|pSivida Announces Top-Line Results from Phase II Study of Medidur; Esperion Announces Removal of Partial Clinical Hold for ETC-1002|
|By David Fowler|
|Tuesday, 07 July 2015 18:54|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 7, 2015.
pSivida Corp. (NASDAQ: PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that top line results from an investigator-sponsored, Phase II study of pSivida's Medidur for uveitis will be presented at the 33rd Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) meeting to be held July 10-14 in Vienna, Austria.
Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC, who is conducting this study, will make the presentation. He also serves as principal investigator in pSivida's first pivotal Phase III trial for Medidur for posterior uveitis, which is currently underway.
Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.
"We are pleased to receive a positive and rapid response from the FDA following our submission in early June of a complete response to the 240 mg partial clinical hold," said Tim M. Mayleben, president and chief executive officer of Esperion. "We look forward to continuing our discussions with the FDA at next month's End-of-Phase 2 meeting as we advance ETC-1002 through the final phase of development."
Esperion's Commitment to Cardiometabolic Disease -- Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two preclinical product candidates.
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced that responses to the U.S. Food and Drug Administration (“FDA”) inquiries regarding the Company’s cervical composite silicon nitride interbody device were submitted to the FDA on June 30, 2015.
AmSurg Corp. (Nasdaq:AMSG) today announced it will release its second quarter 2015 financial results on Tuesday, August 4, 2015, after the market closes.
Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), through its wholly-owned subsidiary, Micron Products, Inc., a diversified contract manufacturing organization that produces highly-engineered, innovative medical device technologies requiring precision machining and injection molding, announced the results of shareholder voting that took place during the Company's 2015 annual meeting, which was held on July 1, 2015.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of web-based revenue cycle management applications and telehealth products and services for healthcare organizations, announced today that Renal Ventures Management, LLC (RVM), a leading provider of dialysis services for patients suffering from chronic kidney failure, selected Authentidate's telehealth solution for the remote monitoring of some of the dialysis patients who have kidney failure. The roll out is expected to begin in the third quarter of 2015.
BioCorRx, Inc. (BICX), developer of the Start Fresh Program® used for the treatment of alcohol and opioid dependence, announces the finalization of an asset purchase agreement with Trinity Compound Solutions (formerly Trinity Rx Solutions) for its Naltrexone implant formula with an option to purchase other formulas from Trinity.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced today that it has entered into a partnership with the Laboratory Services group of ICON plc, the global CRO (Nasdaq:ICLR).
Collain Healthcare, an LG CNS Company; and National HealthCare Corporation (NYSE MKT:NHC) (NHC.PRA), announced the deployment of LG CNS' Electronic Health Record (EHR) solution for the company's skilled nursing operations.
Community Health Systems, Inc. (NYSE:CYH) today announced that it will provide an online Web simulcast and rebroadcast of its second quarter 2015 conference call.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the adoption of its Focal One system under a pay-per-procedure sale contract by two major University hospitals in Switzerland: the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne and Geneva University Hospital (GUH).
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on designing, developing and commercializing products for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced that it has entered into a lease agreement for approximately 19,700 additional square feet to its existing premises in Plymouth, MN.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid-based nutritional ingredients and medical foods, announced today that Dr. Sylvain Rheims, Head of the Department of Functional Neurology and Epileptology at Hospices Civils de Lyon, France, commenced an investigator initiated clinical trial of Vayarin® in managing Attention Deficit Hyperactivity Disorder ("ADHD") in children with epilepsy.
Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announced that the independent Data Safety Monitoring Board (DSMB) recommends the continuation, per protocol, of its phase 2 clinical trial of GTL001 (known in Europe as ProCervix) in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced plans to release second quarter of fiscal year 2015 financial results after market close on August 4th.
K2M Group Holdings, Inc. (NASDAQ:KTWO) today reported preliminary financial results for the three months ending June 30, 2015.
K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced a proposed offering of shares of its common stock, which includes 750,000 shares offered by the Company and 3,750,000 shares offered by the selling stockholders named in the registration statement (the "selling stockholders").
Materialise NV (Nasdaq:MTLS), a leading provider of 3D software and sophisticated 3D printing solutions, and pioneer in medical image based guide technology, today announced that Consensus Orthopedics Inc. will use its Acetabular Cup Orientation (ACO) Hip Guide System.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company, today announced that it will be presenting at the 12th Anti-Infectives Partnering and Deal Making Conference being held July 9-10, 2015, in Boston, MA.
Merge Healthcare Incorporated (NASDAQ:MRGE), a leading provider of innovative enterprise imaging, interoperability, and clinical systems that seek to advance healthcare, announced today the scheduling of its second quarter 2015 earnings call, which will be held at 8:30 AM ET on Thursday, July 23, 2015.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the publication of a study online in Clinical Cancer Research that reinforces the ability of the company's Prosigna® Breast Cancer Assay to inform physician treatment decisions by predicting which patients are most likely to benefit from chemotherapy.
ScripsAmerica, Inc. (OTCBB:SCRC) today announced that its Board of Directors has accepted the resignation of Robert "Bob" Schneiderman as the Company's President, Chief Executive Officer (CEO) and Board member, effective July 1, 2015.
SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs, today announced the completion of its program of human factors studies for its lead drug product candidate, Trevyent, which is in development for the treatment of pulmonary arterial hypertension (PAH).
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy ('DMD') and C. difficile infection, announces that the European Patent Office ('EPO') has granted a composition of matter patent for the small molecule utrophin modulator SMT C1100 and that the period of opposition for this patent has now expired with no opposition having been filed.
Vapir Enterprises, Inc. (OTCQB:VAPI), a developer and manufacturer of revolutionary, state-of-the-art, and user friendly medical-grade vaporization devices, appointed Robert Duncan to its board of directors.
XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced publication of clinical results from an open label pilot study for its antibody therapy for treatment of Type 2 diabetes.