Biotech Releases 'Unequivocally Positive' Topline NASH Study Results
Biotech Targeting Alzheimer's Disease Advances Toward Phase 1
Target Price Raised Ninefold on Biotech After Share Consolidation
Company with Platform to Reduce Healthcare Supply Costs Grows Revenue 39% QOQ
iCo Therapeutics (TSXV: ICO) (OTCQB: ICOTF) Announces First Quarter 2018 Financial Results And Update On Phase 1 Clinical Trial
CSE New Listing - Izotropic Corporation (IZO)
CANCER News Alert: Fewer Men Are Being Screened, Diagnosed, and Treated for #ProstateCancer
Cardiol Therapeutics Closes CDN$10.5 Million Private Placement; #Nanotherapeutics
#Rheumatoid #Arthritis Drugs Taken During Pregnancy May Not Be Linked to Large Infection Risk in Children
Biotech Announces Encouraging HIV Vaccine Results
First Trust NYSE Arca Biotech ETF ( NYSEArca: FBT ) The investment seeks investment results that correspond generally to the price and yield (before the fund's fees and expenses) of an equity index called the NYSE Arca Biotechnology Index(SM). The fund will normally invest at least 90% of its net assets plus the amount of any borrowings for investment purposes in common stocks that comprise the index. The index is an equal-dollar weighted index designed to measure the performance of a cross section of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. The fund is non-diversified.
iShares US Healthcare ( NYSEArca: IYH ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Health Care Index (the "underlying index"), which measures the performance of the healthcare sector of the U.S. equity market. The fund is non-diversified.
iShares US Healthcare Providers ( NYSEArca: IHF ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare providers sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Select Health Care Providers Index (the "underlying index"), which measures the performance of the healthcare providers sector of the U.S. equity market. The fund is non-diversified.
iShares US Medical Devices ( NYSEArca: IHI ) The investment seeks to track the investment results of an index composed of U.S. equities in the medical devices sector. The fund seeks to track the investment results of the Dow Jones U.S. Select Medical Equipment Index (the "underlying index"), which measures the performance of the medical equipment sector of the U.S. equity market. The underlying index includes medical equipment companies such as manufacturers and distributors of medical devices such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, X-ray machines, and other non-disposable medical devices. The fund is non-diversified.
iShares Nasdaq Biotechnology ( NasdaqGIDS IBB ) The investment seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. The underlying index contains securities of NASDAQ® listed companies that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by the NASDAQ OMX Group, Inc. The fund is non-diversified.
Market Vectors Biotech ETF ( NYSE MKT:BBH ) seeks to replicate as closely as possible, before fees and expenses, the price and yield performance of the Market Vectors® US Listed Biotech 25 Index. The fund normally invests at least 80% of its total assets in securities that comprise the fund&#39;s benchmark index. The Biotech Index is comprised of common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology sector. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. It is non-diversified.
PowerShares Dynamic Biotech & Genome ETF ( NYSEArca: PBE ) The investment seeks investment results that generally correspond (before fees and expenses) to the price and yield of the Dynamic Biotechnology & Genome IntellidexSM Index. The fund generally will invest at least 90% of its total assets in common stocks of biotechnology companies and genome companies that comprise the underlying intellidex. The underlying intellidex was composed of common stocks of 30 U.S. biotechnology and genome companies. These companies are engaged principally in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes, etc. It is non-diversified.
4SC (XETRA: VSC.DE) is an innovative biotech company with a strong focus on clinical development. We discover and develop targeted small molecule drugs with an epigenetic mode of action for the treatment of cancer in indications with a high unmet medical need and major economic potential.
Aastrom Biosciences, Inc. (NasdaqCM: ASTM) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI(TM), a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.
ABBOTT LABORATORIES (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.76
Abeona Therapeutics Inc. (NasdaqCM:ABEO) develops and delivers gene therapy and plasma-based products for severe and life-threatening rare diseases. Abeona's lead programs are AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (MPS IIIB and IIIA). We are also developing ABO-201 (AAV CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, we are also developing rare plasma protein therapies including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD using our proprietary SDF™ (Salt Diafiltration) ethanol-free process.
Ablynx (Brussels: ABLX.BR) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease.
Acadia Pharmaceuticals Inc. (NasdaqGS: ACAD) is a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, for which we have reported positive Phase III trial results in Parkinson's disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. We are currently completing NDA-enabling clinical and manufacturing activities for pimavanserin and are planning to submit an NDA with the FDA near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer's disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from internal discoveries.
Access Pharmaceuticals, Inc. (OTC:ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.
AcelRx Pharmaceuticals, Inc. (NasdaqGM:ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.
Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders. Acorda markets three FDA-approved therapies including: AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda. Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure.
Acrux Limited (ASX:ACR.AX) is a dynamic Australian drug delivery business developing and commercialising a range of patient-preferred pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin. Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation, superior cosmetic acceptability, and simple, accurate and flexible dosing.See the full stock directory here
PHOENIX, June 18, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today reiterated its ongoing efforts to fundamentally transform the company. Below is a synopsis of these ongoing efforts.
New Governance, New Employee Base, New Vision and Culture
President and Chief Executive Officer Saeed Motahari joined INSYS in April 2017.
These changes have been essential in building the foundation for a strong culture, which is supported by well-defined compliance practices and, above all, ethical business behavior and values focused on patient needs.
Unwavering Commitment to R&D as Company’s Driving Force
Our company continues to put behind it the significant challenges caused by the inappropriate actions of certain former employees, most of which is over four or more years ago. It is our hope that our actions can help us continue regaining the trust of the healthcare community as we focus on the matters we can control. We believe that we have established a strong foundation to accomplish our stated mission and to bring value to patients and other stakeholders we have the privilege to serve.
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
This news release contains forward-looking statements including discussions regarding the results of our R&D programs and our hope to file NDAs for certain programs and to file at least one NDA per year over the next five years. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release. Actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
VANCOUVER, British Columbia and WARMINSTER, Pa., June 18, 2018 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that it will present at the first annual Roivant Pipeline Day on July 10, 2018, at 4:00 p.m. ET.
A live webcast will be available via the Investors section, under Events and Presentations of Arbutus' website at www.arbutusbio.com. Please connect to the company's website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 30 days following the conference.
About Roivant Pipeline Day
Roivant Pipeline Day will be held on Tuesday, July 10, 2018, in New York City. The event will feature presentations, fireside chats, and Q&A sessions from executives across the Roivant family of companies. The event is scheduled to begin at 2:00 p.m. ET and will continue until approximately 5:30 p.m. ET. Due to limited capacity, attendance is by invitation only but a live webcast will be available to interested parties. To request access to the webcast or to learn more about the event, please email firstname.lastname@example.org.
Arbutus Biopharma Corporation is a publicly traded (Nasdaq:ABUS) biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic Hepatitis B (HBV) infection. Arbutus is developing multiple drug candidates, each of which have the potential to improve upon the standard of care (SOC) and contribute to a curative combination regimen to improve patient outcomes and deliver a potential cure for HBV. For more information, visit www.arbutusbio.com.
SALT LAKE CITY, June 18, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx® to be used as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, talazoparib. The New Drug Application (NDA) for talazoparib has been granted priority review by the U.S. Food and Drug Administration and has a Prescription Drug User Fee Act (PDUFA) goal date of December 2018.
Myriad’s sPMA and Pfizer’s NDA submissions are based on results from the Pfizer-sponsored EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). The primary results of the study were presented at the San Antonio Breast Cancer Symposium in December 2017.
"Myriad was the pioneer in developing companion diagnostics for PARP inhibitors and this submission is another milestone in our collaborations to expand access to this class of drugs across multiple cancers,” said Mark C. Capone, president and CEO, Myriad Genetics. “We are excited to pursue a simultaneous diagnostic approval along with talazoparib, as another outstanding opportunity to advance personalized medicine for oncology patients.”
Myriad estimates there are approximately 125,000 patients with metastatic breast cancer who would immediately qualify for the BRACAnalysis CDx test, followed by 60,000 new patients per year on an ongoing basis.
About BRACAnalysis CDx®
About Myriad Genetics
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
Sunnyvale, June 18, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation Announces Nationwide Allergy Testing Sales and Distribution Network
June 18, 2018 - Sunnyvale, CA – Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces that the company has engaged a nationwide network of professional sales representatives (“sales reps”) to sell and distribute the company’s allergy tests across the Continental United States, with focus areas in the Pacific Northwest, West, Southwest, Rocky Mountain, Midwest, Northeast and Southeast regions. The network comprises 1,700 sales professionals including 500 sales reps with specific training in finger stick sampling, blood card collection and microarray technology. This extensive professional network will be used to enroll hospitals, health maintenance organizations (HMOs), doctor’s and dentist’s offices, health clinics and retail stores into the allergy-testing program.
Arrayit allergy tests utilize non-invasive and convenient finger stick sampling and blood card collection, in conjunction with patented and proprietary protein microarray technology, to rapidly and accurately measure immunoglobulin E (IgE) antibodies in the human bloodstream produced by exposure to 120 common food and environmental allergens. Personalized allergy testing assists health care professionals to more easily identify, treat and prevent allergy and asthma by combining molecular testing with a patient’s medical history, symptomology and a physician’s diagnosis. Arrayit allergy tests are manufactured and processed in the company’s Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the State of California and the Centers for Medicare and Medicaid Services (CMS), and benchmarked by the leading laboratory proficiency testing organization, the College of American Pathologists (CAP).
Arrayit CEO Rene Schena states, “We perceive significant synergies between our highly automated allergy testing technology and our newly-contracted network of medical sales professionals working on our behalf to promote allergy testing nationally to patients covered by private and public health insurance. Arrayit finger stick allergy tests are particularly beneficial to pediatric patients, special needs children, seniors, and immunotherapy patients requiring testing at frequent intervals.”
Safe Harbor Statement
CONTACT: Public Relations Arrayit Corporation Tel: 408-744-1331 Email: email@example.com Web: www.arrayit.com
SCAN Clinical Trial Results Intended to Support CPT Code Application for Incremental Diagnostic Reimbursement
REDWOOD CITY, Calif., June 14, 2018 (GLOBE NEWSWIRE) -- Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the initiation of the SCAN study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. OCT is a light-based, high definition imaging modality, which generates no X-ray radiation. Avinger’s proprietary Lumivascular technology utilizes OCT to provide real-time intravascular imaging during the treatment of peripheral artery disease. The Company’s Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing catheters are the only catheters available worldwide that incorporate the additional benefits of real-time intravascular imaging during PAD treatment.
While the FDA has already cleared OCT diagnostic claims for Avinger’s Pantheris and Ocelot catheters, and reimbursement codes applicable to therapeutic peripheral interventions with the Company’s Lumivascular catheters already exist, the results of the SCAN study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS in this setting. The study will enroll up to 20 subjects diagnosed with peripheral artery disease at two centers in the United States, with the goal to acquire at least 115 matched images generated by OCT and IVUS imaging for analysis. More specifically, OCT and IVUS images will be captured at identical positions within vessel segments so that a comparison can be made between the two imaging modalities. Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals, will serve as physician investigators in this study. Dr. Suhail Dohad, an interventional cardiologist in Los Angeles, will also serve as an advisor to the study.
Dr. Edward Pavillard, who enrolled the first cases in the SCAN study, noted, “As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intravascular view of arterial structures and disease distribution leads to better results for my patients versus if I relied solely on fluoroscopy. Given the correlation between the use of intravascular imaging and clinical outcomes, I am excited to participate in a study that will help expand the incorporation of OCT into the treatment paradigm for peripheral interventions.”
Dr. Luke Sewall commented, “OCT and IVUS have been well accepted imaging modalities for the diagnosis and treatment of atherosclerotic disease. Published data have shown that intravascular imaging may allow a clinician to more accurately assess vessel size, plaque characteristics, anatomical features, and the adequacy of interventional results. OCT and IVUS imaging also have the potential to limit the amount of radiation to which physicians and cath lab staff are exposed, and also reduce the volume of contrast agent used in the intervention, which can be particularly important in successfully treating patients suffering from impaired kidney function.”
“This trial represents an important component of our growth strategy. If successful, the results from this study should help support our application for incremental diagnostic reimbursement in procedures incorporating our Lumivascular technology,” said Jeff Soinski, Avinger’s president and CEO. “With diagnostic reimbursement already in place for IVUS imaging in the peripheral arteries, we believe that the reimbursement structure should also support the use of OCT for these types of interventions, especially given the high quality of intravascular imaging provided by OCT.”
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the PantherisÒ family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.
Public Relations Contact:
February 13, 2018 (Investorideas.com Newswire) Medical malpractice affects thousands of individuals around the world. If you think you have been injured, or wrongfully treated by a medical professional, you may be entitled to compensation.