The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Shots:The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutationsDesignation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…

ByRidhi Rastogi1 day ago

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Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Shots:Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other marketsIn the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…

ByRidhi RastogiMay 12, 2025

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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…

ByRidhi RastogiApril 30, 2025

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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…

ByPrince GiriApril 24, 2025

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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,…

ByRidhi RastogiApril 16, 2025

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Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

Shots:The US FDA has granted full approval to Vitrakvi for adults & pediatrics with NTRK fusion-positive metastatic or inoperable solid tumors, who had disease progression on prior therapy or lacked alternative therapy optionsApproval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were…

ByRidhi RastogiApril 11, 2025

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Bayer Enters Global License Agreement with Suzhou Puhe BioPharma for its PRMT5 Inhibitor

Shots:Bayer & Suzhou Puhe BioPharma have entered into a global license agreement for Puhe BioPharma’s PRMT5 inhibitor to treat MTAP-deleted tumorsAs per the deal, Bayer will obtain rights to develop, manufacture & commercialize MTA-cooperative PRMT5 inhibitor globally; financial terms remain undisclosedBayer to develop the asset under development name BAY 3713372, with first…

ByRidhi RastogiMarch 27, 2025

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Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots:The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

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Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025

Shots:The P-III (QUANTI CNS) trial assessed GBCA gadoquatrane (0.04mmol Gd/kg) vs macrocyclic GBCAs (0.1mmol Gd/kg) in adults (n=305) with confirmed or suspected CNS pathologies undergoing contrast-enhanced MRI Study showed non-inferiority (1EP) & superiority across all visualization criteria (contrast enhancement, delineation, & morphology), plus higher sensitivity & specificity (2EP) for lesion detection & exclusion…

ByRidhi RastogiFebruary 27, 2025

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Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Shots:Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…

ByRidhi RastogiFebruary 14, 2025

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Bayer Submits MAA of Eylea 8mg to Japan’s MHLW for Treating Macular Edema Secondary to Retinal Vein Occlusion (RVO)

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

Top 20 Biopharma Companies of 2025

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

Bayer’s Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors

Bayer Enters Global License Agreement with Suzhou Puhe BioPharma for its PRMT5 Inhibitor

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

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