Shots: The companies shared the additional efficacy and safety data of the ACTT-2 study demonstrating baricitinib + remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 […]readmore
Shots: Regeneron reports first data of seamless P-I/II/III study assessing REGN-COV2 that demonstrated a reduction in viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. It […]readmore
Shots: The approval is based on SUSTAIN 6 CVOT study assessing Ozempic (0.5mg /1mg, inj.) vs PBO + SOC in 3297 patients with T2D with established CVDs The SUSTAIN 6 […]readmore
Shots: The Farxiga’s sNDA is based on P-III DAPA-HF trial involves assessing of Farxiga + SoC (10mg, qd) vs PBO in patients with heart failure and reduced ejection fraction (LVEF […]readmore
Shots: The positive opinion recommendation follows the study assessing arginine and lysine of same content as LysaKare, evaluating its safety and efficacy The EC will review CHMP’s opinion with its […]readmore
Shots: The expanded indication approval is based on the results of P-III FOURIER study assessing Repatha (140mg q2w, 420 mg/month) vs PBO + statin therapy in patients with cardiovascular events […]readmore
Shots: The approval is based on non-inferiority data with the reference biologic (Neulasta) showing biosimilarity in terms of safety, efficacy and quality Ziextenzo is a long-lasting form of filgrastim indicated […]readmore
Shots: The P-II study involves assessing of four doses of GIP/GLP-1 RA, LY3298176 (1 mg, 5 mg, 10 mg, 15 mg) vs PBO and dulaglutide 1.5 mg in 200 patients […]readmore
Shots: Results of P-III ODYSSEY OUTCOMES assessing PRALUENT(alirocumab) IV (N= 18,924), having an acute coronary syndrome (ACS), such as a heart attack, b/w 1-12 mos before being enrolled The US […]readmore
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