Shots: The approval is based on P-IIIb LIBERTY (NCT03096834) study results assessing Aimovig (140mg) vs PBO for duration of 12 weeks The study resulted in 50% reduction of monthly migraine […]readmore
Tags : FDA
Biosimilars
Biotech
Pfizer’s Retacrit (epoetin alfa-epbx, biosimilar) Receives FDA Approval for Anemia
Shots: The approval is based on non-inferiority data demonstrating biosimilarity between Retacrit and the reference product, Epogen & Procrit In May, 2016 Pfizer and Vifor Pharma collaborated for the commercialization […]readmore
Regulatory
Helsinn’s (fosnetupitant + palonosetron) Receives FDA Approval for Managing Chemotherapy-Induced
Shots: The approval is based on two clinical studies results assessing Akynzeo (NEPA) vs Palonosetron in patients with CINV across 80 centers in 11 countries The two clinical studies Trial […]readmore
Regulatory
Proteostasis’ PTI-428 Receives FDA’s Breakthrough Therapy Designation for Cystic Fibrosis
Shots: The FDA’s BT designation is based on P-II study results assessing PTI-428 (50 mg, qd) vs PBO in 24 CF with F508del mutation on background treatment with Orkambi for […]readmore
Regulatory
Uncategorized
Rigel Pharmaceuticals’ Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for
Shots: The approval is based on three FIT studies results assessing Tavalisse (100/150mg, bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1 The FIT studies result: FIT-1 […]readmore
Shots: • The rejection of Ozanimod was based on unmet preclinical and clinical trials results, in patients with relapsing multiple sclerosis • Additionally, Celgene plans to resubmit […]readmore
Regulatory
Janssen’s Erleada (apalutamide) Receives FDA Approval for Non-Metastatic Castration-Resistant Prostate
Shots: The approval is based on P-III SPARTAN study results assessing Erleada (240 mg,qd) vs PBO in 1,207 patients with NM-CRPC in ratio (2:1) in patients with (NM-CRPC) P-III SPARTAN […]readmore
Shots: The FDA’s BT Designation is based on P-II study assessing SAGE-217 vs PBO in 89 patients with moderate to severe major depressive disorder (MDD) The P-II study results: met […]readmore
Shots: The US FDA grants BT designation to Promacta (eltrombopag) + standard immunosuppressive therapy (SIT) for patients with 1L severe aplastic anemia (SAA) The BT designation is based on research […]readmore
Shots: The FDA’s BT designation is based on P-III MONALEESA-7 study assessing Kisqali + tamoxifen/ aromatase inhibitor + goserelin vs tamoxifen/aromatase inhibitor + goserelin in 672 pre/perimenopausal women with HR+/HER2- […]readmore