This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Read More: Daiichi Sankyo and Merck
Gilead…
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Biocon Biologics has received Health Canada’s NOC for Yesintek & Yesintek IV, biosimilars to Stelara, with approval on Oct 17 and commercial availability expected in mid-October
Approval was supported by data showing YESINTEK is highly similar to Stelara with no meaningful differences in efficacy, safety, or immunogenicity. It will be offered via the My…
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Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France
Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland
Ranibizumab is a recombinant humanized…
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Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets
As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities
Tuznue, biosimilar of Herceptin, with…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:
Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas
Read More: Arcus Biosciences
HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…
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The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.)
Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…
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Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US
Biocon Biologics & Civica entered into a multi-year exclusive distributorship where Biocon will manufacture & supply Insulin Glargine, & Civica will handle its commercialization in the US under its own label, incl. the CalRx brand in California
No…
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Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM
As per the deal, Klinge will receive…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:
AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer
Read More: AstraZeneca and Daiichi Sankyo
AstraZeneca Reports P-III (Bax24) Trial Data on…
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Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada
The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing
BAT2506 is an IgG1 monoclonal antibody that targets…

