This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below:
 Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant RecipientsÂ
Read More: Memo therapeutics
Eli Lilly Reports Topline P-III (BRUIN…
Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases
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The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
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The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regionsÂ
Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below:Â
AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC
Read More: AstraZeneca
Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…
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The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)
Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss
Additionally, Fresenius & Amgen…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below:
Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)
Read More: Takeda
AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…
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Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US
Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
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FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)
BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
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The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog
Kirsty is a rapid-acting human…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below: 
PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy 
Read More: PulseSight Therapeutics
BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…

