Tags : Studies

Merck Reports Results of Gefapixant (45mg) in Two P-III Studies

Shots: The two P-III studies (COUGH-1 & -2) involves assessing of gefapixant (45/15mg, bid) vs PBO in 2,044 patients with refractory or unexplained chronic cough for 12 & 24wks. respectively In both the studies, gefapixant (45 mg) resulted in reduction of objectively measured 24hrs.-cough frequency @12 & 24wks. (18.45% & 14.64%), reduction in cough frequency […]Read More

Roche Report Mixed Results of Etrolizumab in P-III Studies for

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance In […]Read More

Gilead Reports the Initiation of Two P-III Studies of Remdesivir

Shots: The studies will evaluate 5-day and a 10-day dosing regimen of remdesivir (IV). One study will assess remdesivir + SOC in ~400 patients in a ratio (1:1) with sev. clinical manifestations of COVID-19 while the second study will assess remdesivir vs SOC as monothx. in ~600 patients in a ratio (1:1:1) with mod. clinical […]Read More

Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation

Shots: The two P-III studies, PHOTON and PULSAR will assess aflibercept 8mg formulation for intravitreal injection in adults with visual impairment due to DME & wet AMD respectively for 12wks with their expected initiation in 2020 In 2006, the companies collaborated for aflibercept, under which Regeneron retains rights to Eylea (aflibercept, 2mg) in the US […]Read More

AstraZeneca Reports Results of Roxadustat in P-III OLYMPUS and ROCKIES

Shots: The P-III OLYMPUS study involve assessing of Roxadustat vs PBO in 2,781 patients with anaemia (Hb<10.0g/dL) in a ratio (1:1) in non-dialysis-dependent -CKD stages, resulted in improvement in Hb levels (1.75g/dL vs 0.40g/dL) and improvement in Hb levels in patients with elevated hsCRP levels > 5mg/L (1.73 g/dL vs 0.62g/dL) The P-III ROCKIES study […]Read More

BMS Reports Pooled Five Year Results of Opdivo (nivolumab) in

Shots: The pooled analysis of the two P-III CheckMate -017 and -057 studies involves assessing of Opdivo (3 mg/kg, q2w) vs Docetaxel (75 mg/m2, q3w) in 854 patients in a ratio (1:1) with previously treated NSCLC across both squamous and non-squamous histologies The P-III studies result: @5yrs. OS (13.4% vs 2.6%); patients continued to see […]Read More

Novartis Reports Results of Entresto (sacubitril/valsartan) in Three P-III PARAGON-HF

Shots: The P-III PARAGON-HF study involves assessing of Entresto vs valsartan in 4,822 HF patients with preserved ejection fraction, resulted in 13% reduction in HF hospitalization and CV death, 15% reduction in total HF hospitalization but narrowly missed the statistical significance, patients with left ventricular ejection fraction ≤57% median showed greater effect The P-IV PROVE-HF […]Read More

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS I

Shots: The P-III ASCLEPIOS I and II (NCT02792218 and NCT02792231) studies involve assessing of Ofatumumab (20mg, SC, monthly) vs Aubagio (teriflunomide, 14mg, qd) in 1,882 patients with MS aged 18-55yrs. across 37 countries The P-III ASCLEPIOS I and II studies resulted in meetings their 1EPs & 2EPs i.e, @30mos. reduction in annualized relapse rate evaluated […]Read More