Industry News

Biomerica, Inc. announced today that the U.S. Food and Drug Administration has determined that the proposed clinical study to validate performance of its InFoods ® IBS product is a nonsignificant risk device study. The Company will not be required to submit an investigational device exemption for the InFoods ® IBS product clinical study."/>
FDA Determines That Biomerica's Proposed InFoods(R) IBS Clinical Investigation Is a Nonsignificant Risk (NSR) Device Study
Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, today announced the decision to discontinue the development of cobiprostone based on the results of a prespecified futility analysis of the Phase 2 a study of an oral spray formulation of cobiprostone for the prevention of oral mucositis in patients that are undergoing radio chemotherapy for head and neck cancer. The futility analysis indicated that the clinical benefit of..."/>
Sucampo Provides Update on Cobiprostone Development Program
Pluristem Therapeutics Inc.,, a leading developer of placenta-based cell therapy products, today announced it has advanced its Phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell..."/>
Pluristem Advances its U.S. FDA Trial in Hematologic Indication
Mylan Launches Generic Temodar® Capsules
AMRI Completes Acquisition of Euticals
Enzo Biochem, Inc. today announced that its subsidiary, Enzo Life Sciences, Inc., has reached and finalized a settlement with Illumina, Inc. that included a payment of $21 million to Enzo in an action brought in Delaware Federal District Court by Enzo alleging infringement of its U.S. Patent No. 7,064,197, entitled System, Array and Non-Porous Solid Support Comprising Fixed or..."/>
Enzo Biochem's Life Sciences Unit Reaches $21 Million Patent Infringement Settlement in Delaware With Illumina, Inc.
Enzo Biochem, Inc. today announced that its subsidiary, Enzo Life Sciences, Inc., has reached and finalized a settlement with Illumina, Inc. that included a payment of $21 million to Enzo in an action brought in Delaware Federal District Court by Enzo alleging infringement of its U.S. Patent No. 7,064,197, entitled System, Array and Non-Porous Solid Support Comprising Fixed or..."/>
Enzo Biochem's Life Sciences Unit Reaches $21 Million Patent Infringement Settlement in Delaware With Illumina, Inc.
Bio-Techne Corp. has agreed to acquire genomic analysis consumables specialist Advanced Cell Diagnostics forUSD 250 min cash plus contingent consideration ofUSD 75 mdue upon the achievement of certain milestones, the company said. The transaction is expected to close on or aboutAugust 1, 2016, with closing subject to the satisfaction of customary closing conditions. This transaction will be financed through a combination..."/>
Bio-Techne to Acquire Advanced Cell Diagnostics for USD 250m Plus Earnouts
CareView Communications, Inc., an information technology provider to the healthcare industry, today announced the execution of a divisional hospital agreement with the West Florida division of the nation's leading provider of healthcare services. The three-year divisional agreement comes after a successful pilot with one of the hospitals in the division. CareView has already installed its CareView System ® in 50 beds and is on schedule to install..."/>
CareView Communications, Inc. Announces Divisional Agreement with Large Healthcare System
PetVivo Advisory Board. MINNEAPOLIS, MN July 11, 2016 PetVivo Holdings, Inc. an emerging biomedical device company focused on the commercialization of innovative medical devices and therapeutics for pets is very pleased to announce that Michael Sterns, DVM has joined the PetVivo Veterinary Advisory Board."/>
Dr. Michael Sterns Joins PetVivo Advisory Board
Emergent BioSolutions Inc. announced today that, on July 10, 2016, its Board of Directors approved the spin-off of Aptevo Therapeutics Inc. and declared a dividend distribution of one share of Aptevo common stock for every two shares of Emergent common stock outstanding as of the close of business on July 22, 2016, the record date for the distribution. Emergent expects to complete the distribution of Aptevo common stock to Emergent..."/>
Emergent BioSolutions’ Board of Directors Approves Spin-Off of Aptevo Therapeutics and Sets Record and Dividend Distribution Dates and Distribution Ratio
Lannett Company, Inc. today announced that it recently received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Paroxetine Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, the therapeutic equivalent to the reference listed drug, Paxil CR Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg, of Apotex Technologies. According to IMS, total U.S. sales in 2015 of Paroxetine Extended..."/>
Lannett Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg
Teleflex Incorporated, a leading global provider of medical technologies for critical care and surgery, has been awarded the Academic Participation Award from Vizient, Inc., the largest member-owned health care company in the country. The award was presented at the 2016 Vizient Supplier Summit, held in Las Vegas. The award honors the supplier who best supported the unique needs of the nation’ s academic medical centers through specialized programs that delivered..."/>
Teleflex Receives Award from Vizient, Inc. for Service Excellence to Academic Medical Centers
MEDNAX, Inc., today announced the acquisition of Pediatric Cardiology Associates, PC, a private physician group practice based in Fairfax, Va. Pediatric Cardiology Associates, established in 1987, was the first full-time pediatric cardiology practice in Northern Virginia as well as the first to receive accreditation from the Intersocietal Commission for the Accreditation of Echocardiography Laboratories. The practice provides a full spectrum of..."/>
MEDNAX Announces Acquisition of Cardiology Practice in Virginia
Acura Pharmaceuticals, Inc., a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that the Company will host a conference call and webcast on Thursday, July 14, 2016 at 8:30 a.m. ET to discuss additional data from Study AP-LTX-400, a pharmacokinetic study in healthy subjects of hydromorphone hydrochloride immediate-release tablets using the Company's new LIMITX™ oral abuse deterrent technology."/>
Acura Pharmaceuticals to Host Webcast on July 14, 2016 to Discuss Additional Data From Study AP-LTX-400
IRIDEX Corporation today announced that Atabak Mokari, 39, will join the Company as Chief Financial Officer and Vice President of Corporate Development effective July 11, 2016.. Mokari brings over 18 years of finance and strategy experience from working with leading companies in the medical technology industry. Over the course of his career, Mr."/>
IRIDEX Announces Atabak Mokari Will Be Chief Financial Officer And VP Corporate Development
BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, today announced that it has entered into a ten year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor and T cell receptor products for various..."/>
BioLife Solutions Executes 10 Year Supply Agreement with Kite Pharma for CryoStor® Use in CAR T Cell Therapies
Concord Medical Services Holdings Limited, a leading specialty hospital management solution provider and operator of the largest network of radiotherapy and diagnostic imaging centers in China, today announced that its board of directors has received a non-binding proposal letter, dated July 11, 2016, from Mr. Jianyu Yang, chairman and chief executive officer of the Company, Morgancreek Investment Holdings Limited, an investment vehicle..."/>
Concord Medical Announces Receipt of Preliminary Non-Binding "Going Private" Proposal
Nobilis Health Corp. today announced Kenneth Efird has been named President, effective immediately. Efird will have responsibility for all of the Company's operating units nationally and will continue to focus on executing the Company's strategic plan. He will report directly to Chief Executive Officer, Harry Fleming."/>
Nobilis Names Kenneth Efird President
Envision Healthcare Holdings, Inc. plans to release its operating results for the three months and six months ended June 30, 2016, after the securities markets close on Wednesday, August 3, 2016, with an investor conference call to follow at 5 p.m. Interested participants may listen to the call by dialing 800-857-6175, or 517-623-4852 for international callers, and referencing participant passcode 909712. A replay will be available beginning one..."/>
Envision Healthcare Holdings, Inc. to Report Operating Results for Second Quarter and First Half of 2016 on August 3, 2016
Mckesson, the prominent civil rights activist who last month was named interim chief human capital officer for Baltimore's public school system after an unsuccessful mayoral bid, was among more than 100 people arrested in Baton Rouge amid nationwide protests against police killings late Saturday and early Sunday. In a widely-circulated image of his arrest, the Baltimore native is seen on one knee, staring directly ahead of him wearing a T-shirt reading "#..."/>
DeRay Mckesson arrested during Baton Rouge protest [The Baltimore Sun]
Sunshine Heart, Inc. announced today an update to its clinical strategy that could benefit an underserved population of patients with Class III heart failure and other related conditions.. After months of collecting data and researching an optimal strategic path forward, Sunshine Heart is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation. In the feasibility trial, Sunshine Heart’ s..."/>
Sunshine Heart Announces Clinical Update and Product Development Strategy
Accelerate Diagnostics, Inc. announced today the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.. The fully automated system provides high-speed identification and antimicrobial susceptibility testing of pathogens from patient samples faster than conventional methods."/>
Accelerate Diagnostics Submits De Novo Request to FDA for Accelerate Pheno™ System and Accelerate PhenoTest™ BC kit
Mazor Robotics Ltd., a leading developer of innovative bone mounted surgical guidance systems, announced today that the Company will host an Analyst and Investor Day“ Platforms and Model for Accelerated Growth” on Tuesday, July 12, 2016 at the Andaz 5 th Avenue Hotel in New York City. Event participation is by invite and RSVP only. Presentations will begin at 8:30 am ET and a live webcast with accompanying slides will be available on the Investor Relations page of..."/>
Mazor Robotics to Host Analyst and Investor Day on July 12th, 2016

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