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 EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion The designation provides potential benefits to the company, which include clinical protocol assistance, reduced regulatory fees, research grants, and up to 10 years of market exclusivity following regulatory approval The company […]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 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: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in 1,882 adults aged 18-55yrs. with a confirmed diagnosis of RMS The study demonstrated a reduction of annual relapses by over 50% and achieved >30% relative risk reduction of 3mos. confirmed […]Read More
Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat multiple chronic inflammatory diseases The approval is based on analytical, pre/ clinical studies, demonstrating that Yuflyma is comparable to the reference product, in terms of safety, efficacy, PK/PD, and immunogenicity […]Read More
Shots: The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved as a 100 units/ml solution for injection in vial & pre-filled pen presentations The EC’s CMA is valid in all EU Member States as well as in the EEA countries […]Read More
Shots: The EC granted ODD for VO659 for the treatment of spinocerebellar ataxia (SCA). The ODD was based on a EMA’s COMP positive opinion The company previously received ODD in Huntington Disease The company focused on the development of RNA modulating therapies for rare neurological disorders VO659 is an antisense oligonucleotide product, designed to suppress […]Read More
Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly The P-II JAKARTA 2 study involves assessing of Inrebic (400mg, qd) in 97 patients with intermediate or high-risk primary or secondary […]Read More
Shots: The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in patients with PsA and AS. The studies demonstrated that it met all 1EPs & 2EPs with a safety profile consistent with that seen in RA The P-III studies met its […]Read More
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