Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots: 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…

ByRidhi RastogiJuly 18, 2025

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The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…

ByRidhi RastogiJuly 18, 2025

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Saluda Medical Reports Full Launch of EVA Sensing Technology for Spinal Cord Stimulation in the US

Shots: Saluda Medical has reported full commercial launch of EVA in the US following its approval in Dec 2024 Saluda Medical will present new clinical data on EVA and the Evoke SmartLoop System at ASPN 2025, featuring 11 abstracts, one oral presentation, & over 37 total publications, incl. 36-month efficacy results from the EVOKE Study…

ByRidhi RastogiJuly 17, 2025

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Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia

Shots: Quince Therapeutics has completed enrolment in its P-III (NEAT) trial to assess eDSP (6 infusions once every 21–30 days) vs PBO in Ataxia-Telangiectasia pts (n=105), incl. 83 pts (6-9yrs.) in primary analysis population & 22 pts aged ≥10yrs. Trial will assess change from baseline to the last efficacy visit using RmICARS as the 1EP; pts…

ByRidhi RastogiJuly 17, 2025

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Nicox and Kowa Enter a Licensing Agreement for NCX 470 to Treat Glaucoma

Shots: Nicox has granted Kowa exclusive global rights to develop & commercialize NCX 470 for glaucoma or ocular hypertension, excl. territories already licensed to Ocumension (China, Korea & Southeast Asia) & to Kowa (Japan) As per the deal, Nicox will receive $8.7M (€7.5M) upfront & near-term milestones tied to positive topline P-III (Denali) trial data…

ByRidhi RastogiJuly 17, 2025

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The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots: The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use Additionally, Shingrix prefilled…

ByRidhi RastogiJuly 17, 2025

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RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

Shots: Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

ByRidhi RastogiJuly 17, 2025

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Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: 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,…

ByRidhi RastogiJuly 17, 2025

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AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

Shots: AstraZeneca has reported P-III (CARES) trial findings assessing anselamimab (QW for 4wks. then Q2W till completion) + SoC vs PBO + SoC in pts (N=406) with stage IIIa (n=281) & stage IIIb (n=125) light chain (AL) amyloidosis Trial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…

ByRidhi RastogiJuly 16, 2025

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Eli Lilly Receives the Health Canada’s Approval for Omvoh (Mirikizumab) to Treat Crohn’s Disease (CD)

Shots: Health Canada has approved Omvoh to treat mod. to sev. active Crohn’s disease (CD) unresponsive/intolerant to conventional or biologic therapy along with its new citrate-free formulation for SC use in both UC & CD Approval was based on P-III (VIVID-1) trial of Omvoh (900mg, IV, wks.0, 4, 8 then 300mg, SC, Q4W from wks.12-52;…

ByRidhi RastogiJuly 16, 2025

Ridhi Rastogi

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Saluda Medical Reports Full Launch of EVA Sensing Technology for Spinal Cord Stimulation in the US

Quince Therapeutics Completes Patient Enrolment in P-III (NEAT) Trial of eDSP for Ataxia-Telangiectasia

Nicox and Kowa Enter a Licensing Agreement for NCX 470 to Treat Glaucoma

The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

Eli Lilly Receives the Health Canada’s Approval for Omvoh (Mirikizumab) to Treat Crohn’s Disease (CD)

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