Fierce Pharma

MAY 3, 2024

Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. | Shortly after Novo Holdings’ parent company elected to resubmit paperwork around the investment firm’s proposed $16.5 billion buyout of CDMO giant Catalent, the U.S. Federal Trade Commission has teed up a further extension on the deal’s review period.

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MedCity News

MAY 3, 2024

Hospitals’ operating margins and patient volumes dropped slightly in March. While hospitals were doing relatively well financially during the first quarter of the year, this new data could suggest more financial challenges ahead for hospitals. But right now, it’s unclear whether the recent declines in hospitals’ margins and volumes will be short- or long-term.

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Patients 123

Fierce Pharma

MAY 3, 2024

During the Q&A portion of Amgen’s quarterly conference call Thursday, eight of the first nine questions were about the company’s investigational efforts in obesity. | The buzz about Amgen’s obesity prospects overshadowed the company’s solid work on the top line as revenue came in at $7.4 billion for a 22% increase. Much of the boost can be attributed to sales of products acquired in Amgen’s $27.8 billion buyout of Horizon Therapeutics, which was completed early in the fourth quarter of last

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Prospecting Sales 280

MedCity News

MAY 3, 2024

Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1. The post Amgen Puts Its Weight Behind Obesity Drug With Potential Edge Over Lilly, Novo Nordisk Meds appeared first on MedCity News.

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Fierce Pharma

MAY 3, 2024

Watch out, Incyte. Leo Pharma and its JAK inhibitor cream delgocitinib are coming to disrupt the topical atopic dermatitis market, currently inhibited by Incyte’s approved Opzelura. | Leo Pharma's delgocitinib, which the company calls a potential growth driver, could shake up the topical JAK market and put pressure on Incyte's approved Opzelura.

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Pharma Marketing 279

MedCity News

MAY 3, 2024

Offering blended options, individual risk pools, and net neutral capitation payments providers can embark on their journey toward value-based care at a pace aligned with their tolerance and readiness. The post Navigating the Transition to Value-Based Care: Addressing Fears and Embracing Risk in ACO REACH appeared first on MedCity News.

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Healthcare Healthcare 108

MedCity News

MAY 3, 2024

Lawmakers have ghost networks in their sights, and payers can prepare now for policy changes. The post Navigating Policy Terrain: Perspectives for Payers on Tackling Ghost Networks appeared first on MedCity News.

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Networking 108

pharmaphorum

MAY 3, 2024

Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim

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Pharmaceutical Technology

MAY 3, 2024

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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pharmaphorum

MAY 3, 2024

Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials

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FDA 120

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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

Pharmaceutical Technology

MAY 3, 2024

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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FDA Safety 105

pharmaphorum

MAY 3, 2024

Some NHS patients in the UK will finally be able to access Pfizer’s sickle cell disease therapy Oxbryta after agreement was reached on a price cut

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Patients 100

Pharmaceutical Technology

MAY 3, 2024

Moderna reported a net loss of $1.2bn in the first quarter (Q1) of 2024, a stark contrast to its net income of $79m in Q1 2023.

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European Pharmaceutical Review

MAY 3, 2024

In final draft guidance , the National Institute For Health and Care Excellence (NICE) has recommended voxelotor (Oxbryta) with or without hydroxycarbamide as a treatment for haemolytic anaemia, which is caused by sickle cell disease. According to NICE, around 4,000 people aged 12 years and older with sickle cell disease in England will be able to benefit from the treatment.

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Food and Drug Administration Medicine Food Patients 83

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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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Pharmaceutical Technology

MAY 3, 2024

The NHS in the UK has announced plans to offer Pfizer's Voxelotor (Oxbryta), a new treatment option for sickle cell disease.

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European Pharmaceutical Review

MAY 3, 2024

An interim analysis of a Phase III trial of Calquence (acalabrutinib) plus chemoimmunotherapy has revealed positive progression-free survival outcomes for adults with untreated mantle cell lymphoma. AstraZeneca ’s ECHO Phase III trial evaluated acalabrutinib in combination with standard-of-care chemoimmunotherapy , bendamustine and rituximab. Calquence (acalabrutinib) is a next-generation, Bruton’s tyrosine kinase (BTK) inhibitor.

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Safety Patients Medicine Medical 78

PharmaTimes

MAY 3, 2024

The INTerpath-001 trial is evaluating Moderna/Merck’s mRNA-4157 in combination with Merck’s Keytruda

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Recruitment Patients 100

PharmaTech

MAY 3, 2024

In this exclusive Drug Digest video interview, Chris Spivey, Director, Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of drug product stability testing.

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Safety

Pharmaceutical Technology

MAY 3, 2024

Amgen announced updates in the obesity space, with topline data for MariTide expected in late 2024.

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PharmaTimes

MAY 3, 2024

Neurological disorders, such as epilepsy or chronic pain, affect over three billion people worldwide

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pharmaphorum

MAY 3, 2024

AI-powered home healthcare model from Cera could save NHS and UK £1bn in 2026 if adopted nationwide, says new study

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Healthcare Healthcare 83

Pharmaceutical Commerce

MAY 3, 2024

The latest news for pharma industry insiders.

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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

PharmaVoice

MAY 3, 2024

With its next earnings report looming, pushback from an investor is adding pressure on Novavax to boost performance.

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Pharma 72

Pharmaceutical Technology

MAY 3, 2024

Techniques such as rapid nanomotion-based susceptibility testing, and MALDI-TOF-MS could be used to identify resistance mechanisms of several deadly organisms.

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Rep-Lite

MAY 3, 2024

Medical sales reps who consistently goes above and beyond is the dream of any company. When medical sales jobs and cutting-edge technologies meet the ever-evolving healthcare needs, having a top-performing team is a necessity. These high-caliber medical sales reps are the bridge between innovative solutions and the medical professionals who can leverage them to improve patient care.

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Medical sales reps Medical sales Sales Medical 52

PharmExec

MAY 3, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, offers a synopsis on what questions cell and gene therapy developers need to answer to inform their distribution strategy.

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Distribution 52

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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 Commerce

MAY 3, 2024

Collaboration will be oncology based—centered around allogeneic CAR-T cell therapy product candidates—and will provide Poseida with up to $550 million if certain milestones are met.

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PharmExec

MAY 3, 2024

In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, talks about the influence of Medicare Part D drug price negotiations on manufacturer go-to-market strategies and decision-making, and the industry’s response to the wider dialogue on pricing transparency.

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Manufacturing Pharmaceutical Marketing 52

Pharmaceutical Commerce

MAY 3, 2024

Per the US strategic partnership agreement, the adalimumab high-concentration interchangeable biosimilar will be distributed under the Quallent Pharmaceuticals private label.

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Distribution Pharmaceutical 52

PharmaTech

MAY 3, 2024

Technological advances are helping advance biologics development and manufacturing and reduce bottlenecks.

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Manufacturing 69

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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