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 launchAccuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer…

ByRidhi RastogiJuly 17, 20250Comments

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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, 20250Comments

INSIGHTS+

Know Your Investor: Invus (July’25 Edition)

Shots:     Welcome to the 2025 edition of Know Your Investor, highlighting leading venture capital firms shaping the future of healthcare innovation This edition highlights Invus, an investment firm focused on supporting life sciences companies committed to advancing breakthroughs that enhance public health In 2024, Invus invested around $4.15B across six funding rounds, expanding its portfolio…

ByPrince GiriJuly 16, 20250Comments

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LIFE SCIENCES | DAILY NEWS | JUL 16, 2025 | PHARMASHOTS

ByTushar MauryaJuly 16, 20250Comments

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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) amyloidosisTrial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…

ByRidhi RastogiJuly 16, 20250Comments

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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 & CDApproval 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, 20250Comments

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JCR Pharmaceuticals Collaborates with Acumen Pharmaceuticals to Develop Novel Alzheimer’s Therapies

Shots:JCR & Acumen have entered into a joint collaboration, option, & license agreement to develop a novel therapy to treat Alzheimer’s disease leveraging JCR’s J-Brain Cargo techAs per the deal, JCR will receive an upfront payment & an option payment if Acumen exercises its exclusive option to develop, manufacture, & commercialize up to…

ByRidhi RastogiJuly 16, 20250Comments

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Debiopharm Enters a ~$267M Licensing Deal with Repare Therapeutics for Lunresertib

Shots:Debiopharm has entered into an exclusive global licensing agreement with Repare Therapeutics for lunresertib (PKMYT1 inhibitor) to treat difficult-to-treat solid tumorsAs per the deal, Repare will receive $10M upfront, ~$257M in clinical, regulatory, commercial & sales milestones, incl. $5M in near-term payments & net sales-based single-digit royaltiesDebiopharm will assume sponsorship of P-I (MYTHIC)…

ByRidhi RastogiJuly 16, 20250Comments

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Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

Shots: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 mellitusApproval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLogKirsty is a rapid-acting human…

ByRidhi RastogiJuly 16, 20250Comments

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KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots:The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…

ByRidhi RastogiJuly 16, 20250Comments

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)

Know Your Investor: Invus (July’25 Edition)

LIFE SCIENCES | DAILY NEWS | JUL 16, 2025 | PHARMASHOTS

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)

JCR Pharmaceuticals Collaborates with Acumen Pharmaceuticals to Develop Novel Alzheimer’s Therapies

Debiopharm Enters a ~$267M Licensing Deal with Repare Therapeutics for Lunresertib

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

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