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Stimuvax Ekes Out OS Benefit in NSCLC Subgroup
Having previously missed its primary endpoint of overall survival (OS) in non-small-cell lung cancer, the company said that median OS was 25.6 months compared to 22.3 months for the placebo group, with a "p" value of 0.123...Injection site reactions occurred in 17.3 percent of patients in the L-BLP25 group, compared to 11.9 percent of patients in the placebo groupBy Catherine Shaffer | BioWorld Today | Friday, May 17, 2013 -
Clinic Roundup
Compared to a placebo group, animals treated with WF10 showed a reduction of the degree of symptomsBioWorld Today | Friday, May 17, 2013 -
Other News To Note
Compared to the placebo group, animals treated with WF10 showed a reduction of the degree of symptomsBioWorld Today | Friday, May 17, 2013 -
Other News To Note
In the GFT505-209-4 study, the effect of GFT505 on measured remnant cholesterol was -24 percent (p = 0.0046) compared to the placebo group after 28 days of treatment...Consistently, after three months of treatment in diabetic patients (GFT505-210-5), the effect of GFT505 on calculated remnant cholesterol compared to the placebo group was -46 percent (p = 0.01BioWorld Today | Thursday, May 16, 2013 -
Clinic Roundup
Based on an intent-to-treat analysis from the 130-patient randomized trial, patients treated with entinostat saw improved median PFS to 4.3 months vs. 2.3 months in the placebo groupBioWorld Today | Wednesday, May 15, 2013 -
Opsona's TLR Biology Will Get a $43M Shot in the Arm
The Phase IIa portion of the trial, which is getting under way shortly, will recruit 144 patients, who will be randomized to one of three dose groups (n = 36) – to receive 0.5 mg/kg of bodyweight, 1.5 mg/kg or 5 mg/kg – or to a placebo group (n = 36By Cormac Sheridan | BioWorld International | Wednesday, May 1, 2013 -
Opsona's TLR Biology Will Get a $43M Shot in the Arm
The Phase IIa portion of the trial, which is getting under way shortly, will recruit 144 patients, who will be randomized to one of three dose groups (n = 36) – to received 0.5 mg/kg of bodyweight, 1.5 mg/kg or 5 mg/kg – or to a placebo group (n = 36By Cormac Sheridan | BioWorld Today | Tuesday, April 30, 2013 -
Photocure Preps for Phase III with HPV PTD Therapy Cervira
The two HPV subtypes were eradicated in 83 percent of the treated CIN2 cohort vs. 33 percent clearance in the placebo group, at six monthsBy Nuala Moran | BioWorld International | Wednesday, April 17, 2013 -
Syk 'Em? Rigel Says RA Data Not Far from Pfizer's Phase III
in RA now, because the placebo groups don't seem to progress very much – that is, they don't get much worse in the term of the study," and ethical concerns prevent continuing beyond six monthsBy Randy Osborne | BioWorld Today | Monday, April 8, 2013 -
Santhera Withdraws Raxone MAA, Plans Resubmission
Santhera's original dossier was based on data from a placebo-controlled Phase II trial, but the CHMP considered the vision gains associated with taking the drug to be insignificant – those in the drug treatment group were able to see an additional three letters on a letter chart compared with those in the placebo groupBy Cormac Sheridan | BioWorld International | Wednesday, March 27, 2013 -
Santhera Withdraws Raxone MAA, Plans Resubmission
Santhera's original dossier was based on data from a placebo-controlled Phase II trial, but the CHMP considered the vision gains associated with taking the drug to be insignificant – those in the drug treatment group were able to see an additional three letters on a letter chart compared with those in the placebo groupBy Cormac Sheridan | BioWorld Today | Monday, March 25, 2013 -
Committee to Scrutinize Titan's Implantable Buprenorphine
And although the placebo group fared worse, the agency speculated that the dose of buprenorphine delivered by the four implants was simply too low, it being less than a third the dose delivered by 16-mg sublingual buprenorphineBy Catherine Shaffer | BioWorld Today | Wednesday, March 20, 2013 -
Clinic Roundup
For the Uceris 9-mg group, 17.4 percent of patients achieved clinical and endoscopic remission, compared to 4.5 percent of the placebo group (p = 0.0047BioWorld Today | Tuesday, March 19, 2013 -
Clinic Roundup
The drug was also well tolerated, with similar rates of occurrence of serious adverse events among drug and placebo groupsBioWorld Today | Friday, March 15, 2013 -
Phase III Clinical Trials Update: February 2013
primary responder analysis showed 41% in the migalastat group vs. 28% in the placebo group demonstrated a 50% or greater reduction in kidney interstitial capillary GL-3 from baseline to month six 2/19/13 Auxilium Pharmaceuticals Inc. (Chesterbrook, Pa.) Xiaflex Collagenase clostridium histolyticum Peyronie's disease Pivotal Phase III data showed that both Xiaflex co-primary endpoints met statistical significance at 52 weeks compared to placebo, and Xiaflex was generally well tolerated 2/5/13BioWorld Insight | Monday, March 11, 2013 -
Companies Look to Capture Part of Growing Respiratory Market
Mean FEV1 value for the active treatment group increased 120ml from baseline to day 42 and decreased 40ml for the placebo groupBy Peter Winter | BioWorld Insight | Monday, March 11, 2013 -
Apremilast Nails Primary Endpoint in Psoriasis Phase III
The results showed that 33.1 percent of patients in the apremilast group met that benchmark, compared to 5.3 percent in the placebo group (p < 0.0001By Catherine Shaffer | BioWorld Today | Tuesday, March 5, 2013 -
Clinic Roundup
People in that dose group experienced influenza-like symptoms for a median of 1.9 days, compared to 3.7 days in the placebo group...Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo groupBioWorld Today | Tuesday, March 5, 2013 -
FDA Briefing Docs: Calcitonin Cancer Risk 'Appears Plausible'
All of the 13 studies had malignancy in the calcitonin-treated group, while seven of the placebo groups were free of malignancyBy Jennifer Boggs | BioWorld Today | Monday, March 4, 2013 -
Clinic Roundup
Vertex plans to conduct two 24-week studies – TRAFFIC and TRANSPORT – in CF patients, ages 12 and older, with each study including two treatment groups and a placebo groupBioWorld Today | Thursday, February 28, 2013
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