|YM BioSciences reports interim data, J&J ordered to pay $327 million in civil penalties over drug marketing violations|
|By BioMedReports.com Staff|
|Friday, 03 June 2011 20:01|
At the 2011 ASCO Annual Meeting, YM BioSciences Inc. (NYSE:YMI), reported updated interim safety and efficacy results from the Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the treatment of myelofibrosis.
The interim results reported at ASCO highlight that CYT387 has a favorable safety profile and can produce significant and durable responses in anemia and splenomegaly in addition to meaningfully improving constitutional symptoms," said Dr. Nick Glover, President and CEO of YM BioSciences. These preliminary multicenter data are very encouraging and show a trend towards similar safety and efficacy outcomes as reported in the Dose Escalation and Dose Confirmation Phases of the study."
The Phase I/II open-label, non-randomized, dose-escalation study is being conducted in three phases: a Dose Escalation Phase to determine the safety and tolerability of CYT387, and to identify a maximum tolerated dose for CYT387; a Dose Confirmation Phase which enrolled a cohort expansion at 150mg and 300mg QD, and a Dose Expansion Phase which continues to enroll patients at multiple study sites at doses of 150mg and 300mg QD and 150mg BID.
J&J's Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson (NYSE:JNJ) was ordered on Friday to pay $327 million in civil penalties to the state of South Carolina over the marketing of Risperdal, for violating, repeatedly, state consumer-protection laws by sending 7,184 "dear doctor" letters in November 2003, touting Risperdal as superior to rivals.
Judge Roger Couch of the Circuit Court for Spartanburg County for South Carolina, awarded the state of South Carolina a total of $174.2 million in penalties over the letters, based on a rate of $4,000 per violation.
In addition, the judge also found that 509,499 sample boxes of Risperdal distributed in the state had labels with deceptive materials, also warranting penalties. Couch awarded the state $152.8 million in penalties, or $300 per violation.
AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading skilled nursing and assisted living provider, has appointed Martin D. Brew as chief financial officer effective as of the company's annual shareholder meeting today, Friday, June 3, 20
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced the pricing of an underwritten public offering of 6,666,667 shares of its common stock, offered at a price of $7.50 per share.
AquaStar Holdings, Inc. (Pink Sheets:RPPR) is pleased to announce that the Company's wholly-owned subsidiary, SUTIMCo, Inc., has retained the services of Mr. Ed Ellsworth as Vice President of Business Development.
China Biologic Products, Inc. (Nasdaq:CBPO) ("China Biologic," or the "Company"), a leading plasma-based biopharmaceutical company in China, today announced that it will present and meet with investors at the Jefferies 2011 Global Healthcare Conference in New York, NY on June 9, 2011.
China Cord Blood Corporation (NYSE:CO) ("the Company") today announced its plan to release financial results for the fourth quarter and full year of fiscal year 2011 on Friday, June 10, 2011, after market close in the US.
CNS Response, Inc. (OTCBB: CNSO) announced that David B. Jones has been elected chairman of the board.
DURECT Corporation (Nasdaq:DRRX) announced today that Jim Brown, President and CEO, will be presenting at the Jefferies Healthcare Conference on Tuesday, June 7 at 4:30 p.m. Eastern time.
EntreMed, Inc. (Nasdaq:ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer today announced the presentation of clinical data for its Phase 2 study with ENMD-2076 in platinum-resistant ovarian cancer patients.
FluoroPharma Medical(OTC.BB: FPMI), a biopharmaceutical company developing the next generation proprietary PET imaging products, announced the change of its official stock ticker symbol from CEWM to FPMI.
Grifols, S.A. (NASDAQ:GRFS) ("Grifols") a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain today announced that on June 1, 2011, Grifols completed its acquisition of Talecris Biotherapeutics Holdings Corp. ("Talecris").
IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) (the "Company" or "IntelGenx") today announced that it has entered into a definitive securities purchase agreement with institutional investors for the issuance and sale in a private placement transaction (the "US Private Offering") of 2,482,536 shares of common stock (the "Common Stock") at a per share purchase price of US$0.67, and three-year warrants (the "Warrants") to purchase up to 1,241,268 shares of common stock at an exercise price of US$0.74 per share, for aggregate gross proceeds of approximately US$1.6 million.
Life Technologies Corporation (NASDAQ:LIFE) has been honored by IDG's CIO magazine as a part of the 2011 CIO 100, an annual award program that recognizes organizations around the world that exemplify the highest level of operational and strategic excellence in information technology (IT).
LifeVantage Corporation (OTCBB: LFVN), the maker of Protandim®, a clinically demonstrated, science-based therapy for the reduction of oxidative stress by the synergistic activation of Nrf2, announced today that a new peer-reviewed review article involving Protandim® was published in the scientific journal Enzyme Research.
Masimo (NASDAQ:MASI) today announced that its management is scheduled to present at the William Blair & Company 31st Annual Growth Stock Conference at the Four Seasons Hotel in Chicago on Wednesday, June 15, at 8:00 a.m. Central Time.
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain announced today that it has selected Alampharm to serve as the exclusive distributor in Lebanon for its Nyloxin™-branded pain relievers.
Orexigen® Therapeutics, Inc. (Nasdaq:OREX) announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
Perma-Fix Environmental Services, Inc. (NASDAQ:PESI) today announced it has signed an exclusive option agreement with Battelle, which operates Pacific Northwest National Laboratory for the U.S. Department of Energy, to license technology from PNNL for use with Perma-Fix's proprietary process to safely and cost-effectively produce Molybdenum-99 (Mo-99), which is used to make Technetium 99m (Tc-99m).
Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced that it is scheduled to speak at the Jefferies 2011 Global Healthcare Conference in New York City.
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today reported updated interim safety and efficacy results from the Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the treatment of myelofibrosis.