Tue.Jan 16, 2024

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Vertex, CRISPR's gene-editing therapy Casgevy wins early FDA nod to treat beta thalassemia

Fierce Pharma

Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date.

FDA 280
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Vertex’s CRISPR Gene Therapy Lands Another FDA Nod in a Rare Blood Disease

MedCity News

The FDA approved Vertex Pharmaceuticals’ gene therapy Casgevy for treating beta thalassemia, an inherited blood disease that leads to low levels of functioning hemoglobin. Last month, the one-time treatment won its first FDA nod for treating sickle cell disease.

FDA 126
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GSK pumps £200M+ into UK manufacturing network to bolster commercial ambitions, API supply

Fierce Pharma

As British pharma giant AstraZeneca looks abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next t | As other British drugmakers like AstraZeneca look abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next two years.

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Boulder Care Extends Virtual Substance Use Disorder Treatment to Adolescents

MedCity News

As the opioid crisis grows for teens, Boulder Care has expanded its substance use disorder treatment to support adolescents. The company is starting its adolescent services in Washington with UnitedHealthcare Community Plan.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Merck's Keytruda again bags industry-first cervical cancer nod—with limitation

Fierce Pharma

After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type. | After crowning Keytruda as the first immunotherapy for advanced cervical cancer back in 2021, the FDA has awarded the drug another industry-first designation in an earlier stage of the tumor type.

FDA 234
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More Than a Survey: How to Holistically Embrace the Patient Experience

MedCity News

Despite the challenges that healthcare providers face and declining patient experience scores, several effective strategies can enhance their work to improve the patient experience and sufficiently satisfy expectations for care.

Patients 118

More Trending

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5 Ways Google Is Protecting Kids’ Mental Health on YouTube

MedCity News

During a session at CES 2024, a Google exec shared several changes the company has made through YouTube to protect children and teens.

Media 127
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Prominent German trade union pushes back on potential Bayer split: Reuters

Fierce Pharma

As Bayer’s new CEO Bill Anderson kicks off his first full year at the helm with an objective to revamp the company, a prominent German trade union is pressing to keep the large conglomerate togethe | As new CEO Bill Anderson presses on with his strategic review, Germany's IG BCE is taking issue with potential German job losses that could stem from a long-rumored split of Bayer's three segments, Reuters reports.

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Allakos Skin Drug Fails 2 Mid-Stage Tests, Sparks Restructuring to Cut 50% of Staff

MedCity News

Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation.

Biopharma 107
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In biopharma, employees at Novartis, GSK, AZ and Genentech are most satisfied with their compensation: analysis

Fierce Pharma

2023 was riddled with labor strikes across industries as workers lobbied for higher pay amid economic headwinds that shook up the global economy. | A USA Today review of millions of Glassdoor ratings found that employees in the biopharma industry are the most satisfied with their pay compared with other fields. Novartis, GSK, AstraZeneca and Genentech stood out in the reviews, according to the report.

Biopharma 203
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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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Innovaccer Acquires Cured to Enhance Its Patient Engagement Strategy

MedCity News

Innovaccer acquired Cured, a healthcare digital marketing and CRM platform. With the deal, Innovaccer gains more than 20 customers to add to its current portfolio of clients. Innovaccer CEO Abhinav Shashank said the main goal of the acquisition was to help his company become a leader in patient experience technology.

CRM 107
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Lonza plots more than 200 layoffs at clinical manufacturing site in California

Fierce Pharma

Just a few months after Lonza unveiled hundreds of new hires, the Swiss CDMO juggernaut is telegraphing nearly as many layoffs in California. | Lonza is axing 218 jobs at its site in Alameda County, California, according to a new Worker Adjustment and Retraining Notification (WARN) alert. The cuts come as Lonza plans hundreds of hires in Switzerland.

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Roche cancer immunotherapy receives new EU approval

European Pharmaceutical Review

The European Commission (EC) has approved the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection. Roche’s Tecentriq ® (atezolizumab) was first approved in Great Britain in August 2023. Compared with standard intravenous (IV) delivery, Roche stated that its monoclonal antibody biologic shortens treatment time by approximately 80 percent.

Safety 95
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Roche bags EU okay for subcutaneous Tecentriq

pharmaphorum

Roche’s Tecentriq has become the first PD-1/PD-L1 inhibitor to be cleared in the EU in a subcutaneous form that will make dosing easier for patients and healthcare providers

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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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XNK Therapeutics’ Evencaleucel gains EMA recommendation

Pharmaceutical Technology

XNK Therapeutics has received scientific recommendation from the EMA's Committee for Advanced Therapies (CAT) for its product evencaleucel.

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Pharma takes a gut check of microbiome drugs

PharmaVoice

On the heels of two FDA approvals for microbiome-based therapies, interest in the space is gaining steam.

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DISCO dances out of the shadows with €20m for ‘surfaceome’

pharmaphorum

DISCO Pharma has emerged from stealth with €20m in seed financing that will be used to advance its surfaceome cancer target-hunting platform

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The Benefits and Privacy Concerns in Utilizing Artificial Intelligence for Early Detection of Breast Cancer

Pharmaceutical Commerce

Cureus report discuss the value of AI, but the medical community must remain aware of privacy pitfalls.

Medical 103
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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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AI Biotech Secures Funding to Speed Up Stem Cell Therapy Development

PharmaTech

CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.

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Google chatbot tops docs on accuracy, bedside manner

pharmaphorum

Medical chatbot designed by Google and DeepMind outperformed doctors on accuracy and empathy in a study but is a long way from being ready for real-world use

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IRA lawsuits will test US’ ability to regulate social pricing in pharma

Pharmaceutical Technology

As the deadline nears for the government to reveal its proposed prices, pharmaceutical companies are continuing to fight regulation.

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FDA chief says agency can’t manage health tech alone

PharmaVoice

FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.

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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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What Is Endoscopy Medical Device Sales With Dustin Schelling

Evolve Your Success

Building relationships is essential in the competitive field of medical device sales. It plays a crucial role in achieving success and turning innovation into life-saving accomplishments. In this episode, Dustin Schelling talks about endoscopy medical device sales. He explores the differences between endoscopy and other medical device sales fields, sharing how intimate relationship-building is essential for success.

Sales 52
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Three steps third-party administrators can use to help employers combat rising care costs

Clarify Health

Employers are struggling under the weight of increasing healthcare costs for their employees — and are turning to third-party administrators to help. U.S. employers expect their health benefit cost per employee will jump an average of 5.4% in 2024, according to a report from Mercer — and that projection includes changes employers plan to make to hold down costs.

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Climbing Health Care Costs Result in Elevated Employer Vigilance

Pharmaceutical Commerce

Soaring healthcare costs show little sign of abating in 2024, and concerns about the affordability of medications and medical services continue to grow, despite investments in technology, clinical innovation, and efforts to manage utilization and waste.

Medical 52
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The Power of Advertising, Netflix, BuzzFeed, Google, and X join The Creative Floor Awards 2024

PM360

The Power of Advertising, Netflix, BuzzFeed, Google, and X join The Creative Floor Awards 2024 LONDON, 15 January, 2024 The Creative Floor Healthcare Awards 2024 launches today and will celebrate the world’s best health and wellness creative, clients and agency talent. The awards continue to be the only health and wellness award show in the world to donate a percentage of profits towards a Talent & Diversity Fund.

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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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Quirky Sales Tactics: Mastering the Unexpected

Contrarian Sales Techniques

In the world of sales, the line between brilliant and bonkers can be thinner than a cold-call script. Sometimes, the most unorthodox tactics land the biggest deals. Here's a peek into the quirky toolbox of top closers: Rapport Builders: Mirrored Manners: Imagine subtly matching a client's handshake, speech rhythm, or even posture. It seems strange, but this unconscious mirroring builds trust like magic.

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Inizio Engage — PROPENSITY4 Welcomes Chris Savage as Managing Director

PM360

Chris Savage, Managing Director, PROPENSITY4 [Fort Washington, PA – 2024] – Inizio Engage is pleased to announce the appointment of Chris Savage as the Managing Director of PROPENSITY4, effective January 1, 2024. His appointment marks a significant milestone for PROPENSITY4, reinforcing Inizio Engage’s commitment to delivering exceptional value to its clients and positioning the company for continued success in the dynamic world of data and analytics.

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How Mental Health Clinics Automate Assessment Forms with Salesforce Health Cloud

Penrod

Titan’s forms for Salesforce are especially useful in the provider space where integration, holistic patient scores, and HIPAA compliance are required. Here at Penrod, we’ve noticed a rising trend among our mental health provider clients: they’re starting to digitize their patient assessment procedures. Accurate and timely patient responses are key in the assessment process, directly affecting the success of patient health outcomes.

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Jamie Halstead

Curzon Consulting

Analyst Contact me +44 (0)1653 628596 Jamie is a dynamic professional, known for his exceptional skills in strategy work, data analytics, and financial modelling. With a versatile approach to problem-solving, Jamie effectively applies his expertise across a variety of sectors, helping clients navigate complex business challenges with innovative solutions.

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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.