BioCentury | May 15, 2019
Company News

NICE's managed access deal for Spinraza could signal more flexibility on orphan drugs

Spinal muscular atrophy patients in England and Wales can now begin to access Spinraza nusinersen after NICE reached a deal with Biogen to provide the drug through a managed access program. NHS England will begin...
BioCentury | Sep 14, 2018
Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies. These tools allow...
BioCentury | Jan 26, 2018
Company News

Biogen to submit Spinraza to NICE for STA

Biogen Inc. (NASDAQ:BIIB) said it plans to submit Spinraza nusinersen for a single technology appraisal (STA) by the U.K.'s NICE in March to treat spinal muscular atrophy (SMA) after receiving a formal request by the...
BioCentury | Jul 21, 2017
Company News

G-BA, NICE recommend Teva's Cinqaero in severe eosinophilic asthma

U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Cinqaero reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) to treat severe eosinophilic asthma. Teva said the decision was based on a...
BioCentury | May 19, 2016
Politics & Policy

NICE proposes abbreviated appraisal pathway

The board of the U.K.'s NICE approved for consultation a proposal to establish the Abbreviated Technology Appraisal (ATA) pathway, which would shorten the appraisal process and eliminate the need for cost-per-quality-adjusted life year (QALY) analysis...
BioCentury | Apr 15, 2016
Company News

CV/NASH play Madrigal finds public path via Synta merger

Synta Pharmaceuticals Corp. (NASDAQ:SNTA) and Madrigal Pharmaceuticals Inc. (Fort Washington, Pa.) will reverse-merge to create a company focused on non-alcoholic steatohepatitis (NASH), cardiovascular and metabolic diseases. The combined, publicly traded company will retain Madrigal's name....
BioCentury | Jan 4, 2016
Finance

Big band swing

Many investors treated biotech's dismal 3Q15 as a buying opportunity, and the effects were apparent in 4Q15. All of the market cap bands showed positive gains save for the microcaps. Big biotechs led the charge...
BioCentury | Oct 26, 2015
Clinical News

Ganetespib: Phase III discontinued

Synta discontinued the open-label, international Phase III GALAXY-2 trial in about 850 patients with stage IIIB/IV NSCLC who received 1 prior chemotherapy-based regimen after a pre-planned interim analysis by an independent DMC showed that second-line...
BioCentury | Oct 22, 2015
Clinical News

Synta halting ganetespib study after futility analysis

Synta Pharmaceuticals Corp. (NASDAQ:SNTA) sank $1.30 (64%) to $0.74 after it said it will terminate the Phase III GALAXY-2 trial of ganetespib ( STA-9090 ) to treat advanced non-small cell lung cancer (NSCLC). Synta said that after...
BioCentury | Sep 17, 2015
Distillery Therapeutics

Therapeutics: v-abl Abelson murine leukemia viral oncogene homolog 1 (ABL1); heat shock protein 90 (Hsp90)

Cancer INDICATION: Cancer In vitro studies suggest inhibiting ABL1 could help sensitize tumors to Hsp90 inhibitors. In a human prostate cancer cell line, a tool compound inhibitor of ABL1 plus the Hsp90 inhibitor ganetespib increased...
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