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Teva
NEWS

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention

Shots: The US FDA has accepted sBLA of Ajovy to prevent episodic migraine in children & adolescents (6-17yrs.; ≥45Kg) Submission was based on P-III (SPACE) trial assessing Ajovy (SC) vs PBO for 12wks. to treat episodic migraine in 237 pediatric pts, which showed improvements in reducing monthly migraine & headache days Ajovy (CGRP antagonist) is…
April 8, 2025

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Johnson & Johnson
NEWS

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…
April 8, 2025

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Intellia Therapeutics
NEWS

Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

Shots: Intellia has reported the first pts dosing in its P-III (MAGNITUDE-2) trial assessing nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN); BLA submission is expected in 2028 Trial will assess nex-z (55mg infusion) vs PBO in ~50 ATTRv-PN pts to evaluate modified neuropathy impairment score & change in serum TTR levels as…
April 7, 2025

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Ethris & Lonza
NEWS

Ethris Partners with Lonza to Develop Intranasal Spray-Dried mRNA Vaccines Against Respiratory Diseases

Shots: Ethris has entered into a collaboration agreement with Lonza to develop room-temperature stable, spray-dried formulations of mRNA-based vaccine candidates designed for mucosal delivery in pts with respiratory diseases As per the deal, Lonza will support Ethris’ vaccine candidates, which are based on Ethris’ stabilized non-immunogenic mRNA (SNIM RNA) & stabilized lipid nanoparticles (SNaP LNP)…
April 7, 2025

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AliveDx
NEWS

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray

Shots: The US FDA has received 510(k) application for MosaiQ AiPlex CTDplus multiplex microarray to improve & accelerate diagnosis of connective tissue diseases (CTDs) CTDplus diagnose CTDs using just 10μL of sample in one step, with its CTD microarray having 15 markers in each panel per pts—DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P,…
April 7, 2025

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Luye Pharma
NEWS

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots: Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorder Erzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…
April 7, 2025

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