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NEWS

Sanofi & Regeneron
Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)
Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
March 28, 2025
BridgeBio
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…
March 28, 2025
Celltrion
Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada 
Shots:  Celltrion has launched Remdantry (formerly Inflectra) injection, a biosimilar to Remicade (infliximab), which will be launched on April 1, 2025, in Canada & received Health Canada NOC on March 7, 2025  Remdantry, consisting of a chimeric IgG1 mAb that binds to human TNFα, will share the same DIN as Inflectra. It was approved by…
March 28, 2025
Bio-Thera and Dr. Reddy's
Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia 
  Shots:  Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab)  As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…
March 28, 2025
Ionis & Sobi
Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides
Shots: Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in Canada As per the deal, Ionis will get an upfront, with potential milestone payments &…
March 27, 2025
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