PharmaShots Weekly Snapshots (Jun 23, 2025 – Jun 27, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and Animal Health. Check out our full report below:   Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention Read More: Teva Merck Reports the Data from P-III (HYPERION)…

ByDipanshu DixitJune 27, 2025

News

Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

Shots:Health Canada has granted NOC for Yesafili (vial & PFS presentations, 2 mg/0.05 mL), a biosimilar to Eylea (aflibercept), anticipated launch on Jul 04, 2025Approval was supported by the P-III (INSIGHT) study in Diabetic Macular Edema(DME), which showed no clinically meaningful differences from EYLEA in PK, safety, efficacy, or immunogenicity.YESAFILI is a…

ByDipanshu DixitJune 27, 2025

News

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots:Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

News

Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

Shots:Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin AmericaAs per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin AmericaDupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…

ByDipanshu DixitJune 26, 2025

News

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Shots:The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA statesAVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…

ByDipanshu DixitJune 24, 2025

News

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Shots: The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards The EC’s approval was supported by the clinical evaluations…

ByDipanshu DixitJune 23, 2025

News

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots:The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference productOpinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…

ByRidhi RastogiJune 23, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:   Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma Read More: J&J Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…

ByRidhi RastogiJune 20, 2025

News

The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

Shots:The US FDA has approved Steqeyma (45mg/0.5mL, SC, single-dose vial), a biosimilar version of Stelara (ustekinumab) for the treatment of pts (6-17yrs.; ≤60kg) with plaque PsO or PsAApproval was supported by extensive clinical data, incl. P-III trial of Steqeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change…

ByRidhi RastogiJune 16, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:  Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN Read More: Apellis Pharmaceuticals and Sobi Daiichi Sankyo Reports First Patient…

ByRidhi RastogiJune 13, 2025

PharmaShots Weekly Snapshots (Jun 23, 2025 – Jun 27, 2025)

Biocon Biologics Reports the Health Canada’s NOC for Yesafili (Biosimilar, Eylea)

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Bio-Thera Solutions and SteinCares Broaden Collaboration to Commercialize (Biosimilar, Dupilumab) in Latin America

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)

The US FDA Approves Additional Presentation of Celltrion’s Steqeyma (Biosimilar, Stelara)

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)

Contact US

OUR INFORMATION

FOLLOW US