Remove tag pd-1
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Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

This is not the first treatment to come with a high price tag. Using this categorization, programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors saw the greatest percentage of RSAs granted.

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Roche nabs breakthrough tag for TIGIT cancer immunotherapy

pharmaphorum

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

Amtagvi is approved for the treatment of unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor and a BRAF inhibitor if the tumor harbors a BRAF V600 mutation. TILs are immune cells that attack and penetrate tumors. Most chimeric antigen receptor (CAR)-T cell therapies cost around $500,000 or less.

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Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics' IL-12 immunotherapy programme

The Pharma Data

Since July, the company has been running the therapy through Phase 1/2 studies to evaluate its efficacy in generating anti-tumour responses in locally advanced or metastatic solid tumours when used as a monotherapy and in combination with PD-1 inhibitors. .

Protein 52
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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

pharmaphorum

Excluded from that study are patients with EGFR mutations, and AbbVie is looking specifically at this group in a phase 1 study that is looking at the combination of Teliso-V and AstraZeneca’s EGFR inhibitor Tagrisso (osimertinib), to see if the ADC can boost efficacy and potentially reduce the risk of resistance developing.

Antibody 111
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Gilead tags Merck for first-line triple negative breast cancer trial

pharmaphorum

Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. While its headline revenue of $7.4

Trials 52
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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

3.4.1: Healthy Subject PD and PK/PD Study Reports. 3.4.2: Patient PD and PK/PD Study Reports. There are four HIGH-severity TRC validation codes for study data (Table 1): Table 1. The correct STF file-tags are used for datasets and corresponding data definition files. 2.3.2: Repeat-Dose Toxicity.