Apricus Announces FDA Clearance for Its Second OTC Anti-Itch Drug. Cell Therapeutic Submits Day 120 Response for Pixantrone Marketing Authorization Application. Print E-mail
By Mary Davila   
Tuesday, 23 August 2011 19:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 23, 2011.

Apricus Biosciences, Inc. (Nasdaq:APRI) announced its wholly owned subsidiary, NexMed USA, has received clearance from the FDA to market its second, over-the-counter ("OTC") anti-itch drug, Hydrocortisone-D™, containing the Company's NexACT® technology.  The active ingredient in the cleared OTC drug, hydrocortisone, is an already approved anti-itch agent, which can be sold as a cream. It is currently used to treat itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, and psoriasis (among others). It is sold under several third party brand names, most notably Cortizone® (Chattem/Sanofi Aventis) and Cortaid® (Johnson & Johnson (NYSE:JNJ)).

Apricus Bio's new Hydrocortisone-D™ product combines hydrocortisone with DDAIP, the main ingredient in NexACT®, the Company's proprietary drug delivery technology. NexACT® temporarily loosens the tight junctions between skin cells to allow more permeation.

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Cell Therapeutics, Inc. (NASDAQ:CTIC), announced it has submitted its response to the Day 120 List of Outstanding Issues to the European Medicines Agency's (the EMA) Committee for Medicinal Products for Human Use (CHMP) in regards to CTI's Marketing Authorization Application for pixantrone (the MAA) to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

With this submission, CTI expects to receive a CHMP opinion regarding approvability of pixantrone during the first quarter of 2012.



Also Tuesday:



Bunge North America, the North American operating arm of Bunge Limited (NYSE:BG), issued the following statement which can be attributed to Soren Schroder, Bunge North America president and CEO.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) today announced that it has submitted its response to the Day 120 List of Outstanding Issues to the European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use ("CHMP") in regards to CTI's Marketing Authorization Application for pixantrone (the "MAA") to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL").

China Cord Blood Corporation (NYSE:CO) ("the Company") today announced its plan to release financial results for the first quarter of fiscal year 2012 on Monday, August 29, 2011, after market close in the US.

FMC Corporation (NYSE:FMC) announced today its Agricultural Products Group has entered into two exclusive agreements covering global development and supply of Chr. Hansen biological products for agricultural and ornamental markets.

NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company with a focus on cell-based therapeutic development, announced today the appointment of Grant Thornton LLP as the Company's independent registered public accounting firm for fiscal year 2011. Grant Thornton LLP replaces Deloitte & Touche LLP.

Reliv International, Inc. (NASDAQ:RELV), Soy Labs LLC and the Missouri Plant Science Center today announced a new joint research and development partnership that will give Reliv greater access to the latest soy and plant biotechnology research.

SANUWAVE Health (OTCBB: SNWV) is suddenly positioned to become one of the leaders in the emerging field of regenerative medicine -- not by harvesting or employing stem cells or creating living tissues, but by using a highly effective, non-invasive medical device which has been perfected to activate a biological response for the repair and regeneration of tissue, musculoskeletal and vascular structures.

Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that Biqi, a branded generic anti-diarrhea drug, has passed EU-GMP inspection.

TheraBiogen, Inc. (OTCBB: TRAB), a manufacturer and distributor of homeopathic nasal sprays for aiding in the relief of allergies and cold and flu symptoms, which recently announced its agreement with Food Lion LLCto carry and sell both TheraMax® Cold & Flu Relief and TheraMax® Allergy, announced today that it has shippedTheraMax® Allergy Relief to approximately 1150 Food Lion, supermarkets.

Unilife Corporation (NASDAQ:UNIS; ASX: UNS) today announced the development and patenting of the Unifill® EZMix multiple-chamber ready-to-fill (prefilled) syringes.

VIVUS, Inc. (NASDAQ:VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has entered into definitive agreements dated August 23, 2011 with a select group of institutional investors to sell 6,889,098 shares of its common stock in a "registered direct" offering.

WaferGen Biosystems, Inc. (OTCBB:WGBS), a leading developer of state-of-the-art genomic analysis systems, announced today that it intends to file its Quarterly Report on Form 10-Q for the period ended June 30, 2011 within two weeks.



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