Eagle Pharma Announces FDA Accepts RTU Bivalirudin NDA for Filing; Omeros Announces FDA Grants Fast Track Designation for aHUS Print E-mail
By Marilyn Mullen   
Thursday, 23 July 2015 19:20
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 22, 2015.
Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) announced the 505(b)(2) New Drug Application (NDA) for its novel ready-to-use bivalirudin product ("RTU bivalirudin") has been accepted for filing by the U.S. Food and Drug Administration (FDA).
This 505(b)(2) NDA requests FDA approval of Eagle's RTU bivalirudin product for the treatment of patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
"We look forward to the FDA's decision on this NDA in March 2016 and, if approved, intend to launch our RTU bivalirudin product the following day," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We expect our RTU liquid formulation will be well received due to its multiple differentiating features. We look forward to continuing to work closely with the FDA through the review process."
Eagle's RTU bivalirudin product, which contains the same active ingredient as Angiomax, is administered as an IV solution at the same dose and rate. Eagle's liquid formulation will allow for immediate administration, with no reconstitution nor initial dilution required, reducing work flow and the risk of dosing errors.
Eagle's intellectual property pertaining to RTU bivalirudin includes two issued patents and an additional patent pending at the U.S. Patent and Trademark Office.
Omeros Corporation (NASDAQ: OMER) announced the U.S. Food and Drug Administration granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. Omeros is currently evaluating the drug in a Phase 2 clinical trial for the treatment of aHUS and other thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. Earlier this year, Omeros announced positive data from the Phase 2 trial and commencement of an investigator-requested compassionate use program for OMS721 to allow extended treatment of patients who completed the trial's four-week dosing. Recent efficacy and safety data from the ongoing Phase 2 clinical trial were submitted to the FDA in the company's request for Fast Track status for OMS721.
FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval. Many drugs that receive Fast Track designation are also considered appropriate to receive Priority Review, and their respective New Drug Applications (NDAs) may be accepted by the FDA as a "rolling submission" in which portions of an NDA are reviewed before the complete application is submitted. Priority Review and rolling submission can each provide further acceleration of FDA's approval process.
"FDA's Fast Track designation of OMS721 for aHUS reflects the unmet need associated with this disease and recognizes the drug's potential as an important option for the treatment of aHUS," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "We look forward to working with the FDA to streamline the development of this promising drug, and we currently remain on track to discuss with the Agency later this year both the data from our Phase 2 trial in TMAs as well as our plans for our Phase 3 program."
The Phase 2 clinical trial evaluating OMS721 in the treatment of TMAs, including aHUS, thrombotic thrombocytopenic purpura and human stem cell transplant-related TMAs, is ongoing in multiple sites in both the United States and Europe. The majority of the patients enrolled to date are those suffering from aHUS.
Also Thursday:
Air Methods Corporation (Nasdaq:AIRM), the global leader in air medical transportation, provided an update on second quarter results. 
Almost Family, Inc. (NASDAQ:AFAM) today announced the acquisition of Jacksonville, FL based Ingenios Health Co. (Ingenios). Ingenios is a leading provider of technology enabled in-home clinical assessments for Medicare Advantage, Managed Medicaid and Commercial Exchange lives in 7 states and Washington, D.C.
Amedica Corporation (Nasdaq:AMDA), a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopedic implants, is pleased to announce that it has signed an original equipment manufacturer (OEM) letter of intent supply agreement with a leading orthopedic device design and manufacturing company.
Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), announced today the appointment of Mr. Marco F. Benedetti to its Board of Directors, effective Wednesday, July 22, 2015.
athenahealth, Inc. (NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced financial and operational results for the second quarter of fiscal year 2015. 
NewYork-Presbyterian (NYP), recognized by U.S. News & World Report as among the best academic medical centers in the nation, today announced a new collaboration with athenahealth, Inc. (NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems. 
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of web-based revenue cycle management applications and telehealth products and services for healthcare organizations was featured this month in an article in Nephrology News & Issues®, a publication that integrates the business and practice of quality kidney care.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL) announced today that Thomas W. Chalberg, Jr., Ph.D., has resigned as chief executive officer (CEO) and president and as a member of the Board of Directors, effective July 23, 2015. 
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that its second quarter 2015 financial results will be released on Friday, August 7, 2015. 
Caladrius Biosciences, Inc. (NASDAQ:CLBS), a cell therapy leader with a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and regenerative medicine, announced today that it has received notice of an award from the National Eye Institute of the National Institutes of Health for a project to investigate 3D retinal constructs for vision restoration in patients with age-related macular degeneration.
Capstone Therapeutics Corp. (OTCQB:CAPS) and its joint venture affiliate, LipimetiX Development, Inc., announced today the conversion of a provisional U.S. Patent application claiming novel, more potent analogs of its lead peptide, AEM-28. The JV has supported research by Dr. G.M. Anantharamaiah at the University of Alabama, Birmingham to identify novel analogs of AEM-28 that demonstrate greater efficacy than the parent peptide and provide new composition of matter patent protection.
Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational antiviral brincidofovir showed a survival benefit in a pivotal study of an animal model for smallpox.
Connecture, Inc. (Nasdaq:CNXR), a provider of web-based information systems used to create health insurance marketplaces, will release its 2015 second quarter financial results on Thursday, August 6, 2015 after market close and will host a conference call to follow at 5:00 p.m. Eastern Time.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, will announce results for the second quarter ended June 30, 2015 on Wednesday, August 5, 2015, after market close. 
Emergent BioSolutions Inc. (NYSE:EBS) will host a conference call on Thursday, August 6, 2015 at 8:00 am (Eastern Time) to discuss the financial results for the second quarter of 2015, recent business developments, financial outlook for full year 2015, and revenue guidance for the third quarter of 2015.
Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on products for the minimally invasive treatment of chronic and recurrent sinusitis patients in the physician office setting or operating room, today announced that it will release its financial results for the second quarter of 2015 after the close of trading on Thursday, August 6, 2015. 
GrowBLOX Sciences, Inc. (OTCQB:GBLX), a biopharmaceutical company with state-of-the-art technologies in plant biology and cultivation designed to produce consistent medicinal cannabis, today announced that over the course of the next few weeks certain changes in management personnel and operating procedures would soon be implemented in preparation for the commencement of cultivation operations through our majority-owned subsidiary, GB Sciences Nevada, LLC.
Hemispherx Biopharma (NYSE MKT:HEB) announced that the United States District Court for the Eastern District of Pennsylvania has issued an order granting final approval of a settlement of the securities class action, Frater v. Hemispherx Biopharma, Inc. 
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that its has again achieved ISO 13485:2003 certification for the design, manufacture, and distribution of instruments, software, reagents and test kits used in the analysis of gene expression.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective antifungal and anti-bacterial therapeutics for the treatment of serious and life-threatening infections, today announced that it appointed David S. Perlin, Ph.D., to its infectious diseases Scientific Advisory Board (SAB).
Media General, Inc. (NYSE:MEG), one of the nation's largest connected-screen media companies, will report its second quarter 2015 earnings results before the market opens on August 6, 2015. 
The American Academy of Professional Coders (AAPC) and Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced a multi-year partnership that will elevate the business of healthcare through the creation of educational materials to promote best practices in wound care treatment and business.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter ended June 30, 2015. Net loss in Q2 2015 was $3.4 million, or $0.07 per share, compared to a net loss in Q2 2014 of $3.2 million, or $0.07 per share. Cash and investments were $37.3 million at June 30, 2015. 
Drug discovery and development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that it has completed an asset purchase agreement with Avista Pharma Solutions for the sale of its contract research and development services business. 
The Spectranetics Corporation (NASDAQ:SPNC) today reported financial results for the three and six months ended June 30, 2015. 
StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of disorders of the central nervous system, announced today that the Company's patent infringement case, StemCells, Inc. v. Neuralstem, Inc., has been dismissed by the U.S. Federal District Court for the District of Maryland for lack of standing.

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