|Update on HyQ Biologics License Application; Vermillion Receives Notice of Allowance for Patent|
|By Staff and Wire Reports|
|Tuesday, 17 April 2012 00:59|
Baxter International Inc. (NYSE: BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced the U.S. FDA is requesting additional information to complete its review of the HyQ Biologics License Application (BLA).
Baxter and Halozyme will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data. The companies expect these requests to require additional time to complete and to delay the companies' anticipated regulatory review and approval timeline.
Vermillion, Inc. (NASDAQ: VRML) has received a notice of allowance from the United States Patent and Trademark Office for a patent, "Biomarkers for Ovarian Cancer."
The patent makes claims in the uses of a urinary Small MBL-associated protein C-terminal fragment (sMAP) in the diagnosis of ovarian cancer, ovarian cancer monitoring, and patient management.
This represents the fifteenth biomarker patent granted or allowed for Vermillion, four of which support the company's ovarian cancer franchise and its flagship product, OVA1®.
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the second patient was dosed in the Company’s Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
American Bio Medica Corporation (ABMC.PK) today announced financial results for the fourth quarter and the year ended December 31, 2011.
ArQule, Inc. (NASDAQ: ARQL) today announced the completion of its previously announced public offering of 8,222,500 shares of its common stock, including 1,072,500 shares issued pursuant to the underwriters’ full exercise of their option to purchase additional shares, at a public offering price of $7.30 per share.
Array BioPharma Inc. (NASDAQ: ARRY) today announced that Howard Holden, Ph.D., has joined the Company as Vice President of Regulatory Affairs and Quality Assurance.
BSD Medical Corporation (NASDAQ:BSDM) (the “Company” or “BSD”) announced today that the John Stoddard Cancer Center (Stoddard Cancer Center) at Iowa Methodist Medical Center has purchased a BSD-500 Hyperthermia System (BSD-500).
BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the 8th GTC Stem Cell Summit 2012 in Boston, Massachusetts at 3:45 p.m. EDT on Thursday, April 19, 2012.
Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it will present at Digestive Disease Week May 19-22, 2012, in San Diego, CA.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that the Afirma® Thyroid FNA Analysis, an innovative approach for improved thyroid nodule diagnosis, is now available to patients across the United States.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today plans to report first quarter 2012 financial results on Wednesday, May 2, 2012.
Medtronic, Inc. (NYSE: MDT) today announced the initiation of its launch of the POWEREASE™ System, an innovative system of electronic instruments designed specifically for use in instrumented, or reconstructive, spine surgery.
Merck, known as MSD, (NYSE: MRK) and Endocyte Inc. (NASDAQ: ECYT), today announced that they have entered into an agreement to develop and commercialize Endocyte's novel investigational therapeutic candidate vintafolide (EC145).
Spectrum Pharmaceuticals (NASDAQ:SPPI) today announced that it commenced on Friday, April 13, 2012 a cash tender offer to purchase all of the outstanding shares of common stock of Allos Therapeutics, Inc. (NASDAQ:ALTH).
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it will webcast its corporate presentation at the 19th Annual Future Leaders in the Biotech Industry Conference on Friday, April 20, 2012, at 1:30 pm Eastern.
SurModics IVD Inc., a wholly owned subsidiary of SurModics, Inc. (NASDAQ:SRDX) and a market leader for immunoassay reagents for diagnostic tests used to detect the absence or presence of disease, is pleased to announce the launch of StabilBlot™ Blocker Family.
West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting.