NovaBay Receives Nonproprietary Name Auriclosene for NVC-422; FDA Issues Guidance for Chelsea Therapeutics' Northera Print E-mail
By Staff and Wire Reports   
Wednesday, 20 February 2013 20:15
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 20, 2013.

NovaBay® Pharmaceuticals, Inc. (NYSE: NBY)
, a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, announced the World Health Organization (WHO) has approved the international nonproprietary name (INN) "auriclosene" (pronounced awr-rih-CLO-zeen) for the Company's lead Aganocide® compound NVC-422. INNs facilitate the identification of active pharmaceutical ingredients, and each INN is a globally recognized unique name.

Aganocides are NovaBay's first-in-class topical antimicrobial compounds, which are active against viruses, fungi, and bacteria, including the bacteria that grow and thrive under biofilm. Testing in-vitro and in-vivo has shown that these non-systemic, non-antibiotic compounds do not give rise to bacterial or fungal resistance. Phase 2 studies for auriclosene are currently ongoing in urology, ophthalmology, and dermatology.

Dr. Ron Najafi, Chairman and Chief Executive Officer, said, "Obtaining the INN for our lead clinical compound NVC-422 confirms that our clinical development is on track, and we anticipate progression into Phase 3 development in each of our three Aganocide programs. We also intend to conduct a Phase 2a proof-of-concept study for auriclosene in an additional ophthalmic indication. NVC-422, now auriclosene, is the first of our proprietary Aganocides to receive a nonproprietary name."


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Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP)
announced it has received written guidance from the Director of the Office of New Drugs ("the Director") at the U.S. FDA) stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera™ (droxidopa) New Drug Application (NDA) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The guidance is in response to a formal appeal by Chelsea to the Director, and follows a meeting with the Director and top staff from the Office of Drug Evaluation I and Division of Cardiovascular and Renal Products (DCRP) at the FDA's Center for Drug Evaluation and Research.

The guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval." It further notes that any decision regarding the outcome of an FDA review, to be performed by the DCRP will be based on the strength of Study 306B and its ability to provide substantial evidence of effectiveness to support approval.

Based on this guidance, Chelsea plans to file a resubmission of the Northera NDA with the DCRP in the late second quarter of 2013. If accepted by the Division, the Company's application will be subject to a 6-month review period.



Also Wednesday:



AbbVie (NYSE: ABBV)
will present at the Cowen and Company 33rd Annual Health Care Conference on Wednesday, March 6, 2013.

Actavis, Inc. (NYSE: ACT)
, a leading specialty pharmaceutical company, announced today that Siggi Olafsson, President, Actavis Pharma, will provide an overview and update of the Company's business at the Cowen & Company 33rd Annual Health Care Conference on Tuesday, March 5, 2013 at 11:20am ET at The Boston Marriott Copley Place in Boston, MA.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that a first patient has been treated for the randomized Phase 2 trial in chemotherapy refractory triple-negative ("ER/PR/HER2-negative") luteinizing hormone-releasing hormone receptor ("LHRH-R")-positive metastatic breast cancer, with the Company's targeted doxorubicin peptide conjugate, AEZS-108.

Alimera Sciences, Inc. (Nasdaq: ALIM)
("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that Dan Myers, president and chief executive officer, will participate in the Credit Suisse London One-on-One Healthcare Conference on March 5 – 6, 2013 in London, UK.

Cytomedix, Inc. (OTCQX: CMXI)
(the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the execution of a comprehensive financing plan for 2013.

As in the case of Incyte Corporation (NASDAQ: INCY), the stock provided steep returns while the company's fortune is dependent on just one drug.

Laser Energetics, Inc.™ (PINKSHEETS: LNGT)
today announced that it has received an order for multiple Dazer Laser® GUARDIANs from the United Kingdom's Ministry of Defence for official Government Test & Evaluation purposes.

Life Technologies Corporation (NASDAQ: LIFE)
today announced a dozen innovative new products for the Ion Torrent™ platform that will make sequencing faster, simpler and more accessible for scientists, driving discovery and advancing clinical research around the world.

Neuralstem, Inc. (NYSE MKT: CUR)
announced that it has granted licenses to intellectual property surrounding its spinal cord delivery platform, floating cannula, and method for delivering therapeutic agents to the spinal cord to Cedars-Sinai Medical Center, a non-profit academic medical center located in Los Angeles, CA.

Oncolytics Biotech Inc. (TSX:ONC; NASDAQ: ONCY)
announced today the pricing of an underwritten public offering of 8.0 million common shares, at a public offering price of US$4.00 per common share.

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY)
today announced the appointment of Dr. Jeremy Grushcow to the role of General Counsel.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
announced today that Leukemia has published results from the Phase 2 trial known as PX-171-005 (NCT00721734), an open-label, multicenter clinical trial evaluating Kyprolis® (carfilzomib) for Injection in patients with relapsed and refractory multiple myeloma and varying degrees of renal insufficiency.

Organovo Holdings, Inc. (OTCQX: ONVO)
("Organovo"), a creator and manufacturer of functional, three-dimensional human tissues for medical research and therapeutic applications, and ZenBio Inc., a leading provider of advanced cell-based solutions and services, are partnering to produce three-dimensional human tissues for drug discovery and advanced tissue therapies.

The Pulse Beverage Corporation (OTCQB: PLSB)
("Pulse"), makers of Cabana™ 100% Natural Lemonade today announced the completion of its initial commercial production of its flagship product PULSE® brand of functional beverages in three health platforms: PULSE® -- Women's Health Formula™, PULSE® -- Men's Health Formula™ and PULSE® Heart Health Formula™ -- a detailed description can be accessed through the Pulse Beverage website at www.pulsebeverage.com.

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported its financial results for the fourth quarter and year-ended December 31, 2012 and recent company highlights.

TRIMEDYNE, INC. (OTCBB: TMED)
today reported its financial results for the first quarter of its fiscal year.

Zacks Equity Research highlights Fortune Brands Home & Security (NYSE: FBHS) as the Bull of the Day and Wal-Mart Stores (NYSE: WMT) as the Bear of the Day.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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