Shots: Biomarin has received approval for its Vimizim, as a first approval by NMPA for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome In May […]readmore
Tags : CFDA
Shots: The approval is based on P-III CAIN457A2318 study results assessing Cosentyx (300/150 mg, q4w) vs PBO in 543 patients with moderate-to-severe plaque PsO. Additionally, P-III study in China assessed […]readmore
Shots: The approval is based on P-III KEYNOTE-189 trial assessing Keytruda + pemetrexed & Pt CT in patients with 1L metastatic non-sq NSCLC, with no EGFR or ALK genomic tumor […]readmore
Shots: The approval is based on P-II NURTURE study results assessing Spinraza in 300 infant patients who were genetically diagnosed with SMA and had not experienced any symptoms by the […]readmore
Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study results: PANSS @6weeks (-19.3 vs -12.7); AEs […]readmore
Shots: The priority review is granted to Zai Lab’s Zejula as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete […]readmore
Biosimilars
Biotech
Innovent Biologics Reports Acceptance of BLA for IBI-305 (bevacizumab, biosimilar)
Shots: The BLA is based on two P-III study results assessing efficacy, safety and PK of IBI-305 vs bevacizumab in patients with advanced non-sq NSCLC and has demonstrated in meeting […]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 ORIENT-1 study results assessing Tyvyt in patients with 2L+ Hodgkin’s lymphoma The ORIENT-1 study resulted in effective complete response rates for CT + radiotherapy in patients […]readmore
Shots: The approval is based on three P-III study (104,111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg, E/C/F/TAF) vs Stribild (E/C/F/TDF,150 mg/ […]readmore