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Tris Pharma
Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) 
Shots:  The US FDA has granted approval to the company’s QD extended-release oral suspension of Onyda XR (clonidine hydrochloride) with nighttime dosing alone or as adj. to approved central nervous system (CNS) stimulant therapies for ADHD treatment in children (≥6yrs.). Its availability is anticipated in H2’24  The approval was supported by the data from studies…
May 29, 2024
Bio-Thera Collaborates with STADA for the Commercialization of BAT2506 (Biosimilar, Simponi) 
Shots:  Bio-Thera and STADA have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab)  Under the collaboration, Bio-Thera is entitled to receive a $10M upfront and an additional $147.5M development and commercial milestones upon certain conditions fulfilment  Furthermore, Bio-Thera will handle the development, manufacturing and supply activities of…
May 28, 2024
Celltrion
Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications 
Shots:  EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024  Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair…
May 23, 2024
Celltrion
The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)
Shots:  Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)  The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…
May 23, 2024
Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology 
  Shots:  The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)  The approval was supported by analytical, nonclinical & clinical data…
May 21, 2024
Amgen (2)
Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer 
Shots:  The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials  The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on…
May 16, 2024
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