Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
The FDA has declined to approve two more cancer therapies developed by drugmakers based in China, in what may be further evidence of a tough […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, […]
Shots: The designation is based on the results of the P-III JUPITER-06 clinical trial that evaluates toripalimab + CT vs CT alone in patients with […]
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 […]
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
Shots: The US FDA has accepted the BLA for toripalimab + CT (gemcitabine & cisplatin) & toripalimab as monothx. to treat advanced recurrent or metastatic […]
Shots: The COLUMBUS-AMD trial evaluates the clinical efficacy, safety & immunogenicity of CHS-201 (q4w for up to 48wks.) vs Lucentis in a ratio (1:1) in […]
Shots: The P-III JUPITER-06 trial evaluates toripalimab + CT vs PBO + CT in a ratio (1:1) in 514 treatment-naive patients with advanced or metastatic […]
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver […]
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, […]
Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The […]
Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, […]
Shots: The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented […]
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 […]
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch […]
Copyright © 2024 | WordPress Theme by MH Themes