BC Week In Review | Oct 31, 2016
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...
BioCentury | Jul 11, 2016
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...
BC Week In Review | Jun 20, 2016
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...
BC Extra | Jun 14, 2016
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 product...
BC Week In Review | May 9, 2016
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...
BC Extra | May 7, 2016
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...
BC Extra | May 6, 2016
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 18-2 that...
BioCentury | Apr 4, 2016
Finance

2Q milestones

2Q milestones Company Product Indication Event Milestone Ablynx N.V. (Euronext:ABLX) ALX-0171 Respiratory syncytial virus (RSV) infection Ph I/IIa data 2Q16 Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) Nuplazid pimavanserin Parkinson's disease psychosis (PDP) PDUFA date 5/1/16 Acucela Inc....
BC Week In Review | Mar 21, 2016
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...
BC Extra | Mar 17, 2016
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)....
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