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 H2’26 Yesafili’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

NEWS

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 options Approval was based on 3 trials: LOXO-TRK-14001, SCOUT, & NAVIGATE, evaluating Vitrakvi in 339 adult & pediatric pts. Key EPs were…

ByRidhi RastogiApril 11, 2025

NEWS

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 tumors As per the deal, Bayer will obtain rights to develop, manufacture & commercialize MTA-cooperative PRMT5 inhibitor globally; financial terms remain undisclosed Bayer to develop the asset under development name BAY 3713372, with first…

ByRidhi RastogiMarch 27, 2025

NEWS

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

NEWS

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

NEWS

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

NEWS

BridgeBio’s Beyonttra (Acoramidis) Gets the EU approval to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: The EU granted marketing authorization to Beyonttra (acoramidis) to treat wild-type or variant ATTR-CM in adult pts.; launch expected in 1H’25 The approval was supported by the results of P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts.. It achieved its 1EP, showing a 42% reduced composite ACM &…

ByRidhi RastogiFebruary 12, 2025

NEWS

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

Shots: The EMA 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). Awaits approval in US and China, with global applications planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…

ByDipanshu DixitFebruary 4, 2025

NEWS

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support

Shots: Bayer launched CanesMeno in the UK to provide menopause support that incl. digital informative resources (CanesMeno Hub) & scientifically-backed products (Hydration & Comfort Gel, Multi-Support, & Night Support). Wider availability in major supermarkets & grocery stores will start from early spring 2025 The hub offers a 3-min. guide, a tracker for personalized insights…

ByDipanshu DixitJanuary 31, 2025

NEWS

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

Shots: The P-III (QUANTI; N=808) trials of gadoquatrane (0.04mmol Gd/kg body wt.) comprised of QUANTI CNS for CNS disorders like brain tumors, brain metastasis & multiple sclerosis; QUANTI OBR for other body regions like head & neck, thorax, abdomen & pelvis as well as QUANTI Pediatric study for children (birth to 18yrs.) Study assessed…

ByRidhi RastogiJanuary 13, 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)

BridgeBio’s Beyonttra (Acoramidis) Gets the EU approval to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

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