Astex Announces FDA ODAC Meeting to discuss its Supplemental NDA for Dacogen; FDA Approves BioDelivery's REMS Print E-mail
By Staff and Wire Reports   
Thursday, 29 December 2011 17:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 29, 2011.

Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), announced the pre-publication notice of the FDA, Oncologic Drugs Advisory Committee (ODAC) Meeting to discuss the supplemental new drug application (sNDA) for Dacogen® (decitabine) for Injection, an application submitted by Eisai, Inc. The proposed indication for this product is for the treatment of elderly acute myelogenous leukemia (AML).

The ODAC meeting will be held on February 9, 2012 at FDA White Oak Campus in Silver Spring, MD and will be open to the public. Dacogen will be discussed during the morning session, beginning at 8 a.m. ET.

The General Function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. FDA intends to make background material available to the public no later than two business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting.

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BioDelivery Sciences International, Inc. (NASDAQ:BDSI) responded to the approval and announcement by the FDA that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved.  The program, which will be referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, was designed to ensure informed risk-benefit decisions before initiating treatment with a transmucosal fentanyl product, and while patients are on treatment, to ensure appropriate use.

The approved program covers all marketed transmucosal fentanyl products under a single program.  BDSI believes one single program will help to enhance patient safety while limiting the potential administrative burden on prescribers of transmucosal fentanyl products and their patients.  One common program also ends the disparity in prescribing requirements for ONSOLIS (fentanyl buccal soluble film), which is commercialized in the U.S. by Meda Pharmaceuticals, compared to other similar products.  The program was driven through a collaborative effort between companies with transmucosal fentanyl products, including our commercialization partner Meda Pharmaceuticals, and FDA.

"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "Unfortunately, companies with similar products being marketed prior to the approval of ONSOLIS were not all held to the same standard.  This resulted in a significant commercial disadvantage for ONSOLIS given the requirements of the REMS and the associated additional steps required by healthcare providers and their patients."   
Healthcare professionals and patients with active enrollment in the ONSOLIS REMS Program (referred to as the FOCUS Program) will be automatically transferred into the new TIRF REMS Access Program.  Additionally, prescribers and patients enrolled in other individual REMS programs will also automatically be transferred into the program.  In addition to consistency in educational materials, technological advances will simplify the process of participation and verification of program participation.  The full program is expected to be implemented in March 2012.


BioDelivery Sciences International, Inc. (BDSI) responded to the approval and announcement by the U.S. Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved.  



Also Thursday:



As previously announced, Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) will conduct a conference call at 9:00AM Eastern Time today, December 29, to discuss the Company’s proposed acquisition of Enobia Pharma Corp.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Enobia Pharma Corp. today announced that the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia.

Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the Goldman Sachs Healthcare CEOs Unscripted Conference will be webcast live on Thursday, January 5, 2012 at 11:00 a.m. ET.

Bristol-Myers Squibb Company (NYSE: BMY) will present at the Goldman Sachs Healthcare CEOs Unscripted conference on Thursday, January 5, 2012, in New York.

Cannabis Science, Inc. (OTCBB: CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to issue Sales Guidance and Outlook for 2012.

China Sky One Medical, Inc. (NASDAQ: CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that Hongyu Pan, the Company's Chief Financial Officer, will be leaving the Company effective December 22, 2011 for personal reasons.

PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced that the Company will present at the J.P. Morgan Healthcare Conference on Wednesday, January 11, 2012, at 2:30 pm Pacific Time at the Westin St Francis Hotel in San Francisco.

OPKO Health, Inc. (NYSE: OPK) announced that it has completed the acquisition of FineTech Pharmaceutical Ltd., a profitable Israeli company which develops and produces high value, high potency active pharmaceutical ingredients (APIs) using its proprietary technology and know-how in complex organic syntheses.

RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic and other biologic implants, was recognized in the 2011 fourth edition of Evolution magazine for achieving a 98.7 percent equipment performance rating for its facilities and processing equipment.

Today, Zacks Equity Research discusses the Pharma & Biotech, including Vertex Pharma (Nasdaq: VRTX), Human Genome Sciences Inc. (Nasdaq: HGSI), Biogen Idec (Nasdaq: BIIB) and Perrigo Company (Nasdaq: PRGO).

Waters Corporation (NYSE:WAT) Douglas A. Berthiaume, Chairman, President and Chief Executive Officer, will speak to the investment community at the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco on Monday, January 9, at 3:00 p.m. pacific time.

Watson Pharmaceuticals, Inc. (NYSE: WPI)
, a leading specialty pharmaceutical company, announced today that Paul Bisaro, Watson's President and Chief Executive Officer, will provide an overview and update of the Company's business at the 30th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2012 at 7:30 am Pacific Standard Time (10:30 am Eastern Standard Time) at the Westin St. Francis in San Francisco, California.



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