|Depomed Submits Serada® NDA; Pfizer Announces Top-Line Results From The ORAL Start Phase 3 Study Of Tofacitinib|
|By Staff and Wire Reports|
|Tuesday, 31 July 2012 17:57|
Depomed, Inc. (Nasdaq: DEPO) announced it has submitted a New Drug Application (NDA) for Serada to the United States Food and Drug Administration. Serada is Depomed's proprietary extended release formulation of gabapentin in development for the treatment of menopausal hot flashes.
"We are pleased to achieve this milestone in our Serada program. We believe that if approved Serada will offer women a non-hormonal option for the treatment of menopausal hot flashes," said Jim Schoeneck, President and CEO of Depomed.
Pfizer Inc. (NYSE: PFE) announced top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).
ORAL Start, an ongoing two-year study in methotrexate (MTX)-naïve patients with moderate-to-severe active RA, randomized to receive tofacitinib 5 or 10 mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg BID doses. Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Sharp Score (mTSS), and in reducing signs and symptoms of RA, as measured by ACR70 response rates. Both primary endpoints assessed tofacitinib versus MTX at six months. The data reported are from a planned analysis at one year.
No new safety signals emerged in the ORAL Start study, and the safety profile of tofacitinib remained consistent with that seen previously in the clinical development program. Safety findings observed in the overall tofacitinib RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; decreased neutrophil counts and neutropenia; and lipid elevations.
A detailed analysis of the ORAL Start findings will be submitted to a future scientific meeting.
Pfizer also noted today during its second quarter earnings call that the U.S. Food and Drug Administration (FDA) has recently requested additional analysis of the existing data in the tofacitinib New Drug Application (NDA). Pfizer is planning to provide FDA with this information in early August and, given this timing, it anticipates that FDA may require additional time beyond the August 21 Prescription Drug User Fee Act (PDUFA) date to review the information.
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today financial results for the three and six months ended June 30, 2012.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced financial results for the quarter ending on June 30, 2012.
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that on July 30, 2012, it completed a registered offering to an institutional accredited investor (the "Initial Purchaser") of an additional 15,000 shares of Series 15 Convertible Preferred Stock (the "Series 15-2 Preferred Stock") convertible into 25,212,203 shares of its common stock with a conversion price of $0.59495 and warrants to purchase up to an aggregate of 16,808,135 shares of common stock with an exercise price of $0.61344 for gross proceeds of $15 million (the "Second Closing") pursuant to the terms of a stock purchase agreement (the "Agreement") that CTI entered into on May 28, 2012.
On Wednesday, August 1, 2012, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of Cell Therapeutics, Inc.'s (CTI) (NASDAQ and MTA: CTIC) management team will host a conference call to discuss the Company's 2012 second quarter achievements and financial results.
Chai-Na-Ta Corp. (OTCBB:CCCFF) (the "Corporation") announced that following payments of the Corporation's liabilities, Cdn$10,166,560 remains for distribution to shareholders of the Corporation
Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company, today announced that it will report its financial results for the second quarter ended June 30, 2012 after market close on Monday, August 13, 2012 and will host a conference call at 5:00 p.m. Eastern Time to discuss those results.
Fresh Start Private Management Inc. (OTCBB: CEYY) (CEYY:US) is a leader in alcohol treatment and rehabilitation. Fresh Start is honored to announce that it has finished developing the new website www.freshstartprivate.com.
Luminex Corporation (NASDAQ: LMNX) today announced financial results for the second quarter ended June 30, 2012.
Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced that Dr. Arun Menawat, the company's President and Chief Executive Officer, will present Novadaq's corporate overview at the Canaccord Genuity 32nd Annual Growth Conference at 4:00 p.m. ET on Tuesday, August 14, 2012.
Nouveau Life Pharmaceuticals Inc. (OTC Pink: NOUV), a provider of quality all-natural dietary supplements, announced today the release of the newest product in the Company's New Life Naturals™ product line: For Your Health – Krill Oil™.
Optigenex Inc. (PINKSHEETS: OPGX), "the Company" or "Optigenex," announced today that it has completed a transaction whereby it paid $1,020,000 in cash and stock to retire approximately $6,000,000 of convertible secured notes owned by a group of investment funds ("the Funds") that were sponsored by The NIR Group LLC. The Company negotiated the terms of the settlement agreement with Ian Stokoe and David Walker, the joint liquidators of the Funds from PwC Corporate Finance and Recovery (Cayman Islands) Limited ("PwC").
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the supplemental biologics license application (sBLA) for ARCALYST® (rilonacept) Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.
Response Biomedical Corporation (TSX:RBM)(OTCBB:RPBIF) (the "Company") today reported that effective July 25, 2012, the Board of Directors of the Company have appointed Jonathan Wang, Ph.D. as a Director.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has completed patient enrollment in its pivotal Phase III clinical trials, designed to demonstrate efficacy and safety of SFP-iron delivered via dialysate to adult CKD patients requiring hemodialysis.
The Pulse Beverage Corporation (OTCBB: PLSB) ("Pulse"), makers of Cabana™ 100% Natural Lemonade and Pulse® NutriPurpose™ brand beverages, today announced that it has secured an international distribution agreement with a Class "A" distributor to ship Cabana™ 100% Natural Lemonade to Bermuda.
Sigma-Aldrich® Corporation (Nasdaq: SIAL) today announced that Sigma Life Science, its innovative biological products and services research business, has signed an agreement with Axiogenesis to market mouse induced pluripotent stem (iPS) cell-derived cardiomyocytes and smooth muscle cells.
Star Scientific, Inc. (NASDAQ: CIGX) is proud to congratulate Anatabloc® Brand Ambassador Fred Couples on his victory at the 2012 Senior British Open in Turnberry, Scotland.
Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that poster presentations on plecanatide that will be given at three separate Gastroenterology society meetings this fall.
Techne Corporation's (NASDAQ: TECH) financial results for the fourth quarter and fiscal year ended June 30, 2012
Zurvita Holdings, Inc. (OTCQB: ZRVT) (OTCBB: ZRVT) ("Zurvita" or the "Company"), a dynamic direct-to-consumer network marketing company, announced today it has reached over $1,000,000 in revenues for the month ended June 30, 2012.