21:20 , Jun 7, 2018 |  BC Extra  |  Politics & Policy

NIH prompts formal review of medication-assisted treatment for opioid addiction

In response to a congressional request, NIH has asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to review evidence on medication-assisted treatments (MATs) for opioid use disorder to identify knowledge gaps where additional...
17:10 , Apr 6, 2018 |  BC Week In Review  |  Company News

ICER to evaluate buprenorphines for opioid disorder

The Institute for Clinical and Economic Review said it will develop a report that will compare the clinical effectiveness of three buprenorphine products to commonly used drugs for medication-assisted treatment of opioid use disorder. In its...
23:17 , Apr 5, 2018 |  BC Extra  |  Politics & Policy

ICER to evaluate buprenorphines for opioid disorder

The Institute for Clinical and Economic Review said it will develop a report that will compare the clinical effectiveness of three buprenorphine products to commonly used drugs for medication-assisted treatment of opioid use disorder. In its...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

Hologic, Ostex deal

The companies will combine and co-promote their bone assessment products and develop a point-of-care NTx test for bone resorption using OSTX's Osteomark assay. The companies will market HOLX's QDR-4500C bone densitometer with a...
08:00 , Jan 21, 2013 |  BC Week In Review  |  Clinical News

AZD0424: Phase I started

Cancer Research U.K. (London, U.K) began an open-label, U.K. Phase I trial of once-daily oral AZD0424 from AstraZeneca for 28 days in about 96 patients. The dose-escalation Phase Ia portion will evaluate AZD0424 alone and...
07:00 , Jun 20, 2011 |  BC Week In Review  |  Clinical News

Alpharadin radium-223: Phase IIa data

Top-line data from the single-arm, open-label, European Phase IIa BC1-09 trial in 23 patients showed that 50 kBq/kg IV Alpharadin given once every 4 weeks for 16 weeks reduced levels of 2 biomarkers of bone...
07:00 , Jun 21, 2010 |  BC Week In Review  |  Clinical News

Vivitrol naltrexone regulatory update

Alkermes said FDA tentatively scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee on Sept. 16 to discuss an sNDA for Vivitrol naltrexone to treat opioid dependence. The PDUFA date for the application, which is...
07:00 , May 31, 2010 |  BC Week In Review  |  Clinical News

Naltrexone: Phase III data

In the double-blind, Russian Phase III ALK21-013 trial in 250 patients, 90% of patients treated with 380 mg monthly intramuscular Vivitrol with counseling for 6 months had opioid-free urine screens, the primary endpoint, vs. 35%...
07:00 , May 31, 2010 |  BC Week In Review  |  Clinical News

Vivitrol naltrexone regulatory update

FDA accepted for filing and granted Priority Review to an sNDA from Alkermes for Vivitrol naltrexone to treat opioid dependence. The PDUFA date is Oct. 12. The injectable sustained-release formulation of naltrexone in polylactide co-glycolide...
07:00 , Jul 13, 2009 |  BC Week In Review  |  Clinical News

ARRY-797: Phase Ib data

Top-line data from a double-blind, placebo-controlled, dose-escalation, U.S. Phase Ib trial in 28 stable RA patients receiving methotrexate showed that 200 mg of ARRY-797 inhibited C-reactive protein (CRP) levels during the first 3 weeks...