STAT

SEPTEMBER 15, 2024

BARCELONA, Spain — An AstraZeneca immunotherapy, given both before and after surgery, improved survival rates in patients with bladder cancer, results that could reshape how muscle-invasive bladder tumors are treated.  The regimen using Imfinzi, the company’s anti-PD-L1 checkpoint inhibitor, cut the risk of death by 25% compared to treating patients before surgery with chemotherapy alone, researchers reported Sunday.

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Chemotherapy 123

pharmaphorum

SEPTEMBER 15, 2024

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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Labelling 111

STAT

SEPTEMBER 15, 2024

Exact Sciences, which has for years sold a stool-based colon cancer test, on Monday announced that a blood-based test it’s developing showed promise in accurately detecting the disease. In a study of more than 3,000 samples, the company reported that its test detected 88.3% of cancers and correctly returned a negative result 90.1% of the time, test features known as sensitivity and specificity, respectively.

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pharmaphorum

SEPTEMBER 15, 2024

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

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

SEPTEMBER 15, 2024

This is the online edition of ESMO in 30 Seconds, a pop-up newsletter from the European Society for Medical Oncology’s annual meeting in Barcelona, Spain. Sign up for the remaining editions  here. AZ hits in bladder cancer, as regulatory issue looms The applause mentioned above was for AstraZeneca’s Phase 3 NIAGARA study in bladder cancer, which showed that giving patients the checkpoint inhibitor Imfinzi — both before and after surgery — cut the risk of death by

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Pharmacy Times

SEPTEMBER 15, 2024

Overall survival results from the phase 3 KEYNOTE-522 study provide evidence of improved long-term outcomes from this pembrolizumab-based regimen.

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Chemotherapy 131

Pharmacy Times

SEPTEMBER 15, 2024

Clinical research presented at ESMO 2024 highlights the significant survival benefits of perioperative and neoadjuvant immunotherapy with nivolumab and nivolumab plus ipilimumab, while emphasizing the role of biomarkers such as ctDNA and KRAS mutations in guiding treatment decisions.

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Fierce Pharma

SEPTEMBER 15, 2024

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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Chemotherapy 87

The FDA Law Blog

SEPTEMBER 15, 2024

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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FDA 69

The Happy PharmD

SEPTEMBER 15, 2024

Wondering how our healthcare professionals, especially pharmacists, are faring lately? Well, now’s the perfect time to dive into a discussion with me about the latest insights from the 2023 report by the Well-Being Index. Whether you’re new here or a regular viewer, a warm welcome awaits you! And if you’re eager to stay updated with insightful content, don’t forget to hit that subscribe button and notification bell.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

The Checkup by Singlecare

SEPTEMBER 15, 2024

Dupixent (dupilumab) is an injectable medication used to treat moderate-to-severe atopic dermatitis (AD), also known as eczema, in adults and children 6 years and older. It is also approved by the Food and Drug Administration (FDA) for several other uses, including: As an add-on maintenance treatment for severe asthma in adults and children 6 years and older As an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps in adults As a treatment for prurigo nodularis in adults A

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Medication Guidelines FDA Immunization Hospitals 52

OctariusRx

SEPTEMBER 15, 2024

It’s Fall Prevention Awareness Week and the OctariusRx team is recognizing and helping to spread the word on behalf of the National Council on Aging (NCOA). There are many factors that impact our risk of falls, but it’s important to remember that falling is NOT a normal part of aging. Join us the week of Sept. 16-20 in a nationwide effort to prevent falls among older adults.

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Nursing Homes Communication 52

Med Ed 101

SEPTEMBER 15, 2024

Many drugs cause insomnia. What is most frustrating to me in my practice is when we start medications for a “new condition” prior to ruling out medication adverse effects. Here is the list of my top 5 drugs that cause insomnia (an important adverse effect that could show up on your board exam). Corticosteroids. They […] The post Top 5 Drugs That Cause Insomnia appeared first on Med Ed 101.

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Pharmaceutical Technology

SEPTEMBER 15, 2024

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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Pharmacy Management Software

Pharmaceutical Technology

SEPTEMBER 15, 2024

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

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