Sun.Nov 05, 2023

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Biotech Startup Triveni Unveils $92M to Address Barrier to Treating Inflammation

MedCity News

Available atopic dermatitis drugs work by blocking inflammation, but Triveni Bio is developing an antibody that addresses a root cause of the chronic condition. The startup is out of stealth to advance its lead program and a pipeline of other inflammation and immunology drugs.

Leads 122
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Innoviva’s ‘game changer’ antibiotic tackles gonorrhoea

pharmaphorum

Innoviva’s ‘game changer’ antibiotic tackles gonorrhoea Phil.

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Trending Sources

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West Monroe: 64% of Health Insurer Execs Say Digital Transformation is a Top Priority

MedCity News

Despite most insurer execs saying that digital transformation is a top priority, only 8% believe the majority of their staff embrace digital transformation, according to data from West Monroe.

Insurance 114
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5 Mistakes In Key Account Selection

Cesare Ferrari

In my previous post, I discussed key accounts and their role in product development. Today I would take the analysis several steps further by sharing a few common mistakes in selecting and categorizing key accounts.   In my experience in medical device marketing, suppliers and distributors are frequently small and medium size companies and I have always believed their process to properly identify and select their key accounts can be improved.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A Paradigm Shift Towards Reimbursing the Root Causes of Diseases

MedCity News

Medicare needs to incentivize providers by reimbursing them for identifying and addressing social determinants of health. Doing so will ultimately improve patient health outcomes and simultaneously save risk-bearing organizations money.

Patients 115
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Unlocking Revenue: Top Sales Strategy Examples from Industry Leaders

Contrarian Sales Techniques

In the ever-evolving landscape of global commerce, the art of selling has become a nuanced ballet of persuasion, analytics, and strategy. The difference between stagnant sales and exponential growth can often be traced back to a company’s willingness to adapt and innovate in its sales strategy. As we pull back the curtain on the sales strategies of industry titans, we find actionable insights ripe for the picking.

More Trending

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Case Study: Meeting An Aggressive Go-To-Clinic Timeline

PharmaTech

When a large CDMO couldn’t give a mid-size pharma company the proper attention, Adare stepped in to help manufacture CTM batches and get their project to the clinic quickly.

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The Case for Hiring an Investment Bank: Adding Value to Your Value Proposition

MedCity News

The “right” investment banker for you with the appropriate experience can not only tell you what your company is worth, they can also utilize their expertise to establish and run an appropriate, bespoke transaction process that will serve to reduce risk and maximally benefit you and your company’s future potential, valuation or even sale price – and they should be equally willing and able to

Sales 106
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Improving Care for Patients with Kidney Disease Who Are Pregnant, Undergoing Dialysis

Pharmacy Times

Other than dialysis, Shah notes that patients with kidney disease who are pregnant can receive either nifedipine or labetalol to control blood pressure.

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Signal: Medtech’s Covid boom is well and truly over as Avail, Olive shutter

Pharmaceutical Technology

Two more medtech darlings have closed their doors this week, signalling an end to the funding rush of Covid.

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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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Novel Biomarkers, Diagnostic Approaches for Subtyping Bone Turnover, Improving Patient Outcomes

Pharmacy Times

Nickolas also describes how the use of novel imaging technologies, microRNA, and transcriptomics help experts better understand underlying pathogenesis of ROD.

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ABP-671 by Jiangsu Atom Bioscience and Pharmaceutical for Hyperuricemia: Likelihood of Approval

Pharmaceutical Technology

ABP-671 is under clinical development by Jiangsu Atom Bioscience and Pharmaceutical and currently in Phase II for Hyperuricemia.

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Systemic Issues Contribute to Health Inequities in LGBTQ+ Community

Pharmacy Times

Deep-rooted discrimination and stigma can contribute to stressors that worsen disease progression and access to care, according to experts.

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KT-253 by Kymera Therapeutics for Myeloproliferative Disorders: Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myeloproliferative Disorders.

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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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Streamline Early-Stage Development to Reach the Clinic Faster

PharmaTech

In this article, gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.

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XB-002 by Exelixis for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval

Pharmaceutical Technology

XB-002 is under clinical development by Exelixis and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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Nitrosamine Impurities Deadline: Are You Compliant?

PharmaTech

A discussion of the FDA's guidance on nitrosamine impurities, various approaches for reducing the presence of impurities, and how Adare's unique nitrosamine mitigation process can help products achieve compliance.

FDA 40
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KT-253 by Kymera Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).

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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.

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Overcoming The Challenges Of Pediatric Formulation

PharmaTech

To help improve adherence in children, drug developers need to consider innovative new dosage forms that can deliver flexible and convenient medications for young patients.

Medical 40
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KT-253 by Kymera Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).

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BGB-16673 by BeiGene for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval

Pharmaceutical Technology

BGB-16673 is under clinical development by BeiGene and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).

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ALTO-100 by Alto Neuroscience for Post-Traumatic Stress Disorder (PTSD): Likelihood of Approval

Pharmaceutical Technology

ALTO-100 is under clinical development by Alto Neuroscience and currently in Phase II for Post-Traumatic Stress Disorder (PTSD).

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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ALTO-100 by Alto Neuroscience for Post-Traumatic Stress Disorder (PTSD): Likelihood of Approval

Pharmaceutical Technology

ALTO-100 is under clinical development by Alto Neuroscience and currently in Phase II for Post-Traumatic Stress Disorder (PTSD).

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KT-253 by Kymera Therapeutics for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Refractory Acute Myeloid Leukemia.

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Birociclib by Sihuan Pharmaceutical Holdings Group for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Birociclib is under clinical development by Sihuan Pharmaceutical Holdings Group and currently in Phase I for Solid Tumor.

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KT-253 by Kymera Therapeutics for Myeloproliferative Disorders: Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myeloproliferative Disorders.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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ALTO-300 by Alto Neuroscience for Major Depressive Disorder: Likelihood of Approval

Pharmaceutical Technology

ALTO-300 is under clinical development by Alto Neuroscience and currently in Phase II for Major Depressive Disorder.

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ABSK-021 by Abbisko Therapeutics for Small-Cell Lung Cancer: Likelihood of Approval

Pharmaceutical Technology

ABSK-021 is under clinical development by Abbisko Therapeutics and currently in Phase I for Small-Cell Lung Cancer.

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(Favezelimab + pembrolizumab) by Merck for Bladder Cancer: Likelihood of Approval

Pharmaceutical Technology

(Favezelimab + pembrolizumab) is under clinical development by Merck and currently in Phase II for Bladder Cancer.

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KT-253 by Kymera Therapeutics for Myelodysplastic Syndrome: Likelihood of Approval

Pharmaceutical Technology

KT-253 is under clinical development by Kymera Therapeutics and currently in Phase I for Myelodysplastic Syndrome.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.