MonoSol Rx announced that the U.S. Patent and Trademark Office will decide by August 2015 whether BioDelivery Sciences International's BEMA drug delivery technology infringes on a patent protecting its Suboxone sublingual film.
BioDelivery Sciences International announced today that it will add about 80 patients to its Phase III pivotal trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.
More than two years ago the pain specialist Endo Pharmaceuticals stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International, even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.
BioDelivery Sciences has completed enrollment of it Phase III study clonidine topical gel for the treatment of painful diabetic neuropathy (PDN).
The success (or failure) of still-unproven biotech BioDeliverySciences will depend in great part on its buccal film for opioid dependence, Bunavail. The candidate is barreling toward its June 6 PDUFA date.
Raleigh, NC's BioDelivery Sciences is expecting to win FDA approval for its opioid-dependence patch this summer, and the biotech has enlisted global contractor Quintiles to handle the launch.
BioDelivery Sciences is looking at a possible $60 million boost to programs in its lineup including the launch of its opioid dependence film Bunavail and continue on the approval path for its pain gel for diabetic neuropathy.
Raleigh, NC's BioDelivery Sciences has signed a deal to trade 7.5 million shares for $60 million, planning to spend the lion's share of the proceeds to launch Bunavail, a gel designed to treat opioid dependence.
North Carolina's BioDelivery Sciences International locked down $20 million in debt financing, cash the company will use to develop two treatments with proprietary drug delivery methods.
BioDelivery Sciences secured rights from Arcion Therapeutics to commercialize the company's first-of-its-kind topical gel to treat painful diabetic neuropathy.