Tag:
data monitoring committee
Latest Headlines
Latest Headlines
Hemispherx forms data-monitoring team
A three-member independent data-monitoring committee will now oversee drug development, provide interim analyses of outcomes data, and ensure subject safety for Hemispherx Biopharma. The committee
HGS stock dives on drug safety concerns
Human Genome Sciences watched its stock take a dive this morning after an independent data monitoring committee noted lung-related side effects in patients receiving 1200-microgram injections of the
SPOTLIGHT: Committee backs Via trials
Shares of Via Pharmaceuticals jumped this morning after a monitoring committee endorsed safety and efficacy data for two mid-stage trials of VIA-2291, its lead therapy for cardiovascular disease.
Enrollment halted as researchers study safety signal
Potential safety issues have prompted Forest Laboratories and its development partner, Germany's Paion, to halt enrolling patients in a late-stage trial of a compound that mimics a protein found in bat saliva. The independent monitoring committee says they want time to analyze more of the data from the drug, desmoteplase, to evaluate a "safety signal." No other details were provided. Desmoteplase is a clot-dissolving protein intended as a treatment for stroke.
- see the release on the trial
Icagen trial gets a green light from committee
Icagen got some good news from an independent data monitoring committee, which has endorsed the advancement of a Phase III trial of its ICA-17043 compound in conjunction with hydroxyurea therapy for sickle cell disease. The same committee recommended last month that the trial of ICA-17043 alone should not continue, sending its shares into a free fall.
- read the Local Tech Wire report on Icagen
ALSO NOTED: Sirion completes Sytera merger; BioMS to pursue pivotal trial; and much more...
> Sirion Therapeutics has completed a merger with Sytera, a La Jolla, CA-based biopharmaceutical firm working on new treatments for dry AMD. Release
> BioMS has won the approval of its data monitoring committee to continue its pivotal study of MBP8298 for the treatment of secondary progressive multiple sclerosis. …
Side effects prompt Inspire to shutter trial
Inspire Pharmaceuticals announced that it shuttered a mid-stage drug trial on the recommendation of its data monitoring committee after seeing data on a "range of bleeding complications among volunteers. There were no deaths reported among the 160 participants in the trial, who were taking the experimental INS50589 Antiplatelet after undergoing coronary artery bypass graft surgery utilizing a cardiopulmonary bypass pump. The company said it would undertake a thorough review of what …
ALSO NOTED: Generic Plavix to arrive soon;Alzheimer's drug effective against poisoning; and much more...
> Bristol-Myers Squibb says that it expects Apotex to quickly begin delivering a generic version of its blockbuster anti-blood clotting drug Plavix. Apotex had agreed to delay rolling out a generic Plavix until 2011, but a group of state attorneys general rejected that agreement and a federal judge has refused BMS' request for a temporary restraining order. Plavix provides about a third of BMS' revenue. Its stock plunged 7.5 percent on Friday after Medco projected the likely arrival of …
Shares plunge as Icagen cuts patients from trial
Shares of Durham, NC-based Icagen went into a tailspin this morning after the company announced that it was cutting half of the patients in a pivotal study of its flagship drug on the recommendation of an independent monitoring committee. Icagen stock dropped 77 percent on the news, which indicated that the drug may be effective for a much smaller group of patients than originally believed. No specific reason for the recommendation of the monitoring committee was given, but Icagen noted …
Genitope shares slip after committee review
Shares of Genitope took a nasty hit this morning after the company reported that an independent monitoring committee recommended that it continue a trial for MyVax as planned. The trial should be wrapped by the end of 2007.
- take a look at the report on Genitope from StreetInsider.com
