|Savient's KRYSTEXXA® Demonstrates Improved QoH in RCG Patients; FDA Approves Cornerstone's ANDA for Generic Tussionex|
|By Staff and Wire Reports|
|Monday, 02 July 2012 20:11|
Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced a new publication showing adult patients with refractory chronic gout (RCG) treated bi-weekly with KRYSTEXXA® (pegloticase) experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The article confirms that chronic gout, especially refractory chronic gout, is associated with decline in HRQOL and physical functioning compared to patients without chronic gout. The results were published in the print edition of the July 2012 issue of The Journal of Rheumatology.
"The significant improvements we observed in KRYSTEXXA-treated patients' pain, physical function and health-related quality of life are important as the daily burden of untreated RCG can be tremendous for these patients," said Vibeke Strand, M.D., Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine. "These improvements in quality of life measures also translate into meaningful savings in terms of cumulative treatment costs for patients with RCG."
Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced the U.S. FDA approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product. The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex® Pennkinetic® brand name. The product is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older.
CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its proprietary formulation technology, Dynamic Time Release Suspension® (DTRS®), and Neos will be the exclusive manufacturer of the approved drug product.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the second patient in its Phase 1/2 clinical trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion™, Optina™ & Zertane™), licensing distribution of these drugs and developing additional new drugs, today announced that it is proceeding with the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED).
BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI); Israeli Channel 2 TV interviewed today a patient suffering from Myasthenia Gravis (MG) and recently diagnosed with ALS.
Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the second quarter of 2012 on Wednesday, July 25, 2012. During a conference call at 10:30 a.m. EDT on July 25, company executives will review financial information and will address inquiries from investors and analysts.
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced that two patients at two different hospitals were treated with its new, 6 French guide catheter-compatible, electric orbital atherectomy system.
Catalyst Health Solutions, Inc. (NASDAQ: CHSI), the fastest growing national pharmacy benefit management (PBM) in the U.S., announced today that at a special meeting of stockholders held this morning, its stockholders approved, among other things, the proposal to adopt the previously disclosed Agreement and Plan of Merger with SXC Health Solutions Corp. (SXC), a leading provider of PBM services and healthcare information technology solutions to the healthcare benefits management industry.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) (the “Company”), a retail and wholesale distributor of pharmaceutical and other healthcare products in China, today reported earnings results for the fiscal year ended March 31, 2012.
Compugen Ltd. (NASDAQ: CGEN) announced today the development of "NexGen," a new platform designed to significantly enhance Compugen’s overall infrastructure for predictive drug and drug target discovery.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that Robert J. Perez, currently Executive Vice President and Chief Operating Officer (COO), has been named President and COO, and Michael Tomsicek, currently Vice President of Corporate Finance, has been named Senior Vice President and Deputy Chief Financial Officer.
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today announced that the European Patent Office (EPO) has issued a patent covering the Company’s tumor-targeting linker platform technology and pharmaceutical compositions.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Ibandronate Sodium tablets (150 mg), a bioequivalent generic version of BONIVA ® tablets in the US market on June 29, 2012 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Ibandronate sodium tablets.
Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the industrial enzyme, bioenergy, and biopharmaceutical industries, announced today that its research and development center in the Netherlands is a member of the Bio-Mimetic Project, a new multidisciplinary research consortium that has been awarded a EUR 3.5 million grant from the European Community's Seventh Framework Programme (FP7) of the European Community for Research, Technological Development and Demonstration Activities.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received a conditional Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the TRANSFORM Trial, a prospective, multi-center study that will evaluate the EDWARDS INTUITY valve system.
Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2013 First Quarter financial results before the U.S. stock market opens on Tuesday, July 17, 2012.
IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shoham today announced that the company has developed new drug detectors (field test kits), for Synthetic Cannabinoids and for Bath Salt.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat cancer, announced today that it will expand its current Phase IIb trial of ICT-107 from 102 to up to 123 patients with glioblastoma multiforme (GBM) and who are HLA-A1/A2 positive.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company focused on developing inhaled therapeutics for serious diseases of the lung, today announced that it has entered into a loan agreement with Hercules Technology Growth Capital, Inc. (NYSE: HTGC), a leader in customized debt financing for companies in life sciences and technology-related markets.
K-V Pharmaceutical Company (NYSE: KV.A/KV.B) today addressed the additional guidance provided by the U.S. Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena®).
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today that its Zero Coupon Convertible Subordinated Notes due 2021 (Zero Coupon Notes) may be converted as set forth below.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that former Celgene Corporation Chairman and Chief Executive Officer, Sol J. Barer, PhD. (age 65) has been appointed as the Chairman of the Board.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that it has received its official business license from the Chinese government to operate Unis Tonghe MMR International Health Management Service Co., Ltd., a joint venture between Unis-Tonghe Technology (Zhengzhou) Co., Ltd. and MMRGlobal.
MYOS Corporation (OTCBB: MYOS) (the "Company") today announced that it has entered into agreements with various institutions, accredited investors and insiders for a $5.6 million private placement of its common stock.
NHS Health Solutions, Inc.'s (PINKSHEETS: NHSH) and its subsidiary Mineseeker Operations Overseas Limited ("Mineseeker") have recently entered into several strategic alliances and partnerships designed to provide a clear route to market its services.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has amended its license agreement with Amgen for royalties from sales of cinacalcet HCl (Sensipar®/Mimpara®).
Omeros Corporation (NASDAQ: OMER) today announced that it has closed the underwritten public offering that was priced and allocated to investors prior to the opening of the market on June 27, 2012, relating to the sale of 3,365,854 shares of its common stock at a price of $10.25 per share for gross proceeds of approximately $34.5 million.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal® (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction.
Protalix BioTherapeutics, Inc. (NYSE-MKT:PLX, TASE:PLX), announced today that new clinical data on taliglucerase alfa was presented at the 10th Annual European Working Group on Gaucher Disease Meeting that took place June 28-30 in Paris, France.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted an investigational new drug application (IND) to the Food and Drug Administration for a first-in-human study of RX-5902 to treat advanced or metastatic solid tumors.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year.
Rosetta Genomics(NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announced that data from a study validating the Company's miRview® lung assay was published in the online edition of the Journal of Molecular Diagnostics in an article titled, "Classification of the Four Main Types of Lung Cancer Using a MicroRNA-Based Diagnostic Assay."
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, today announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication.
ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of enabling technologies for the processing, storage and administration of cell therapies, said today that Asahi Kasei Medical Co., Ltd., has exercised its option to purchase the Company's CryoSeal Fibrin Sealant System wound care product line for $2 million in cash, effective June 30, 2012.