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## FDA Issues Boxed Safety Warning for Elevidys, Removes Non-Ambulatory Duchenne Indication

The agency is cautioning patients about the risk of serious, possibly fatal, liver injuries and has limited the gene therapy's use to ambulatory patients.

## NSGC Navigating Government Shutdown, Midterms in Continued Push for Medicare Recognition

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At its annual meeting, the society discussed progress it has made in pushing ahead the Access to Genetic Counselor Services Act and other policy priorities.

## FDA Introduces 'Plausible Mechanism Pathway' to Spur Personalized Therapy Development

A sponsor will have to demonstrate success with "with several consecutive patients with different bespoke therapies" to receive an approval.

## Nearly a Year on, Genetic Counselors Track Initial Effect of New CPT Code

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Two analyses presented at the National Society of Genetic Counselors' annual meeting indicate the CPT code change has led to an increase in billable hours.

## Makers of N-of-1 Rare Disease Therapies Feel Moral Obligation to Broaden Access via New Strategies

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Investigators who designed a base-editing treatment are planning an "umbrella of umbrellas" trial, while others are developing roadmaps to guide personalized treatments.

## Kura Oncology, Kyowa Kirin Net FDA Approval for Komzifti in NPM1-Mutant AML

The agency reviewed data from a Phase II study, in which around 21 percent of patients had a complete response to the menin inhibitor.

Business, Policy & Funding

- ## Bio-Rad to Commercialize UMich Digital PCR Assay for HPV-Positive Head and Neck Cancer Recurrence

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- ## Captain T Cell Secures €20M to Advance Autologous Cell Therapy to Phase I Trial
- ## Artios Pharma Raises $115M in Series D Funding
- ## CHMP Recommends High-Dose Regimen of Biogen's Spinraza for Spinal Muscular Atrophy
- ## SPORE-Funded Work to Test if CSF-1R Inhibitor Overcomes PARP Inhibitor Resistance in Breast Cancer

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Precision Oncology

- ## Bio-Rad to Commercialize UMich Digital PCR Assay for HPV-Positive Head and Neck Cancer Recurrence

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- ## CHMP Recommends High-Dose Regimen of Biogen's Spinraza for Spinal Muscular Atrophy
- ## Labcorp, Lunit Collaborating to Combine AI, Digital Pathology for Cancer Research
- ## AMP Group Unveils New Draft Guidelines for Interpreting, Reporting Cancer Sequencing Variants

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- ## CHMP Recommends Ionis' Dawnzera for Prevention of Hereditary Angioedema Attacks

Precision Medicine Diagnostics

- ## Bio-Rad to Commercialize UMich Digital PCR Assay for HPV-Positive Head and Neck Cancer Recurrence

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- ## Captain T Cell Secures €20M to Advance Autologous Cell Therapy to Phase I Trial
- ## Artios Pharma Raises $115M in Series D Funding
- ## Labcorp, Lunit Collaborating to Combine AI, Digital Pathology for Cancer Research
- ## AMP Group Unveils New Draft Guidelines for Interpreting, Reporting Cancer Sequencing Variants

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Disease Areas

- ## Bio-Rad to Commercialize UMich Digital PCR Assay for HPV-Positive Head and Neck Cancer Recurrence

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- ## Artios Pharma Raises $115M in Series D Funding
- ## SPORE-Funded Work to Test if CSF-1R Inhibitor Overcomes PARP Inhibitor Resistance in Breast Cancer

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- ## FDA Issues Boxed Safety Warning for Elevidys, Removes Non-Ambulatory Duchenne Indication
- ## Kura Oncology, Kyowa Kirin Net FDA Approval for Komzifti in NPM1-Mutant AML

Breaking News

- ## Captain T Cell Secures €20M to Advance Autologous Cell Therapy to Phase I Trial
- ## Artios Pharma Raises $115M in Series D Funding
- ## CHMP Recommends High-Dose Regimen of Biogen's Spinraza for Spinal Muscular Atrophy
- ## Labcorp, Lunit Collaborating to Combine AI, Digital Pathology for Cancer Research
- ## CHMP Recommends Ionis' Dawnzera for Prevention of Hereditary Angioedema Attacks
- ## EMA's CHMP Recommends Fondazione Telethon's Gene Therapy for Wiskott-Aldrich Syndrome

What's Popular?

- ## Personalis Receives Medicare Coverage for MRD Assay in Breast Cancer
- ## First Ascent Expands Access to Functional Precision Medicine Testing After Promising Clinical Results

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- ## Ultrasensitive Liquid Biopsy Approach Improves Lung Cancer Patient Stratification
- ## Cancer Patients Who Get COVID-19 mRNA Vaccines May Respond Better to Immunotherapies

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- ## Phase II Trial Validates Predictive Biomarker for Hormone Therapy Use in Prostate Cancer

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