Shots: The approval is based on three P-III studies results assessing Epidiolex (cannabidiol, PO) vs PBO in 516 patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged ≥ 2yrs. The study […]readmore
Regulatory
Uncategorized
Medicines Development for Global Health’s (MDGH) Moxidectin Receives FDA Approval
Shots: The approval is based on two clinical studies results assessing Moxidectin vs SoC Ivermectin in patients with river blindness aged ≥ 12 yrs. The study resulted in meeting 1EPswith […]readmore
Regulatory
Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active
Shots: The approval is based on P-III RA-BEACON study results assessing Olumiant vs PBO in 527 patients with inadequate response or intolerance to one or more TNF inhibitor therapies P-III […]readmore
Biosimilars
Regulatory
Sandoz’s Zessly (infliximab) Receives EU Approval for Gastroenterological, Rheumatological And
Shots: The approval is based on non-inferiority and P-III REFLECTIONS B537-02 study results assessing Zessly vs reference drug and demonstrated meeting 1EPs with safety, efficacy and quality Zessly is 3rd […]readmore
Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase-pqpz, 20mg qd or 40mg qd) in patients in ratio (2:1) with high level of phenylalanine (Phe) The […]readmore
Shots: The approval is based on five studies assessing Lokelma vs PBO in patients with hyperkalaemia The study resulted in onset of action was at 1.0 hour and the median […]readmore
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
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
Shots: Novartis to receive $13B (£9.2B) as total deal value from GSK. GSK to acquire 36.5% stake (63.5% already acquired in 2014) in Consumer Healthcare Joint Venture, formed in 2014 […]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