Forest Labs, Gedeon Richter Receive CRL from FDA for Cariprazine; Oncolytics Announces Positive Top-Line Data of REOLYSIN Print E-mail
By Staff and Wire Reports   
Thursday, 21 November 2013 20:20
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 21, 2013.

Forest Laboratories, Inc. (NYSE: FRX)
and Gedeon Richter Plc. announced that the U.S. FDA issued a complete response letter regarding the New Drug Application (NDA) for cariprazine, an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

In the complete response letter, the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed. “Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug”, said Dr. Marco Taglietti, President, Forest Research Institute.

Dr. Taglietti further noted that “the unmet medical need for schizophrenia and bipolar disorder remains high. We are committed to pursuing novel treatment options like cariprazine to address patient needs. Forest and Gedeon Richter plan to meet with the FDA in the very near future to discuss the complete response letter and define a path forward.”



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Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY)
announced positive top-line data for the endpoints in its double blinded, randomized clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in patients with second-line platinum-refractory, taxane-naïve head and neck cancers (REO 018).

 "The overall goal of this clinical trial was to determine the specific parameters for the use of REOLYSIN in a registration study in head and neck cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are excited to move forward with our head and neck program, and intend to discuss the design and execution of a follow-on registration study with regulators in the near future."



Also Thursday:



ACETO Corporation (Nasdaq:ACET)
, a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that Salvatore Guccione, President and CEO, is scheduled to present at the 25th Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2013 in New York City.

ActiveCare, Inc. (OTCBB:ACAR)
, a leader in diabetes management wellness services, today announces the agreement to provide their diabetes wellness solution for International Benefits Administrators (IBA) of Long Island, New York.

Analogic Corporation (Nasdaq:ALOG)
announced today that it will conduct a conference call on Monday, December 9, 2013, at 5:00 p.m. (ET) to discuss results for the first quarter ended October 31, 2013.

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, today introduced Quantum™ Plus Technology* across its entire portfolio of ultrasound platforms, resulting in a new level of image quality, usability and reliability.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, announces its participation in the third annual Latin American Human Genetics Congress and thirty-eighth annual National Human Genetics Congress on November 20 to November 23, 2013 in Riviera Maya, Mexico.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today announced that Thomas M. Patton, President and Chief Executive Officer, will present at the sixth annual LD MICRO conference on Tuesday, December 3, 2013, at 3:30 p.m. Pacific time.

Energy crop company Ceres, Inc. (Nasdaq: CERE) today announced financial results for the fiscal year ended August 31, 2013 and provided an update on its business in Brazil.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that Peter Kissinger, Ph.D., a member of the company's board of directors and professor of chemistry at Purdue University, has received the Outstanding Commercialization Award for Purdue University for 2013.

Cleveland BioLabs, Inc. (Nasdaq:CBLI)
and Incuron, LLC, a joint venture between CBLI and Bioprocess Capital Ventures today announced a poster presentation at the 2013 Society for Neuro-Oncology Meeting, held November 21-24, 2013 in San Francisco, California.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement with America's Choice Provider Network® (ACPN®) for coverage of its diagnostic laboratory services.

Competitive Technologies, Inc., (OTCQX: CTTC)
, a pain mitigation biotechnology company, was notified yesterday, Wednesday, November 20, 2013 at 2:24 EST that it had returned to good listing compliance with the OTCQX.

Compuware Corporation (Nasdaq:CPWR)
, the technology performance company delivering a new generation of application performance management (APM), today announced that its providing a daily analysis of the HealthCare.gov site to determine if improvements being made throughout November are having a positive impact on performance.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced today financial results for the third quarter ended September 30, 2013.

In a release issued on October 15, 2013, under the headline "Reno Diagnostic Centers Implement eRAD's Cloud-Based Teleradiology Solution" by eRAD, Inc. (Nasdaq:RDNT), please note that the company implementing the solution is Advanced Radiology Ltd. and not Reno Diagnostic Centers, as stated in the headline and throughout the release.

ICU Medical, Inc. (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced that Company management will be presenting at the Piper Jaffray 25th Annual Healthcare Conference to be held on December 3-4, 2013, at The New York Palace in NYC.

Ingen Technologies Inc. (OTC:IGNT)
, a holding company with wholly owned subsidiaries in the medical device market and telecom industry, announces today the following statement from the Chairman of the Board, Gary B. Tilden.

LipoScience, Inc. (Nasdaq:LPDX)
today announced that it will discuss revenue guidance for 2014 on the Company's Fourth Quarter 2013 conference call rather than on December 3, 2013 as previously announced.

Medical Marijuana, Inc. (OTC:MJNA)
, a leading cannabis and industrial hemp industry innovator, today announced the release of its quarterly financial and shareholders report (Post 11/15/2013 - OTC Markets).

NEXGENRX INC. (TSX VENTURE:NXG)
is pleased to report financial results for its second quarter, ended September 30, 2013.

OraSure Technologies, Inc. (Nasdaq:OSUR)
announced today that it has reached an agreement with Thermo Fisher Scientific, to develop and supply up to 12 homogenous fully automated oral fluid drugs of abuse assays to be used with a new Intercept® oral fluid specimen collection device.

OraSure Technologies, Inc. (Nasdaq:OSUR)
announced today that its assay collaboration agreement with Roche Diagnostics has been terminated. As part of the termination, Roche will continue to supply certain of the assays developed under that collaboration on a transitional basis for use with OraSure's existing Intercept® collection device.

The University of Arizona's Tech Launch Arizona today announced that the medication management software and business model developed by UA faculty and researchers has been acquired by SinfoniaRx, a new division of the healthcare company Sinfonia HealthCare Corp., launched in February by pioneering healthcare executives Fletcher McCusker and Michael Deitch, the founders of Providence Service Corporation (Nasdaq:PRSC).

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN)
, a specialty pharmaceutical company, today announced that the Company's management will present an overview of the Company at the Piper Jaffray Healthcare Investor Conference.

Venaxis, Inc. (Nasdaq: APPY)
, an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1™ Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced it will present at the Piper Jaffray 25th Annual Healthcare Conference, to be held December 3-4, 2013, at The New York Palace Hotel in New York, NY.

VIVUS, Inc. (Nasdaq:VVUS)
, today announced its support of new clinical practice guidelines urging healthcare providers to take an active role in helping overweight or obese patients achieve and maintain a healthy body weight.



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