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NEWS

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Shots: The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…
September 24, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
September 22, 2025

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TOP 20

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…
September 18, 2025

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NEWS

Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Shots: The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks. Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…
September 9, 2025

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TOP 20

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…
September 3, 2025

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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022,…
September 3, 2025

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Abbott
NEWS

Abbott Reports the Approval for its Denosumab Biosimilar in Thailand 

Shots:  Abbott has secured regulatory approval for its denosumab biosimilar in Thailand, increasing access to advanced treatments for osteoporosis and cancer-related bone loss  Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation   Abbott will offer denosumab as part of its strategy to expand access to quality medicines in…
August 26, 2025

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NEWS

Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

Shots: Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950M As per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…
August 26, 2025

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TOP 20

Top 20 R&D Spending Biopharma Companies of 2025  

Shots:  Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being  The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
August 21, 2025

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