Teva revises planned US submission date for new Copaxone dosing regimen

Teva Pharmaceutical Industries has pushed back its timelines for a US submission for its new three-times-weekly dosing regimen for Copaxone (glatiramer acetate injection), the company revealed, ahead of presenting detailed positive Phase III data for the blockbuster multiple sclerosis drug.

Teva Pharmaceutical Industries has pushed back its timelines for a US submission for its new three-times-weekly dosing regimen for Copaxone (glatiramer acetate injection), the company revealed, ahead of presenting detailed positive Phase III data for the blockbuster multiple sclerosis drug.

The company has already, in June, reported positive top-line results supporting the new dose regime, which if approved, could help...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Neurological

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By 

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By 

Oral RNA splicing modulator has gone into a Phase II/III trial

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

More from Therapeutic Category

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.