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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

Drugs 264
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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Drugs 72
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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

pharmaphorum

The c-Met protein thought to be both a driver of cancer itself, as well as a resistance mechanism that tumours can develop to protect them from some widely-used NSCLC therapies, including EGFR inhibitors. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.

Antibody 111
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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

That alliance also yielded $6 billion blockbuster Darzalex as well as Rybrevant (amivantamab), J&J’s first bispecific antibody which is used to treat EGFR-mutated non-small cell lung cancer (NSCLC). Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Delveinsight

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases.

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Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

Since every pharmaceutical is unique, closely monitoring labs such as estimated glomerular filtration rate (eGFR) to detect any changes in renal function with increasing exposures is also critical. As noted earlier, the accumulated dose within the kidneys is also an important consideration during the dose selection process.

DNA 66
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What to expect from PEGS Europe 2023: Day 3

Drug Discovery World

Kathya Rashida de la Luz Hernandez, PhD, Head, Analytical, Center of Molecular Immunology, on: ‘Development of a new high-concentrated formulation of anti-tumour mAbs for subcutaneous administration: Anti-EGFR mAb study case’.

Protein 59