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High risk, high reward – the future of CAR-T therapy in CLL

Pharmaceutical Technology

According to GlobalData’s analyst consensus forecast, Yescarta is expected to reach peak sales of $1.8bn in 2028, and Kymriah is expected to reach sales of $686m in the same year. From a clinical perspective, CAR-T therapy may not be appropriate for patients who are typically eligible for cell therapies.

In-Vitro 279
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Aevitas to sell sCFH asset rights to 4D Molecular

Pharmaceutical Technology

sCFH is an engineered and improved version of complement factor H (CFH) that can fit into adeno-associated virus (AAV) vectors with solid expression and applications confirmed in cultured human cells in vitro, in addition to various preclinical animal models in vivo. The firm will also receive single-digit royalties on net sales.

In-Vivo 130
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Betta to commercialise C4 Therapeutics’ CFT8919 in greater China

Pharmaceutical Technology

In vivo and in vitro pre-clinical studies demonstrated that CFT8919 provides wider coverage of on-target resistant mutations and intracranial activity, indicating its potential to be effective against brain metastases. The company will also secure low single-digit percentage royalties on net sales outside these territories.

In-Vivo 130
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Could CRISPR cure HIV? US biotech Excision raises $60m to find out

pharmaphorum

CEO is Daniel Dornbusch, who used to be Americas sales director for Novartis and CEO and co-founder of US cancer biotech Acteris. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

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Eucure Biopharma and Chipscreen NewWay sign licence deal for YH008

Pharmaceutical Technology

Eucure Biopharma will receive up to $28.17m (¥196m) in potential sales milestone payment and tiered royalties on net sales. The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials.

In-Vivo 130
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Risk adjusted net present value: What is the current valuation of Pharma Mar’s Ecubectedin?

Pharmaceutical Technology

Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others.

Hormones 100
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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).