|Actavis Confirms Appeals Court Grants Injunction; PositiveID Announces First Firefly Dx Testing and Delivery of Positive PCR Results|
|By Marilyn Mullen|
|Thursday, 12 March 2015 19:48|
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 12, 2015.
Actavis plc (NYSE: ACT) confirmed the United States Court of Appeals for the Federal Circuit has granted AstraZeneca's request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort RESPULES® (budesonide inhalation suspension) 0.25, 0.5 mg.
Under the ruling, Actavis' sales of generic Pulmicort have been enjoined pending the resolution of AstraZeneca's appeal before the Court. The Court has set an expedited briefing schedule for the appeal, with expedited briefing to be concluded within 33 days. The injunction does not address product shipped prior to its issuance.
Actavis' sales of generic Pulmicort had previously been enjoined under a temporary injunction granted by the Appeals Court on February 16, 2015. The Appeals Court ruling followed the Feb. 13, 2015 launch of Actavis' product after the United States District Court for the District of New Jersey (i) found United States Patent No. 7,524,834 invalid, and (ii) denied AstraZeneca's request for a permanent injunction.
Pulmicort RESPULES® is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014, total U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.1 billion.
PositiveID Corporation (OTCQB:PSID), announced that it has successfully completed its first round of testing of its phase II Firefly Dx prototype handheld real-time PCR (polymerase chain reaction) pathogen detection system, and has delivered positive PCR results within 20 minutes. The Company's Firefly Dx testing was performed at standard laboratory volumes and achieved equivalent results to laboratory-based PCR instruments, which can take hours to perform the same PCR process.
The Company previously announced it completed its Firefly Dx PCR design, and it has now completed successful testing on its Phase II breadboard Firefly Dx system, with consistent and repeated detection of each positive challenge. With the completion of the PCR chip design with confirmatory results, the Company is now in the next phase of testing to encompass optimization and a broader spectrum of tests.
"Having recently completed our Firefly Dx breadboard prototype, these initial positive results of our new PCR chip, which could fundamentally change the real-time PCR industry, are very encouraging," stated William J. Caragol, Chairman and CEO of PositiveID. "These test results also validate our approach covered in the PCR chip patent application we just filed. Our Firefly Dx testing and development continues to progress on schedule."
Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment and can take hours or even days to provide results. Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets' report Polymerase Chain Reaction (PCR) - Products/Tools - A Global Market Watch, 2009-2015. Firefly's applications include point of need monitoring of pathogenic outbreaks (such as Ebola, influenza, etc.), agricultural screening in both domestic sectors and developing countries, and for the detection of biological agents associated with weapons of mass destruction.
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), today announced positive efficacy and safety results from a phase 2 study with masitinib in patients with triple negative breast cancer (TNBC).
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today the appointments of Dr. Alan Colowick and Dr. Kent Lieginger to its Board of Directors. In conjunction with these appointments, Dr. Scott Rocklage and Camille Samuels resigned from Achaogen's Board of Directors effective March 20th, 2015.
Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today that it will present at the Jefferies 2015 Antibiotic Summit in New York, New York.
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced today that it intends to offer shares of its common stock in an underwritten public offering.
Athersys, Inc. (Nasdaq:ATHX) today announced its financial results for the fourth quarter and year ended December 31, 2014.
Avinger, Inc., (Nasdaq:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that it has completed enrollment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the Company's Pantheris™ system.
Avinger, Inc., (Nasdaq:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today reported financial results for the fourth quarter and year ended December 31, 2014.
ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today reported financial results for the fourth quarter ended December 31, 2014 and provided an update on the Company's corporate and clinical development activities expected in 2015.
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced that clinical data from its DRM01 Phase 2a trial in acne will be presented at the Late-Breaking Research in Dermatology Forums during the American Academy of Dermatology (AAD) Annual Meeting being held March 20-24, 2015, in San Francisco.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced it intends to offer shares of its common stock and warrants to purchase its common stock in an underwritten public offering.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer and administrator of affordable, cloud-based individual health insurance plans and ancillary products, announced today that it will report fourth quarter and fiscal 2014 financial results on Wednesday, March 18, 2015 after market close.
Manny Villafaña, Chairman and Chief Executive Officer of Kips Bay Medical, Inc. (OTCQB:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery, today announced that the Company had reached its targeted enrollment goal for its eMESH I clinical feasibility trial and provided a business update and financial results for its fourth quarter and full year ended December 31, 2014.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, offers the Verigene® Gram-Negative Blood Culture Test (BC-GN), approved by the FDA in June 2014 as the first and only FDA-cleared test that rapidly identifies the five carbapenem resistance genes most commonly associated with carbapenem-resistant Enterobacteriaceae (CRE).
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development, today announced financial results for the third quarter of fiscal year (FY) 2015 ended January 31, 2015.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the year ended December 31, 2014 and provided an update on recent corporate developments.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that its Board of Directors has appointed Todd C. Schermerhorn to the Board, effective March 12, 2015.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) today reported its consolidated financial results for the quarter and the year ended December 31, 2014. All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it will host a conference call on Thursday, March 19, 2015 at 4:30 p.m. ET to discuss its financial results for the fourth quarter and the full year ended December 31, 2014.