business for $6.5 million in cash.
Fuse Science, Inc. (OTCQB: DROP), (www.fusescience.com) an innovative consumer products company that possesses proprietary technologies set to redefine how consumers receive energy, medicines, vitamins and minerals, today announced that it has engaged New York-based investment banking firm Atlas Strategic Advisors (www.atlasadvisors.com) to explore strategic transactions involving Fuse's proprietary technology.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that it has acquired from The SmartPill Corporation, a U.S. based-company, the assets related to the SmartPill® GI Monitoring System for $6 million.
InSite Vision Incorporated (OTCBB: INSV) today announced that oral arguments are scheduled for November 6, 2012, in Washington, D.C. in connection with the University of California, San Francisco’s (UCSF) appeal of the November 2011 favorable judgment of the United States Patent and Trademark Office (USPTO).
Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced a 1-for-7 reverse split of the company's issued and outstanding Class A common stock and a corresponding decrease in the number of its authorized shares of Class A common stock.
Medicago Inc. (TSX: MDG) (OTCQX: MDCGF), ("Medicago") a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus Like Particles ("VLP"s), and Cellectis plant sciences, a US-based subsidiary of Cellectis Group (Alternext: ALCLS), ("Cellectis"), the specialist in genome engineering, today announced the successful completion of the first step in their research collaboration to improve therapeutic proteins produced in tobacco plants.
Milestone Scientific, Inc. (OTCQB: MLSS), the recognized leader in advanced, computer-controlled injection technologies, today announced that Dental American Group has begun the rollout of Milestone's STA Single Tooth Anesthesia System® across five offices in the South Florida region.
Pfizer Inc. (NYSE:PFE) today announced top-line data assessing immunogenicity, tolerability and safety of Prevenar 13®* (Pneumococcal polysaccharide conjugate vaccine [13-valent, absorbed]) in adults 18 to 49 years of age.
PremierEquityReports.com, the U.S. leader in equity reports, offers quality reports to investors looking for the most undervalued companies in the market. Premier Equity Reports provides its subscribers with timely information and exclusive analysis on U.S. companies with substantial upside potential and today issues a report on Pazoo Inc. (OTCBB: PZOO).
PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that the Company's clinical trial of UMK-121 has received IRB (Institutional Review Board) approval and is now ready for the recruitment of patients.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that it has amended and expanded the scope of the protocol PV-10-LC-01, “A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant.”
PURE Bioscience, Inc. (NASDAQ:PURE), the creator of the patented silver dihydrogen citrate (SDC) antimicrobial, announced Italian export company TICE as its general sales agent and distributor for Italy.
Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the pricing of its initial public offering of 11,250,000 shares of its common stock at $4.00 per share.
Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) and its operating division, Tribute Pharmaceuticals ("Tribute"), are pleased to announce that CAMBIA®, the only available prescription NSAID with an indication for the acute treatment of migraine attacks with or without aura* in adults over 18 years of age, is now available to patients across Canada.
XTL Biopharmaceuticals Ltd. (TASE: XTL) (OTC: XTLBY) (the "Company"), a biopharmaceutical development company, announced today that following the announcement from September 24, 2012, its American Depositary Receipts ("ADRs") to ordinary shares ratio has changed today to 1:20 (1 ADR represents 20 ordinary shares).