Fri.Aug 02, 2024

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FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Fierce Pharma

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

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Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products

MedCity News

Many medtech products, very often too technical and scientific, emphasize features at the expense of processes and their interactions. While the approach to patient and treatment safety is crucial, there is a notable shift towards processes centered around patients and healthcare professionals. The post Beyond Engineering: Integrating UX for Safer and More Efficient Medical Products appeared first on MedCity News.

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Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam

Fierce Pharma

As growth in Vertex's cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year. | As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter.

Sales 321
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Disrupting Trajectory of Chronic Kidney Disease Mortality Rates Through Digital Health Platforms

MedCity News

Digital solutions are changing the way CKD is managed. Through enhanced connectivity and personalized care plans tailored to individual patient needs, digital technologies allow patients to take proactive steps in managing CKD. The post Disrupting Trajectory of Chronic Kidney Disease Mortality Rates Through Digital Health Platforms appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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Fierce Pharma Asia—Merck's surprise hiccup in China; Leqembi's slow ramp; Lawmakers' new biosecurity target

Fierce Pharma

Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp. | Merck is trying to determine the reasons behind the surprise decline of Gardasil in China. Eisai and Biogen's Leqembi was rejected by European authorities amid a continued slow sales ramp.

Sales 216
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FDA approves innovative engineered cell therapy

European Pharmaceutical Review

For the first time in over a decade, there is a new treatment option for patients with synovial sarcoma, a rare soft tissue cancer. The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease. Adaptimmune Therapeutics highlighted that TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy.

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Otsuka Pharmaceutical to Purchase Jnana Therapeutics

Pharmaceutical Commerce

In deal that has the potential to reach $1.1 billion, Otsuka aims to grow its drug pipeline, specifically in the field of rare and autoimmune diseases.

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Top-10 ways for Pharma to leverage AI according to…AI

Impetus Digital

A version of this article was previously published on PharmaPhorum. Like most people these days, I have been experimenting with various artificial intelligence (AI) tools this past year. It’s remarkable to see the progress made in the technology compared to only a few months ago and there are no signs of the progress slowing down. The pharmaceutical industry has numerous use cases for AI.

Pharma 94
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Why Hospitals Are Decrying CMS’ New Inpatient Payment Rule

MedCity News

CMS finalized a rule this week that will boost hospitals’ inpatient payment rates by 2.9%. Hospitals groups are unhappy with this payment update, arguing that it is insufficient and will exacerbate hospitals’ financial challenges. The post Why Hospitals Are Decrying CMS’ New Inpatient Payment Rule appeared first on MedCity News.

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Lilly gets first heart outcomes readout with tirzepatide

pharmaphorum

Eli Lilly's dual GLP-1/GIP agonist tirzepatide has been shown to reduce the risk of worsening disease in people with heart failure and obesity in a phase 3 trial, the first to show a benefit on cardiovascular outcomes with the drug.

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

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Adaptimmune’s FDA Approval Marks the First for an Engineered Cell Therapy for Solid Tumors

MedCity News

The FDA approved Adaptimmune Therapeutics’ Tecelra as a treatment for advanced cases of synovial sarcoma. It’s the first engineered cell therapy approved for treating a solid tumor. The post Adaptimmune’s FDA Approval Marks the First for an Engineered Cell Therapy for Solid Tumors appeared first on MedCity News.

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What pharma has learned from AI

PharmaVoice

As AI tools move from hype to a daily reality at pharma companies, here are the insights users are gaining.

Pharma 111
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Researchers reveal CAR-enhancer therapy could help overcome cancer relapse

PharmaTimes

Cancer is estimated to affect more than three million people living in the UK, according to Macmillan Cancer Support

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AbbVie acquires Cerevel Therapeutics for $8.7bn

Pharmaceutical Technology

AbbVie has completed its acquisition of all outstanding shares of Cerevel Therapeutics in a deal valued at $8.7bn.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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GSK bags sought-after Jemperli okay in endometrial cancer

pharmaphorum

FDA clears GSK's Jemperli as first-line therapy for all endometrial cancer patients, seen as key to driving sales above the $1bn threshold

FDA 92
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Study reveals non-statin cholesterol drugs could reduce liver cancer risk

PharmaTimes

The third leading cause of cancer mortality accounts for over 700,000 deaths every year

Leads 92
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FDA clears Adaptimmune T-cell therapy for soft tissue cancer

pharmaphorum

FDA has approved Adaptimmune's Tecelra for synovial sarcoma, the first engineered T-cell therapy for solid tumours

FDA 94
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Pharma Pulse 8/2/24: Overcoming Challenges to Drive Digital Customer Engagement, Mental Health Leaves of Absence Continue to Proliferate & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sonde Health launches voice-based cognitive fitness tracker

pharmaphorum

Sonde Health has made a name for itself with the development of software that can detect illness from the sound of a patient's voice. Now, it has launched a dedicated app for tracking cognitive fitness, which it hopes may be able to spot signs of decline early.The app – Sonde Cognitive Fitness – allows users to monitor brain exertion in real-time by analysing vocal biomarkers using machine learning, an approach that is analogous to the use of fitness trackers to monitor physical and heart health

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FDA Expands Approval of GSK’s Jemperli in Combination with Chemotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer

PharmExec

Approval marks the first time an immuno-oncology regimen has demonstrated a survival benefit for all adults with primary advanced or recurrent endometrial cancer, company says.

FDA 52
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Optimizing HCP Engagement: The Power of Timely, Precise, and Actionable Patient Alerts

Prognos Health

Effective HCP engagement is a cornerstone of successful pharmaceutical marketing. The right information, delivered at the right moment to the right HCP with a brand eligible patient, can significantly influence treatment decisions and drive brand growth. However, many pharmaceutical marketing teams grapple with patient alert solutions that are limited in scope, accuracy, or geographic reach.

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Obstacles Facing Biologics Preservation

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Dan Gagnon, UPS Healthcare’s VP of Global Strategy & Acquisition Integration, dives into the challenges of safeguarding these products, while also sharing his keys to sustaining stability in the ‘recession resistant’ healthcare industry.

Pharma 52
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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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Informing Organon’s Strategic Approach From an OB-GYN POV

PharmExec

In this part of her Pharmaceutical Executive video interview, Charlotte Owens, MD, FACOG, Head of Medical Affairs and Outcomes Research at Organon, discusses how she's using her in-practice experience as an OB-GYN to inform Organon's strategic approach to addressing maternal health challenges.

Medical 52
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Going Green: Updating Your Filings

PharmaTech

The implementation of new quality control methods must be reported to regulators, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

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Casgevy: Launch sequence and price analysis of the first marketed CRISPR therapy

Pharmaceutical Technology

In 2023, Casgevy was approved in the US to treat sickle cell disease (SCD), making it the first FDA-approved gene therapy to use CRISPR-based gene editing.

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Understanding IDNs and What They Mean to the Pharmaceutical Industry–Q&A with Greg Skalicky

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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Merck buys Mirus Bio to boost viral vector bioprocessing capacity

Pharmaceutical Technology

Merck KGaA has concluded the acquisition of Mirus Bio for €500m ($600m), enhancing its viral vector bioprocessing capabilities.

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FDA Grants Accelerated Approval to Adaptimmune Therapeutics’ Tecelra for Adults with Synovial Sarcoma Who Have Undergone Prior Chemotherapy

PharmExec

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

FDA 52
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Adaptimmune’s Tecelra gains accelerated approval for synovial sarcoma

Pharmaceutical Technology

The MAGE-A4-targeted genetically modified T cell therapy is indicated for the treatment of synovial sarcoma.

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Blue Shield of California Offers Blue Zones Challenge App to Members

PharmExec

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

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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.