Copaxone Promos Can’t List Risks Product Doesn’t Have, Especially Incorrectly, FDA Warns

The first warning letter of the year from FDA’s Office of Prescription Drug Promotion goes to Teva for web pages and materials displayed at a medical conference that overstated the safety and efficacy of its MS drug Copaxone.

In its eagerness to take on the likes of Novartis AG’s oral multiple sclerosis treatment Gilenya (fingolomod), Teva Neuroscience Inc. prepared an exhibit for the American Academy of Neurology meeting last year inaccurately listing a number of risks that it said its relapsing-remitting MS drug Copaxone (glatiramer acetate) doesn’t have but other MS drugs do, FDA’s Office of Prescription Drug Promotion says in a warning letter.

The offending exhibit panels included a table suggesting “that Copaxone is not associated with immunosuppression/infections, decrease in pulmonary...

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

More from United States

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.

More from North America