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Keeping Track: US FDA Receives Submissions Galore As Year Ends

 
• By Bridget Silverman

A roundup of new applications submitted to FDA’s Center for Drug Evaluation and Research.

Keeping Track Feature image

The last weeks of 2018 saw a flurry of submissions to the US FDA’s Center for Drug Evaluation and Research, including at least four novel agents. Indeed, had the partial government shutdown not precluded further submissions, the end of the year might have turned into a downright blizzard.

AbbVie Inc.’s upadacitinib could become the third oral rheumatoid arthritis therapy targeting Janus kinase (JAK), joining Pfizer Inc.’s...

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Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

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Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By Cathy Kelly

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 
• By Francesca Bruce

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.