On Wednesday, Shares of BioDelivery Sciences International, Inc. (NASDAQ:BDSI), remained flat at $6.08.
BioDelivery Sciences International, declared short-term supply constraints for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) due to a delay in the release to wholesalers of four recently manufactured batches of the product. The delay is the result of the recent introduction of a new source of a standard polymer by the supplier to BDSI’s contract manufacturer of BUNAVAIL. This new source has led to an unforeseeable product specification change requiring U.S. Food and Drug Administration (FDA) approval, and as such, is preventing the release of these four batches to wholesalers. BDSI is interacting with FDA on a daily basis and has presented to FDA requested documentation to support the specification change needed together with a request for approval to release the existing product to wholesalers. FDA has told BDSI that their decision regarding the requested specification change can be predictable within days and no later than next week. A positive decision will allow release of these batches of BUNAVAIL to wholesalers.
Since BDSI’s contract manufacturer also has polymer not related to this source change, this issue applies only to product batches awaiting shipment to wholesalers and not to product presently in production. The issue has no impact on any other BDSI product, counting BELBUCA, which has a PDUFA date of October 23.
The batches awaiting the FDA decision are more than adequate to meet current and anticipated market demand for BUNAVAIL. Assuming a positive FDA decision, any near-term supply outages should be limited. Regardless of the decision by FDA, BDSI anticipates having the product presently being manufactured in the field in November.
BioDelivery Sciences International, Inc., a specialty pharmaceutical company, engages in the development and commercialization of pharmaceutical products principally in the areas of pain administration and addiction.
Shares of Heron Therapeutics Inc (NASDAQ:HRTX), declined -2.72% to $23.28, during its last trading session.
Heron Therapeutics, declared the appointment of Neil J. Clendeninn, M.D., Ph.D. as Senior Vice President and Chief Medical Officer. Dr. Clendeninn joins the Company recently and will report to Barry D. Quart, Pharm.D., Chief Executive Officer of Heron.
“Neil has been instrumental as an advisor to the Company, specifically in his guidance during our recently accomplished MAGIC study for SUSTOL® (granisetron) Injection, extended release, and we are delighted that he will be joining us as a permanent member of our team,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “Neil brings over 30 years of experience in drug development and clinical practice to his role at Heron, and we look forward to his leadership in all areas of our business as we move forward in our aims of developing best-in-class medicines with the potential to improve the lives of patients suffering from cancer or pain.”
Since 2001, Dr. Clendeninn has been the president of CANAID, Inc. his own consultancy firm, and preceding to joining Heron, he was an advisor to the Company in that capacity. Additionally, Dr. Clendeninn is presently a practicing physician and serves as Program Director for Palliative Medicine Partners: Complex Illness Coordination, a program of Kauai Hospice in Kauai, Hawaii. From 1993 until 2001, Dr. Clendeninn served as Senior Vice President and Head of Clinical Affairs at Agouron Inc. Preceding to this, startning in 1985, he was Director of the Clinical Oncology Department at Burroughs-Welcome Company. Simultaneous to these roles, Dr. Clendeninn served as a practicing physician and held academic faculty roles at various institutions, among them, the University of North Carolina at Chapel Hill and the National Cancer Institute at the National Institutes of Health in Rockville, MD. In addition, Dr. Clendeninn presently sits on several Boards, counting the Board of Directors at OncoGenex Pharmaceuticals in Bothell, WA, and is a Scientific Medical Advisor at the Cancer Prevention & Research Initiative of Texas. Formerly, he served on the Board of Scientific Advisors at the National Cancer Institute of the National Institutes of Health, from 2001 through 2005. He received an M.D. and Ph.D. degree in microbiology and pharmacology from New York University in New York, NY.
Heron Therapeutics, Inc. is a biotechnology company. The Company uses its technology to develop products to address unmet medical needs. Its Biochronomer polymer-based drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals. The Company’s product candidate, SUSTOL (granisetron injection, extended release), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). Sustol is in Phase III Clinical trials.
Finally, SM Energy Co (NYSE:SM), ended its last trade with 2.46% gain, and closed at $39.62.
SM Energy Company, is planned to release third quarter of 2015 earnings and operating results after the close of trading on October 27, 2015. The Company will host a conference call and webcast to discuss results on October 28, 2015 at 8:00 a.m. Mountain time (10:00 a.m. Eastern time).
SM Energy Company, an independent energy company, engages in the acquisition, exploration, development, and production of crude oil and condensate, natural gas, and natural gas liquids in onshore North America.
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