00:28 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

Intellipharmaceutics receives CRL from FDA for oxycodone ER

In September, Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) received a complete response letter from FDA for an NDA for oxycodone ER, a controlled-release formulation of oral oxycodone, to treat pain. Intellipharmaceutics said the CRL recommended the...
23:42 , Sep 14, 2017 |  BC Extra  |  Company News

Management tracks: SymCel, Taro, Akcea

SymCel Sverige AB (Spanga, Sweden) named Jesper Ericsson CEO. He was director of marketing and sales at BioLamina AB (Stockholm, Sweden). SymCel offers a cell-based assay for real-time monitoring of cell metabolism. Prescription and OTC...
21:43 , Aug 11, 2017 |  BC Extra  |  Company News

Management tracks: Orchard, Maverick, Pieris

Gene therapy company Orchard Therapeutics Ltd. (London, U.K.) named Mark Rothera president and CEO. He was chief commercial officer at PTC Therapeutics Inc. (NASDAQ:PTCT). T cell therapy company Maverick Therapeutics Inc. (Brisbane, Calif.) named James...
19:59 , Jul 28, 2017 |  BC Week In Review  |  Clinical News

Panel rejects Intellipharmaceutics' Rexista abuse deterrence claims

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety & Risk Management Advisory Committees voted 22-1 against approval of Rexista oxycodone XR from Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI), and voted 23-0 that available data were...
00:19 , Jul 27, 2017 |  BC Extra  |  Company News

Panel rejects Rexista abuse deterrence claims

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety & Risk Management Advisory Committees voted 22-1 against approval of Rexista oxycodone XR from Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI), and voted 23-0 that available data were...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
19:45 , Jul 5, 2017 |  BC Week In Review  |  Clinical News

FDA Panel to review Rexista NDA from Intellipharmaceutics

Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) said FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees will meet on July 26 to review an NDA for the company's Rexista oxycodone XR...
19:41 , Jul 3, 2017 |  BC Extra  |  Company News

FDA panel to review Intellipharmaceutics' analgesic

Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) said FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees are to meet July 26 to review an NDA for the company's Rexista oxycodone XR...
22:44 , Feb 8, 2017 |  BC Week In Review  |  Clinical News

Rexista regulatory update

FDA accepted for review an NDA from Intellipharmaceutics for Rexista Oxycodone XR to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternatives are inadequate. The PDUFA date is Sept....
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Ground up

Steve Edelson, Senior Editor   As the third quarter gets under way, biotech is shaking off the hangover of the Brexit vote while facing the overhang of the November election in the U.S. Fifteen bankers...