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Speed Is Everything In CGRP Race As Amgen/Novartis Reveal Phase III Data

 
• By Mandy Jackson

Amgen and Novartis revealed the first set of Phase III data for a CGRP inhibitor in the treatment of episodic migraine, potentially positioning the companies’ biologic erenumab at the head of the drug class.

Four development programs are neck-and-neck in the race to bring a calcitonin gene-related peptide (CGRP) inhibitor to market, and Amgen Inc. is the first company – with its partner Novartis AG – to report positive Phase III results for their biologic erenumab (AMG 334) in episodic headache sufferers.

Speed of development is key, because Amgen and Novartis may have to be the first anti-CGRP developers to commercialize a...

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• By Lisa Takagi

Sumitomo Pharma's iPSC therapy for Parkinson's has been filed for approval in Japan after showing safety and efficacy in a Phase I/II trial and may become one of the first such therapies to reach the market in the country, which has invested heavily in the modality.

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Biogen Edges Closer To Growth On Strong Q2

 
• By Jessica Merrill

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Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.

Jazz’s Modeyso Approved For Rare Glioma With Expansion Targeted

 
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The accelerated approval came three months after Jazz completed the acquisition of Modeyso’s developer, Chimerix.