Mon.Mar 18, 2024

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Bluebird, short on cash, takes on $175M in debt financing

Bio Pharma Dive

The funding could extend the cash-strapped gene therapy maker’s financial runway to 2026, but only if the company successfully hits certain milestones.

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Empowering clinical trials: The technological revolution in patient retention

Pharmaceutical Technology

In the realm of clinical trials, participant retention is a cornerstone for success, offering robustness to the data collected and ensuring the validity of the trial outcomes.

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The digital divide: Balancing automation and human interaction regardless of the patient support program model

Bio Pharma Dive

Balancing automated patient support with human touch is key in healthcare. Hybrid models offer a pragmatic path forward, prioritizing patient-centricity.

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FDA endorses Johnson & Johnson’s multiple myeloma therapy

Pharmaceutical Technology

The US FDA's ODAC has recommended Johnson & Johnson’s CARVYKTI to treat relapsed or refractory multiple myeloma (R/R MM).

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Give HCPs a proactive way to reach your field team: Add inbound

Bio Pharma Dive

HCPs today want inbound channels for help when they need it. See how you can meet their preferences.

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Defining the HTA landscape for France and Germany: 2019–2023

Pharmaceutical Technology

Using GlobalData’s POLI & HTA database, analysis has been conducted that will provide insight into how the HTA landscape adapted between 2019 and 2023.

Marketing 130

More Trending

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Despite inquiry, FDA AdCom backs BMS Abecma approval

Pharmaceutical Technology

AdCom voted eight to three in favour of BMS and 2seventy bio’s CAR-T cell therapy, Abecma in triple-class exposed multiple myeloma patients.

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CAR-Ts set to move earlier in multiple myeloma therapy

pharmaphorum

FDA advisors have said that two BCMA-targeted CAR-T therapies can be used earlier in the treatment pathway for multiple myeloma, setting up FDA approvals for use in a broader patient population.

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Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

Drugs 130
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Pfizer set to collect roughly $2.6B in selloff of Haleon shares, reducing stake from 32% to 24%

Fierce Pharma

Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is | Two months after GSK sold a significant chunk of its stake in Haleon, Pfizer is prepared to do the same with a larger selloff, according to the consumer healthcare company. Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering.

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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.

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Optinose’s XHANCE nasal spray gains approval for chronic sinusitis

Pharmaceutical Technology

The US FDA has granted approval for Optinose’s XHANCE nasal spray for chronic rhinosinusitis without nasal polyps in adult patients.

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Reading the Tea Leaves on Recent Surge in Pharma Dealmaking

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the positive signs from rising activity levels in biopharma M&A— and what the momentum may mean for industry dealmaking and partnership efforts in the months ahead.

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Norgine secures Pedmarqsi licence from Fennec in deal worth up to $272m

Pharmaceutical Technology

Fennec’s Pedmarqsi/Pedmark is the only approved therapy to treat cisplatin-induced hearing loss in paediatric cancer patients.

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Patient-centricity and HCP engagement: 7 Challenges in pharma and life sciences outreach

pharmaphorum

Discover the top 7 challenges faced by pharmaceutical and life sciences companies in achieving patient-centricity and engaging healthcare professionals (HCPs). Explore strategies to overcome these obstacles for successful outreach efforts.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Novartis begins expansion of Singapore biopharmaceutical plant

Pharmaceutical Technology

Novartis has broken ground on the expansion of its $256m biopharmaceutical manufacturing facility in Singapore.

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Agreement reached on EU health data framework

pharmaphorum

Agreement has been reached in the EU on a European Health Data Space (EHDS), which will make it easier to exchange and access electronic health data.

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Tempol by DMK Pharmaceuticals for Radiodermatitis: Likelihood of Approval

Pharmaceutical Technology

Tempol is under clinical development by DMK Pharmaceuticals and currently in Phase II for Radiodermatitis.

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AZ/Merck’s Lynparza approved by SMC to treat advanced prostate cancer in Scotland

Pharma Times

Up to 20% of prostate cancer cases are classified as castration-resistant

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Ulotaront hydrochloride by Sumitomo Pharma America for Generalized Anxiety Disorder (GAD): Likelihood of Approval

Pharmaceutical Technology

Ulotaront hydrochloride is under clinical development by Sumitomo Pharma America and currently in Phase III for Generalized Anxiety Disorder (GAD).

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Eli Lilly strikes deal with Amazon: Will the ecommerce giant become go-to destination for GLP-1s?

BioPharma Reporter

Eli Lilly is partnering with ecommerce titan Amazon to deliver its weight loss drug Zepbound straight to patientâs doors, in a bid to address ongoing shortages.

Drugs 59
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Denosumab biosimilar by Sandoz Group for Humoral Hypercalcemia of Malignancy: Likelihood of Approval

Pharmaceutical Technology

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Humoral Hypercalcemia of Malignancy.

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NHS will expand use of waiting list-busting AI after pilot

pharmaphorum

AI software designed to tackle missed appointments and reduce waiting lists will see its use by NHS England ramp up after a successful pilot deployment.

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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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Denosumab biosimilar by Sandoz Group for Post Menopausal Osteoporosis: Likelihood of Approval

Pharmaceutical Technology

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Post Menopausal Osteoporosis.

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Birmingham’s VR-assisted training centre for excellence to support future vaccine makers

Pharma Times

The centre will deliver free training, outreach materials and programmes

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Adalimumab biosimilar by Biocon for Plaque Psoriasis (Psoriasis Vulgaris): Likelihood of Approval

Pharmaceutical Technology

Adalimumab biosimilar is under clinical development by Biocon and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris).

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OS data set up wider Jemperli use in endometrial cancer

pharmaphorum

GSK's PD-1 inhibitor Jemperli improves overall survival when used first-line in an all-comer endometrial cancer trial

Trials 66
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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Denosumab biosimilar by Sandoz Group for Giant Cell Tumor Of Bone: Likelihood of Approval

Pharmaceutical Technology

Denosumab biosimilar is under clinical development by Sandoz Group and currently in Pre-Registration for Giant Cell Tumor Of Bone.

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BMS completes $14bn takeover of Karuna

pharmaphorum

Bristol-Myers Squibb gets its $14bn takeover of Karuna Therapeutics over the finish line, taking control of schizophrenia candidate KarXT ahead of an FDA decision in September

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Ulotaront hydrochloride by Sumitomo Pharma America for Schizophrenia: Likelihood of Approval

Pharmaceutical Technology

Ulotaront hydrochloride is under clinical development by Sumitomo Pharma America and currently in Phase III for Schizophrenia.

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What are the global pharma giants' goals at DCAT 2024? A written roundtable reveals all

Outsourcing Pharma

The curtains have risen on DCAT 2024 in the vibran heart of New York City, and leading pharmaceutical companies from around the world have converged for a week of innovation, collaboration, and strategic dialogue.

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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.