Provectus' PV-10 Data to Be Presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference; MannKind Confirms FDA Panel Recommends Approval of AFREZZA Print E-mail
By Staff and Wire Reports   
Tuesday, 01 April 2014 21:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 1, 2014.

Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, announced today that data on PV-10 for cutaneous melanoma will be included in a session at HemOnc Today – Melanoma and Cutaneous Malignancies Conference. HemOnc Today will be held this year at the Sheraton New York Times Square in New York City on Friday, April 11 and Saturday, April 12, 2014.

Dr. Robert H.I. Andtbacka, associate professor in the Division of Surgical Oncology, Department of Surgery at the University of Utah School of Medicine, will moderate Session 4: Local and Regional Therapy. Session 4 will be held on Friday, April 11 at 2:15 pm. Sanjiv S. Agarwala, MD, Program Director of the Conference, has said data regarding “PV-10 will be an integral part of session 4.” Provectus has recently submitted an application to the FDA for breakthrough therapy designation for PV-10 based on the results from its Phase 2 clinical study.

Craig Dees, PhD, CEO of Provectus said, "We are very pleased to have our data form such a significant part of this important, cutting-edge conference.”


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MannKind Corporation (Nasdaq: MNKD)
announced the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 13 to 1 to recommend that AFREZZA^® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, AFREZZA would be the first ultra rapid-acting mealtime insulin therapy available in the United States.

"We are pleased with the Advisory Committee's approval recommendation in support of AFREZZA, and we appreciate the thoroughness of their review," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We look forward to working with the FDA as they complete their evaluation of AFREZZA. Diabetes is a major health problem in the United States, and we are committed to bring AFREZZA to the many patients who might benefit from this novel product."

The FDA is not bound by the Advisory Committee's recommendation but will consider its guidance in reviewing the New Drug Application (NDA) that was submitted for AFREZZA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of AFREZZA is April 15, 2014.


Also Tuesday:


Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for three U.S. patent applications (12/213,696, 13/254,607, and 11/415,271) with claims of each application related to the Company's proprietary cancer immunotherapy platform technology.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the Company will be presenting at the 13th Annual Needham Healthcare Conference on April 8, 2014, at 2:20 p.m. Eastern Time.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced financial results for the full year ended December 31, 2013.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that effective as of the close of the market on Monday, March 31, 2014, the Company was added to the Russell 2000® and the Russell 3000® indexes, as part of the quarterly Initial Public Offering (IPO) update to the Russell indexes.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the appointment of Lisa Ricciardi to the Company's Board of Directors.

eRAD, a division of RadNet, Inc. (Nasdaq:RDNT), an industry leader in Web-based RIS, PACS and Teleradiology workflow solutions, announced today the company has taken more than fourteen orders from new customers during the first quarter of 2014.

For the second year in row, Emeritus Senior Living (NYSE:ESC) is seeking to help combat senior malnutrition by delivering more than 10,000 meals to seniors across America in the next 60 days in honor of National Food Month in April.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that following a mediation process with Neptune Technologies & Bioressources, Inc. (Nasdaq:NEPT), in conjunction with litigation in the U.S. International Trade Commission ("ITC"), and based on latest developments regarding Neptune's patents in the U.S. Patent and Trademark Office ("USPTO"), it has decided that it will not continue its efforts to negotiate a final settlement agreement with Neptune.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Aron Knickerbocker, Chief Business Officer, will present at the 13th Annual Needham Healthcare Conference on April 8, 2014 at 4:20 PM Eastern Time.

Hemp, Inc. (OTC:HEMP)
announced today that its wholly owned subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company, Inc. (IHMMCC) has facilitated the largest order, to date, for Liberated Energy, Inc.'s (OTC:LIBE) Guard LiteTM Security Lighting System, less than one week after its strategic partnership.

Hyperion Therapeutics (Nasdaq:HPTX)
announced today that the company is scheduled to present at the 13th Annual Needham Healthcare Conference on Tuesday, April 8, 2014 at 10:00 a.m. ET.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the global leader in robotic-assisted minimally invasive surgery, today announced the FDA clearance and U.S. introduction of the da Vinci Xi Surgical System, a technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach.

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has completed the previously announced transaction with BioScrip®, Inc. (Nasdaq:BIOS) to purchase two of its operating subsidiaries, doing business as Deaconess HomeCare and Elk Valley Health Services, for $59.5 million.

MacroGenics, Inc. (Nasdaq:MGNX),
a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that Jim Karrels, Vice President and Chief Financial Officer, and Eric Risser, Vice President of Business Development, will present at the 13th Annual Needham Healthcare Conference.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to announce that its subsidiary company and contracted marketing agent, HempMedsPX™, is launching a public awareness campaign—"DON'T MOVE"— to counter recent reports by the mainstream media that one must relocate to a legalized medical marijuana state to access cannabidiol (CBD) oil.

MEDL Mobile, Inc. (OTCBB:MEDL)
– a pioneer in the creation, development, marketing and monetization of mobile apps – today announced that the company has been retained to create a native mobile experience for the My GI Health Patient-Provider Portal.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that the Company and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), will present at multiple upcoming conferences in April.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
and Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), a Neptune subsidiary, announce that they have been unable to conclude a final settlement agreement through mediation with Enzymotec Ltd. and Enzymotec USA, Inc. (collectively, "Enzymotec") that would resolve the International Trade Commission ("ITC") investigation into infringement of Neptune's composition of matter patents, as well as related federal court actions initiated by Neptune against Enzymotec and its distributors.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has signed a Master Services Agreement with Translational Drug Development (TD2) pursuant to which TD2 will conduct preclinical and clinical studies in support of the development of Nuvilex's pancreatic cancer and other treatments utilizing Cell-in-a-Box® technology.

RestorGenex Corporation (OTCQB:SMDID)
, announced today the closing of its acquisition of two biopharmaceuticals companies, Paloma Pharmaceuticals, Inc. and VasculoMedics, Inc. RestorGenex is a biopharmaceutical company with an initial focus on dermatology, ocular diseases and women's health.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today that Rick Matros, the Company's Chairman and Chief Executive Officer, Harold Andrews, the Company's Chief Financial Officer, and Talya Nevo-Hacohen, the Company's Chief Investment Officer, will be participating in the 2014 Jefferies Global Healthcare and Life Science REIT Conference to be held on Tuesday, April 8, 2014 in New York City.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that it has submitted a 510(k) Premarket Notification with the Food and Drug Administration (FDA) for the Company's Vdrive™ Robotic Navigation System with V-Loop™ Variable Loop Catheter Manipulator.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced that recent advances in its anti-viral product platform were presented at the 6th International Symposium of Filoviruses, which is taking place in Galveston, Texas from March 30 to April 2, 2014.

TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG)
today announced that data published in the April issue of Molecular Cancer Therapeutics further advances the preclinical characterization of its lead SMAC-Mimetic birinapant, which is currently being tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors.



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