|Gilead Sciences Resolves FDA Warning Letter. U.S. FDA sets review for Amylin diabetes drug.|
|By Staff and Wire Reports|
|Wednesday, 10 August 2011 20:02|
Gilead Sciences, Inc. (NASDAQ:GILD) announced it has resolved all outstanding issues raised in a Warning Letter issued by the U.S. Food and Drug Administration (FDA) in September 2010 related to its San Dimas, California manufacturing facility.
The FDA notified Gilead that the Company’s response and the actions that have been adopted and implemented at the San Dimas site have sufficiently addressed the FDA’s observations, which were primarily related to the manufacturing environment for AmBisome (amphotericin B) liposome for injection, as well as general observations related to systems, procedures and controls focused on ensuring product quality at the San Dimas facility.
The companies submitted an application for the drug, Bydureon, last month after the regulatory agency declined on two separate occasions to approve it.
Amylin said in early July that a trial of exenatide, the active ingredient in Bydureon, found no link between the drug and changes in heart rhythms.
The FDA has set a Jan. 28, 2012 deadline for its review of a diabetes drug being developed by Amylin Pharmaceuticals Inc (NASDAQ:AMLN) ), Eli Lilly and Co (NYSE:LLY) and Alkermes Inc (NASDAQ:ALKS).
The FDA asked last year for more data on Bydureon's impact on the heart before deciding whether to clear it as a treatment for Type 2 diabetes.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today reported financial and operating results for the quarter ended June 30, 2011.
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that Barry D. Quart, PharmD, president and chief executive officer, will present at the Wedbush Securities 2011 Life Sciences Management Access Conference in New York, NY at 12:40 p.m. EDT on Tuesday, August 16, 2011.
Boston Scientific Corporation (NYSE:BSX) has launched its Neuromodulation Learning Institute™ (NLI), a clinical education program and online resource center for healthcare providers to enhance their knowledge and awareness of spinal cord stimulation (SCS) technology, procedures and techniques.
China Medical Technologies, Inc. (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that the Ministry of Health (the "MOH") of the People's Republic of China recently issued clinical guidelines which for the first time include FISH-based molecular cytogenetics tests as one of the tests to be performed for patients of myelodysplastic syndromes ("MDS"), chronic lymphocytic leukemia ("CLL") and chronic myelocytic leukemia ("CML") during their hospitalization.
Delcath Systems, Inc. (NASDAQ:DCTH) announced today that management will present at the Wedbush 2011 Life Sciences Management Access Conference on Tuesday, August 16, 2011 at 2:25 P.M. ET in New York.
Genesis Biopharma, Inc. (OTC/BB: GNBP), a biotechnology company developing targeted cancer immunotherapies, today announced it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that results from the Phase 2 clinical trial of LX1031 in patients with non-constipating irritable bowel syndrome (IBS) were published earlier this week in the August 2011 edition of the journal Gastroenterology.
Misonix, Inc. (NASDAQ:MSON), a medical device company that designs, manufactures and markets innovative therapeutic ultrasonic products worldwide for wound debridement, spinal surgery, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications, has announced its immediate entry into surgical wound debridement by adding their SonicOne® technology to the BoneScalpel™ surgical platform.
Neuralstem, Inc. (NYSE Amex:CUR) reported its financial results for the three months and six months period ended June 30, 2011 and provided a business and clinical update.
Northwest Biotherapeutics (OTC.BB: NWBO) reminded markets, in response to recent investor concerns about Dendreon's Provenge immune therapy, that NWBT's DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today that Michelle Burris, OncoGenex' Executive Vice President of Operations and Chief Financial Officer, will be presenting at the 2011 Wedbush Securities Life Sciences Management Access Conference.
PROLOR Biotech, Inc. (NYSE Amex:PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the Israeli Office of the Chief Scientist (OCS) has approved a 2011 grant to PROLOR's Israeli-based R&D subsidiary for the company's development program for hGH-CTP, its long-acting version of human growth hormone (hGH).
WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for the second quarter of 2011.