193 documents

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00:00 , Aug 11, 2018 |  BioCentury  |  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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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