|Repros Says FDA Provided Guidance for Phase 2 Study of Proellex; Novabay Announces Neutrophase Available in Spray Pump|
|By Staff and Wire Reports|
|Monday, 27 August 2012 18:32|
Repros Therapeutics (Nasdaq: RPRX) announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex^® in the treatment of endometriosis. The following are the key elements of the guidance:
* Trial patient population includes women diagnosed within the last 5 years via laparoscopic or other surgical techniques and as having severe endometriosis requiring narcotic analgesics. * The primary endpoint is percent reduction in narcotic usage to control endometriosis related pelvic pain from baseline to the end of the four month study comparing placebo to Proellex. * Other endpoints include reduction in individual elements of endometriosis related pain and overall analgesic usage.
Repros plans to submit the revised protocol to the FDA as soon as practicable. Once received, the FDA agreed to review the design within 30 days, at which time, if the protocol is acceptable, Repros could commence the Phase 2 trial in the fourth quarter of this year. The Company intends to enroll up to 90 women into the study (30 per arm).
NovaBay Pharmaceuticals (NYSE: NBY) announced it has received 510k clearance from the Food and Drug Administration to market NeutroPhase® Skin and Wound Cleanser under widened indications including the moistening and debriding of graft and donor sites. Concurrently, the FDA cleared NeutroPhase to be administered through a new convenient spray pump.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the official opening of the Company’s new corporate headquarters at the Ardsley Park life science campus in Ardsley, New York.
AdCare Health Systems, Inc.(NYSE MKT: ADK), a leading long-term care provider, has signed a definitive purchase agreement for a skilled nursing facility in South Carolina for $4.2 million.
Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today reported preliminary financial results for the second quarter of 2012, subject to further review by the Company and its auditors.
Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today announced the appointment of Bruce Kutinsky as its Chief Operating Officer of its US operations effective September 1, 2012.
The Board of Directors of AMERICAND DIVERSIFIED HOLDINGS CORPORATION (PINKSHEETS: ADHC) (http://www.americandiversifiedholdings.com/) has today approved the conversion of the Company's outstanding debt totaling over $500,000 USD into newly authorized Preferred "B" shares with its main secured creditor.
Arrowhead Research Corporation (NASDAQ:ARWR) today announced that it will report its financial results for the fiscal 2012 third quarter ended June 30, 2012, on Monday, August 13, 2012 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).
Avita Medical Ltd. (ASX: AVH), (PINKSHEETS: AVMXF), (OTCQX: AVMXY), the regenerative medicine company, announced a brief summary of recent manufacturing improvements, a direct result of the combined efforts of R&D and Operations and implementation of the company's commitment to a Continuous Improvement Model.
AxoGen, Inc. (OTCBB:AXGN), a leading regenerative medicine company focused on the development and commercialization of products and technologies for peripheral nerve reconstruction and regeneration, today announced approval by the Rizzoli Orthopaedic Institute of its first commercial shipment of Avance® Nerve Graft to MD for Life, its new distribution partner in Italy.
Baxter International Inc. (NYSE:BAX) today announced that it has entered into a manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) in the Netherlands that will provide Baxter up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-derived treatments.
Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has approved a new 4000 IU dosage strength of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. ADVATE is a full-length recombinant factor VIII (FVIII) product that is indicated for the control and prevention of bleeding episodes in patients with hemophilia A.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that its second quarter 2012 financial results will be released on Thursday, August 2, 2012.
Bioject Medical Technologies Inc. (Pink Sheets:BJCT), an innovative developer and manufacturer of needle-free injection therapy systems, today reported unaudited financial results for the year and quarter ended December 31, 2011 and for the first quarter ended March 31, 2012. The financial results are unaudited and actual results may vary.
BioTime, Inc. (NYSE MKT:BTX) announced today that Chief Executive Officer Michael D. West, Ph.D. will present at the 2012 Agora Financial Investment Symposium on Tuesday, July 24, 2012, 4:40 p.m. PDT, at the Fairmont Hotel in Vancouver, British Columbia, Canada.
BrainStorm Cell Therapeutics (OTC:BCLI) announced today that it has completed the planned interim safety review of its Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicating that autologous transplantation of the Company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.
Compugen Ltd. (NASDAQ: CGEN) today reported financial results for the second quarter ending June 30, 2012.
Covidien plc (NYSE: COV) today announced that its Board of Directors has declared a quarterly cash dividend of $0.225 per ordinary share.
Lewisham Healthcare NHS Trust has become one of the first trusts to adopt CSC’s (NYSE: CSC) next-generation laboratory solution under a project to overhaul cellular pathology services across the new organization, formed by the merger of acute and community services in Lewisham.
Celgene Corporation (NASDAQ: CELG) senior management will host a conference call and live audio webcast on Thursday, July 26, 2012 at 9 a.m. ET to discuss the company’s second quarter 2012 financial and operational results.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced the issuance of patents 8,207,233 and 8,207,234 by the U.S. Patent and Trademark Office.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced its unaudited consolidated financial results for the quarter ended June 30, 2012 under International Financial Reporting Standards (IFRS).
EasyMed Services Inc.® (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("EasyMed" or the "Company") today announced the launch of its new global website, www.EasyMedMobile.com, to promote its suite of eHealth and telemedicine applications including International Medical Passport and Easy SmartCare.
Emerging nutraceuticals provider Neutra Corp. (OTCBB:NTRR) announced today that the company has placed its initial order for two new all-natural male enhancement supplements in order to move forward with clinical trials.
EncounterCare Solutions, Inc. (PINKSHEETS: ECSL) (or the "Company") today commented on the recent BBC news Article, New BioFuels Offer Hope to Hungry World, published on 8 August 2012.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company will host webcasts and conference calls to discuss its second-quarter 2012 financial results and of its annual meeting of stockholders.
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic breast cancer (mBC) compared to the combination of lapatinib and Xeloda® (capecitabine).
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA™ (alemtuzumab) as a treatment for relapsing multiple sclerosis.
GlaxoSmithKline plc (LSE: GSK) and Human Genome Sciences (NASDAQ: HGSI) today announced that the companies have entered into a definitive agreement under which GSK will acquire HGS for US$14.25 per share in cash.
IGSM Group, Inc. (PINKSHEETS: IGSM) has concluded negotiations with a Biotech Company to commercialize the opportunity presented by a small protein named Crotamine.
Illumina, Inc. (NASDAQ:ILMN) today launched its real-time PCR reagent portfolio, including a novel, probe-based chemistry for gene expression analysis called NūPCR™.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Roche has reported that updated results from its EMILIA Phase III trial show that patients treated with trastuzumab emtansine had a significant improvement in OS compared to those randomized to standard-of-care therapy.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be participating in the BMO Capital Markets Biotech Corporate Access Day on July 31, 2012, in Boston.
InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the second quarter ended June 30, 2012 on Tuesday, July 31, 2012.
InterMune, Inc. (NASDAQ: ITMN) today announced that an oral presentation and three poster presentations related to the company's research programs in idiopathic pulmonary fibrosis (IPF) will be presented at the Annual Congress of the European Respiratory Society (ERS) being held in Vienna, Austria, September 1-5.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its licensee, Onyx Pharmaceuticals (Nasdaq: ONXX), received accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis™ (carfilzomib) for Injection, a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Lpath, Inc. (OTCQB: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported that the FDA has lifted the clinical hold on iSONEP™, Lpath's anti-S1P monoclonal antibody that is being developed as a potential treatment for wet AMD and possibly other ocular disorders.
Medgenics, Inc. (NYSE MKT: MDGN and MDGN.WS and AIM: MEDG and MEDU), the developer of BiopumpTM, a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced the availability of a current prospectus following the effectiveness of its registration in the United States of common stock issuable upon the exercise of outstanding warrants to purchase 2,829,000 shares of common stock.
Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index has appreciated 28.7% during the first half of 2012.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced final results from the STARTMRK study – the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adults with HIV-1.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, to coordinate the regulatory review and approval to conduct the first human trials in Australia for Flucide™, the Company’s broad-spectrum anti-influenza drug.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that clinical data from a head-to head study comparing its amyloid imaging candidate, AZD4694, to the benchmark amyloid imaging agent, 11C-PiB (PiB), was presented at the Alzheimer's Association International Conference – AAIC in Vancouver, Canada by Professor Christopher Rowe, MD, FRACP, Director of the Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia.
NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that its Chief Medical Officer was interviewed by KIDELA TV, a financial news network.
Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced it will report financial results for the second quarter ended June 30, 2012 on Thursday, August 2 after market close, followed by an investor conference call on the same day at 4:30 p.m. EDT (1:30 p.m. PDT).
OPKO Health, Inc. (NYSE:OPK) is pleased to announce the appointment of Juan F. Rodriguez as its new Senior Vice President and Chief Financial Officer.
Orgenesis Inc. (OTCBB: ORGS) (“Orgenesis” or “the Company”), a development-stage company with a novel therapeutic technology dedicated to converting a patient’s own liver cells into functioning insulin-producing cells as a treatment for diabetes, was featured in two online publications during the week of June 11.
Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced that it will report its financial results for the second quarter ended June 30, 2012, on Monday, July 30, 2012.
PerkinElmer, Inc., (NYSE:PKI) a global leader focused on improving the health and safety of people and the environment, today announced that on Thursday, August 2, 2012, after market close, the Company will release second quarter 2012 results.
Perrigo Company (Nasdaq: PRGO;TASE) and Tris Pharma, Inc. today announced the commercial launch of a major new store brand product.
Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture.
Pfizer Inc. (NYSE: PFE) announced today that top-line results for Lyrica® (pregabalin) capsules CV Study A0081104 – Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers – demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.1
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, and Liz Cermak, the Company’s Executive Vice President and Chief Commercial Officer, will present at the 2012 Stifel Nicolaus Healthcare Conference on Thursday, September 6, 2012 at 3:15 p.m. (ET), at the Four Seasons Hotel in Boston.
Premier Biomedical, Inc. (OTC-BB: BIEI) has announced the successful outcome of a Proof of Concept Test performed by the University of Texas at El Paso (UTEP).
RBC Life Sciences, Inc. (OTCQB: RBCL) announced today that the Company's stem cell supplement, Stem-Kine™, has been approved for importation and sale in Taiwan. Stem-Kine is marketed in Taiwan under the name SK Plus.
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) (“the Company” or “RegeneRx”) today announced that it has entered into a licensing agreement with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong (“Lee’s”), for the license to Lee’s of RegeneRx's Thymosin Beta 4-based products, including the Company’s RGN-259, RGN-352 and RGN-137 product candidates, in China (including Hong Kong and Macau) and Taiwan. Lee’s previously paid RegeneRx $200,000 upon signing of a term sheet and will pay RegeneRx an additional $200,000 with the completion of this license agreement.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, announced today that it plans to release financial results from the second quarter on Tuesday, July 31, 2012 prior to the market open.
Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that Louis Ferrari, Chief Executive Officer and President of Savient, will present at the Rodman & Renshaw 14th Annual Healthcare Conference on Monday, September 10th at 4:30 pm Eastern Time at the Waldorf=Astoria Hotel in New York City.
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro”) announced today that the Special Committee of its Board of Directors unanimously rejected the October 18, 2011 unsolicited, non-binding offer from Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and affiliates, “Sun Pharma”) to purchase all of the issued and outstanding shares of Taro not currently held by Sun Pharma for $24.50 per share as inadequate and not in the best interests of Taro’s minority shareholders.
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced a full line of Weck® Access Devices, including a broad offering of Weck Vista™ bladeless access ports as well as the Weck EFx™ Endo Fascial Closure System.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will announce its second quarter 2012 financial results on Monday, July 30, 2012 after the financial markets close.
XenoPort, Inc. (Nasdaq: XNPT) announced today that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults.
MultiCorp International, Inc. /XTend Medical Corporation (PINKSHEETS: XMDC), has finalized the name/symbol change with FINRA and the company will begin trading under the symbol MCIC effective on August 28, 2012.
Zalicus Inc. (NASDAQ: ZLCS) today reported financial results for the second quarter ended June 30, 2012.