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 H1’25Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…
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 &…
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 &…
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 ~$4.3BThis quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…
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 ~$3BThe first quarter of the year also showcases regulatory events…
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…
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…

