18:23 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

FDA approves CV label update for Pfizer's Celebrex

FDA approved a label supplement for Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) to include data from a postmarketing cardiovascular outcomes trial showing that the lowest approved dose of Celebrex had similar CV safety to that...
19:56 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

FDA panel affirms safety of Pfizer's Celebrex

FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) had comparable cardiovascular safety to...
20:48 , Apr 25, 2018 |  BC Extra  |  Company News

FDA panel affirms safety of Pfizer's Celebrex

FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) had comparable cardiovascular safety to...
21:25 , Feb 14, 2018 |  BC Innovations  |  Translation in Brief

Poring over pain

Harvard Medical School researchers have figured out how to hijack the pores formed by bacterial toxins on nerves to deliver normally membrane-impermeable compounds into the cells and treat pain the pathogens cause. While the January study...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

ALZT-OP1: Phase III started

AZTherapies began the double-blind, placebo-controlled, international Phase III trial to compare ALZT-OP1 vs. each of its components -- inhaled cromolyn and oral ibuprofen -- in about 600 patients. The company has an SPA from FDA...
07:00 , Aug 11, 2014 |  BioCentury  |  Strategy

Profusion of exclusions

Express Scripts Holding Co.'s 2015 formulary exclusions offer hope that companies can renegotiate once-excluded drugs back into coverage. But the pharmacy benefits manager appears to be expanding the number of drugs and drug classes it...
07:00 , Aug 4, 2014 |  BC Week In Review  |  Clinical News

Duexis ibuprofen/famotidine regulatory update

Horizon said it will “immediately accelerate its patient- and physician-focused commercial model to focus prescriptions through other channels,” work with other PBMs and “evaluate price increases.” According to the Red Book, the average wholesale price...
07:00 , Aug 4, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell $4.44 (41%) to $6.39 on Monday after receiving a complete response letter from FDA for an NDA for Zalviso sufentanil sublingual tablet system to treat moderate-to-severe acute pain. AcelRx said...
00:26 , Jul 29, 2014 |  BC Extra  |  Company News

Horizon falls on Duexis, Vimovo coverage concerns

Horizon Pharma Inc. (NASDAQ:HZNP) dropped $4.69 (34%) to $9.20 on Monday after disclosing that pharmacy benefit managers CVS Caremark Corp. (NYSE:CVS) and Express Scripts Holding Co. (NASDAQ:ESRX) notified the company that arthritis drugs Duexis ibuprofen/famotidine...
07:00 , Jun 23, 2014 |  BC Week In Review  |  Clinical News

OXP001: Phase I data

A single-blind, U.K. Phase I trial in 43 healthy volunteers showed that OXP001 met the primary endpoint of reducing gastric irritation as measured by mean Lanza score vs. Brufen ibuprofen (reduction of 0.9 compared to...