Quidel Wins CE Market for HSV 1+2/VZV Test; Japan Approves Bayer's Colorectal Cancer Drug Stivarga Bags Print E-mail
By Staff and Wire Reports   
Monday, 25 March 2013 19:13
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 25, 2013.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic solutions, announced it received the CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in active lesions.

Quidel's new PCR assay kit distinguishes between three infectious diseases: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults.


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Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Stivarga® (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC).  

In September 2012, Stivarga was approved by the U.S. FDA for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It was approved by the U.S. FDA for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate in February 2013.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

The approval of Stivarga by the MHLW is based on data from the international multicenter pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial which evaluated regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC, whose disease has progressed after approved standard therapies. The CORRECT study included 20 sites in Japan.



Also Monday:



CANTEL MEDICAL CORP. (NYSE: CMN)
, through its Mar Cor Purification subsidiary, has continued the expansion of its water purification and filtration unit with the purchase of the hemodialysis water business from Siemens' Water Technologies business unit.

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it launched the 36 and 54 milligram (mg) dosage strengths of Methylphenidate HCl Extended-Release (ER) Tablets USP (CII), generic version of CONCERTA®.

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin* was recently submitted to the Food and Drug Administration (FDA) in the United States for the treatment of type 2 diabetes mellitus (T2D) in adults.

InSite Vision Incorporated (OTCBB: INSV)
today announced that the last patient has completed dosing and evaluation in the DOUBle Phase 3 clinical trial of AzaSite Plus™ and DexaSite™ for the treatment of blepharitis.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records ("PHRs"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced the launch of seamless connectivity between the MyMedicalRecords Personal Health Record and Electronic Medical Record ("EMR") systems in medical clinics starting April 15, 2013.

NeuroVive, (NASDAQ :NVP)
a leading mitochondrial medicine company, announces that its shares have been approved for listing on NASDAQ OMX Stockholm by the exchange's Listing Committee.

Nutra Pharma Corporation (OTCQB: NPHC)
, a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that it has received notification that their patent and trademarks for its Nyloxin™ line of pain relievers have been published in India's Official Journal.

Pfizer Inc. (NYSE: PFE)
announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved XELJANZ® (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies.

Fortissimo™ -- a voice-activated and hands-free speakerphone from Chattanooga's Clarity, a division of Plantronics (NYSE: PLT) -- is one of 15 innovations selected as a 2013 da Vinci Awards® finalist.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic solutions, announced today that it received the CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in active lesions.

Shire plc (LSE: SHP, NASDAQ: SHPG)
today announced that it will acquire SARcode Bioscience Inc., a privately held biopharmaceutical company based in Brisbane, California.

Vycor Medical, Inc. (OTCBB: VYCO)
, a provider of innovative and superior surgical and therapeutic solutions, announced it has been issued patent number 10106385.8 for its ViewSite™ Brain Access System ("VBAS") for the Hong Kong market.



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