Ampio Receives FDA Confirmation that The Spring Study is Pivotal and Will Initiate the Final Pivotal Trial for Ampion™ Biological License Application (BLA)
Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. The FDA letter includes the following statements:
ERBA Diagnostics, Inc. Exhibits at MEDICA 2013, Dusseldorf Germany “World Forum for Medicine”
ERBA Diagnostics, Inc. (NYSE MKT:ERB), a fully integrated in vitro diagnostics company, is pleased to announce that it will be exhibiting its full range of products at the World's largest medical show, MEDICA 2013 in Dusseldorf Germany Nov. 20-23.
While ERBA group will be showcasing its entire product range from its Global Subsidiaries that include the Elisa range for Auto Immune and Infectious Disease, Chemistry Analyzers, Hematology analyzers, Urine Analyzers and Coagulation systems along with the wide range of reagent kits we offer, we are particularly excited about the launching of two new high tech product offerings – the Laura XL and Hb–Vario.
Inovio Pharmaceutical's DNA Vaccine for the Deadly MERS Virus Induces Robust Immune Response in Preclinical Trial
No vaccine exists for the MERS virus that has killed 42% of those infected
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that preclinical testing of a DNA synthetic vaccine for the virulent Middle East Respiratory Syndrome coronavirus (MERS) induced robust and durable immune responses, demonstrating the potential for a SynCon® DNA vaccine to prevent and treat this deadly virus.
Since 2012, when the virus was first identified, 153 cases from nine Middle Eastern countries have been reported and, alarmingly, 42% of these cases have been fatal.
NovaBay Pharmaceuticals Announces Publication of Novel Surgical Procedure for Life Threatening Wounds and Flesh Eating Bacteria
New Procedure Utilizes Adjunctive NeutroPhase® Therapy Paper in the Medical Journal WOUNDS Describes First Successful Procedure that Removes Toxins from Wounds with Less Invasive Debridement and Avoids Possible Amputation
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced the publication of a scientific paper by Dr. John R. Crew of Seton Medical Center, Daly City, California, describing the first use of adjunctive NeutroPhase®* irrigation therapy in conjunction with Negative Pressure Wound Therapy (NPWT) to successfully manage the severely-infected wound in the arm of a patient with life-threatening ‘flesh-eating’ disease.
Organovo Reports Q2 Fiscal 2014 Results, Provides Business Update
Organovo Holdings, Inc. (NYSE MKT: ONVO) ("Organovo"), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, has reported its second quarter results and provided highlights of its recent activities.
Keith Murphy, Chairman and Chief Executive Officer of Organovo, commented on the results, "The quarter was marked by excellent progress across financial, operational and business development areas. Our progress in the development of 3D liver tissues has been exceptional, including the demonstration of 40 days of viability and functionality, and we remain on-track for releasing our first commercial liver toxicity assay product in calendar 2014. Our new strategic agreements are expected to assist in growing our commercial opportunities long term.
InspireMD to Report Financial Results for Quarter Ending September 30, 2013 on Monday, November 11, 2013
InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic protection stents, announced today that it will release its financial results for the quarter ended September 30, 2013 on Monday, November 11, 2013.
The Company will host a conference call at 4:30 p.m. ET on Monday, November 11th to review the Company's financial results and business outlook. Participants should call (877) 407-4018 (United States) or (201) 689-8471 (International) and request the InspireMD call or provide confirmation code 13572723. A live webcast of the call will also be available on the Investor Relations section of the Company's website at www.inspire-md.com/site_en/for-investors/. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.
BioTime’s Subsidiary OncoCyte Corporation and The Wistar Institute To Collaboratively Develop Cancer Diagnostics
- PanC-DxTM Markers to be Tested in Multi-Center Lung Cancer Study Currently Underway -
BioTime, Inc. (NYSE MKT: BTX), and its subsidiary OncoCyte Corporation today announced that OncoCyte has entered into a Sponsored Research Agreement and a Material Transfer Agreement with The Wistar Institute to collaboratively develop lung cancer diagnostic products. As part of the collaboration, Wistar investigators are conducting a multi-center patient study in which they are assessing gene expression patterns in blood cells of patients with malignant versus non-malignant lung disease.
Phase 1 Data Presented on First Oral Combination 17β-Estradiol and Progesterone Capsule to Treat Menopausal Symptoms Being Developed for FDA Review
Phase 3 REPLENISH Trial Now Under Way Investigational hormone therapy also avoids use of peanut oil, a known allergen
TherapeuticsMD, Inc. (NYSE MKT: TXMD) - Pharmacokinetic study being presented tomorrow evening in a poster session at The North American Menopause Society 2013 Annual Meeting in Dallas suggests that the first combination 17β-estradiol and progesterone capsule in clinical development may have overcome the well-recognized difficulties of achieving good bioavailability with oral administration of these hormones in combination.
Oragenics and Intrexon to Develop Genetically Modified Probiotics
New Exclusive Channel Collaboration focused on Probiotics for the Treatment of Oral Cavity, Throat, Sinus and Esophagus Diseases Intrexon Invests $3.9 Million in Oragenics' Common Stock
Oragenics, Inc. (NYSE MKT: OGEN), a leader in the development of novel, effective antibiotics and oral care probiotics, and Intrexon Corporation (XON), a leader in synthetic biology, today announced the establishment of an Exclusive Channel Collaboration (ECC) to develop and commercialize genetically modified probiotics for the treatment of diseases of the oral cavity, throat, sinus and esophagus. The team is expected to initially focus on therapies for Behcet's disease and aphthous stomatitis.
FAB Universal Signs Distribution Agreement with Future TV Co., Ltd.
- Company Launches Subscription TV Business Segment -
FAB Universal (NYSE MKT:FU), a worldwide distributor of digital media and entertainment, has entered into an agreement with Future TV Co. Ltd. to distribute its copyright-protected media content through pay TV terminals used in the home by Future TV’s subscribers.
Under the terms of the agreement, FAB will provide copyright protected content including high-definition video, music lessons, children's programs, and other educational and related programming. Future TV will integrate the content provided by FAB Universal with its operational platform and manage subscriber payments.
Mexco Energy Corporation Announces Additional Development Of Properties
Mexco Energy Corporation (NYSE MKT: MXC) today announced developments regarding certain oil and gas properties in New Mexico and Texas.
Mexco Energy Corporation ("Mexco") has entered into an agreement with Concho Resources, Inc. ("Concho") to develop the Bone Spring formation using horizontal drilling and multi-stage fracture stimulation on acreage in southwestern Lea County, New Mexico. The first two horizontal wells of twelve prospective wells will target the Avalon shale portion of the Bone Spring zone. To date, 67 wells have been completed in the Avalon shale in this area with numerous other wells in the process of drilling or completing. Concho will pay 62.5% of the cost to drill and complete the two initial wells in order to earn 50% working interest (37.5% net revenue interest).
Synthetic Biologics Responds to Recent CDC Report on Threat of "Super Bugs"
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious diseases, has issued a response to the recent report issued by the Centers for Disease Control and Prevention (CDC) earlier this week that detailed the growing threat of antibiotic-resistant "super bugs" (see here: Untreatable: Report by CDC details today's drug-resistant health threats).
Below is a statement from the Company:
"We applaud the CDC for taking the step forward in acknowledging the major public health crisis surrounding drug-resistant "super bugs."
Retractable Technologies, Inc. Announces Verdict
Retractable Technologies, Inc. (NYSE MKT: RVP), a leading maker of safety medical devices, announced today that a Tyler, Texas jury returned a verdict in the litigation of Retractable Technologies, Inc. v. Becton, Dickinson and Company in favor of Retractable. After a six year battle, the verdict vindicates Retractable’s claim that industry giant Becton, Dickinson and Company illegally engaged in anticompetitive conduct with the intent to acquire or maintain monopoly power in the safety syringe market and engaged in false advertising under the Lanham Act. The jury awarded Retractable $113,508,014 in compensatory damages subject to being trebled pursuant to federal statute. Retractable is represented by Locke Lord LLP; Ireland, Carroll & Kelley, P.C.; and Jim Parsons Law.
MACOM and GigOptix Announce Final Settlement of All Pending Suits Between Them
M/A-COM Technology Solutions Holdings, Inc. (MTSI) ("MACOM"), a leading supplier of high performance RF, microwave, and millimeter wave products, and GigOptix, Inc. (NYSE MKT:GIG) ("GigOptix"), a leading supplier of advanced semiconductor and optical communications components, today announced that they have agreed to a global settlement of all pending lawsuits between them.
These include: (1) the state court case filed by GigOptix against MACOM subsidiary Optomai, Inc., three former employees of GigOptix who founded Optomai, Vivek Rajgarhia, Vikas Manan and Stefano D'Agostino, and MACOM, in Santa Clara County, for alleged misappropriation of trade secrets and breach of contract, and (2) the federal court case filed by MACOM against GigOptix in the Northern District of California, for alleged patent infringement.
NovaBay Pharmaceuticals Announces Positive Results from Phase 2 Clinical Study of Auriclosene to Reduce Urinary Catheter Blockage and Encrustation
Primary Endpoints Achieved Showing Statistically Significant and Clinically Meaningful Benefits for Patients with Long-Term Indwelling Catheters Results Pave the Way for Phase 3 Pivotal Studies
NovaBay Pharmaceuticals, Inc., an advanced clinical-stage biopharmaceutical company developing anti-microbial products, today announced positive top-line results from its recently completed Phase 2 clinical study CL1001 for auriclosene (NVC-422) to prevent urinary catheter blockage and encrustation (UCBE) of indwelling urinary catheters.
New Non-Clinical Data Confirm SparVax® Anthrax Vaccine Can Provide Protection Against Lethal Anthrax Challenge
PharmAthene, Inc. (NYSE MKT: PIP) announced today that new non-clinical animal data from the Company's SparVax® next-generation anthrax vaccine program were presented at the 53rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Co. The data presented showed that immunization with SparVax® provides dose-dependent protection against lethal anthrax infection.
Dr. Sherry Crowe, Director, Immunology at PharmAthene, discussed the results in an oral presentation entitled, "Recombinant Protective Antigen Vaccine (SparVax®) Provides Protection against Lethal Challenge with Bacillus anthracis in New Zealand White Rabbits."
Nevsun Reports 75 m of 1.7% Copper and 3.0% Zinc at Hambok
Nevsun Resources Ltd. (NSU.TO)(NYSE MKT:NSU) announces previously unreported assay results from drilling completed by the previous owner of the Mogoraib River exploration license that includes the Hambok mineral deposit.
HIGHLIGHTSDrilling confirms continuity of the massive sulphide body Hambok mineral deposit still open to the south, north and at depth Further mineral resource definition drilling underway Updated Mineral Resource estimate anticipated in early 2014 High potential exploration targets in immediate mineral deposit area
Avino Reports Q2, 2013 Net Earnings of $1.45 Million "$0.05" per Share and Cash Flow from Operations of $2,343,377 "$0.09" per Share
Avino Silver and Gold Mines Ltd. (TSX VENTURE:ASM)(NYSE MKT:ASM)(GV6.F) ("Avino" or "the Company") is pleased to report its financial results for the second quarter ended June 30, 2013. All financial information is prepared in accordance with IFRS and all dollar amounts are expressed in Canadian dollars unless otherwise specified. The information in this news release should be read in conjunction with the Company's unaudited condensed interim consolidated financial statements for the three and six months ended June 30, 2013 and associated management discussion and analysis ("MD&A") which are available on the Company's website at www.avino.com and under the Company's profile on SEDAR at www.sedar.com.
FieldPoint Petroleum Provides Update for Well #3 in Lea County, New Mexico
FieldPoint Petroleum Corporation (FPP) today provided an update on the production from its most recently completed well in Lea County, New Mexico.
FieldPoint's Executive Chairman, Roger Bryant, stated, "Our drilling partner, Cimarex Energy Co. (XEC), has provided us with a progress report on our newest well, the East Lusk Federal 15 #3, in Lea County, New Mexico. For the dates August 14 through August 20, the well averaged producing oil at 730 Bopd and natural gas at 569 Mcfpd. Needless to say, we are very pleased with the way this well is performing at this point. As we have done in the past, we will provide periodic updates on this well as it goes through this early stage production."
Inovio Pharmaceuticals' Malaria DNA Vaccine Demonstrates Robust Immune Responses in Animal Models
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its SynCon® DNA vaccine containing multiple malaria antigens delivered via its CELLECTRA® electroporation device demonstrated strong and durable antibody and T-cell immune responses in small animals and non-human primates. With these strong preclinical results, Inovio plans to initiate a phase I/IIa clinical trial next year.
These results appear in the American Society for Microbiology's peer-reviewed journal, Infection & Immunity, in a paper entitled: "Inducing humoral and cellular responses to multiple sporozoite and liver-stage malaria antigens using pDNA," authored by Inovio researchers and collaborators.