BioCentury | Dec 8, 2018
Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
BioCentury | Aug 11, 2018
Product Development

Exacerbation management

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...
BC Week In Review | Jun 29, 2018
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...
BC Week In Review | Apr 27, 2018
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...
BC Extra | Apr 25, 2018
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...
BC Innovations | Feb 14, 2018
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...
BC Week In Review | Sep 28, 2015
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...
BioCentury | Aug 11, 2014
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...
BC Week In Review | Aug 4, 2014
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...
BioCentury | Aug 4, 2014
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...
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