Sat.Mar 16, 2024 - Fri.Mar 22, 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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Aging And Schizophrenia Share Striking Similarities in 2 Types of Brain Cells

AuroBlog - Aurous Healthcare Clinical Trials blog

Similar genetic changes in two different types of brain cells may contribute to cognitive impairment in schizophrenia and aging. US researchers examined gene expression in more than a million brain cells collected post-mortem from 191 donors.

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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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5 Steps to Find the Best Dentist in Whittier for Your Needs

Pharma Mirror

Finding the right dentist in Whittier can be daunting, but it’s crucial for maintaining oral health. From routine check-ups to specialized treatments, a reliable dentist can make all the difference. In this article, we’ll walk you through five essential steps to help you find the best dentist in Whittier for your specific needs. So, let’s dive right in!

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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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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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DoP releases new UCPMP for pharma and medical devices companies

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department of Pharmaceuticals (DoP) has issued a new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, permitting pharma companies to provide brand reminders such as informational and education items and free samples to medical professionals with restrictions on sample packs and total value.

More Trending

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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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Contineum, a startup born from a Roche buyout, files for IPO

Bio Pharma Dive

The biotech, formed as a successor to a company Roche acquired in 2018, has two drugs in clinical testing for neurological and immune diseases.

Drugs 156
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DGFT implements stricter regulations for export of chitin and chitosan derivatives

AuroBlog - Aurous Healthcare Clinical Trials blog

In a move aimed at enhancing compliance and facilitating smoother trade operations, the Directorate General of Foreign Trade (DGFT) has introduced stringent policy conditions for the export of chitin and chitosan derivatives.

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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.

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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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Pfizer to Lower Its Stake in GSK Consumer Health Spinoff Haleon

BioSpace

Following GSK’s lead, Pfizer plans to lower its interest in Haleon from 32% to approximately 24%, with the sale of 630 million ordinary shares in the consumer healthcare spinoff.

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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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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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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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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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AstraZeneca Shows Lynparza Combo Could Address Unmet Endometrial Cancer Need

BioSpace

AstraZeneca reported Monday that adding Lynparza to Imfinzi improved outcomes in mismatch repair proficient endometrial cancer, more than doubling the median duration of response in 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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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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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.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Madrigal’s Rezdiffra Energizes MASH Space, Sets Bar for Future Therapies

BioSpace

With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.

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New tentative approval for Zydus Pharms drug empagliflozin;linagliptin;metformin hydrochloride

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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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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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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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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FDA Action Alert: Orchard, ITF, Merck and More

BioSpace

The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.

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New tentative approval for Sandoz Inc drug rifaximin

Drug Patent Watch

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in one NDA. There are twenty-nine patents protecting this compound.

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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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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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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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AstraZeneca Caps US Inhaler Out-of-Pocket Costs on Heels of Boehringer

BioSpace

With Boehringer Ingelheim’s announcement earlier this month that it was capping U.S. inhaler costs at $35 per month, AstraZeneca on Monday followed suit.

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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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New tentative approval for Zydus Pharms drug empagliflozin;linagliptin;metformin hydrochloride

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

Drugs 59
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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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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.