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Bayer
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Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC ptsApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…
1 day ago

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Bayer
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Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots:The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications plannedApproval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…
July 14, 2025

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Bayer
News

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoingApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP),…
June 4, 2025

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Bayer
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Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Shots:The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regionsTrial showed reduced VMS frequency (1EP), with…
June 3, 2025

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Bayar
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Bayer Reports Post-Hoc Data from P-III (ARANOTE) Trial of Nubeqa to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:Bayer has reported post-hoc analyses from P-III (ARANOTE) trial assessing Nubeqa (darolutamide; 600mg, BID) + androgen deprivation therapy (ADT) (n=446) vs PBO + ADT (n=223) in mHSPC pts (N=669)Post-hoc analyses showed that 42.6% pts achieved ultra-low PSA levels (<0.02ng/mL) vs 7.8% pts on PBO & this response was associated with prolonged rPFS, delayed…
April 30, 2025

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Top 20 Biopharma 2025
TOP 20

Top 20 Biopharma Companies of 2025 

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
April 24, 2025

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Biocon Biologics
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Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots:Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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