Mon.Jun 10, 2024

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GSK notches another Zantac win as plaintiff drops case in Illinois

Fierce Pharma

As the year rolls on, GSK continues to knock out personal injury lawsuits in the long-running legal saga over whether the popular heartburn medication Zantac can cause cancer. | Plaintiff Eugenia Kasza, who alleged her use of Zantac caused her to develop breast cancer, has voluntarily dismissed her case against GSK. The case was set to start trial in Illinois state court on Monday.

Medical 298
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Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment

MedCity News

Physical and mental health are inextricably intertwined — senior-focused primary care can help bridge the treatment gap The post Mental Health and Aging: The Role of Primary Care in Overcoming Barriers to Treatment appeared first on MedCity News.

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GSK, attempting to stage Blenrep comeback, bids adieu to combo studies with SpringWorks' Ogsiveo

Fierce Pharma

Despite the recent approval of SpringWorks Therapeutics’ Ogsiveo, GSK is calling it quits on prior plans to wed the Pfizer spinout’s drug with its withdrawn cancer med Blenrep. | SpringWorks has received a notice of termination on an amended collaboration and licensing deal with GSK from 2022. Under the updated pact, GSK and SpringWorks were working together to develop and potentially market combinations of Blenrep and Ogsiveo in multiple myeloma.

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Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial

MedCity News

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses. The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA accepts Eisai's subcutaneous Leqembi filing, sets January 25 decision date

Fierce Pharma

About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. agency has accepted the filing. | The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025.

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Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program

MedCity News

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. The post Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program appeared first on MedCity News.

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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Rapid Translation of Therapeutic Discoveries into the Clinic through Purposeful Collaboration

MedCity News

How academia and biotech can team up to bring impactful new drug therapies to patients faster The post Rapid Translation of Therapeutic Discoveries into the Clinic through Purposeful Collaboration appeared first on MedCity News.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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Pelago Launches Inpatient Centers of Excellence Network

MedCity News

Pelago’s new Inpatient Centers of Excellence network offers Pelago members access to a nationwide network of inpatient substance use disorder treatment centers. The network includes organizations like the Recovery Centers of America and Banyan Treatment Centers. The post Pelago Launches Inpatient Centers of Excellence Network appeared first on MedCity News.

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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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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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New Startup Launches to Reduce Medical Practices’ HR Burden

MedCity News

Stitch PEO — a startup built at Redesign Health — officially launched and announced that it has raised $8.75 million in seed funding. The company is a professional employer organization for independent medical practices, designed to improve recruiting, hiring, onboarding, and other human resources processes. The post New Startup Launches to Reduce Medical Practices’ HR Burden appeared first on MedCity News.

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Boehringer, Lilly face off in MASH at EASL

pharmaphorum

Eli Lilly's tirzepatide and Boehringer Ingelheim's survodutide grab the spotlight at EASL with new phase 2 data in metabolic dysfunction-associated steatohepatitis (MASH)

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New paediatric blood test to prevent sudden death from hereditary heart condition

PharmaTimes

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA OKs wider use of Almirall’s actinic keratosis drug

pharmaphorum

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri. First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can be a precursor to skin cancer.

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Five-year data from Genentech SMA study released

European Pharmaceutical Review

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). What did the FIREFISH extension study find? The study found that after five years without treatment, 91 percent of children were alive.

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Drug Shortage Reports Emphasize Continuing Problems

PharmaTech

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

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Risk adjusted net present value: What is the current valuation of Sensei Biotherapeutics’s SNS-101?

Pharmaceutical Technology

SNS-101 is a monoclonal antibody commercialized by Sensei Biotherapeutics, with a leading Phase II program in Non-Small Cell Lung Cancer.

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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.

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Innovative radioligand manufacturing facility inaugurated

European Pharmaceutical Review

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Orano Med (a subsidiary of the Orano Group)’s ATLab (Alpha Therapy Laboratory) facility in Brownsburg, near Indianapolis, Indiana, US, is set to help address the production and supply challenges of lead-212 radioligand therapies.

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Risk adjusted net present value: What is the current valuation of Pyxis Oncology’s PYX-201?

Pharmaceutical Technology

PYX-201 is a monoclonal antibody conjugated commercialized by Pyxis Oncology, with a leading Phase I program in Thyroid Cancer.

Leads 81
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Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

PharmaTimes

Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK

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Pharma Pulse 6/10/24: Sustainability in Clinical Trials, Merck Bets on AI Drug-Design Partnerships & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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Moderna says COVID/flu shot clears phase 3 hurdle

pharmaphorum

Moderna says it has become the first company in the pharma sector with phase 3 data on a combined vaccine for both COVID-19 and influenza

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Shanghai Junshi Bioscience gets grant for isotope-enriched compounds for improving drug delivery and efficacy

Pharmaceutical Technology

Enhance drug effectiveness with isotope-enriched compounds! Discover how Shanghai Junshi Bioscience's patented technology improves therapeutic outcomes for PI3K mediated diseases.

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Content is Indeed King

Pharmaceutical Commerce

Beneath all the “organized chaos,” industry shows such as LogiPharma Europe spotlight the valuable opportunity offered by these events to further educate our most valuable asset: our readers.

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How to Conduct a Website Tracking Audit

Penrod

The first step in assessing your company’s risk of non-compliance is figuring out which trackers are running on your website by running a website tracking audit. One of the easiest ways to find them is to use a self-service vendor that tracks the use of technologies across the Internet. Some require paid plans, and the ones with free versions may have limitations.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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AI and Patient Behavior

Pharmaceutical Commerce

The June issue of Pharmaceutical Commerce is headlined by a look at the influence of artificial intelligence and real-world evidence/real-world data on patient behavior and ultimately, the many complex factors that go into medicine adherence.

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Survodutide Demonstrates Significant Improvement in Patients with Liver Fibrosis Associated with Metabolic Dysfunction-Associated Steatohepatitis

PharmExec

Survodutide is the first glucagon/GLP-1 receptor dual agonist to show a high level of benefit in treating liver fibrosis associated with metabolic dysfunction-associated steatohepatitis.

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Kodiak Sciences gets grant for method of treating eye disorder with anti-VEGF antibody conjugate

Pharmaceutical Technology

Discover Kodiak Sciences Inc's innovative method for treating wet age-related macular degeneration with an anti-VEGF antibody conjugate. Patented approach offers extended therapeutic effects for at least 12 weeks, providing a less frequent treatment option.

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Challenges Integrating GenAI into Various Departments

PharmExec

In this part of his Pharmaceutical Executive video interview, Brice Challamel, Vice President, AI Products & Platforms, Moderna, speaks about challenges Moderna faced integrating generative AI,like mChat and GPTs, into its various departments and how they overcame them.

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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.