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

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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 tech As 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, 2025

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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 tumors As 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 royalties Debiopharm will assume sponsorship of P-I (MYTHIC)…

ByRidhi RastogiJuly 16, 2025

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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 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…

ByRidhi RastogiJuly 16, 2025

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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, 2025

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Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M

Shots: Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10 Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…

ByRidhi RastogiJuly 15, 2025

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Becton Dickinson’s Biosciences & Diagnostic Solutions Business to Combine with Waters in a $17.5B Deal

Shots: BD to combine its Biosciences & Diagnostic Solutions business with Waters in a Reverse Morris Trust transaction As per the deal, BD shareholders will receive $4B in cash & a 39.2% stake in the combined company, while Waters will assume $4B in debt & retain 60.8%, with the total deal value of $17.5B reflecting cash,…

ByRidhi RastogiJuly 15, 2025

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Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

Shots: The US FDA has granted clearance to TAVIPILOT Soft for real-time intra-operative guidance of transcatheter heart valve implantation TAVIPILOT Soft, set to launch by the end of 2025, is compatible with all cardiac imaging systems & will support all TAVI heart valves available on the market, thereby, allowing seamless integration in clinical settings TAVIPILOT…

ByRidhi RastogiJuly 15, 2025

Ridhi Rastogi

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)

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

Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M

Becton Dickinson’s Biosciences & Diagnostic Solutions Business to Combine with Waters in a $17.5B Deal

Caranx Medical’s TAVIPILOT Soft Receives the US FDA Clearance for Real-Time Guidance of Transcatheter Heart Valve Implantation

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