Fri.May 24, 2024

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Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec

Fierce Pharma

While it’s hard to overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latest deep dive into semaglutide data in chronic kidney disease (CKD) could help set a n | Early Friday, Novo shared full, positive results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and chronic

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Why Allegheny Health Network Created Its Own Chat-GPT For Employees

MedCity News

Allegheny Health Network rolled out a large language model designed exclusively for use by its staff members. You can think of the tool as the health system’s own version of Chat-GPT, said Ashis Barad, AHN’s chief digital and information officer. The post Why Allegheny Health Network Created Its Own Chat-GPT For Employees appeared first on MedCity News.

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Even after sharp sales drop, Pfizer sees bright side with priority review voucher from Paxlovid approval

Fierce Pharma

In a change of pace from the recent COVID-related business struggles for Pfizer, the drugmaker has picked up a valuable reward from the FDA in the form of a priority review voucher (PRV). | The FDA awarded the voucher based on Paxlovid's status as a countermeasure to a material medical threat, according to a notice in the Federal Register.

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MedCity Pivot Podcast: A Conversation With Walgreens’ Head of Specialty Drugs

MedCity News

Tracey James, chief operating officer of Walgreens’ specialty pharmacy business, talked about the retailer’s vision of innovating in the specialty pharmacy world, as well as about affordability and access. The post MedCity Pivot Podcast: A Conversation With Walgreens’ Head of Specialty Drugs appeared first on MedCity News.

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

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Fierce Pharma Asia—AstraZeneca eyes China's innovation, plots Singapore ADC plant; FDA rejects Hengrui's PD-1 drug

Fierce Pharma

AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore. | AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore.

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ASCO: AffyImmune claims a first with CAR-T for solid tumours

pharmaphorum

AffyImmune Therapeutics has recorded what it says is the first documented complete response in a patient with a solid tumour treated with CAR-T therapy. The case comes from a phase 1 study of its ICAM-1 targeting CAR-T autologous candidate AIC100 in patients with relapsed/refractory poorly differentiated thyroid cancer (PDTC) and anaplastic thyroid cancer (ATC), which will be reported at the ASCO congress next week.

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FDA advisory committee reviews Novo Nordisk insulin icodec for T1D

Pharmaceutical Technology

The US FDA's EMDAC is set to hold a meeting to assess the benefit-risk profile of Novo Nordisk's insulin icodec, to treat type 1 diabetes.

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Lyra Health Announces Mental Health Offering for Teens

MedCity News

Lyra Care for Teens will be available starting in June. Patients will gain access to therapists who specialize in evidence-based treatments and personalized digital lessons. The post Lyra Health Announces Mental Health Offering for Teens appeared first on MedCity News.

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ADC developer Pheon raises $120m, and other bio financings

pharmaphorum

This week’s round-up of biotech financings is led by a $120 million round for UK-based antibody-drug conjugate (ADC) developer Pheon, with SixPeaks also pulling in nine figures and smaller rounds for Progentos, LabGenius, and Grey Wolf, and Imvax.

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Merck KGaA Announces $600 Million Deal to Acquire Mirus Bio

PharmaTech

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

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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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King’s Doctoral Training Centre to investigate MS symptom management

PharmaTimes

The lifelong autoimmune disease affects more than 150,000 people living in the UK

Doctors 109
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NICE, NHS England unveil new pathway for medtech

pharmaphorum

NICE and NHS England are seeking feedback on proposed new rules and commissioning principles for medtech products.

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Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro

MedCity News

Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro. The post Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro appeared first on MedCity News.

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ASCO: Merus bispecific garners attention after abstract drop

pharmaphorum

Shares in Merus spike on ASCO abstract on phase 2 trial of EGFRxLGR5 bispecific petosemtamab in head and neck cancer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Agenda announced for FlyPharma Vienna 2024

PharmaTimes

The conference will take place on 23 to 24 October at Vienna AirportCity

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ASCO 2024: Merus touts positive Phase II data for head and neck cancer antibody

Pharmaceutical Technology

Shares in Merus rose by 15% in premarket trading, following the announcement of positive Phase II data to be presented at ASCO.

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9 Patient Intake Mistakes Healthcare Providers Make During Acquisition

Penrod

1. Inefficient Appointment Scheduling An inefficient appointment scheduling system can lead to long wait times, double booking, and limited appointment availability, frustrating your existing and potential patients. These issues can disrupt the flow of your practice, causing dissatisfaction and potentially leading to a loss of patients. To solve this problem, you need a comprehensive booking system that offers consistency at each intake location.

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A Day At The Medalist: Where Vision, Mindset, and Grit Met on the Golf Course

Scott Burrows

A few weeks ago, I had the incredible opportunity to tee off at the prestigious Medalist Golf Club in Jupiter, Florida. As I made my way down the manicured fairways and navigated the challenging greens, I couldn’t help but feel a sense of awe knowing that I was playing on the same course frequented by golf legends like Tiger Woods and Rory McIlroy.

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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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Therapy reprogrammes immune cells to shrink prostate and bladder cancers

PharmaTimes

JHU083 reduced tumour growth and triggered tumour cell death in mice

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Biogen to Acquire HI-Bio in Deal Worth Potentially Up to $1.8 Billion

PharmaTech

With the acquisition, Biogen gains felzartamab, HI-Bio's lead investigational mAb candidate being developed for the treatment of a range of immune-mediated diseases.

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EC approves Celltrion’s Omlyclo for allergic conditions

Pharmaceutical Technology

The EC has approved Celltrion’s Omlyclo, an omalizumab biosimilar for reference product Xolair to treat allergic conditions.

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Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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ASCO 2024: MediLink’s NSCLC and breast cancer ADC shows early safety success

Pharmaceutical Technology

The clinical-stage biotech will share preliminary safety and efficacy data with its ADC at the 2024 ASCO meeting.

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Cityblock Health Announces Further Partnerships with Centene Corporation to Bring Value-Based Healthcare to Florida

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Grey Wolf gains $50m boost for antigen modulation tech

Pharmaceutical Technology

Grey Wolf Therapeutics has concluded an oversubscribed $50m in Series B financing expansion to advance its antigen modulation technology.

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Pharma Pulse 5/24/24: Counsel Patients on Nutrition and Following a Balanced Diet Complementary to GLP-1s, Neuralink’s First Brain-Implant Patient Stays Upbeat & more

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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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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MilliporeSigma to Purchase Mirus Bio

Pharmaceutical Commerce

With the acquisition, Merck’s US and Canada life science business aims to further increase its viral vector manufacturing capabilities.

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Cystic fibrosis: global clinical trials landscape and treatments

Pharmaceutical Technology

Affecting more than 162,000 patients worldwide, global clinical trials are researching innovative new treatments for cystic fibrosis.

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Study Finds Semaglutide Improves Chronic Kidney Disease in Patients With Type 2 Diabetes

Pharmacy Times

The role of semaglutide as a glucagon-like peptide-1 (GLP-1) receptor antagonist could offer further treatment options to improve patient outcomes.

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ASCO 2024: MSD’s ADC shows efficacy in lung and breast tumours

Pharmaceutical Technology

MSD licenced the antibody-drug conjugate (ADC) therapy, sacituzumab tirumotecan, from China-based Sichuan Kelun-Biotech in 2022.

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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.