|Aethlon Medical Announces Ebola Humanitarian Use Device Submission to the FDA; Acura to Develop Abuse Deterrent Hydrocodone With Acetaminophen Tablets|
|By Mary Davila|
|Thursday, 09 April 2015 19:59|
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 9, 2015.
Aethlon Medical, Inc. (OTCQB: AEMD), a pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, announced it has submitted a Humanitarian Use Device submission to the United States Food and Drug Administration (FDA) to support potential market clearance of the Aethlon Hemopurifier® as a treatment for Ebola virus. The Hemopurifier is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. The device targets antiviral drug resistance and could serve as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.
A Humanitarian Use Device (HUD) is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. If the HUD application is designated by the FDA, Aethlon may then submit a Humanitarian Device Exemption (HDE) marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review. There is no assurance that Aethlon will receive HDE approval to market the Hemopurifier as a treatment for Ebola virus.
Acura Pharmaceuticals Inc. (NASDAQ: ACUR), announced today that it is initiating development of an immediate-release hydrocodone bitartrate with acetaminophen tablet ("hydrocodone/APAP") incorporating Acura's novel LIMITX™ abuse deterrent technology. Hydrocodone/APAP, with over 135 million dispensed prescriptions in 2014 in the United States, is the largest prescribed opioid to treat moderate to severe pain. It also is the single most abused prescription opioid, predominately by swallowing multiple tablets. LIMITX is designed specifically to address this route of abuse.
The Food and Drug Administration's (FDA) April 2015 Abuse-Deterrent Opioids Evaluation and Labeling Guidance singles out immediate-release combination opioids with acetaminophen as being predominately abused by the oral route and that reducing nasal snorting of these products may not be meaningful. Development of the Company's LIMITX technology is currently being supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health (NIH) to develop an immediate-release hydromorphone tablet. The Company intends to initiate formulation development of the LIMITX hydrocodone/APAP tablet upon the conclusion of formulation optimization of the LIMITX hydromorphone product. Acura had previously advanced the development of a hydrocodone/APAP product using our AVERSION® technology, which was designed to deter nasal snorting, but intends to indefinitely suspend those efforts.
"Based on the recent FDA Guidance as well as comments made by the former-FDA Commissioner at a March 2015 Appropriation Hearing, we believe the best course for Acura is to develop immediate-release acetaminophen combination opioids with our novel LIMITX technology", said Bob Jones, President and CEO of Acura. "We are pleased to be partnered with the NIH on our LIMITX technology and believe it may also be applicable to snorting abuse, which we continue to believe is a route of abuse for these products that needs addressing."
Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that Gregory T. Went, PhD., Chief Executive Officer, will present at the 2015 Needham Healthcare Conference in New York on Tuesday, April 14, 2015 at 10:00 AM Eastern Standard Time.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, has appointed Jorge Plutzky, M.D., to its Board of Directors, effective immediately.
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, and Squalan Natural Health B.V., a privately held, personal care product company based in The Netherlands, have entered into agreements for the production and marketing of Neossance Squalane-based personal care products.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the third quarter ended February 28, 2015.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today a worldwide licensing agreement with privately-held EmboMedics Inc., of Minneapolis, Minn., which develops injectable and resorbable microspheres.
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material, today announced preliminary unaudited results for the first quarter of 2015.
Baystate Health, a long-time member of Premier, Inc. (Nasdaq:PINC), has signed a seven-year contract to extend and expand the partnership to leverage additional performance improvement services that support the delivery of high-value care across its continuum.
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the European Patent Office has granted the Company European Union (EU) patent no. 2376075 for its lead product candidate, EVK-001.
ExamWorks Group, Inc. (NYSE:EXAM) announced today that it has priced its previously announced offering of $500.0 million in aggregate principal amount of 5.625% senior unsecured notes due 2023 (the "Notes") pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on April 7, 2015.
Forward Pharma A/S (Nasdaq:FWP) announced today an agreement among all of its pre-IPO shareholders to voluntarily lock-up their shares for an additional 365 days beyond the expiration of the original IPO lock-up.
iKang Healthcare Group, Inc. (Nasdaq:KANG), China's largest private preventive healthcare services provider, launched its personalized medical examination mobile app on March 27, 2015.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 82 new employees.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability, and clinical systems that seek to advance healthcare, today announced the launch of a new business unit, iConnect Network Services, to deliver interoperability services to healthcare enterprises seeking to reduce the labor and overhead costs associated with prior-authorization processes, improve physician engagement among provider communities, and boost referral success.
OncoMed Pharmaceuticals Inc. (Nasdaq:OMED) will present new data from the company's Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) at the 5th European Lung Cancer Conference (ELCC) being held April 15-18, 2015 in Geneva, Switzerland.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that Sunil Patel, Chief Financial Officer, Senior Vice President, Corporate Development and Finance, will speak at the 14th Annual Needham Healthcare Conference in New York on Wednesday, April 15, 2015 at 12:50 pm Eastern Time.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the nomination of Garry A. Nicholson for election to the Company's Board of Directors. He will stand for election as an independent director at TESARO's 2015 annual meeting of stockholders, which is scheduled for May 14, 2015.
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that J. Kevin Buchi, President and Chief Executive Officer, will present at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015 at 10:00 a.m. Eastern Time at the Westin Grand Central Hotel in New York.
Trinity Biotech plc (Nasdaq:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, announced today that Trinity Biotech Investment Limited, its wholly-owned subsidiary (the "Issuer"), closed its offering of $115 million aggregate principal amount of Exchangeable Senior Notes due 2045 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced the pricing of its follow-on public offering of 3,000,000 ordinary shares at price to the public of $29.50 per ordinary share.
VBI Vaccines (Nasdaq:VBIV) provided an update on the progress of its cytomegalovirus vaccine development program yesterday at the World Vaccine Congress 2015 in Washington, D.C.
Vocera Communications, Inc. (NYSE:VCRA) today announced that it expects to release results for its first quarter 2015 on Thursday, April 23 after market close.
Wellness Center USA, Inc. (OTCQB:WCUI) today announced the successful introduction of its targeted UV LED Phototherapy device, Psoria-Light®, at the recent 73rd Annual Meeting hosted by the American Academy of Dermatology in San Francisco, CA.