Fierce Pharma

SEPTEMBER 8, 2024

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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MedCity News

SEPTEMBER 8, 2024

As poverty, food insecurity, inadequate housing, and complex comorbidities persist, it is essential that rural healthcare leaders have tools and systems in place to address the health of their neighbors. The post Rural Healthcare Goes Beyond Care: Targeting SDOH to Improve Health Outcomes appeared first on MedCity News.

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Healthcare Healthcare Food Transportation 124

pharmaphorum

SEPTEMBER 8, 2024

CDC reports the first-ever US case of an H5 strain of avian influenza without a known occupational exposure to sick or infected animals

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MedCity News

SEPTEMBER 8, 2024

As the FDA continues its work to ensure that AI is deployed safely within healthcare, there are a couple prevalent issues that frequently pop up, said Luke Ralston, one of the agency’s reviewers. The post These Are 2 of The Biggest Issues with Healthcare AI, According to an FDA Reviewer appeared first on MedCity News.

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Healthcare Healthcare FDA 120

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pharmaphorum

SEPTEMBER 8, 2024

Results of Ideate-Lung01 trial at WCLC back up MSD and Daiichi Sankyo's decision to move anti-B7-H3 ADC I-Dxd into phase 3 for small cell lung cancer

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MedCity News

SEPTEMBER 8, 2024

NeOnc Technologies is preparing to go public via the less common path of a direct listing as it continues mid-stage testing of its intranasally administered brain cancer drug. Meanwhile, the mostly stagnant biotech IPO pipeline is showing new signs of life with two large stock market debuts expected this week. The post A Biotech Going Through the Nose to Treat the Brain Plots Alternative Path to Public Markets appeared first on MedCity News.

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MedCity News

SEPTEMBER 8, 2024

The ruling, which limits federal agencies’ power to interpret ambiguous laws, now leaves crucial legislation like the Mental Health Parity and Addiction Equity Act vulnerable to court challenges, potentially unraveling years of hard-won progress. The post Supreme Court’s Chevron Decision Threatens Decades of Progress in Access to Mental Health Care appeared first on MedCity News.

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PharmaTech

SEPTEMBER 8, 2024

Drug stability impacts efficacy and safety. Choosing the right packaging is crucial. This paper outlines key factors affecting stability and provides packaging guidelines.

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Safety 52

Pharmaceutical Technology

SEPTEMBER 8, 2024

MNV-201 is under clinical development by Minovia Therapeutics and currently in Phase I for Subacute Necrotizing Encephalomyelopathy (Leigh Disease).

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PharmaTech

SEPTEMBER 8, 2024

Insights into molecular behaviors and predictive capabilities are bringing numerous benefits.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Safety

Pharmaceutical Technology

SEPTEMBER 8, 2024

Sonidegib phosphate is under clinical development by Sun Pharma Advanced Research and currently in Phase I for Non-Small Cell Lung Cancer.

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Pharma 52

Pharmaceutical Technology

SEPTEMBER 8, 2024

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Refractory Acute Myeloid Leukemia.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Relapsed Acute Myeloid Leukemia.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

Safinamide mesylate is under clinical development by Zambon Co and currently in Phase II for Drug-Induced Dyskinesia.

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Distribution

Pharmaceutical Technology

SEPTEMBER 8, 2024

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Cardiovascular Disease.

Pharmaceutical 52

Pharmaceutical 52

Pharmaceutical Technology

SEPTEMBER 8, 2024

PEP-07 is under clinical development by Sentinel Oncology and currently in Phase I for Mantle Cell Lymphoma.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

MNV-201 is under clinical development by Minovia Therapeutics and currently in Phase I for Pearson Syndrome.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Gastric Ulcers.

Pharmaceutical 52

Pharmaceutical 52

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Safety

Pharmaceutical Technology

SEPTEMBER 8, 2024

BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Duodenal Ulcer.

Pharmaceutical 52

Pharmaceutical 52

Pharmaceutical Technology

SEPTEMBER 8, 2024

Mirdametinib is a small molecule commercialized by SpringWorks Therapeutics, with a leading Pre-Registration program in Neurofibromatoses Type I (Von Recklinghausen's Disease).

Leads 40

Leads 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

Gedatolisib is a small molecule commercialized by Celcuity, with a leading Phase II program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

Leads 40

Leads 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

Interferon alfa-2b is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase II for Genital Warts (Condylomata Acuminata).

Engineering 40

Engineering 40

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

Pharmaceutical Technology

SEPTEMBER 8, 2024

Navitoclax dihydrochloride is a small molecule commercialized by AbbVie, with a leading Phase III program in Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).

Leads 40

Leads 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

Diazoxide choline CR is a small molecule commercialized by Soleno Therapeutics, with a leading Pre-Registration program in Prader-Willi Syndrome (PWS).

Leads 40

Leads 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

Eblasakimab is a monoclonal antibody commercialized by Aslan Pharmaceuticals, with a leading Phase II program in Atopic Dermatitis (Atopic Eczema).

Leads 40

Leads Pharmaceutical 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

FPI-1434 is a monoclonal antibody conjugated commercialized by Fusion Pharmaceuticals, with a leading Phase II program in Cervical Cancer.

Leads 40

Leads Pharmaceutical 40

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Pharmaceutical Technology

SEPTEMBER 8, 2024

Chenodiol is under clinical development by Mirum Pharmaceuticals and currently in Pre-Registration for Cerebrotendinous Xanthomatosis.

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Pharmaceutical 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

RMC-6236 is a small molecule commercialized by Revolution Medicines, with a leading Phase II program in Metastatic Colorectal Cancer.

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Medicine Leads 40

Pharmaceutical Technology

SEPTEMBER 8, 2024

Omalizumab biosimilar is under clinical development by Kashiv BioSciences and currently in Phase III for Chronic Urticaria Or Hives.

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Pharmaceutical Technology

SEPTEMBER 8, 2024

TN-201 is a gene therapy commercialized by Tenaya Therapeutics, with a leading Phase I program in Hypertrophic Cardiomyopathy.

Leads 40

Leads 40

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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