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Regeneron

Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

Shots:  The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.  The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…

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Biocon,Bayer and Regeneron

Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

Shots:  Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada   Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved…

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Bayer and Regeneron Receive the EC’s Approval for Eylea (aflibercept, 8mg) for the Treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Shots: The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changes Both the studies met…

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Spending on R&D Top 20 2022

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

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Companies Spending on R&D Top 20 2022

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

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VIEWPOINTS_Boaz Hirshberg_2023

Boaz Hirshberg, SVP, Clinical Development at Regeneron Shares Insights from the US FDA Approval of Evkeeza (evinacumab-dgnb)

Shots: Boaz spoke about the US FDA approval of Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH) Boaz also talked about the study design of the pivotal pediatric trial evaluating Evkeeza(evinacumab-dgnb) . He then extended his talk on HoFH and how Regeneron is creating awareness about the disease The…

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