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Courts, Not FDA Panel, Likely Bigger Hurdle For Amgen's Humira Biosimilar

 
• By Donna Young

Amgen Inc. appears to have a smooth path to FDA approval of its biosimilar of AbbVie Inc.'s tumor necrosis factor Humira (adalimumab) based on documents released ahead of a July 12 advisory committee meeting. But don't expect AbbVie to just sit back and take it.

Amgen Inc. has been eyeing the $14bn in cash rival AbbVie Inc. has been hauling in with its blockbuster Humira (adalimumab) – in fact the world's top-selling drug – and the FDA doesn't appear it will stand in the way.

Indeed, in briefing documents released ahead of a July 12 meeting of the FDA's Arthritis Advisory Committee, regulators all but said Amgen's biosimilar of Humira, a tumor necrosis factor (TNF) blocker, had the full blessing of the agency – declaring that the totality of the evidence demonstrated the California biotech giant's product was

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Stock Watch: Market Optimism Outshines Q1 Currency And Tariff Woes

 
• By Andy Smith

The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.

Vertex Sinks On Below-Consensus Revenue, Limited Sales From New Launches

 
• By Mandy Jackson

Vertex is in need of diversification, but in addition to its lower-than-expected Q1 revenue, sales of the company’s newest CF drug Alyftrek and pain medicine Journavx disappointed.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

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Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.

Vertex Sinks On Below-Consensus Revenue, Limited Sales From New Launches

 
• By Mandy Jackson

Vertex is in need of diversification, but in addition to its lower-than-expected Q1 revenue, sales of the company’s newest CF drug Alyftrek and pain medicine Journavx disappointed.