Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Almirall CEO Sounds Alarm Over Europe’s Reduced Competitiveness

 
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The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.

Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?

 

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Wave Aspires To Accelerated Approval In DMD With 48-Week Data

 
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With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.


Stock Buyback Is Vote Of Confidence From Genmab Board

 
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The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares

Cassava At Crossroads As Simufilam Finally Exits, Stage Left

 

The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.

Sanofi Nabs Priority Review For MS Drug Tolebrutinib

 
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A decision from the FDA is due by 28 September.

Does Shingrix Really Lower Dementia Risk? GSK Funds Real World Research To Verify

 

A new “quasi-experimental” study using UK National Health Service data might confirm that GSK’s shingles vaccine helps cut dementia cases.


Generative AI In Drug Discovery And India’s Potential To Leapfrog

 
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Heads of Novartis Biomedical, World Economic Forum and Indian majors like Sun Pharma’s SPARC, among others, discuss generative AI in drug discovery along with pointers for India to leapfrog the R&D process

Deloitte Sees Rising Industry ROI, But Challenge In Sustaining It

 
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Projected return on investment for the 20 pharmas with the highest R&D spend is expected to rise for the second straight year, Deloitte says. How to get there is less clear.

Novo Gets Its Own ‘Triple G’ Obesity Drug To Rival Lilly

 

The obesity market leader is teaming up with China’s United Bio-Technology to develop a product they believe could beat Lilly’s late-stage same-class candidate retatrutide.

Crunch Time Close For Abivax’s IBD Ambitions

 
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Obefazimod has been heralded as a potential blockbuster for ulcerative colitis and there will be great interest in the readout of Phase III induction trials in the third quarter of this year.


Major Cash Injection Advances Augustine’s HDAC6 Hopes

 
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The Belgian firm banks nearly €77.7m to push its Charcot-Marie-Tooth to proof-of-concept.

Profile: Anil Koul’s Journey From ‘Jumping Genes’ To Sirturo And AI-Led Drug Discovery

 

Professor Anil Koul shares vignettes of his life and career trajectory, a captivating mix of hope, science and destiny that took him to the lab of eminent cancer biologist Alex Ullrich at the Max Planck Institute and also saw him contribute to the development of breakthrough TB drug bedaquiline. He also talks about Medicine 3.0 and the intersection of science and spirituality.

Pipeline Watch: Nine Approvals And Nine Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Regenxbio Rises After Duchenne Update And Sarepta Safety Scare

 

Encouraging results in younger children with Duchenne is keeping Regenxbio on track for a potential mid-2026 filing for its gene therapy, RGX-202.


Sanofi Advances Immunology Ambitions With Dren Deal

 
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The France-based giant inks a transaction potentially worth around $1.9bn to get hold of Dren Bio’s autoimmune disease treatment DR-0201.

Roivant Phase III Batoclimab Trial Is Positive, But No Filing Planned

 

The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.

After Securing Biogen Pact, Stoke’s CEO Edward Kaye Bows Out

 

The 75-year-old veteran of rare disease drug development is handing over the reins to a successor, but will stay to help Stoke Therapeutics expand its pipeline.

Almirall Looks To Dominate Across Derma Spectrum

 
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CEO Carlos Gallardo tells Scrip the Barcelona-based group has laid the foundations to advance four promising assets that have considerable potential for a variety of dermatological diseases.