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Pharmalink wins US orphan designation for Busulipo

 
• By Gemma Collier

Pharmalink, a Swedish specialty company, has received orphan drug designation from the US FDA for its transplant conditioning agent Busulipo (busulfan), which the company plans to file in late 2014.

Pharmalink, a Swedish specialty company, has received orphan drug designation from the US FDA for its transplant conditioning agent Busulipo (busulfan), which the company plans to file in late 2014.

Busulipo is used prior to bone marrow transplantation as a conditioning regimen. The product is Pharmalink's "me-better" formulation of an...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Enliven Raises $230m To Fund Scemblix Leukemia Challenger

 
• By Andrew McConaghie

The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.

Stock Watch: Generics Firms Trapped Between US Tariffs And European Austerity

 
• By Andy Smith

Successive annual reductions in European drug prices following the pandemic are affecting the global sales of generic pharmaceutical companies. Additionally, the imposition of US import tariffs may result in generic drug supply becoming unprofitable.

Innovent Builds Metabolic Pipeline While Retaining Oncology Backbone

 
• By Xu Hu

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.