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KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients

Shots: The US FDA has received the 510(k) premarket notification for FreedomEDGE infusion system to subcutaneously administer Phesgo (Perjeta/Herceptin/hyaluronidase-zzxf) in HER2+ breast cancer The Infusion System enables efficient large-volume SC drug delivery, addressing unmet needs in oncology infusion centers by improving nurse administration experience while supporting faster, more streamlined clinical workflows The system supports SC…

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Henlius & Organon

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…

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EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…

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Alkem Laboratories launches Pertuza (Biosimilar, Perjeta) Across India for Treating HER2-Positive Breast Cancer 

Shots:  Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer   In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product   Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer  Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release Related News:- CuraTeQ Biologics Reports…

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Top 20 Monoclonal Antibodies of 2025 

Shots:  Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas  As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…

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Top 20 Oncology Companies of 2025 

Shots:  ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care  In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

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Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)

  Shots:  The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP  The 1EP of the trial includes total pathological complete response (tpCR) rate as…

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Top Performing Drug – Perjeta (January Edition)

Top Performing Drug – Perjeta (January Edition)

Shots:   In continuation of our previous series on the Top-Performing Drug of the month, based on 2021 revenue, this month we have selected Perjeta and prepared a curated analysis report for our readers  Perjeta is indicated for the treatment of HER2-positive metastatic breast cancer, neoadjuvant HER2-positive breast cancer, Adjuvant HER2-positive breast cancer PharmaShots presents a concise…

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