|FDA Confirms Endpoints of Androxal Study; Paladin Labs Announces the Canadian Launch of Veregen®|
|By Staff and Wire Reports|
|Wednesday, 16 July 2014 19:40|
Repros Therapeutics Inc.® (Nasdaq: RPRX) today announced it has received additional guidance from the FDA regarding primary endpoints for the two studies, ZA-304 and ZA-305, that it is currently conducting comparing Androxal® to the leading approved testosterone gel and placebo. The FDA proposed three co-primary endpoints:
Percentage change from baseline in sperm concentration comparing Androxal® to the leading U.S. testosterone replacement therapy; Proportion of men obtaining a testosterone in the normal range; and Percentage of men that exhibit sperm ≥ 10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal® to a testosterone gel as well as comparing Androxal® to placebo.
The primary endpoints and statistical analysis plan outlined for ZA-304 and ZA-305 below are being modified to comply with the FDA suggestions. The Company believes the two studies are adequately powered to meet these endpoints.
Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) +0.96% CA:ENL -0.87% and a leading Canadian specialty pharmaceutical company, today announced the launch of Veregen® (sinecatechins) Ointment, 10%, a topical treatment for external genital and perianal warts (condylomata acuminata) in immunocompetent patients aged 18 years and over.
Clinically visible warts are present in approximately 1% of sexually active adults, making genital warts the most common sexually transmitted infection(1). Studies have demonstrated that for individuals with external genital warts, the reduction in their quality of life is of similar magnitude to that seen in people with moderate to severe asthma or osteoarthritis(2).
"We are pleased to announce the launch of Veregen® in Canada," said Mark Beaudet, President of Paladin Labs Inc. "Sexually transmitted infections (STIs) such as external genital warts can cause tremendous psychological stress(3). Canadians who suffer from external genital warts now have a new, non-invasive and effective topical treatment option with a demonstrated tolerability profile."
Paladin obtained the exclusive rights to market Veregen® in Canada from Medigene AG in May 2014.
Abiomed, Inc. (Nasdaq:ABMD) announced today that on Thursday, July 31, 2014, the Company will release financial results for the first quarter of fiscal 2015.
Athersys, Inc. (Nasdaq:ATHX) will release its second quarter 2014 financial results at approximately 4:00 PM (Eastern Time) on Monday, August 11, 2014, and host a conference call shortly thereafter at 4:30 PM (Eastern Time) to review the results.
Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, announced today encouraging analysis of the completion of its MRI data at the six-month time point from Capricor's Phase I ALLSTAR trial.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, today announced that it has earned a $500,000 milestone payment from Maruishi Pharmaceutical Company, Ltd., for the completion of Maruishi's Phase 1 clinical trial of the I.V. formulation of Cara's novel kappa opioid agonist, CR845, in Japan.
DS Healthcare Group, Inc. (NASDAQ: DSKX), a leading developer of personal care products and specialty pharmaceuticals, announced today that Mark Wolfson has joined its Board as an Independent Director and will serve on the Company's Audit Committee, and its Nominating and Corporate Governance Committee.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today details relating to the release of its second quarter 2014 financial results, which will take place on Wednesday, July 30, 2014 after the close of the market.
Harris & Harris Group, Inc. (Nasdaq:TINY), an investor in transformative companies enabled by disruptive science, announced today its investment in UberSeq, Inc. Harris & Harris Group invested $500,000 in UberSeq's Series Seed Financing in June of 2014.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, will announce results for its second quarter before market trading hours on Thursday, July 31, 2014.
Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment and diagnosis of metabolic disease, announced today that its collaborators at the Yale University School of Medicine have published key data highlighting the efficacy of Islet's novel diabetes diagnostic in Endocrinology, the journal of the Endocrine Society.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced today that the Company will release its financial results for the second quarter ended June 30, 2014, after the close of the stock market on Tuesday, July 29th, 2014.
SmallCapVoice.com, Inc. (SCV) announced today that a new audio interview with Wellness Managed Services' MPS International (MPSI), a Medical Marijuana, Inc. (OTC Pink:MJNA) subsidiary, is now available.
MedAssets (Nasdaq:MDAS) today announced that Baylor Scott & White Health, now the largest not-for-profit health care system in Texas, has renewed and expanded its relationship with MedAssets to support the recently merged health system in unifying organizational processes and workflows to drive greater operational efficiency and performance improvement.
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today reported financial results for the three and six months ended June 30, 2014 and the filing with the U.S. Securities and Exchange Commission (SEC) of the Company's Quarterly Report on Form 10-Q.
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, announced today that the Company has received authorization from the Israeli Ministry of Health to market and distribute NexoBrid® for the removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced that it will provide an online Web simulcast of its 2014 second quarter conference call on Wednesday, August 6, 2014.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it will report financial results for the second quarter of 2014 on Wednesday, July 23, 2014.
SmallCapVoice.com, Inc. announced today that a new audio interview with VeriTeQ Corporation (OTCQB:VTEQ), a provider of implantable medical device identification and radiation dose measurement technologies, is now available.
Tandem Diabetes Care®, Inc. (Nasdaq:TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, plans to release its second quarter 2014 results after the financial markets close on Thursday, July 31, 2014.
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified life sciences company, announced today it has signed a non-exclusive licensing agreement with Targeted Medical Pharma Inc. (OTCQB:TRGM) to reformulate and rebrand Targeted Medical's medical food formulations into dietary supplements as part of Tauriga's "Cannabis Complements" product line.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) expects to announce its Q2 2014 financial results after market closes on Thursday, August 7, 2014.