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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

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FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

The FDA approved it under the brand name Gavreto on September 4. The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.

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Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events.

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Codon Digest: Injected Gene Editors

Codon

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Nature Neuroscience. Read You love to see it! Press release.

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The Promise of Gas Vesicles

Codon

. ” However, studies over the last six decades have repeatedly affirmed that ultrasound is safe , at least when used in the short durations common to medical imaging and treatment. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

KEYTRUDA Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation. This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KENILWORTH, N.J.–(BUSINESS