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Novartis' Siponimod Emerges With Solid Safety, Skirts Gilenya's Heart Effects

 
• By Emily Hayes

Positive results from the Phase III EXPAND study of oral siponimod in secondary progressive multiple sclerosis, presented at ECTRIMS, lift Novartis ahead of Gilenya patent expiry and may be enough to support early approval.

In addition to scoring on efficacy in a multiple sclerosis population with high unmet need, Novartis AG's siponimod demonstrated an attractive safety profile in the EXPAND study, data that position the drug to succeed the company's aging Gilenya and possibly support early approval.

Siponimod (BAF312) is an oral, sphingosine-1-phosphate (S1P) receptor modulator and a follow-on to Gilenya (fingolimod),

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Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

 
• By Andrew McConaghie

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Ferrer Signs Deal For Prilenia’s Pridopidine In Europe

 
• By Sushmita Panda

The companies will co-develop the drug for additional indications beyond Huntington’s disease, while Prilenia retains rights in key global markets.

More from Therapy Areas

Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.