FDA Approves Updates To Eli Lilly's Humalog Label. Neurologix Announces New Results for NLX-P101. Print E-mail
By BioMedReports.com Staff   
Wednesday, 08 June 2011 20:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 7, 2011.

The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's (NYSE:LLY) supplemental new drug application (sNDA) with the following updates to the Humalog label:

Continuous insulin infusion pump therapy in children four years of age and over with type 1 diabetes extension of the time-in-use in the external pump reservoir to a maximum of seven days.

Extension of the time-in-use of the infusion set and of the infusion set subcutaneous insertion site to a maximum of three days.

Based on the updated label, people with type 1 diabetes using Humalog for pump therapy can use the insulin in the pump reservoir for up to seven days and should change the infusion set and infusion set insertion site at least every three days.

The previous label indicated that Humalog in the external insulin pump reservoir should be replaced and a new infusion site selected every 48 hours or less.

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As part of a comprehensive presentation of study findings to the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), Neurologix, Inc. (OTC:NRGX) announced several new results from the second Phase clinical trial for its, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD).

These findings, which demonstrate patients treated with NLX-P101 maintained statistically significant, positive, long-term improvements at 12 months, were included in presentation of results from the Second Phase trial. Patients with moderate to advanced PD often suffer from reduced effectiveness of medication, including less time spent each day in the better or "ON" state.

The new findings of the NLX-P101 Phase 2 study demonstrated that treatment with the novel gene therapy resulted in an average daily increase of 2.5 hours of "ON" time at 3 months (p<0.01 relative to baseline; t-test) and this increase was sustained at 2.1 hours of greater "ON" time at 12 months (p<0.01 relative to baseline; t-test).


Also Wednesday:  


Anavex Life Sciences Corp., ("Anavex") (OTCBB: AVXL) today announced the initiation of scale-up manufacturing of ANAVEX 1-41, its lead compound for a range of important neurological diseases and a potential back-up compound to ANAVEX 2-73 in Alzheimer's disease.

BioElectronics Corp. (OTCQB: BIEL) (PINKSHEETS: BIEL
), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce a significant advancement for the relief of back and body pain, based on its award winning therapeutic technology.

CDEX Inc. (OTCBB: CEXI), a leading developer of chemical detection products, using patented technologies, for use in healthcare and security markets, announced today its ID2™ Product line has successfully passed independent testing to verify conformance to the protection requirements of the European Economic Area (EEA) gaining full CE certification.

InVivo Therapeutics (OTCBB: NVIV), a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced it has expanded the "Field of Use" of its existing patent license to include parts of the peripheral nervous system, the cavernous nerve surrounding the prostate, the brain, the retina and cranial nerves.

Luminex Corporation (NASDAQ:LMNX) and the Kliniken der Stadt Koln, Institute of Pathology and Institute for Hygiene today announced that Luminex's newly released xTAG® Gastrointestinal Pathogen Panel (GPP) is being used successfully as a first-line screen for patients at Kliniken der Stadt Koln suspected of having an E. coli infection.

Medical Marijuana Inc (PINKSHEETS: MJNA) and BullnBear Group, S.A. announced today that final terms have been reached for the distribution of pure spring water as a stand-alone product and for its use as the base of Medical Marijuana Inc's revolutionary Hemp and THC-free water beverage products.

Neurologix, Inc. (OTCBB: NRGX) announced today several new results from the Company's successful Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD) as part of a comprehensive presentation of study findings to the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC).

Regenicin, Inc. (OTCBB: RGIN) announces it is in advanced discussions with various developers in the State of Florida to determine the best strategic location and partners for the company to establish its research facilities.



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