Fri.Aug 09, 2024

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Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

Fierce Pharma

With Gilead's stated focus to grow in oncology, the company's recent quarterly updates have placed a heavy emphasis on its developments in the cancer space. | The HIV-focused drugmaker looks to position its long-acting Sunlenca as a prime PrEP option after the med aced a phase 3 study.

Marketing 299
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An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs

MedCity News

The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. The post An Upcoming White House Decision May Jeopardize Americans’ Access to Life-Saving Drugs appeared first on MedCity News.

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Purdue, after playing major role in US opioid epidemic, wins FDA nod for overdose-reversal injection

Fierce Pharma

As Purdue Pharma attempts to restore its image following its role in | As Purdue Pharma attempts to restore its image following its role in the U.S. opioid crisis, the Connecticut-based company has scored a win with a green light for a new overdose rescue treatment.

Pharma 290
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A Snapshot of MedCity’s INVEST Conferences

MedCity News

This latest eBook highlights the content of our conferences — INVEST in Chicago and INVEST Digital Health in Dallas. It spotlights talks such as Small business Education and Entrepreneurial Development funding, investor perspectives on AI, women’s health, health tech implementation, medtech trends, cybersecurity, and drug development innovation.

Education 102
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor

Fierce Pharma

Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged. | Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged.

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Eleanor Health, Thriveworks Launch Partnership To Support Patients With SUD

MedCity News

Through a new partnership, Eleanor Health’s patients can access Thriveworks’ therapists for additional mental health support beyond their substance-use disorder, including couples and family counseling. Likewise, Thriveworks’ patients in Louisiana, Massachusetts, New Jersey, North Carolina, Ohio, Texas and Washington can receive substance-use disorder treatment from Eleanor Health.

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“Friendly” PC Models: Key Contractual and Compliance Considerations

MedCity News

Business and compliance considerations for MSOs and PCs, the contractual structure, and general recommendations for establishing a model that runs efficiently and mitigates levels of risk The post “Friendly” PC Models: Key Contractual and Compliance Considerations appeared first on MedCity News.

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Revolutionising Drug Discovery: The Impact of AI and Patient-on-Chip Technology

Pharma IQ

Discover how AI and patient-on-chip technology are revolutionising drug discovery and development.

Patients 100
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Pharma execs react to final drug price negotiations with Medicare

PharmaVoice

Here’s what the leaders of the companies with the 10 drugs in the first wave of price negotiations with Medicare said about how the new prices will impact their portfolio.

Pharma 89
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Children and Mental Health: Using Behavioral Activation to Combat the ‘Summer Slump’

MedCity News

It’s important to keep in mind that parents, with physician support, can beat the summer slump, particularly with planning and resources. Behavioral activation includes scheduling activities that encourage children to reconnect with environmental positive reinforcement and decrease avoidant behaviors and negative emotions. The post Children and Mental Health: Using Behavioral Activation to Combat the ‘Summer Slump’ appeared first on MedCity News.

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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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Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue

Pharmaceutical Technology

Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.

Sales 98
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Lilly says tirzepatide supply issues are resolving

pharmaphorum

Eli Lilly raises guidance for 2024 by $3 billion on strong growth for tirzepatide in diabetes and obesity and improved supply capacity

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KCL and UCL scientists develop accurate AI brain imaging model for research

PharmaTimes

In the UK, there are an estimated 11 million people living with a neurological condition

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Second time lucky at FDA for Citius' lymphoma drug

pharmaphorum

At the second attempt, the FDA has approved Citius Pharmaceuticals' Lymphir for rare lymphoma CTCL

FDA 107
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Study reveals genetic variants are more common in Parkinson’s disease patients

PharmaTimes

The study revealed that 13% of patients have a genetic form of the neurological disease

Patients 101
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How the GLP-1 receptor agonist market could hit $168bn by 2033

Pharmaceutical Technology

In the past few years, there has been a significant increase in the use of GLP-1 receptor agonists as a treatment for Type 2 diabetes and obesity.

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More bad vibes for TIGIT as MSD stops another trial

pharmaphorum

Another TIGIT trial failure has been abandoned, casting a shadow once again over the target as a cancer immunotherapy strategy.The latest setback is in a phase 3 trial of MSD's anti-TIGIT antibody vibostolimab and PD-1 inhibitor pembrolizumab in small cell lung cancer (SCLC), with a lack of efficacy and side effects both contributing to the decision.

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US Drug Wholesaling 2024: Staying the Course

Pharmaceutical Commerce

Even as pharma technology evolves, and payers argue over reimbursement practices throughout healthcare, drug wholesaling is a thriving business.

Pharma 64
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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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HDFN drug trial shows capability for alloimmune diseases

European Pharmaceutical Review

Clinical data indicates that nipocalimab could provide benefit to foetuses, newborns and pregnant mothers at risk for a rare blood disorder. Findings from the Phase II UNITY study show that the treatment has potential to delay or prevent anaemia and the need for intrauterine blood transfusions in babies who are at high risk for haemolytic disease of the foetus and newborn (HDFN).

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Abzena, Angiex Collaborate for Phase I Trial of Solid Cancer Tumor Therapy

PharmaTech

AGX101 targets the cancer cells and vasculature of a tumor, and works to eliminate the tumor blood vessels, kill tumor cells capable of invasion or metastasis, and direct the immune system to attack the cancer.

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Merck to Acquire Investigational Bispecific Antibody for B-Cell Associated Diseases From Curon Biopharmaceutical

PharmExec

As part of the acquisition of CN201, Curon is expected to receive an upfront payment of $700 million, with the opportunity to earn an additional $600 million in milestone payments linked to the drug's development and regulatory approval.

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Focusing on Psychosocial Factors

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, outlines the main challenges surrounding medication adherence.

Pharma 52
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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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FDA Approves Citius Pharmaceuticals’ Lymphir for Relapsed or Refractory Cutaneous T-Cell Lymphoma

PharmExec

Lymphir is the first therapy to target the IL-2 receptor in the treatment of relapsed or refractory cutaneous T-cell lymphoma and the first FDA-approved product for Citius Pharmaceuticals.

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Leadership, Business, Safety: How You Can Impact Your Workplace

Scott Burrows

In my time as a keynote speaker, I have found that my story resonates with groups in high-risk occupations. About 6 months ago, I had the privilege of delivering a presentation on Business, Leadership, and Safety to leaders and supervisors at the Elevator Contractors Association Annual Meeting. The crowd was amazing, everyone was so lively and willing to learn.

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Getting Unstuck on the Path to Digital Transformation

Pharmaceutical Commerce

The transition to AI and machine learning was well underway long before ChatGPT burst onto the marketplace; however, organizations were, and still are, constrained by data challenges.

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Balancing Profitability and Mission

PharmExec

In this part of his Pharmaceutical Executive video interview, Brian Hillberdink, EVP, LEO Pharma and President of LEO Pharma's US affiliate, talks about how they balance the need for profitability with the mission of providing treatments for rare diseases.

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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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More bad news for TIGIT as MSD stops another trial

pharmaphorum

MSD abandons another phase 3 TIGIT inhibitor trial, in another setback for the beleaguered cancer immunotherapy class

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FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis

PharmExec

Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections.

FDA 52
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Enhancing Patient Access and Support Through Technology: A Comprehensive Assessment

Pharmaceutical Commerce

Why the integration of AI-enabled solutions has the potential to boost patient support and engagement across numerous patient care settings.

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Could the Jobs Report Help Reverse Biotech’s Underperformance?

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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.