|Keryx Says FDA Accepted Filing for Zerenex NDA; Alnylam Announces Advancement of ALN-AS1|
|By Staff and Wire Reports|
|Tuesday, 08 October 2013 18:48|
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced that its New Drug Application (NDA) for Zerenex™ (ferric citrate coordination complex) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The acceptance for filing of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it is advancing its Development Candidate for ALN-AS1, an RNAi therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the treatment of hepatic porphyrias including acute intermittent porphyria (AIP).
The new pre-clinical research findings, presented at the 9th Annual Meeting of the Oligonucleotide Therapeutics Society being held October 6 – 8, 2013 in Naples, Italy, show that subcutaneous administration of a GalNAc-siRNA targeting ALAS-1 leads to rapid, dose-dependent, and long-lasting knockdown of ALAS-1 mRNA and complete inhibition of the toxic intermediates that mediate the symptoms and pathology of AIP.
Based on these findings, including results in non-human primate studies, the company has selected its ALN-AS1 Development Candidate and expects to file an Investigational New Drug (IND) application for this RNAi therapeutic in 2014. ALN-AS1 is part of the company's “Alnylam 5x15” product development and commercialization strategy, in which the company aims to advance five genetic disease target programs into clinical development, including programs in late stages, by the end of 2015. In addition, the company presented new pre-clinical data with its proprietary, clinically validated GalNAc-siRNA conjugate delivery platform for subcutaneous delivery of RNAi therapeutics with a wide therapeutic index.
Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg. Actavis' ANDA product is a generic version of Reckitt Benckiser's Suboxone® Sublingual Film, which is indicated for maintenance treatment of opioid dependence.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, today announced its top line financial results for the third quarter of fiscal year 2013, ended September 30, 2013.
AmbiCom Holdings, Inc. (OTCQB: ABHI), a leading designer and developer of wireless products for the medical and automotive industries, and a distributor of innovative healthcare products, today announced that it has received an order worth more than $200,000 for WL54-CF (CompactFlash cards) used in patient monitoring systems.
Covance Inc. (NYSE: CVD) announced today that it has entered into a note purchase agreement for the private placement of senior notes totaling $250 million with a group of institutional investors.
Healthcare Services Group, Inc. (Nasdaq:HCSG) reported that revenues for the three months ended September 30, 2013 increased approximately 10% to $298,549,000 compared to $272,681,000 for the same 2012 period.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 50 new employees.
mCig, Inc. (OTCBB: MCIG) is pleased to announce that CEO Paul Rosenberg has been recently interviewed by noted investment analyst Alan J. Brochstein CFA.
MAKO Surgical Corp. (Nasdaq:MAKO) today announced that it has completed the acquisition of Pipeline Biomedical Holdings, Inc.'s business dedicated to the design, development, manufacture and commercialization of orthopedic devices and related instruments for use with both robotic devices and manual medical procedures.
Nektar Therapeutics (Nasdaq: NKTR) will present an overview of the company's proprietary drug candidate pipeline during the company's R&D Day for investors and analysts today from 11:30 a.m. to 4:30 p.m. ET in New York City.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced details relating to its third quarter 2013 earnings announcement, which will take place on Tuesday, October 29, 2013, after the close of the market.
OAISYS®, a leader in business call recording and contact center management solutions, today announced version 7.4 of its award-winning Talkument® and Tracer call recording software applications, now featuring enhanced integration capabilities with industry-leading business communications platforms from Avaya (NYSE: AV), Mitel (NASDAQ: MITL) and ShoreTel (NASDAQ: SHOR).
OPTIMIZERx Corp. (OTCQB: OPRX) today announced preliminary 2013 third quarter results.
Profit Planners Management, Inc. (OTCQB: PPMT) is pleased to announce the launch of Organically Crafted, a new e-commerce website that provides consumers with healthy choices for food, supplements, vitamins, homeopathy, personal care, pet and home supplies. Organically Crafted currently offers over 12,000 products and more than 100 brands.
Stevia Corp. (OTCQB: STEV), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to offer the third in a series of insights regarding key aspects of its planned expansion plans.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced the key programs and goals into 2014 for its RNAi therapeutic product pipeline.
VIVUS, Inc. (Nasdaq:VVUS) today announced new data published online in Diabetes Care demonstrating the effects of Qsymia® (phentermine and topiramate extended-release) capsules CIV, on the progression to type 2 diabetes.
Z Trim Holdings, Inc. (OTC Markets: ZTHO), a bio-technology company providing value-added ingredients to a variety of industries, is presenting a variety of baked food applications at this year's International Baking Industry Expedition ("IBIE") Show, today through October 9, at the Las Vegas Convention Center in Las Vegas, Nevada.