Tags : Celltrion

Weekly Snapshot

PharmaShots Weekly Snapshots (Apr 26 – 30, 2021)

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma Published: Apr 30, 2021 | Tags: BMS, US, FDA, Opdivo, sBLA, Priority Review, nivolumab, Muscle Invasive Urothelial Carcinoma Janssen Reports MAA Submission to EMA for Cilta-cel to Treat Relapsed/ Refractory Multiple Myeloma Published: Apr 30, 2021 | […]Read More

Insights+

Insights+ Key Biosimilars Events of February 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Feb, Biocon collaborated with CHAI to expand access […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, […]Read More

Biosimilars

Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the

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

Weekly Snapshot

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene […]Read More

Biosimilars

Celltrion Initiates P-III Study of CT-P42 (biosimilar, aflibercept)

Shots: Celltrion has launched a global P-III clinical trial of CT-P42 which is an investigational biosimilar candidate referencing Regeneron’s Eylea (aflibercept) The study will enroll 300 patients with DME and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including CT-P17 (referencing Humira), […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission […]Read More

Insights+

Insights+ Key Biosimilars Events of December 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More