00:04 , Dec 15, 2018 |  BC Extra  |  Politics & Policy

Firdapse re-catalyzes pricing debate

A decision by Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) to charge $375,000 a year for Firdapse amifampridine phosphate, a drug that was previously available for free, has re-catalyzed debate about the U.S. government’s drug exclusivity policies. The...
22:14 , Jan 12, 2017 |  BC Week In Review  |  Clinical News

Kineret: Ph II anaGO started

Swedish Orphan Biovitrum began the double-blind, placebo-controlled, North American Phase II anaGO trial to compare 100 and 200 mg subcutaneous Kineret once daily for 5 days plus intramuscular triamcinolone acetonide (TCA) vs. TCA alone in...
07:00 , Sep 12, 2016 |  BioCentury  |  Politics, Policy & Law

Executive power

Years of congressional gridlock have caused power in Washington to shift to the White House, making the levers of power less accessible to pharmaceutical industry lobbyists. While Congress will continue to mine outrage over drug...
08:00 , Jan 18, 2016 |  BioCentury  |  Politics, Policy & Law

Compounding prices

Joshua Sharfstein, associate dean at the Johns Hopkins Bloomberg School of Public Health, wants to deploy the FDA to battle companies like Turing Pharmaceuticals AG that have enraged the public by obtaining sole U.S. distribution...
07:00 , Oct 5, 2015 |  BC Week In Review  |  Clinical News

Bucillamine: Interim Phase IIa data

Interim data from 29 patients with acute gout flares in an open-label, U.S. Phase IIa trial showed that once-daily 900 and 1,800 mg oral REV-002 for 7 days led to a >=50% reduction in target...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Clinical News

Arhalofenate: Phase IIb data

Top-line data from a double-blind, international Phase IIb trial in 239 patients with gout, hyperuricemia and a history of >=3 flares in the last 12 months showed that 800 mg once-daily oral arhalofenate met the...
08:00 , Feb 2, 2015 |  BC Week In Review  |  Clinical News

Arhalofenate: Preliminary Phase II data

Preliminary data from an open-label, U.S. Phase II trial in 32 patients with gout showed that 7%, 43% (p<0.05) and 79% of patients receiving once-daily 600 mg oral arhalofenate plus 40 mg febuxostat and 20%,...
08:00 , Jan 15, 2015 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: Tubulin

Cancer INDICATION: Cancer Cell culture and mouse studies have identified furanoallocolchicinoid-based tubulin inhibitors that could help treat cancer. Chemical synthesis and testing in a tubulin polymerization assay of colchicine analogs identified several furanoallocolchicinoids as tubulin...
08:00 , Dec 8, 2014 |  BC Week In Review  |  Clinical News

Bucillamine: Phase IIa start

At year end, Revive Therapeutics will begin an open-label, U.S. Phase IIa trial to evaluate a high- and moderate-dose of once-daily oral REV-002 in combination with low-dose colchicine for 7 days in about 66 patients....
07:00 , Oct 13, 2014 |  BioCentury  |  Strategy

Streamlining Takeda's Profit Story

After spending a decade growing the company via acquisition, Takeda Pharmaceutical Co. Ltd. is now focused on getting its costs in line with its global pharma peers. But to grow EPS in line with Street...