Tags : Marketing

NightWare Receives the US FDA’s Approval for the First Medical

Shots: The US FDA has permitted marketing of a device intended for the temporary reduction of sleep disturbance related to nightmares in patients aged ≥22 yrs. suffering from nightmare disorder or PTSD Nightware utilizes Apple Watch and an iPhone that is configured and logged into a software application and the Nightware server and monitors the […]Read More

Sun Pharma Reports Submission of Manufacturing and Marketing Authorization Application

Shots: Sun Pharma has filed manufacturing and marketing authorization of Tildrakizumab to the PMDA for moderate-to-severe psoriasis and psoriatic arthritis in Japan Additionally, Sun Pharma has acquired Pola Pharma and will leverage Pola’s strong presence in the dermatology to commercialize Tildrakizumab in Japan which will expand Sun Pharma’s global franchise and robust its dermatology pipeline […]Read More

Sanofi Reports Results of Cablivi (caplacizumab) in P-III HERCULES Study

Shots: The P-III HERCULES study involves assessing Cablivi vs PBO in 145 patients with acquired thrombotic thrombocytopenic purpura (aTTP) in plasma exchange & immunosuppression P-III HERCULES study results: achievement in normal platelet count (1.55 times); reduction in death/recurrence of aTTP (74%); reduction in aTTP recurrence (67%); refractory disease developed (0 vs 3); normalization in three […]Read More

Sanofi’s Cablivi Receives EU Marketing Approval for the Treatment of

Shots: The approval is based on P-II TITAN and P-III HERCULES studies enrolling 220 adults assessing Cablivi (caplacizumab) vs PBO, testing its safety and efficacy P-III HERCULES results:  significantly shorter time to platelet count response, reduction in aTTP-related death, lower number of aTTPrecurrence, meaningful reduction in use of plasma exchange (PEX) compared to PBO Cablivi […]Read More