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Big US Step For Mitsubishi Tanabe As Edaravone Filed For ALS

 
• By Ian Haydock

Japan's Mitsubishi Tanabe has taken an important step forward in the US with an approval filing for what will be its key strategic product in this market.

The filing by Mitsubishi Tanabe Pharma Corp. of a US approval filing for edaravone marks the start of what the mid-sized Japanese firm hopes will be a path to increased sales in a market where it has so far had only a limited direct presence.

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Korean Biotech Roundup: GNT Set For First Direct Korean Biopharma IPO On Nasdaq

 
• By Jung Won Shin

GNT Pharma prepares for the first listing of a Korean biotech on Nasdaq, while others sign major global out-licensing deals with large multinational partners.

US Tariffs And Manufacturing Concentration: Double-Edged Sword?

 
• By Anju Ghangurde

India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.

Will China’s Retaliatory Tariffs Galvanize Manufacturing Onshoring?

 
• By Dexter Jie Yan

China’s imposed large retaliatory tariffs on US pharmaceuticals on 10 April, but some domestic firms with in-licensed, US-origin assets were already moving to localized manufacturing.

New Data Strengthen Case For RemeGen’s Telitacicept In gMG

 
• By Dexter Jie Yan

Results from a China Phase III trial show the potential of RemeGen's fusion protein telitacicept in generalized myasthenia gravis. But study design differences make direct comparisons with argenx's FcRn inhibitor Vyvgart challenging.

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Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 
• By Andrew McConaghie

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.