1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Tysabri’s PML Risk Quantified In Revised Label; Can Added Certainty Add Scripts?

 
• By Martin Berman-Gorvine

Multiple sclerosis and Crohn’s disease patients with anti-JC virus antibodies who have previously taken other immunosuppressants have a 1.1% risk of developing the deadly neurological condition after taking Biogen Idec /Elan’s Tysabri for more than two years.

A first-ever quantification of the risks to multiple sclerosis and Crohn’s disease patients who take Biogen Inc. and Elan Corp. PLC’s Tysabri (natalizumab) of developing the deadly, incurable infection progressive multifocal leukoencephalopathy may, along with a newly approved diagnostic, help alleviate anxiety among patients and health care providers.

“We see the inclusion in the Tysabri label of the exact risk of developing PML while on Tysabri as a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown

 
• By Sue Sutter

Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.

Gene Therapy Sponsors Seek More US FDA ‘Platform’ Guidance, Offer Master File Idea

 
• By Michael McCaughan

One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.

Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

More from North America

Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

Legal ‘Squishiness,’ DoJ Reorganization Could Shape Ad/Promo Enforcement Strategy

 
• By Sue Sutter

The extent of FDA and Justice Department coordination on recent warning and untitled letters is unclear, but the “squishy” issues cited in many of the letters and recent elimination of DoJ’s Consumer Protection Branch could influence legal action, industry lawyers said.

First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher

 
• By Sarah Karlin-Smith

Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds of candidates.