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Latest Investigational New Drug Stories

2014-09-11 23:06:23

Leader in Ion Channel Research to have a prominent presence at SPS with particular focus on the Investigational New Drug (IND) application process. Cleveland, Ohio (PRWEB) September 11, 2014 ChanTest will host a sponsored session entitled “The ABC’s of IND’s” at the Safety Pharmacology Society (SPS) Annual Meeting on Monday, October 20th. This session will touch on the shortcomings of the current nonclinical and clinical assays used for cardiac risk assessment, and address some...

2014-09-04 08:30:35

ALBANY, N.Y., Sept. 4, 2014 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced today that it has expanded into the protein market, with an initial focus on protein expression and purification. The global revenue of the total proteomics market is anticipated to grow at a compound annual growth rate of about 4.1% to about $9.2 billion by 2018(1). AMRI's current and ongoing activities - as part of its New York State Public-Private Partnership in Buffalo, N.Y. - encompass the production of...

2014-08-11 08:28:23

MELBOURNE, Australia, Aug. 11, 2014 /PRNewswire/ -- -- Single dose pharmacokinetic (PK) study reproduces earlier results -- Therapeutic oxymorphone blood levels achieved in all 15 subjects -- Drug elimination indicates favourable safety profile Australian drug delivery company, Phosphagenics Limited (the Company) (ASX: POH, OTCQX: PPGNY),announces that the first of its additional studies designed to further characterise the TPM®/Oxymorphone patch, in support of an...

2014-07-23 08:30:59

MARIETTA, Ga., July 23, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it has filed its initial Investigational New Drug ("IND") application with the Food and Drug Administration ("FDA"). The IND submission, which was filed yesterday, July 22, 2014, is the Company's initial submission for certain indications...

2014-06-12 08:28:37

SANTA ROSA, Calif., June 12, 2014 /PRNewswire/ -- Ruthigen, Inc., (NASDAQ: RTGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application without a clinical hold to begin human clinical testing of RUT58-60. Ruthigen...

2014-06-10 08:31:44

MOMENCE, Ill., June 10, 2014 /PRNewswire/ -- In a recent comment on the FDA's Guidance for Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (IND) (79 Fed. Reg. 7204. Docket FDA-2010-D-0503), FutureCeuticals expressed its strong support for gold-standard, peer-reviewed clinical research on food and dietary ingredients and urged the FDA to properly supervise any clinical research on food or dietary ingredients under the purview...

2014-05-19 08:29:19

Scilex has commenced with its pivotal bioequivalence study of Ztilido versus Lidoderm® in accordance with FDA recommendations to support approval of Ztilido submitted as a 505(b)(2) NDA MALVERN, Pa., May 19, 2014 /PRNewswire/ -- SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain, announced today that it has initiated a pivotal pharmacokinetic (PK) study of its investigational...

2014-05-05 08:29:54

BUFFALO, N.Y., May 5, 2014 /PRNewswire/ -- Kinex Pharmaceuticals, Inc. announced today that the United States Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for Oratecan, an oral form of an approved anti-cancer drug irinotecan with enhanced oral absorption. This is the Company's second IND to be allowed in the past 10 months that uses the Orascovery technology platform for oral delivery of anti-cancer drugs. In July 2013, the US FDA...

2014-05-02 08:24:18

SANTA ROSA, Calif., May 2, 2014 /PRNewswire/ -- Ruthigen, Inc., (NASDAQ: RTGN), a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for its lead drug candidate RUT58-60. The Company plans to initiate its combined Phase 1/2...

2014-04-30 08:33:40

Grant Supports Steps Towards Investigational New Drug Filing and Clinical Trials SEATTLE, April 30, 2014 /PRNewswire/ -- Oricula Therapeutics, LLC, a biotech company uniquely positioned to introduce medicines to preserve hearing, announced that it has received a grant of $169,398 through the Small Business Innovation Research Program by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health. The award supports preclinical studies to...


Word of the Day
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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