Fierce Pharma
JUNE 10, 2024
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.
MedCity News
JUNE 10, 2024
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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Fierce Pharma
JUNE 10, 2024
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of SpringWorks Therapeutics’ Ogsiveo, GSK is calling it quits on prior plans to wed the Pfizer spinout’s drug with its withdrawn cancer med Blenrep.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.
MedCity News
JUNE 10, 2024
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.
Fierce Pharma
JUNE 10, 2024
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.
pharmaphorum
JUNE 10, 2024
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
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
JUNE 10, 2024
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.
MedCity News
JUNE 10, 2024
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.
European Pharmaceutical Review
JUNE 10, 2024
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.
MedCity News
JUNE 10, 2024
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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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.
European Pharmaceutical Review
JUNE 10, 2024
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.
MedCity News
JUNE 10, 2024
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.
pharmaphorum
JUNE 10, 2024
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)
PharmaVoice
JUNE 10, 2024
A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?
pharmaphorum
JUNE 10, 2024
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.
Pharmaceutical Technology
JUNE 10, 2024
Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.
MedCity News
JUNE 10, 2024
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.
PharmaTimes
JUNE 10, 2024
Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK
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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.
PharmaTech
JUNE 10, 2024
USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.
Pharmaceutical Technology
JUNE 10, 2024
SNS-101 is a monoclonal antibody commercialized by Sensei Biotherapeutics, with a leading Phase II program in Non-Small Cell Lung Cancer.
PharmaTimes
JUNE 10, 2024
Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK
Pharmaceutical Technology
JUNE 10, 2024
PYX-201 is a monoclonal antibody conjugated commercialized by Pyxis Oncology, with a leading Phase I program in Thyroid Cancer.
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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
PharmaTech
JUNE 10, 2024
The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.
pharmaphorum
JUNE 10, 2024
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
Pharmaceutical Commerce
JUNE 10, 2024
The latest news for pharma industry insiders.
Pharmaceutical Technology
JUNE 10, 2024
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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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
Pharmaceutical Commerce
JUNE 10, 2024
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.
Penrod
JUNE 10, 2024
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.
Pharmaceutical Commerce
JUNE 10, 2024
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.
PharmExec
JUNE 10, 2024
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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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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