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

News

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

Shots: The P-III (OASIS 4) study assessed elinzanetant (oral, QD) vs PBO for 52wks. to treat mod. to sev. VMS caused by endocrine therapy in women (n=474) & for another 2yrs. for those with or at high risk of HR+ breast cancer The study achieved its 1EP of VMS severity reduction at 4 &…

ByRidhi RastogiJanuary 10, 2025

News

BridgeBio & Bayer Report the CHMP’s Positive Opinion of Beyonttra (Acoramidis) to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: The CHMP has recommended Beyonttra to treat wild-type or variant transthyretin amyloidosis cardiomyopathy (ATTR-CM) in adults, expected to launch in H1’25 Opinion was based on a P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO in ATTR-CM patients. It achieved its 1EP, showing a 42% reduced composite ACM & recurrent CVH events &…

ByDipanshu DixitDecember 13, 2024

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…

BySaurabh ChaubeyMay 1, 2024

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

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

BridgeBio & Bayer Report the CHMP’s Positive Opinion of Beyonttra (Acoramidis) to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

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