Sun.Sep 15, 2024

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Ten-year survival data show long-term benefit of immunotherapy in melanoma

Bio Pharma Dive

Final follow-up results suggest Opdivo and Yervoy could be close to a cure for some people with advanced melanoma, shifting how doctors administer follow-up care.

Doctor 310
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Your Eyesight Could Be Putting You at Risk of Developing Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

(ImagesBazaar/Getty Images) A new study suggests staying on top of your eye health could offer a simple avenue for reducing your risks of future brain problems.

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ESMO 2024: Enhertu to eclipse SOC for HER2+ breast cancer with brain metastases

Pharmaceutical Technology

GlobalData forecasts predict Enhertu will retain its dominant market position in the ADC treatment landscape.

Marketing 234
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NABH introduces 6th edition of accreditation standards for hospitals

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has unveiled a major update to its accreditation standards for hospitals, with the release of the 6th edition.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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ESMO 2024: TIGIT race tightens with first look at GSK/iTeos’s TIGIT in NSCLC

Pharmaceutical Technology

The published belrestotug/dostarlimab data is still too immature to prove the combination’s capability to disrupt the NSCLC treatment paradigm.

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ESMO: Enhertu shows its worth in brain metastases

pharmaphorum

Women with HER2-positive breast cancer can be treated with AstraZeneca and Daiichi Sankyo's Enhertu, regardless of whether their cancer has spread to the brain, according to a new study.The results of the open-label DESTINY-Breast12 trial – reported at the ESMO cancer congress in Barcelona – showed that nearly two-thirds (61.6%) of patients with brain metastases at baseline who were treated with the HER2-directed antibody-drug conjugate (ADC) were alive without disease progression at one year.

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ESMO: GSK, iTeos bring some optimism back to TIGIT

pharmaphorum

GSK, iTeos TIGIT drug belrestotug shows efficacy in PD-L1-high NSCLC trial at ESMO, giving some positive news for the beleaguered class

Trials 115
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ESMO: Bayer hopes to expand Nubeqa's prostate cancer reach with chemo-free regimen

Fierce Pharma

Bayer is targeting a broader use of Nubeqa in metastatic hormone-sensitive prostate (mHSPC) cancer with a combination free of chemotherapy. | Bayer is targeting a broader use of Nubeqa in metastatic hormone-sensitive prostate cancer with a combination free of chemotherapy.

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The Greatest Trick the Devil Ever Pulled was Convincing the World He Didn’t Exist: Senate Judiciary Set to Mark-Up Patent Reform Bills that Could Significantly Affect Hatch-Waxman and the BPCIA

FDA Law Blog

By Kurt R. Karst — “Inter Partes Review” and “Section 101” are not terms you typically run into on this all-things-FDA blog, but we have talked about such patent-related issues before ( here and here ), and they are important legal (patent) principles, particularly in the context of drug and biological products (and the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act (“BPCIA”)).

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How important are Disaster Recovery and Business Continuity Plans for eClinical Systems?

Cloudbyz

Having a disaster recovery (DR) plan and business continuity plan (BCP) is critical for any eClinical systems and servers that manage clinical trials data. These systems handle vast amounts of sensitive and regulated information, and any disruptions or data loss can have severe consequences for patient safety, trial integrity, and regulatory compliance.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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ST-Segment Elevation in a Woman With Out-of-Hospital Cardiac Arrest

JAMA Internal Medicine

This case report describes a patient in their mid 70s who had an out-of-hospital cardiac arrest and was found to have irregular, narrow atrial fibrillation with rapid ventricular rhythm on electrocardiography imaging.

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