Wed.May 15, 2024

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With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide

Fierce Pharma

Though Galapagos has undergone plenty of staff shakeups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following | Galapagos has teamed up with the largest blood supply network in the U.S. to help establish decentralized CAR-T production on a national scale.

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Telehealth Is Far From Dead, Says Providence’s Virtual Care Chief

MedCity News

This year has been a messy one for virtual care companies, but that doesn’t mean that telehealth is dead, according to Eve Cunningham, Providence’s chief of virtual care and digital health. In her view, virtual care can definitely still be an important part of the care delivery model — but only if it is embedded into the greater healthcare delivery ecosystem.

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In Novo pricing probe, Sanders cranks up the heat with dire warning on projected GLP-1 spending

Fierce Pharma

After recently placing a spotlight on Novo Nordisk’s "outrageous" U.S. | A new Senate HELP Committee report says GLP-1 drugs could "bankrupt our entire health care system" because of their high prices coupled with high uptake.

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GSK, UK govt put £130m into antimicrobial resistance fight

pharmaphorum

GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.

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

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Eli Lilly settles with spa selling knockoff Mounjaro, Zepbound amid crackdown on fake GLP-1 meds

Fierce Pharma

After Eli Lilly sued several companies that were allegedly selling unauthorized versions of its tirzepatide products, the drugmaker has successfully cracked down on one of them. | Under legal pressure from Eli Lilly, a medical spa has agreed to pay an undisclosed settlement and undertake several "corrective actions," such as noting publicly that compounded versions of Lilly's tirzepatide products are not approved by the FDA.

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Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck

MedCity News

Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi. The post Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck appeared first on MedCity News.

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Home testing devices for sleep apnoea backed for NHS use

pharmaphorum

Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.

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Merck KGaA's CDMO unit continues to slide but company sees an uptick coming

Fierce Pharma

Two years ago, when Merck KGaA restructured, forming a new life science business, the goal was to maximize the enticing potential of its contract development and manufacturing organization (CDMO). | On Wednesday—amid largely positive news for Merck KGaA overall—the company reported a 17% decline in sales for its CDMO unit, blaming (PDF) “unfavorable project phasing” and a streamlining of the supply chain of one of its customers.

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

Pharma 105
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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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Wisp Begins Offering Diagnostics Through Partnership With TBD Health

MedCity News

Wisp members can now order TBD Health’s STI/STD testing kits on Wisp’s website for free delivery. The post Wisp Begins Offering Diagnostics Through Partnership With TBD Health appeared first on MedCity News.

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Eisai, Biogen start delayed subcutaneous Leqembi filing

pharmaphorum

Eisai and Biogen have filed a rolling biologics license application in the US for a subcutaneous formulation of Alzheimer’s disease therapy Leqembi that was delayed by the FDA on procedural grounds.

FDA 101
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When It Comes to Preventive and Proactive Wellness, Accessibility Is Key

MedCity News

Holistic care requires proactive pursuit of health services, which more people might seek if financing options are available to manage costs. The post When It Comes to Preventive and Proactive Wellness, Accessibility Is Key appeared first on MedCity News.

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Updated BIOSECURE Act draft clears House committee

pharmaphorum

House Oversight Committee passes BIOSECURE Act, which would restrict US companies from contracting with Chinese biotechs including WuXi AppTec, MGI and BGI

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Ensuring sterility of a novel anti-VEGF bispecific antibody

European Pharmaceutical Review

Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”. Their study compared the stability, sterility, and binding affinity to VEGF and Ang-2 of faricimab.

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AbbVie takes option on Gilgamesh CNS drugs in $2bn deal

pharmaphorum

AbbVie has agreed to pay $65 million on an option deal with start-up Gilgamesh Pharma, lining up rights to neuroplastogen compounds that can improve neuroplasticity - the ability of the brain to respond to changes. The two companies will work together on the development of a “next-generation” of psychiatric medicines, although – for now – the drugs themselves and the target indications are being kept under wraps. other than to say they include mood and anxiety disorders.

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FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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FDA clears BMS’ Breyanzi for follicular lymphoma

pharmaphorum

BMS gets another FDA approval for its CD19-directed CAR-T Breyanzi, this time as a third-line or later therapy for follicular lymphoma

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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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FDA clears IND for Verismo Therapeutics’ CAR-T therapy 

Pharmaceutical Technology

Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.

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AbbVie takes option on Gilgamesh psychedelics in $2bn deal

pharmaphorum

AbbVie joins a select group of big pharma groups working on psychedelic medicines, paying $65m on an option deal with Gilgamesh Pharma

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The Interplay Between Copyright Licensing and Exclusive Rights; AI Edition

Copyright Clearance Center

The post The Interplay Between Copyright Licensing and Exclusive Rights; AI Edition appeared first on Copyright Clearance Center.

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Nabla Bio secures $26m in Series A funding round

Pharmaceutical Technology

Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.

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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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NIHR and TJBCM announce new funding initiative for novel brain tumour research

PharmaTimes

The condition is the ninth most common cancer in the UK and affects 12,300 people annually

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Reddit Rising: Increasing Visibility and Credibility for Discussions and Forums

Eversana Intouch

Reddit, on its way to becoming the third most visited global website, has formed a symbiotic relationship with Google, highlighting its growing digital importance. This presents a golden opportunity for pharma brands to utilize community-driven platforms like Reddit. Thanks to its recent Google partnership and exponential YoY growth in search appearances, Reddit is emerging as a key hub for genuine engagement and peer insights.

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Uniquity Bio emerges with $300m for MSD immunology drug

pharmaphorum

New biotech startup Uniquity Bio emerges with $300m in funding from Blackstone and a clinical-stage asthma and COPD drug licensed from MSD

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GLP-1 receptor agonist sales expected to reach $125bn by 2033

Pharmaceutical Technology

Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of incretin mimetic medicines for the treatment of Type 2 diabetes and obesity.

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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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Meeting the Challenges and Opportunities in Scholarly Communications with FAIR Data

Copyright Clearance Center

During a time of thorough transformation towards Open Access and, moreover, Open Science, the field of scholarly communications is facing new challenges. Some of the challenges are related to an aging and somewhat antiquated infrastructure, and others are related to new technologies and the evolving landscape of scientific dissemination, where the disclosure of data is becoming central to and an essential part of research and reproducibility.

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Risk adjusted net present value: What is the current valuation of Corcept Therapeutics’s Miricorilant?

Pharmaceutical Technology

Miricorilant is a small molecule commercialized by Corcept Therapeutics, with a leading Phase II program in Obesity.

Leads 75
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Seven Amazing Activities at the LTEN Conference 2024

Quantified

The LTEN Conference is the premier gathering for professionals in the life sciences training field, and 2024 promises to be the best year yet. Whether you’re a seasoned educator, a training leader, or just stepping into the world of life sciences, this event offers tons of enriching experiences. Here are seven must-do activities to ensure a great experience at the conference. 1.

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Leading Sales Teams To Global Success: A Mother’s Day Special With Sydney Selby

Evolve Your Success

A Mother’s Day special! Join us as we sit down with Sydney Selby , the innovative Vice President of Sales, Marketing, and Medical Education at Renata Medical , during a week when we honor mothers and the gifts they bring into our lives. Sydney illuminates the often-invisible struggles within pediatric congenital heart disease treatment, revealing how Renata Medical’s Minima Renata stent system is revolutionizing care for the tiniest hearts.

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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.