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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 &…
December 13, 2024

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Neurocrine Biosciences
NEWS

Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH) 

Shots:   The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione at…
December 13, 2024

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Celltrion
NEWS

Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair) 

Shots: The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab) The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs Omlyclo (75mg/0.5mL &…
December 9, 2024

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Merus
NEWS

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC 

Shots:   The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to…
December 4, 2024

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Key Biosimilars Events of November 2024
INSIGHTS+

Key Biosimilars Events of November 2024

Shots:      Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency       Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients       A major highlight was the EC’s approval of Sandoz’ Afqlir for treating…
December 3, 2024

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Intas & Coherus
NEWS

Intas Pharmaceuticals to Acquire Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta) 

   Shots: Intas Pharmaceuticals, through its US specialty division Accord BioPharma, has entered into an agreement to acquire Coherus’ Udenyca business (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta, to enhance Accord’s biosimilar product portfolio. Deal is expected to conclude in Q1’25 Udenyca is indicated to reduce infection risk from febrile neutropenia in patients with non-myeloid malignancies,…
December 3, 2024

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Biocon Biologics
NEWS

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara) 

Shots: The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab) Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…
December 1, 2024

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BridgeBio
NEWS

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM 

Shots:   The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…
November 22, 2024

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