Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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Pharmaceutical Technology

MARCH 11, 2024

Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.

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Fierce Pharma

MARCH 11, 2024

Bluebird Bio has secured its first Medicaid outcomes-based agreement for its sickle cell disease gene therapy Lyfgenia, signing on with Michigan.

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pharmaphorum

MARCH 11, 2024

Shares in Amylyx have cratered after the company reported a confirmatory trial of its amyotrophic lateral sclerosis (ALS) therapy Relyvrio missed all its objectives, putting its accelerated approval in jeopardy.

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Fierce Pharma

MARCH 11, 2024

Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Co | Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Copaxone.

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FDA 220

MedCity News

MARCH 11, 2024

On Monday at HIMSS24, Innovaccer unveiled a preview of its new AI copilot for providers, which is slated to go on the market by the end of 2024. The solution is a portable tablet device designed to provide clinicians with point-of-care support — it flags care and coding gaps, assists with clinical documentation and advises clinicians on possible diagnosis pathways.

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European Pharmaceutical Review

MARCH 11, 2024

Since the HIV epidemic began in the early 1980s, more than 85 million people have been diagnosed worldwide and about 40 million have died as a result of complications from the virus. 1 Now, four decades later, 39 million people around the world are living with HIV, primarily due to advances in treatment. 1 With continued innovation on the horizon in terms of prevention and treatment methods, what was once a wishful hope of ending the epidemic has become a conceivable goal.

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Medicine Pharmacology Healthcare Healthcare 92

Fierce Pharma

MARCH 11, 2024

Ever since its first FDA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. | The company hopes its long and bumpy five-year journey will soon see an end with an FDA approval. Lexicon looks to resubmit the drug by the middle of the year.

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MedCity News

MARCH 11, 2024

With its acquisition of TAO Connect, UpLift now serves over 170 enterprise customers in the U.S. and Canada. It covers four million people, including more than two million students at more than 120 higher education institutions.

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Education 88

Fierce Pharma

MARCH 11, 2024

Ahead of a high-stakes FDA meeting to review CAR-T data in multiple myeloma, Legend Biotech CEO Ying Huang, Ph.D., laid out some of his expectations about the event. | J&J and Legend have submitted two more overall survival updates for Caryvkti since the original data release last year, Legend's CEO said on an analyst call. The FDA is expected to release more data on the CAR-T therapy later this week, ahead of an advisory committee meeting set for Friday.

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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

European Pharmaceutical Review

MARCH 11, 2024

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. The authors explained: “inadequate sterile compounding techniques or storage conditions, or exceeding the limit of a fungal count, can result in fungal contamination.

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pharmaphorum

MARCH 11, 2024

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese

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FDA 86

European Pharmaceutical Review

MARCH 11, 2024

The manufacturer Olympus Corporation has announced the rescission of an earlier acquisition deal due to reported data integrity issues of medical device products from Taewoong Medical Co., Ltd. Olympus originally announced the closing of its agreed share acquisition of Taewoong Medical in January 2024. Data integrity issues The concerns around these products were found after the closing of the deal, Olympus noted.

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MedCity News

MARCH 11, 2024

We can no longer simply worry about the enrollment form as the only hurdle in therapy initiation. We must view the entire patient journey as an interconnected set of challenges that need solving. And I believe achieving that goal is within reach.

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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

Pharmaceutical Commerce

MARCH 11, 2024

A USC study discovers that an increasing share of both generic and brand-name meds are being excluded from approval.

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MedCity News

MARCH 11, 2024

Episode 2 of the Debunked (audio) show focuses on how hospitals are inflating prices for outpatient procedures and how California is looking at healthcare M&A and trying to address price increases and anti-competitive behavior.

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Competition Healthcare Healthcare 80

Pharmaceutical Technology

MARCH 11, 2024

Boehringer Ingelheim has entered a deal with Sosei Heptares for the development of treatments for all schizophrenia symptoms.

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pharmaphorum

MARCH 11, 2024

Boehringer Ingelheim has taken an option on a family of GPR52 agonist compounds with potential in schizophrenia from Sosei Heptares, in a €755m deal

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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

MedCity News

MARCH 11, 2024

Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025.

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Biopharma Pharma 70

pharmaphorum

MARCH 11, 2024

J&J says oral IL-23 inhibitor JNJ-2113 shows a durable effect in psoriasis, making it a potential companion to its injectable Tremfya.

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Pharmaceutical Technology

MARCH 11, 2024

Discover how 4D Molecular Therapeutics Inc. is revolutionizing gene therapy with a patent for delivering nucleic acids to treat disorders like Fabry disease.

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MedCity News

MARCH 11, 2024

By eliminating the term “obesity” in favor of person-centric language, we pave the way for a more equitable healthcare system that prioritizes the well-being of all individuals, regardless of their size or shape.

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Healthcare Healthcare Management 60

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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

Pharmaceutical Technology

MARCH 11, 2024

Sun Pharma has announced a recall of 55,000 bottles of Febuxostat, a medication used to treat gout, from the US market

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Pharma Medical Marketing 80

PharmaTimes

MARCH 11, 2024

The neurodevelopmental condition affects up to four in 100 children

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PharmaVoice

MARCH 11, 2024

One rare disease survivor’s diagnosis experience highlights the need for pharma companies to better understand the patient journey.

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Pharma Patients 64

PharmExec

MARCH 11, 2024

In an interview with Pharm Exec, Chris Down, SVP, Market Development, ConnectiveRx, gives his thoughts on the evolution of copay adjustment and accumulator programs in healthcare.

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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

Pharmaceutical Technology

MARCH 11, 2024

However, a significant limitation of the early data is that the majority of trial participants were excluded from the analysis following GCP violations at multiple trial sites.

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Spotio

MARCH 11, 2024

In a world where revenue is king, it’s natural to design your sales incentives programs to reward those with the highest sales. While this method make sense, it’s flawed. It keeps top performers motivated but doesn’t engage the rest of the team who can’t see themselves in that top spot. Sales contests are a great way to motivate the whole team. Beyond rewarding sales and revenue, they offer the ability to reward many different types of actions that align with your business objectives.

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Pharmaceutical Commerce

MARCH 11, 2024

The company’s twice-daily, branded ruxolitinib cream 1.5% presents a significant reduction in abscess and inflammatory nodule (AN) count for the treatment of Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa.

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Patients 52

PharmExec

MARCH 11, 2024

In this Pharmaceutical Executive video interview, Chris Dowd, senior vice president of market development, ConnectiveRx, discusses the evolution of drug copay adjustment programs and the circumstances that fueled their controversy across industry, political, and healthcare community circles.

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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