Fierce Pharma

JULY 9, 2024

Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team, shaking up its structure, personnel and operations. | Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team. And the division’s newly named commercial chief Christine Roth is among those changes.

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MedCity News

JULY 9, 2024

Illinois, Kentucky, Oregon, Utah and Vermont have been authorized by HHS to provide Medicaid/Children’s Health Insurance Program coverage to those transitioning out of incarceration up to 90 days before they’re released. Several healthcare leaders called the action a necessary step. The post Health Leaders Applaud HHS’ Action Giving Some Incarcerated Individuals Medicaid Coverage Before Release appeared first on MedCity News.

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Fierce Pharma

JULY 9, 2024

Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. | Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. House Speaker Mike Johnson has pledged to hold a vote for the controversial bill before the year is out.

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MedCity News

JULY 9, 2024

A uniQure gene therapy for Huntington’s disease has interim clinical data showing an 80% slowing of disease progression. An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. The post With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA appeared first on MedCity News.

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Fierce Pharma

JULY 9, 2024

As Gilead Sciences tussles with a web of HIV drug litigation, a high-stakes case tied to patents for prevention medicines is coming back to test the drugmaker. | As Gilead Sciences tussles with a web of HIV med litigation, a case tied to patents for prevention regimens of Truvada and Descovy is not quite settled. Late last week, the U.S. government appealed Gilead's prior win in the fight.

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Eversana Intouch

JULY 9, 2024

MM+M recently named Agios Pharmaceuticals’ “Do You See It?” campaign as their Campaign of the Week! The campaign focuses on the hidden dangers of thalassemia, a rare genetic condition affecting an estimated 8,000 Americans. The disease can result in anemia-like symptoms, with severe cases requiring regular blood transfusions, while milder cases often go untreated.

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European Pharmaceutical Review

JULY 9, 2024

Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceutical products. The team tested various samples two ion chromatography analytical methods. This included a range of water types eg, purified and potable water, according to the paper. Kumar et al. explained that “accurate determination of nitrite content in process water will support an understanding of the potential for nitrosamine formation from nitrite in process water

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Fierce Pharma

JULY 9, 2024

A storm of scrutiny relating to Johnson & Johnson’s pricing and patenting of its tuberculosis med bedaquiline (branded as Sirturo) is clearing up after reaching a fever pitch last year. | The country's antitrust authority opened a probe into J&J last year after it filed for a secondary patent on its tuberculosis drug. Now, authorities won't move forward with a complaint.

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MedCity News

JULY 9, 2024

Here’s a look at three innovative software solutions that support healthcare transformation and are having a significant impact. The post Streamlining Healthcare: How Technology is Removing Friction for Providers appeared first on MedCity News.

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Healthcare Healthcare 103

Fierce Pharma

JULY 9, 2024

Introduction | PhytoSquene® is the world’s first GMP-quality, plant-based squalene. Read this study to find out how it compares to shark-derived squalene.

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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.

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pharmaphorum

JULY 9, 2024

After languishing in the doldrums for a few quarters, there are signs that the winds of investment are starting to blow again in the US digital health sector.

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MedCity News

JULY 9, 2024

HarmonyCares raised $200 million dollars to scale its in-home primary care delivery model for high-risk senior patients. The money will be used to expand HarmonyCares’ market reach, particularly in the Medicare Advantage space — even as health systems continue to drop their MA contracts. The post HarmonyCares Snags $200M to Scale Its In-Home Primary Care Model For Medicare & MA Plans appeared first on MedCity News.

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pharmaphorum

JULY 9, 2024

A long-awaited report from the US Federal Trade Commission (FTC) on pharmacy benefit managers (PBMs) is out – and will make uncomfortable reading for the pharma supply chain middlemen.Its central message is clear. The six largest PBMs in the US manage nearly 95% of all prescriptions filled in the US, a “concentrated market structure” that has allowed them to “profit at the expense of patients and independent pharmacists,” according to the financial regulator.

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PharmaVoice

JULY 9, 2024

Vetigenics believes it’s found a way to make pricey antibody-based technologies more accessible for animals.

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MedCity News

JULY 9, 2024

Achieving true national interoperability requires that all constituents have access to information that is trustworthy, accurate and presented in a way that is usable and actionable. The post The Healthcare Interoperability Road Trip – “Are We There Yet?” appeared first on MedCity News.

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Healthcare Healthcare 77

PharmaTimes

JULY 9, 2024

Myricx Bio’s therapies include treatments for breast, lung and colorectal cancer

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MedCity News

JULY 9, 2024

In healthcare, a faulty algorithm can be a matter of life and death. The post Reining In the Wild West of AI appeared first on MedCity News.

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PharmaTimes

JULY 9, 2024

The serious, progressive kidney disease affects nearly 850 million people worldwide

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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

pharmaphorum

JULY 9, 2024

In this latest pharmaphorum podcast, web editor Nicole Raleigh speaks with Michael Kyle, chief medical officer at Currax Pharmaceuticals – a company working to advance a greater understanding of how to effectively treat obesity – about perceptions and options beyond the bounds of GLP-1s, including evolution of hypertension treatments.

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Pharmaceutical Commerce

JULY 9, 2024

The latest news for pharma industry insiders.

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pharmaphorum

JULY 9, 2024

Roche will reintroduce its Susvimo implant wet AMD, which was withdrawn from sale in 2022 due to manufacturing defects.

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PharmaVoice

JULY 9, 2024

Recent history suggests an Alzheimer’s approval doesn’t necessarily translate to market triumph. Perhaps for Eli Lilly’s Kisunla, this time could be different.

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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

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pharmaphorum

JULY 9, 2024

Mikael Dolsten exits Pfizer, putting R&D leadership in flux Phil.

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PharmExec

JULY 9, 2024

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

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FDA 52

Penrod

JULY 9, 2024

The full AHA Lawsuit order can be read here. The order follows years of criticism from the AHA, who viewed the bulletin as an overextension of executive power that prevented providers from serving their communities via online trackers that improved web experiences. However, the order was surprisingly narrow in scope. What does this mean for providers?

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PharmExec

JULY 9, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, discusses results of the Femaseed pivotal trial, Fembloc birth control, and how the outcome of the 2024 United States presidential election could impact women's health.

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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

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Penrod

JULY 9, 2024

Google’s Policy Restrictions on Healthcare Advertising Google’s internal rules heavily restrict healthcare players like pharmaceutical manufacturers. The search engine imposes strict policies to ensure that health-related ads are accurate, ethical, and compliant with legal standards. Some of the most important policy guidelines include the following. 1.

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PharmExec

JULY 9, 2024

Executives in the life sciences and medical device industries see promise in artificial intelligence (AI) and medical technologies, but must also navigate the changing healthcare ecosystem, varied stakeholder needs, and the impact of AI on market access and commercialization strategies.

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Pharmacy Times

JULY 9, 2024

In a new report, the FTC says pharmacy benefit managers act as middlemen in the pharmaceutical industry, leading to the squeezing of independent pharmacies and increases in prices for patients.

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PharmExec

JULY 9, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, discusses results of the Femaseed pivotal trial, Femblock birth control, and how the outcome of the 2024 United States presidential election could impact women's health.

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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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