|Mylan's Zidovudine Gets FDA Approval. Sinovac Achieves Positive Results.|
|By BioMedReports.com Staff|
|Thursday, 10 March 2011 19:50|
Mylan Inc.'s Pediatric HIV/AIDS Drug Zidovudine Gets FDA Approval - Matrix Laboratories Ltd. has received final approval on its New Drug Application for Zidovudine Tablets, 100 mg to treat children with HIV/AIDS from The U.S. Food and Drug Administration. Matrix Laboratories Ltd. is a subsidiary of Mylan Inc. (NASDAQ:MYL). The FDA approved Zidovudine under the President's Emergency Plan for AIDS Relief or PEPFAR. Zidovudine's NDA was based on the reference listed drug Retrovir Tablets by HIV/AIDS specializing company ViiV Healthcare. That means Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards, Mylan said in its statement.
Zidovudine, the first of its kind in water-dispersible tablet form, is a pediatric antiretroviral or ARV. It belongs in a class of drugs known as nucleoside reverse transcriptase inhibitors.
Sinovac Achieves Positive Results In Preliminary Phase I Trial For EV71 Vaccine - Sinovac Biotech Ltd. (NASDAQ:SVA) reported positive preliminary Phase I clinical trial results for the enterovirus 71 or EV71 vaccine in adults. The Phase I design is a single center, randomization, double blinded, and placebo controlled study.
The Phase I clinical trial is on track to enroll 168 healthy volunteers in three different groups: adults, young children and infants. The study will evaluate the safety and preliminary immunogenicity profile in the different age groups.
The Amergence Group (PINKSHEETS: AMNG) announced today that its president, Brian Cook, has ordered the company's name be changed to Altitude Organic Corporation (www.altitudeorganix.com).
AmbiCom Holdings (OTCQB: ABHI), a leading developer of wireless solutions for healthcare and automotive suppliers, today announced its shares are now being exclusively quoted on OTC Markets Group's OTC Link™ quotation platform.
Cytori Therapeutics (NASDAQ: CYTX) grew product sales 41% and made substantial progress in advancing its cardiovascular device product pipeline during 2010.
eHealth, Inc. (NASDAQ: EHTH) today announced a slate of executive speaking engagements in March and April 2011 addressing the topic of state health insurance exchanges envisioned by the Patient Protection and Affordable Care Act.
GeckoSystems Intl. Corp. (PINKSHEETS: GOSY) (http://www.geckosystems.com/) announced today the agenda for their third annual "Mobile Robots in Motion" Conference April 13-14, 2011.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced updated clearance from the U.S. Food and Drug Administration (FDA) for the PillCam® SB video capsule, including clearance to promote its use in monitoring lesions that may indicate Crohn's disease.
Green Bridge Industries, Inc. (PINKSHEETS:GRBG) is pleased to announce that the Company now holds a ten percent interest of the private Florida based corporation, Team Energy, Inc.
Healthnostics, Inc. (PINKSHEETS: HNSS) will file Full-Disclosure documents with the OTC Markets (formerly known as the "Pink Sheets") during the second quarter of 2011. Full Disclosure will provide greater transparency, improve shareholder access to information, and increase market liquidity for shareholders.
Hiru Corporation (PINK SHEETS:HIRU) (www.hirucorporation.com) subsidiary Jiangxi Shuangshi Animal Health Products Co. updates on the company's development in the agricultural expansion.
Integrated Management Information, Inc. (IMI Global) (OTCBB:INMG) - 2010 revenue up 23% to $3.3 million from $2.7 million in 2009.
Phototron Holdings Inc. (OTCQB: PHOT) (PINKSHEETS: PHOT) ("Phototron") began trading on the OTC Markets OTCQB market tier under the symbol PHOT on March 9, 2011.
SeaBridge Freight Corp. (PINKSHEETS: TCSR) today announced the execution of an Agreement and Plan of Reorganization (the "Reorganization Agreement") by and among the corporation, SeaBridge Freight, Inc., a Delaware corporation and a wholly owned subsidiary of the corporation, UGH Delaware Acquisition LLP, a Delaware limited liability partnership and wholly owned subsidiary of the corporation, UGH Texas Acquisition LP, a Texas limited partnership and wholly owned subsidiary of the corporation, University General Hospital, LP, a Texas limited partnership, University Hospital Systems, LLP, a Delaware limited liability partnership and the general partner of University General Hospital, LP (collectively "UGH") upon the terms and for the consideration specified in the Agreement and Plan of Reorganization, pursuant to the Reorganization Agreement we will acquire 100% of the limited partnership interests of UGH.
Simulated Environment Concepts (PINKSHEETS: SMEV), the manufacturer and developer of medical, aesthetic, weight loss, wellness, and slimming equipment, sees a growing interest from the fitness industry to offer the company's flagship product, SpaCapsule, in fitness centers around the world.
SK3 Group, Inc. (PINK SHEETS:SKTO) announces today that it has completed its acquisition of W&M Medical Management, Inc. ("W&M") of Rancho Cucamonga, CA.