Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA, and the SUNFISH study assesses Evrysdi in children & young adults aged 2-25yrs. with Type 2 or 3 SMA Evrysdi demonstrated improvement in motor function, 29.3% of participants […]Read More
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.), ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death), Grade 3+ AEs […]Read More
Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results: Improvement in DFS in all population, 83% reduction in the […]Read More
Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The use of the therapy across multiple indications is based on the efficacy and safety profile of Xolair in allergic asthma, CIU, and nasal polyps, supported with a clinical development program, […]Read More
Shots: The EC has approved MB02 biosimilar to Avastin (Bevacizumab) in the EU for the treatment of carcinoma of the colon or rectum, BC, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Mabxience’s MB02 to be marketed as Alymsys and Oyavas both show comparable quality, safety & efficacy […]Read More
Shots: The approval is based on the P-III study that involves assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients aged 6-<18 yrs. with mod. to sev. PsO Results: @ 12wks., patients achieving PASI 75 (89% vs 25%); patients achieving sPGA 0,1 […]Read More
Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who had received 1 to 3 prior lines of treatment The result demonstrated a reduction in the risk of disease progression or death by 45%. At pre-planned interim analysis, median PFS […]Read More
Shots: The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia The result showed a reduction of LDL cholesterol by 72% with 40mg/10mg dose and 64% with 10 mg/10mg dose. The level of LDL-reduction indicates from both the statin component i.e rosuvastatin […]Read More
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC The results demonstrated significant improvement across all efficacy EPs. The trial met its 1EPs i.e. showed doubled mPFS (16.6 vs 8.3mos.); ORR (55.7% vs. 27.1%); CR (8.0% vs 4.6%); OS (40% […]Read More
Shots: In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi’s Peter C. Adamson, and Regeneron’s Israel Lowy shared their views on the US FDA’s approval of Libtayo and the data supporting the approval. Regeneron and Sanofi received the US FDA’s approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have […]Read More
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