|Gilead Sciences Received Orphan Drug Status For Liver Treatment; Alere Announces FDA CLIA Waiver for Alere Influenza A&B Test|
|By Josh Gee|
|Wednesday, 07 January 2015 19:49|
Gilead Sciences, Inc. (NASDAQ: GILD) obtained orphan drug status on Monday for its simtuzumab as a treatment for a rare disorder related to the liver.
The designation, which concerns its potential as a treatment for primary sclerosing cholangitis, may provide Gilead increased patent protection and lower regulatory hurdles.
The status is reserved for treatments of diseases that affect fewer than 200,000 people in the United States, or for drugs that aren't expected to recover development costs. Liver transplant is the only current treatment for primary sclerosing cholangitis.
Gilead is also attempting to develop simtuzamab as a treatment for liver Fibrosis and nonalcoholic steatohepatitis. Simtuzamab in September proved unsuccessful in a Phase II trial as a treatment for pancreatic cancer.
Shares of Gilead Sciences changed hands recently at $98.73, up 1.1 percent.
Alere Inc. (NYSE: ALR), a global leader in rapid diagnostic tests, announced the U.S. FDA has granted CLIA waiver for the Alere™ i Influenza A & B test, the only molecular test to detect and differentiate influenza A and B virus in under 15 minutes. Alere i Influenza A & B is the first-ever molecular test to receive a CLIA (Clinical Laboratory Improvement Amendments) waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings.
First-ever CLIA-waived molecular flu test delivers lab-accurate results at the point of care in less than 15 minutes
"This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season," said Avi Pelossof, Global President of Infectious Disease at Alere. "By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza – improving patients' clinical outcomes, protecting their communities, and reducing healthcare costs."
The Alere i test was cleared for marketing by the FDA in June 2014, and was made available in September for health facilities and laboratories licensed to conduct tests of moderate complexity under the CLIA program. With CLIA waiver, the test will be available in a significantly broader range of healthcare settings.
About the Alere i Influenza A & B test -- Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. Unlike polymerase chain reaction (PCR) testing, Alere's proprietary Molecular. In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings.
The clinical performance of Alere i Influenza A & B was established in a multi-center study conducted in the U.S., in which 630 nasal swab specimens, were evaluated with Alere i, and compared to an FDA cleared Real-Time PCR (RT-PCR) assay.
Additional tests on the Alere i platform are currently in development. Alere recently filed a 510k application for Strep A, and the company is planning to initiate clinical trials for a respiratory syncytial virus (RSV) test during the current respiratory season.
Anthera Pharmaceuticals (NASDAQ: ANTH), today announced the appointment of Klara A. Dickinson as Senior Vice President, Chief Regulatory Officer.
Medical practices may be able to secure new revenue while they improve outcomes for patients with diabetes by using Health-e-Connect, the remote diabetes care management system from ALR Technologies Inc. (OTCQB: ALRT).
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis in circulating tumor cell (CTC) and circulating tumor DNA (ctDNA), today announced that Michael Nall, Biocept President and CEO, is scheduled to present a corporate overview at the 8th Annual OneMedForum 2015 on Tuesday, January 13 at 2:40 PM PT at the Marriot Marquis Hotel in San Francisco.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) testing, today announced that its proprietary liquid biopsy testing that is performed at the Company's CLIA-certified and CAP-accredited laboratory will be offered to participants in the America's Choice Provider Network (ACPN), a Preferred Provider Organization (PPO).
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that, after a tenure of more than a decade, Pierre Lapalme has elected to step down as Chairman of the Company's Board of Directors following the annual meeting of stockholders anticipated in June of this year.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, reports preliminary unaudited top-line results for the fourth quarter and full year ended December 31, 2014.
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care diagnostic tests for infectious diseases, today announced that its chief executive officer, John J. Sperzel III, will present a corporate update at the 7th Annual Biotech Showcase Conference in San Francisco, CA.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015 at 10:00 am PST (1:00 pm EST) at the Westin Saint Francis Hotel in San Francisco.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced that Mark McDonough, CEO of CombiMatrix, will be presenting at the upcoming 8th Annual OneMedForum Conference in San Francisco.
Fibrocell Science, Inc., (Nasdaq:FCSC), an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that David Pernock, chairman and chief executive officer of Fibrocell Science will present at the Biotech Showcase 2015 Conference at 11:00 a.m. PT on Monday, January 12, 2015, at the Parc 55 Wyndham San Francisco Union Square Hotel.
Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that final results from its Phase 1 trial show that GR-MD-02 had an effect on a serum biomarker (as assessed by FibroTest®) and liver stiffness (as assessed by FibroScan®) that suggest a potential for therapeutic effect on fibrosis that warrants further exploration.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, today announced management will provide an update on the company followed by a breakout session at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015 starting at 10:30 a.m. Pacific Time in San Francisco.
The Joint Corp. (Nasdaq:JYNT), a national healthcare franchisor of chiropractic clinics, today reported that, in accordance with its strategy to operate and develop company owned units and to reacquire select regional developer rights, it has repurchased six franchises in Los Angeles County, California and reacquired and terminated the regional developer rights for that region.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, announced today that Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm, is scheduled to present at the J.P. Morgan 33rd Annual Healthcare Conference in San Francisco on Tuesday, January 13, 2015 at 2:30 p.m. PST.
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that Arie Belldegrun, MD, FACS, President and Chief Executive Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2015 at 12:00 PM Pacific Time.
Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the Company has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T Cell Receptor (TCR)-based product candidates directed against human papillomavirus (HPV)-16 E6 and E7 oncoproteins for the treatment of cancers associated with HPV infection.
Immune Design Corp. (Nasdaq:IMDZ), a clinical-stage immunotherapy company, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 15, 2015 at 11:30 a.m. PT.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will be participating in the Sidoti & Company, LLC, Emerging Growth Institutional Investor Forum at the Grand Hyatt Hotel in New York, NY on Monday, January 12, 2015.
MannKind Corporation (Nasdaq:MNKD), focused on discovering, developing and commercializing therapeutic products for diabetes, announced today that it will present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015 at 1:30 PM (PST) at Westin St. Francis Hotel in San Francisco, California.
NewLink Genetics Corporation (Nasdaq:NLNK) today announced that Charles J. Link, Jr., M.D., NewLink's Founder and Chief Executive Officer, is scheduled to present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, on Wednesday, January 14, 2015 at 4:00 p.m. PT.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that Stanley C. Erck, President and CEO, will present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2015 at 11:30 a.m. PT in San Francisco, CA at The Westin St. Francis Hotel.
Nuvilex, Inc. (OTCQB:NVLX) today announced that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol "PHCB" on the OTCQB electronic platform.
Pazoo, Inc. (OTCQB Symbol:PZOO) (German WKN#: A1J3DK) is pleased to announce that Pazoo's Inspiration Expert Jenna Lowthert has launched a new blog at http://justjennarose.pazoo.com.
Phibro Animal Health Corporation (Nasdaq:PAHC) will host a webcast and conference call to review second quarter financial results.
Protea Biosciences Group, Inc. (OTCQB:PRGB) announced today that Stephen Turner, CEO and Chairman, will be presenting at the Biotech Showcase™ 2015 Conference being held in San Francisco, CA.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced the appointment of Krishna R. Polu, M.D., as its Chief Medical Officer and Michael P. Smith as Chief Financial Officer, effective January 12, 2015.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, announced today that Peter D. Suzdak, PhD, the Company's Chief Executive Officer, will be presenting at the Biotech Showcase 2015 Conference being held in San Francisco, CA.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that two individual abstracts for Triferic have been selected by the Annual Dialysis Conference for presentation at their Annual Meeting, January 31 – February 3, 2015 in New Orleans, Louisiana.
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that it has exclusively licensed from CanBas Co., Ltd. (4575:Tokyo) the rights to develop and commercialize a novel, oral small molecule reversible inhibitor of Exportin-1 (XPO1), a nuclear transport target also known as Chromosome Region Maintenance-1 (CRM1).
Stemline Therapeutics, Inc. (Stemline) (Nasdaq:STML), a clinical-stage biopharmaceutical company developing oncology therapeutics targeting cancer stem cells (CSCs) and tumor bulk, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced a license agreement with Inserm Transfert SA and Institut du Cerveau et de la Moelle Epiniere (ICM) for intellectual property related to the treatment of Huntington's disease with triheptanoin (UX007).