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Pfizer’s Tofacitinib Clears FDA Without Limited Indication

 
• By Mary Jo Laffler

With FDA’s early approval of tofacitinib for rheumatoid arthritis – the first JAK inhibitor and, unlike the popular TNF inhibitors, an oral agent – the agency appears to have sided with Pfizer on many issues left up in the air after an advisory committee review.

FDA has cleared Pfizer Inc.’s JAK inhibitor Xeljanz (tofacitinib) for rheumatoid arthritis without the limited indication suggested by the Arthritis Drugs Advisory Committee.

The product was approved Nov. 6 for treatment of moderate to severely active rheumatoid arthritis in adults who have had...

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Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 
• By Francesca Bruce

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

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.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.