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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.

Business


Finance Watch: European And Japanese Biotechs See VC Investor Interest In March

 
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Private Company Edition: The latest group of drug developers to announce venture capital financings is remarkable for its geographic diversity, from Character Biosciences’ $93m series B round in the US to Augustine’s $85m series B in Belgium to a $29.2m series C for Aculys in Japan.

Almirall CEO Sounds Alarm Over Europe’s Reduced Competitiveness

 
• By 

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.

Deal Watch: Eyenovia Looks At New Direction In Proposed Merger With Betaliq

 
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Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.

Scrip Originals


Finance Watch: European And Japanese Biotechs See VC Investor Interest In March

 
• By 

Private Company Edition: The latest group of drug developers to announce venture capital financings is remarkable for its geographic diversity, from Character Biosciences’ $93m series B round in the US to Augustine’s $85m series B in Belgium to a $29.2m series C for Aculys in Japan.

Deal Watch: Eyenovia Looks At New Direction In Proposed Merger With Betaliq

 
• By 

Plus deals involving Relmada/Trigone, Alvotech/Xbrane, OPKO Health/Entera, iOncologi/TargImmune and more.

Stock Watch: Are Gene Therapy Prices Too High For Success?

 
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The promise of innovative therapies seems to have been constrained not by efficacy or safety concerns, but because the high price of treatments is incongruous with the reimbursement of short-course therapies.

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.