BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25 Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…

ByRidhi RastogiMarch 28, 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

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2024

Shots: The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…

BySenior EditorApril 1, 2024

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2022

The first quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Stryker signed a definitive agreement to acquire Vocera Communications for ~$3.09B, Biohaven acquire Channel Biosciences for ~$3B The first quarter of the year also showcases regulatory events…

BySenior EditorMarch 31, 2022

INSIGHTS+

Insights+: The US FDA New Drug Approvals in May 2021

The US FDA has approved 4 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 29 novel products in 2021. Additionally, last year in 2020, the US FDA…

BySenior EditorJune 17, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US…

BySenior EditorMarch 18, 2021

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

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

PharmaShots’ Key Highlights of First Quarter 2024

PharmaShots’ Key Highlights of First Quarter 2022

Insights+: The US FDA New Drug Approvals in May 2021

Insights+: The US FDA New Drug Approvals in February 2021

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BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

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

PharmaShots’ Key Highlights of First Quarter 2024

PharmaShots’ Key Highlights of First Quarter 2022

Insights+: The US FDA New Drug Approvals in May 2021

Insights+: The US FDA New Drug Approvals in February 2021

FOLLW US

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