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NEWS

Geron
Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS 
Shots:    The CHMP has recommended Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy, with the EC’s decision expected in the coming months  Opinion was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within…
December 13, 2024
MERCK
 Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma 
Shots:     The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25  Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…
December 13, 2024
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
Neurocrine Biosciences
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
Merus
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
Intas & Coherus
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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