Fierce Pharma

APRIL 8, 2024

With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.< | With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s reach in the United States.

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FDA 311

MedCity News

APRIL 8, 2024

A new study found that enrollees with zero-premium MA plans are three times as likely to be non-White compared to other MA enrollees and traditional Medicare enrollees. The post Report: How MA Plan Design Affects Utilization, Health Equity appeared first on MedCity News.

Medical 130

Medical 130

Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. | Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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FDA Medicine 285

MedCity News

APRIL 8, 2024

Leaders need a framework to identify, understand, effectively address diversity gaps, and measure improvement across the continuum of care. A data-driven approach can provide valuable insights into demographic trends, disparities in healthcare access and outcomes, and the underlying factors contributing to these discrepancies. The post Overcoming Key Diversity Gaps Within the Healthcare Continuum appeared first on MedCity News.

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Healthcare Healthcare 124

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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

Fierce Pharma

APRIL 8, 2024

The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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FDA 278

MedCity News

APRIL 8, 2024

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

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FDA Patients Marketing Biopharma 123

MedCity News

APRIL 8, 2024

UPMC researchers published a study demonstrating the efficacy of Pip Care, a surgical app and healthcare coaching platform. The research showed patients who used Pip Care reduced their hospital stay by nearly a day and cut in half their risk of readmission within a week of surgery compared to those who didn’t. The post Meet The App UPMC Is Using To Slash Surgical Patients’ Readmission Risk by Half appeared first on MedCity News.

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Patients Healthcare Healthcare 116

Fierce Pharma

APRIL 8, 2024

As Pfizer races to grow the respiratory syncytial virus (RSV) vaccine market along with rival GSK, the company has been looking to expand its vaccine's reach. | As Pfizer races to grow the RSV vaccine market along with rival GSK, the company has been looking to expand its vaccine's reach. Now, with fresh data for Abrysvo in adults at higher risk of disease, the New York drugmaker is plotting a new approval filing.

Marketing 174

Marketing 174

MedCity News

APRIL 8, 2024

To ward off the worsening economic impact and escalating costs associated with neglected oral health in the U.S., we must work with policymakers and state governments to expand access to routine dental healthcare and improve dental insurance availability and service coverage for all. The post The Price We Pay for Poor Oral Health appeared first on MedCity News.

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Insurance Government Healthcare Healthcare 116

Healthcare Success

APRIL 8, 2024

As an engineering undergrad, I took a Marketing 101 class on a lark, seeking to better understand the psychology behind consumer behavior and developing products with a competitive edge. On the first day of class, we learned the fundamental concept of the 4 Ps of marketing. However, today, I like to use an expanded “7 Ps” definition. In any event, this marketing mix remains essential for any successful marketing strategy.

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Marketing Competition Patients Healthcare 112

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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

MedCity News

APRIL 8, 2024

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class. The post AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med appeared first on MedCity News.

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FDA Medical Biopharma Pharma 114

PharmaVoice

APRIL 8, 2024

The market is huge, but will companies overcome the triple hurdles of payer hesitance, prescriber reluctance and sluggish consumer demand?

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Doctors Marketing 122

Pharmaceutical Commerce

APRIL 8, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value & Access Advisor, Schoonveld Advisory, offers his thoughts on lower drug prices in the US and provides a sneak peak into future PC features.

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Pharma 105

PharmaVoice

APRIL 8, 2024

GenAI is profoundly reshaping various facets of the pharmaceutical industry. Projections indicate that the global GenAI market in pharma will soar to USD 2258.1 million by 2032.

Pharma 106

Pharma Pharmaceutical Marketing 106

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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.

Specialization

pharmaphorum

APRIL 8, 2024

Drugs from Ionis and Arrowhead Pharma that block apolipoprotein C-III (apoC-III) have shown their value in treating diseases associated with elevated triglyceride levels in two studies presented at the American College of Cardiology annual congress. The two companies are racing to bring their apoC-III inhibitors to market for severe hypertriglyceridaemia (HTG) and ultra-rare disorder familial chylomicronaemia syndrome (FCS).

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Pharma Marketing 102

PharmaVoice

APRIL 8, 2024

Underrepresentation of women in clinical trials affects the resulting drugs that are available down the line. Encouraging more women to partake is a critical step in promoting more equitable healthcare.

Healthcare 106

Healthcare Healthcare 106

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) is indicated for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

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Food and Drug Administration FDA Medicine Physicians 98

pharmaphorum

APRIL 8, 2024

SGLT2 inhibitors have transformed the treatment of heart failure in the last few years, but an attempt to extend their use into the setting of post-heart attack patients has suffered a setback.

Patients 97

Patients 97

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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

APRIL 8, 2024

The FDA has approved the NDA for SH-201, an oral liquid drug that slows or stops the growth of certain types of leukaemia.

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FDA 105

pharmaphorum

APRIL 8, 2024

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

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FDA 93

Pharmaceutical Technology

APRIL 8, 2024

Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma have received FDA approval for relapsed or refractory multiple myeloma (RRMM).

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FDA 95

pharmaphorum

APRIL 8, 2024

FDA approves AstraZeneca and Daiichi Sankyo’s Enhertu for all HER2-positive solid tumours, in a first for both the HER2 inhibitor and ADC category.

FDA 100

FDA 100

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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.

Management

Pharmaceutical Technology

APRIL 8, 2024

J&J and Legend’s CAR-T cell therapy has been approved as a second-line therapy for patients with multiple myeloma (MM).

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FDA Patients 98

PharmaTimes

APRIL 8, 2024

The project aims to advance therapeutics for tuberculosis, malaria and hepatitis C in LMICs

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Integrity Solutions

APRIL 8, 2024

Sales has always meant navigating highs and lows, dealing with rejection and remaining focused in the face of new business demands and pressures. Lately, though, it’s as if those pressures have been magnified times ten. As the sales environment has grown more complex, one of the biggest challenges salespeople are confronting is an internal one: how to stay self-motivated when sales conversations are harder to come by, buying cycles are only getting longer , buying committees are larger tha

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Sales Training Product Knowledge Management 73

PharmaTimes

APRIL 8, 2024

Around three million people in the UK were estimated to be living with cancer in 2022

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Healthcare Healthcare Pharmaceutical 104

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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

Integrity Solutions

APRIL 8, 2024

Sales has always meant navigating highs and lows, dealing with rejection and remaining focused in the face of new business demands and pressures. Lately, though, it’s as if those pressures have been magnified times ten. As the sales environment has grown more complex, one of the biggest challenges salespeople are confronting is an internal one: how to stay self-motivated when sales conversations are harder to come by, buying cycles are only getting longer , buying committees are larger tha

Sales 64

Sales Training Product Knowledge Management 64

Pharmaceutical Commerce

APRIL 8, 2024

The latest news for pharma industry insiders.

Pharma 101

Pharma Medical 101

PharmaTech

APRIL 8, 2024

Ensure the success of clinical biomanufacturing programs by focusing on key tech transfer practices from the sponsor, commercial, scientific, and program management stakeholders.

Manufacturing 52

Manufacturing Management 52

PharmExec

APRIL 8, 2024

PIONEER AF-PCI exploratory trial found that elderly patients experienced a lower rate of clinically significant bleeding after 12 months of treatment with Xarelto (rivaroxaban).

Patients 52

Patients 52

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients