Sun.Sep 08, 2024

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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

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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Rural Healthcare Goes Beyond Care: Targeting SDOH to Improve Health Outcomes

MedCity News

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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WCLC: MSD/Daiichi build case for phase 3 ADC for lung cancer

pharmaphorum

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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These Are 2 of The Biggest Issues with Healthcare AI, According to an FDA Reviewer

MedCity News

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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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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First bird flu case with no known animal contact seen in US

pharmaphorum

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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A Biotech Going Through the Nose to Treat the Brain Plots Alternative Path to Public Markets

MedCity News

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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Supreme Court’s Chevron Decision Threatens Decades of Progress in Access to Mental Health Care

MedCity News

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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Enhancing Drug Stability via Packaging Choice

PharmaTech

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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MNV-201 by Minovia Therapeutics for Subacute Necrotizing Encephalomyelopathy (Leigh Disease): Likelihood of Approval

Pharmaceutical Technology

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

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Molecular Modeling in Formulation Development

PharmaTech

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

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

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Sonidegib phosphate by Sun Pharma Advanced Research for Non-Small Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

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

Pharma 52
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PEP-07 by Sentinel Oncology for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

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

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PEP-07 by Sentinel Oncology for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

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

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Safinamide mesylate by Zambon Co for Drug-Induced Dyskinesia: Likelihood of Approval

Pharmaceutical Technology

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

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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BR-6002 by Boryung Pharmaceutical for Cardiovascular Disease: Likelihood of Approval

Pharmaceutical Technology

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

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PEP-07 by Sentinel Oncology for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

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

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MNV-201 by Minovia Therapeutics for Pearson Syndrome: Likelihood of Approval

Pharmaceutical Technology

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

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BR-6002 by Boryung Pharmaceutical for Gastric Ulcers: Likelihood of Approval

Pharmaceutical Technology

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

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BR-6002 by Boryung Pharmaceutical for Duodenal Ulcer: Likelihood of Approval

Pharmaceutical Technology

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

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Risk adjusted net present value: What is the current valuation of SpringWorks Therapeutics’s Mirdametinib?

Pharmaceutical Technology

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
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Risk adjusted net present value: What is the current valuation of Celcuity’s Gedatolisib?

Pharmaceutical Technology

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
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Interferon alfa-2b by Center for Genetic Engineering and Biotechnology for Genital Warts (Condylomata Acuminata): Likelihood of Approval

Pharmaceutical Technology

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

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Risk adjusted net present value: What is the current valuation of AbbVie’s Navitoclax dihydrochloride?

Pharmaceutical Technology

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
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Risk adjusted net present value: What is the current valuation of Soleno Therapeutics’s Diazoxide choline CR?

Pharmaceutical Technology

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

Leads 40
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Risk adjusted net present value: What is the current valuation of Aslan Pharmaceuticals’s Eblasakimab?

Pharmaceutical Technology

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

Leads 40
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Risk adjusted net present value: What is the current valuation of Fusion Pharmaceuticals’s FPI-1434?

Pharmaceutical Technology

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

Leads 40
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Chenodiol by Mirum Pharmaceuticals for Cerebrotendinous Xanthomatosis: Likelihood of Approval

Pharmaceutical Technology

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

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Risk adjusted net present value: What is the current valuation of Revolution Medicines’s RMC-6236?

Pharmaceutical Technology

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

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Omalizumab biosimilar by Kashiv BioSciences for Chronic Urticaria Or Hives: Likelihood of Approval

Pharmaceutical Technology

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

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Risk adjusted net present value: What is the current valuation of Tenaya Therapeutics’s TN-201?

Pharmaceutical Technology

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

Leads 40
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.