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Navigating Regulatory Hurdles in Drug Development

DrugBank

Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

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ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs

Alta Sciences

Nonclinical safety assessment serves as a cornerstone in drug development, providing essential data to identify early signs of potential toxicity and inform subsequent clinical trial design. CAR T cells) WHAT IS THE BENEFIT OF NONCLINICAL CYTOKINE RELEASE EVALUATION?

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

Ibtrozi was approved based on a pair of trials showing response rates of 90% and 85%, respectively, in patients who hadn’t previously received another tyrosine kinase inhibitor. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. You can unsubscribe at anytime. Registered in England and Wales.

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GSK Licenses Shigella Vaccine Candidate to Bharat Biotech

The Pharma Data

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech in Push for Global Health Equity GSK today announced a significant step forward in the battle against Shigella a leading cause of diarrhoeal disease and death in children under five by licensing its Shigella vaccine candidate, altSonflex1-2-3 , to Bharat Biotech International Limited (BBIL).

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Tackling complex manufacturing challenges in modern drug development

Drug Target Review

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. This global role allowed him to develop the application of innovative technologies to bring new ATMPs to the clinic.

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Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinical development strategies that promote agility, efficiency and effectiveness.

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Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

The drug’s clearance came after an unusual clinical development journey and, in the ensuing months, has swelled Soleno’s market value past $4 billion amid optimism about the drug’s sales prospects. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5 billion in worldwide yearly sales at its peak.

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