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2013-10-09 08:26:12

FDA decision on approval of BUNAVAIL expected by early June 2014 RALEIGH, N.C., Oct. 9, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that its New Drug Application (NDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review....

2013-10-08 08:28:50

Patent estate includes nine issued U.S. patents, nineteen patents worldwide REDWOOD CITY, Calif., Oct. 8, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided an update regarding its growing patent estate which totals 19 issued patents worldwide. These issued patents cover AcelRx's sufentanil...

2013-09-30 08:28:57

Zalviso NDA submitted for the management of moderate-to-severe acute pain in adult patients in the hospital setting REDWOOD CITY, Calif., Sept. 30, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zalviso(TM)...

Opioid Painkillers To Get New Addiction-Warning Labels
2013-09-11 11:01:32

Michael Harper for redOrbit.com - Your Universe Online The FDA announced plans to change the way opioid painkillers will be labeled in an effort to sheer off climbing addiction numbers. The new labels will emphasize the potential dangers of the drugs, particularly extended-release and long-acting varieties, while emphasizing that safer options should be considered before prescribing these drugs. Going beyond the labels, the FDA will also begin requiring drug manufacturers to do their...

2013-09-09 16:24:22

NEWARK, Calif., Sept. 9, 2013 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) announced today it has expanded the geographic scope of its non-exclusive license agreement with a subsidiary of Merck for certain patents directed to metformin extended release technology for use in JANUMET(®) XR (sitagliptin and metformin hydrochloride (HCl) extended-release). The territory covered by the license agreement is now worldwide. Under terms of the agreement originally entered into in July 2009,...

2013-09-06 08:22:23

RALEIGH, N.C., Sept. 6, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the Stifel Nicolaus 2013 Healthcare Conference. The presentation is scheduled for Wednesday, September 11, 2013 at 2:40 p.m. Eastern Time at the Four Seasons Hotel in Boston. (Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO ) BDSI recently submitted a New Drug Application...

2013-09-04 08:31:33

NEWARK, Calif., Sept. 4, 2013 /PRNewswire/ -- Depomed, Inc. (NASDAQ:DEPO) today announced that it will be presenting at the 2013 Stifel Nicolaus Healthcare Conference at the Four Seasons Hotel in Boston, Massachusetts. The presentation at the Stifel Nicolaus conference is scheduled for 8:35 am EDT (5:35 am PDT) on Wednesday, September 11, 2013. The presentation will be webcast, and the webcast can be accessed via the Investor Relations page of the Depomed website at...

Chronic Pain Management Training Should Be Required For All Doctors
2013-08-13 05:17:43

Enid Burns for redOrbit.com - Your Universe Online Most doctors are trained and well-equipped to treat acute pain, or pain that results from an injury and will subside with treatment, but few doctors are trained to address chronic pain. A new study from Henry Ford Hospital in Detroit finds that of the 117 US and Canadian medical schools, only four US medical schools put a required course for pain management on the schedule for medical students. Chronic pain is a growing issue with more...

2013-08-12 16:26:44

REDWOOD CITY, Calif., Aug. 12, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and six months ended June 30, 2013. "With the successful completion of our Zalviso(TM) clinical program that includes data from all three Phase 3 studies, each of which met its...

2013-08-09 08:24:34

BUNAVAIL NDA submitted to FDA; first buccal film to compete in growing opioid dependence marketplace RALEIGH, N.C., Aug. 9, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's recent achievements and an update on business operations and upcoming milestones for...