Category Archives: Press Releases
Jazz Pharma, FDA declines fibromyalgia drug
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) U.S.the Palo Alto, Calif., drug maker, said on Monday that the U.S. Food and Drug Administration declined to clear for marketing JZP-6, a potential treatment for fibromyalgia. In a complete response letter to the company, the FDA addressed “the need for additional clinical studies, the appropriate patient population, methods for [...]
BIOD Downgrade to Market Perform
Leerink Swann downgrades Biodel, Inc. (Nasdaq: BIOD) from Outperform to Market Perform. Leerink analyst says, “The PDUFA date for BIOD’s Linjeta is Oct. 30, 2010, and shares have appreciated nearly 40% over the past three months as this event draws near. We are moving to the sidelines pending visibility on the FDA decision. We believe [...]
Idenix Provides Update on HCV Clinical Development Activities
Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical [...]
Idenix Pharma (IDIX) Receives Clinical Hold from U.S. FDA for IDX184 and IDX320 Programs
Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) receives notice from the U.S. FDA that a clinical hold has been placed on IDX184 and IDX320 programs. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The hold was put on after Idenix [...]
Inhibitex Successfully Completes Phase 1a Trial of INX-189
Inhibitex, Inc. (Nasdaq:INHX – News)announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 [...]
Alexza’s Staccato® Nicotine Licensed to Cypress Bioscience
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA – News) announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. (Nasdaq:CYPB – News). The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by [...]
FDA panel rejects Jazz drug
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) U.S. advisory panel on Friday rejected a Jazz Pharmaceuticals Inc (JAZZ.O) Nasdaqmedicine to treat the pain disorder fibromyalgia amid concerns the product could be misused as a “date-rape” drug. A Food and Drug Administration advisory committee voted 20-2 against recommending approval of sodium oxybate or JZP-6. The medicine contains a [...]
RPRX has received positive written feedback from the FDA
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has received positive written feedback from the FDA (the “Agency”) regarding the Company’s drug candidate Androxal®. The Agency concurred with Repros’ indication statement for the use of Androxal in the treatment of secondary hypogonadism in men wishing to preserve fertility. In the written advice letter the [...]
Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA – News) announced today that company Senior Vice President and Chief Financial Officer, August J. Moretti will present during the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference. The Alexza presentation will be on Friday, August 13, 2010 at 10:40 am ET. The presentation will be webcast from the Southampton [...]
Aeterna Zentaris Announces NIH Grant for a Phase 1/2 Study in Advanced Prostate Cancer with AEZS-108
Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) AEZS a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the National Institutes of Health (“NIH”) has awarded Dr. Jacek Pinski, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California, a grant of about US $ [...]