07:00 , Oct 31, 2016 |  BC Week In Review  |  Company News

Acura, KemPharm deal

Acura granted KemPharm rights to develop and commercialize up to three immediate-release candidates using Acura’s version abuse-deterrent technology. KemPharm said it will develop KP415, a prodrug of methylphenidate and a ligand, to treat ADHD; KP201...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Shedding red

Steve Edelson, Senior Editor   Brexit nearly wiped out what looked to be a rebound quarter for biotech. Only two market cap segments finished in positive territory, and smaller companies continued to get pounded. Big...
07:00 , Jun 20, 2016 |  BC Week In Review  |  Clinical News

Apadaz benzhydrocodone/acetaminophen regulatory update

FDA issued a complete response letter to KemPharm for Apadaz benzhydrocodone/acetaminophen as an abuse-deterrent product for the short-term management of acute pain. The letter follows an FDA panel vote of 16-4 that the agency should...
01:14 , Jun 14, 2016 |  BC Extra  |  Top Story

FDA rejects KemPharm's Apadaz

KemPharm Inc. (NASDAQ:KMPH) fell $1.79 (28%) to $4.35 in early after-hours trading Monday after it received an FDA complete response letter for Apadaz benzhydrocodone/acetaminophen ( KP201/APAP ). The candidate was under review as an abuse-deterrent...
07:00 , May 9, 2016 |  BC Week In Review  |  Clinical News

Apadaz benzhydrocodone/acetaminophen regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Risk Management advisory committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen from KemPharm for the short-term management of acute pain but 18-2 that the treatment should...
00:36 , May 7, 2016 |  BC Extra  |  Company News

KemPharm hammered after FDA panel

KemPharm Inc. (NASDAQ:KMPH) sank $8.76 (56%) to $6.91 on Friday, a day after FDA advisory committees voted against labeling analgesic Apadaz benzhydrocodone/acetaminophen as an abuse deterrent product. The committees did vote in favor of Apadaz's...
01:45 , May 6, 2016 |  BC Extra  |  Company News

Panel backs KemPharm analgesic, doubts abuse deterrence

FDA's Anesthetic and Analgesic Drug Products and Risk Management Advisory Committees voted 16-4 that the agency should approve Apadaz benzhydrocodone/acetaminophen ( KP201/APAP ) from KemPharm Inc. (NASDAQ:KMPH) for the short-term management of acute pain, but...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

2Q milestones

2Q milestones...
07:00 , Mar 21, 2016 |  BC Week In Review  |  Clinical News

Benzhydrocodone/acetaminophen regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet on May 5 to discuss an NDA for KemPharm’s KP201/APAP for short-term management of acute pain. The NDA for...
01:04 , Mar 17, 2016 |  BC Extra  |  Politics & Policy

FDA panels to discuss two more pain products

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet in June to discuss pain candidates CEP-33237 from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and ALO-02 from Pfizer Inc. (NYSE:PFE)....