|Nymox Reports Positive Safety Data for Phase 3 NX02-0022; Mylan Launches Generic Version of Aciphex|
|By Staff and Wire Reports|
|Monday, 11 November 2013 20:04|
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported a favorable update and recent Safety Monitoring Committee review of safety data for the Company's NX02-0022 reinjection study for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The most recent Safety Monitoring Committee meeting found no significant safety concerns to date. Enrollment in this study at participating investigational sites across the U.S. has passed the 50% accrual level.
Trial NX02-0022 is an open label study of the safety and efficacy of NX-1207 reinjection for the treatment of BPH. The study is open to subjects who had previously participated in an NX-1207 BPH study. All patients are given an intraprostatic injection of NX-1207 2.5 mg. The first of two NX-1207 reinjection studies (NX02-0020) was successfully completed in January 2013. Patients with BPH in the earlier NX02-0020 reinjection study received one or two injections of NX-1207 into the prostate. Mean overall improvement in the 192 treated men was 7.6 points in their AUA BPH Symptom Scores (p < .001). The mean duration from the initial injection to the final assessment was 26 months.
Mylan (NASDAQ: MYL) announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Rabeprazole Sodium Delayed-release Tablets, 20 mg. Rabeprazole Sodium Delayed-release Tablets are the generic version of Eisai Corporation's Aciphex® Tablets, and are indicated for short-term treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease, and for short-term treatment in the healing and symptomatic relief of duodenal ulcers. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Aciphex Tablets, 20 mg, had U.S. sales of approximately $830.1 million for the 12 months ending Sept. 30, 2013, according to IMS Health.
Currently, Mylan has 179 ANDAs pending FDA approval representing $90.5 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health.
Acasti Pharma (Nasdaq:ACST) (TSX-V:APO), a subsidiary of Neptune Technologies & Bioressources Inc., announces that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Pharmacokinetic (PK) trial of CaPre® in the USA.
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that it plans to introduce its Galaxy BioMill CAD/CAM System at the upcoming Greater New York Dental Meeting, the largest dental congress and exposition in the United States, which will be held from November 29 through December 4, 2013.
Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., has released its financial results for the third quarter ended September 30, 2013.
Cancer Genetics, Inc. (Nasdaq:CGIX), a DNA-based diagnostics company focused on developing genomic-based, oncology tests and services, will hold a conference call on Wednesday, November 13, 2013, at 4:30 p.m. Eastern Time to discuss its results for the third quarter ended September 30, 2013.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that preliminary data from "ReACT: a Phase 2 Study of Rindopepimut Vaccine (CDX-110) Plus Bevacizumab in Relapsed Glioblastoma", was published in the 2013 abstract supplement to the journal Neuro-Oncology; abstracts were also published online at http://neuro-oncology.oxfordjournals.org/.
CollabRx, Inc. (Nasdaq:CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, today announced a multi-year, non-exclusive agreement with Quest Diagnostics (NYSE:DGX), the world's leading provider of diagnostic information services, related to medical annotation for new next-generation sequencing test services for cancer.
Enzymotec Ltd. (Nasdaq:ENZY), reported today its financial results for the third quarter and nine months ended September 30, 2013.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) Conference 2013 on November 7-10, 2013, in National Harbor, Maryland.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer, administrator and private exchange for affordable, cloud-based individual health insurance plans and ancillary products, today reported financial and operating results for the third quarter and nine months ended September 30, 2013.
LeMaitre Vascular, Inc. (Nasdaq:LMAT), a provider of peripheral vascular devices and implants, announced today changes in the composition of its Board of Directors.
MacroGenics, Inc. (Nasdaq:MGNX) today announced that Boehringer Ingelheim has nominated a bi-specific antibody therapeutic candidate generated by MacroGenics' Dual-Affinity Re-Targeting (DART™) technology for pre-clinical development.
MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that pre-clinical data on targeting CD123-positive leukemic cells with its DART®-based molecule, MGD006, will be featured in an oral presentation at the 55th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans on December 7-10, 2013.
MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Tokyo Stock Exchange (Code Number: 4875), announced that a new U.S. patent has been granted which covers MN-221 in the treatment of irritable bowel syndrome.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported a favorable update and recent Safety Monitoring Committee review of safety data for the Company's NX02-0022 reinjection study for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH).
OmniComm Systems, Inc. (OTC:OMCM), one of the fastest growing companies in the Electronic Data Capture (EDC) marketplace, today announced the addition of two industry experts to their organization.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) and Takeda Pharmaceuticals U.S.A., Inc., today announced multiple Contrave® (naltrexone sustained release (SR)/bupropion SR) abstracts accepted for poster presentations and an oral presentation at the upcoming ObesityWeek meeting.
Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced initial results from a Phase 2 proof-of-concept study of andexanet alfa, its investigational Factor Xa inhibitor antidote, in healthy volunteers who were administered the Factor Xa inhibitor XARELTO® (rivaroxaban). Results from the first two dosing cohorts of the study demonstrated that andexanet alfa is able to dose-dependently reverse the anticoagulant effects of XARELTO®.
Premier, Inc. (Nasdaq:PINC) today reported financial results for the fiscal 2014 first quarter ended September 30, 2013.
Prosensa Holding N.V. (NASDAQ: RNA) today announced that the Company will host a conference call and live audio webcast on Monday, November 18 at 11:00am EST/ 5:00pm CET to report its third quarter financial results and provide a corporate update.
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced that Vicente Anido, Jr. has resigned from the Board of Directors of the Company, effective immediately.
RCM Technologies, Inc. (Nasdaq:RCMT), a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty healthcare services, today announced that it has mailed a letter to stockholders commenting on the problematic backgrounds and experience of the nominees that the Legion Group has proposed for election to the RCM Board at the 2013 Annual Meeting of Stockholders and stating why RCM believes that such nominees should not be elected to the RCM Board.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that its President and Chief Executive Officer, Faheem Hasnain, will be presenting at the 2013 Credit Suisse Healthcare Conference at the Phoenician Hotel in Scottsdale, AZ.
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced the launch of Doxorubicin Hydrochloride Injection, USP, an antineoplastic agent, in three vial presentations. According to IMS, for the 12 months ending September 2013, the US market for Doxorubicin Hydrochloride Injection, USP approximated $14 million.
SpectraScience, Inc. (OTCQB:SCIE) announced today that the Company will host a conference call at 4:30 p.m. Eastern (1:30 p.m. Pacific) on November 18, 2013 to provide an update on its business.
Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing products and services, today announced that it will report its third quarter 2013 results after market close on Tuesday, November 12, 2013 and will host a conference call and live webcast to discuss the results on that day at 5:00 PM Eastern time.
TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced its results for the third quarter ended September 30, 2013 and recent company developments.
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced financial results for its second quarter and first half of fiscal year 2014, ended September 30, 2013.