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Celltrion’s Biosimilar Rituximab First In Line For FDA Review

 
• By Jung Won Shin

After launching its biosimilar infliximab Inflectra in the US late last year, Celltrion is targeting a leading position in oncology in the US with its biosimilar rituximab emerging as the first to be accepted for review by the US FDA.

Celltrion Headquarters

The US FDA has accepted for review Celltrion Inc..’s BLA for CT-P10, a proposed monoclonal antibody biosimilar to Roche ’s Rituxan (rituximab), placing it well ahead of competition, currently in late stages of development.

According to Datamonitor Healthcare's analyst Hristina Ivanova, CT-P10, also known as Truxima, is expected to be the first rituximab biosimilar in the US, while a few other late stage candidates are expected to come and compete for market share afterwards. Sandoz’ GP2013, Pfizer Inc

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Lundbeck Lifted By Leap In Migraine Therapy Sales

 
• By Kevin Grogan

Vyepti revenues rise by nearly 70% in the first quarter.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

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AbbVie On MFN: ‘We Have To Take It Seriously’

 
• By Jessica Merrill

AbbVie chief commercial officer Jeffrey Stewart called Trump’s drug pricing plan a “disruption” but said ultimately the delta between US and EU drug prices may not be as high as some expect.

Industry Leaders Grapple With Trump’s MFN Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on what Trump’s executive order on drug pricing could mean for US and European drug prices.

GSK Pays $1.2bn For Phase III-Ready MASH Contender

 
• By Andrew McConaghie

The acquisition of Boston Pharma’s once-a-month FGF21 analog adds to GSK’s liver disease portfolio.