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FDA Accepts NDA for Raptor's RP1013 Nephropathic Treatment; FDA Clears New Siemens CT Scanner
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 13, 2012.
Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced the U.S. FDA has accepted for filing the Company's New Drug Application ("NDA") for its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules ("RP103"), for the potential treatment of nephropathic cystinosis.
The FDA has granted Standard Review designation for RP103.
Siemens Healthcare (NYSE: SI) has announced that the FDA has cleared the SOMATOM® Perspective – an advanced 128-slice computed tomography (CT) scanner engineered to drive efficiency and reduce costs. The SOMATOM Perspective is designed especially for community hospitals, critical access hospitals and outpatient centers, offering the ability to extend the range of available examinations to their communities at reduced radiation dose in a budget-conscious environment.
The SOMATOM Perspective is an example of Siemens' approach to delivering innovative solutions that provide maximum value to customers – primary goals of the Healthcare Sector's recently announced Agenda 2013 global initiative.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced the publication of preclinical research with ADXS-PSA (ADXS31-142), Advaxis’ Lm-LLO immunotherapy targeting the PSA antigen associated with prostate cancer.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Vikas Sinha, Chief Financial Officer of Alexion Pharmaceuticals, will present at the Wells Fargo Securities Healthcare Conference in Boston at 2:40 p.m. Eastern time on Wednesday, June 20, 2012.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that research underlying its EDP 10 project for the treatment of type 1 diabetes won the Hebrew University's prestigious Kaye Innovation Award for a researcher at the Hebrew University of Jerusalem.
Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM) ("Biostar" or "the Company"), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that it signed a Letter of Intent ("LOI") with The Fourth Military Medical University ("FMMU") to jointly conduct Phases I to III clinical trials for Viacom Pine II Cream ("Viacom") drug.
Celgene Corporation (NASDAQ: CELG) today announced that during its June meeting the Company's Board of Directors authorized the repurchase of up to an additional $2.5 billion of the Company's common stock.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, reports today that it has participated in a meeting with the U.S. Food and Drug Administration ("FDA") pertaining to the Company's psoriasis compound, Prurisol™.
Crown Dynamics Corp., (OTCBB: CDYY) today announced the release of its patented AIR® Sleep/Snore product line.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced that it is expected to join the Russell Microcap® Index when Russell Investments reconstitutes its family of U.S. indexes on June 25, 2012, according to a preliminary list of additions posted on www.russell.com.
Fluidigm (NASDAQ:FLDM) today unveiled the details of its new C1™ Single-Cell AutoPrep System to attendees at the International Society for Stem Cell Research (ISSCR) meeting in Yokohama, Japan.
Generex Biotechnology Corporation (OTCBB: GNBT) announced today that two interviews conducted at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago earlier this month featuring the on-going Phase II clinical trial of the Antigen Express AE37 immunotherapeutic breast cancer vaccine are now available for online viewing at OncUView.tv.
GTx, Inc. (Nasdaq: GTxI) announced today that Dr. Adrian Sandra Dobs, Director, John Hopkins Clinical Research Network Professor of Medicine and Oncology at the John Hopkins University School of Medicine, will present her abstract on the “Prevalence and Impact of Hypogonadism in Cancer Patients with Muscle Wasting in a Phase IIb Enobosarm Trial” in a poster presentation during the 2012 Annual Meeting of the Endocrine Society.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) announced today that a paper entitled "Cell Carriage, Delivery, and Selective Replication of an Oncolytic Virus in Tumor in Patients," has been published in the latest issue of the journal Science Translational Medicine (Vol. 4 Issue 138 138ra77).
Patient Safety Technologies, Inc. (OTCBB:PSTX, OTCQB:PSTX) today announced that it has filed a lawsuit against ClearCount Medical Solutions in the United States District Court for the Central District of California, asserting a claim against ClearCount for infringement of United States Patent No. 5,931,824 entitled "Identification and Accountability System for Surgical Sponges."
PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today reported financial results for its third fiscal quarter ended April 30, 2012.
Siemens Healthcare (NYSE: SI) has announced that the Food and Drug Administration (FDA) has cleared the SOMATOM® Perspective – an advanced 128-slice computed tomography (CT) scanner engineered to drive efficiency and reduce costs.
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced today that it has signed a collaboration agreement with a top-5 pharmaceutical company to extend and enhance its oral cavity dosing model within its industry gold standard GastroPlus™ simulation software program.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that data from studies of AZILECT® (rasagiline tablets) and Parkinson’s disease (PD) will be featured at the 16th Annual International Congress of Parkinson’s Disease and Movement Disorders in Dublin, Ireland, 17-21 June 2012.
Trovagene, Inc. (Nasdaq: TROV), (Nasdaq: TROVU),a developer of trans-renal molecular diagnostics, announced the full exercise of the over-allotment option granted to the underwriters to purchase 172,500 additional units, at a public offering price of $8.00 per unit, in connection with its previously announced underwritten public offering of 1,150,000 units, bringing total gross proceeds from the offering to $10,580,000.
Union Equity Inc. (OTC: UNQT) is pleased to announce that its wholly owned subsidiary, Natural Product Laboratories LLC, has developed Allevium, a creme that contains natural ingredients and plant extracts, which aids in soothing the effects of chemotherapy treatment.
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