Santhera Setback Could Have Wide-Reaching Effects For DMD Drugs

The DMD community faces another setback as FDA pushes back timelines for Santhera and its respiratory drug, pushing the market to question what will come for other DMD treatments in development.

microscope

In an unsurprising move, FDA has asked Santhera Pharmaceuticals AG for further data before it considers the company's Duchenne muscular dystrophy (DMD) drug for approval. While in-line with typical FDA approval protocol, the decision could have wide-ranging implications for the other companies in the space and ultimately Santhera's command of the market.

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 Business

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

In Brief: Sanofi Gains €10bn From Opella Sale

 

Sanofi sold a 50% stake in consumer health unit Opella for €10bn, backing its shift to prescription drugs and funding a €5bn buyback.

Finance Watch: Biohaven Gains Up To $600m In Fresh Capital

 
• By 

Public Company Edition: Biohaven secured $250m up front from Oberland Capital to support its future US troriluzole launch after pulling its EU filing. Also, Procaps arranged $130m in private equity and Rezolute grossed $96.9m in a rare follow-on offering, among other financings.

Lilly’s Ricks Urges Trump To Pick Tax Incentives Over Tariffs

 

On Lilly’s Q1 earnings call, CEO David Ricks voiced concerns about the Trump Administration’s tariff policy, which he said could adversely affect Lilly and the industry as a whole.

More from Scrip

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By 

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies