Wed.Jul 03, 2024

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Sanofi and Regeneron's Dupixent scores in Europe as the first biologic to treat COPD

Fierce Pharma

After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week. | After more than a decade with no treatment advances for chronic obstructive pulmonary disease (COPD), two have been approved by regulators on either side of the Atlantic within a week.

Medicine 220
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Beacon lights up with $170m for retinal disease gene therapy

pharmaphorum

Beacon Therapeutics raises $170m for a pivotal trial of its gene therapy for X-linked retinitis pigmentosa, an inherited cause of blindness

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Trending Sources

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Abbott Says Its Latest CGM Sensor Is Its Most Discreet Yet

MedCity News

Abbott recently launched the FreeStyle Libre 3 Plus sensor, which it says is the smallest and most discreet sensor on the market. It will soon be available in U.S. retail pharmacies and medical equipment suppliers. The post Abbott Says Its Latest CGM Sensor Is Its Most Discreet Yet appeared first on MedCity News.

Retail 89
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Lilly gets FDA OK for Alzheimer’s drug, cites cost advantage

pharmaphorum

Eli Lilly finally has FDA approval for its amyloid-busting Alzheimer’s disease therapy donanemab and will launch it at a cost it claims could deliver savings compared to a rival therapy from Eisai/Biogen.

FDA 85
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Foodsmart Snags $200M Investment Led By TPG’s Rise Fund

MedCity News

The Rise Fund will lead a $200 million investment in Foodsmart. The funding will help the telenutrition company scale its business. The post Foodsmart Snags $200M Investment Led By TPG’s Rise Fund appeared first on MedCity News.

Leads 87
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EU first to approve Dupixent for COPD

pharmaphorum

EU is first to approve Sanofi and Regeneron's Dupixent for COPD, ending a 10-year hiatus in new therapies

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GSK goes all-in on CureVac’s mRNA vaccines

pharmaphorum

GSK has upgraded its longstanding alliance with CureVac on mRNA-based vaccines for respiratory infections, paying €400 million ($429 million) upfront for global rights to its influenza and COVID-19 jabs.

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Capitation Technology Drives Financial Viability in Value-Based Care Models

MedCity News

Finding a payment technology solution that is specifically designed for alternative payment models like capitation helps payers and providers achieve financial sustainability in a value-based system. The post Capitation Technology Drives Financial Viability in Value-Based Care Models appeared first on MedCity News.

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Left in limbo: When pharma halts rare disease research

Pharmaceutical Technology

Academic institutions and nonprofit organisations are jumping in to save access to complex gene therapies.

Pharma 96
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Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration

MedCity News

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. The post Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration appeared first on MedCity News.

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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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Study reveals cardiovascular health could be biggest risk factor for dementia

PharmaTimes

Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK

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Advantage J&J in multiple myeloma CAR-T tussle with BMS

pharmaphorum

J&J’s multiple myeloma CAR-T Carvykti improves survival when used as a second-line or later therapy, raising the pressure on BMS’ rival Abecma

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Study finds headache drug could prevent overuse of acute migraine medications

PharmaTimes

Chronic migraine is a neurological condition estimated to affect up to 2.

Medical 103
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Six trends to watch for the global MedTech industry

Clarivate

The medical technology industry is emerging from a turbulent pandemic era strong, with some really exciting innovations making their way to patients, several of which we showcased in our recent Medical Technologies to Watch report. However, to realize the promise of these and other innovations, MedTech companies must navigate a fast-changing clinical, competitive and regulatory environment that presents a complex web of challenges.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves Pyzchiva for Use in the United States

Pharmaceutical Commerce

The Stelara biosimilar will be commercialized by Sandoz, and is expected to launch by February 2025 for multiple indications, including for the treatment of adult patients with active psoriatic arthritis.

FDA 52
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Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines

PharmExec

Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus.

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Healthcare Media Trailblazer Ray Rosti Named President, Klick Media

PM360

Former Publicis Chief Digital Officer joins Klick to take its growing Media team into the future Klick Health today announced that healthcare media veteran Ray Rosti has been named President, Klick Media. The agency’s Chief Operating Officer Greg Rice said that Rosti’s proven innovative approach and deep understanding of digital strategies made him the perfect candidate for the new role as Klick continues to expand and enhance its media capabilities. “We are thrilled to welcome Ray as Pres

Media 52
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Genezen Purchases uniQure’s Gene Therapy Operations in Massachusetts

Pharmaceutical Commerce

The deal provides the CDMO with ownership of the Lexington facility, allowing for late-phase and commercial gene therapy development and manufacturing of a branded severe Hemophilia B product.

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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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How LinkedIn Content Can Transform Your Medical Sales Career With Vendela Martin

Evolve Your Success

Join us for an insightful conversation with Vendela Martin, a trailblazing medical sales rep and LinkedIn content creator who transitioned from B2B sales at ADP to an impactful role in medical device sales, specializing in minimally invasive surgery for GYN surgeons. Vendela shares her journey and the pivotal moments that validated her career change, offering a glimpse into the importance of her product and the collaborative dynamics of her team.

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Johnson & Johnson gains FDA and EC approvals for TB treatment

Pharmaceutical Technology

Johnson & Johnson (J&J) has received the US FDA and EC approvals for SIRTURO (bedaquiline) to treat pulmonary tuberculosis (TB).

FDA 59
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In the rapidly shrinking COVID market, this company still sees opportunity

PharmaVoice

GeoVax is developing a next-gen COVID vaccine targeting a population that’s so far been elusive: immunocompromised patients.

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Health In Tech Announces New Partnerships to Expand Health Insurance Options for Employers in Southern Ohio

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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GSK and CureVac restructure mRNA vaccine development deal

Pharmaceutical Technology

GSK and CureVac have announced the restructuring of their existing partnership into a new licensing agreement for mRNA vaccine candidates.

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Pharma Pulse 7/3/24: What to Know About New and Future ALZ Drugs, Bridging the Gap Between Innovation and Implementation & more

PharmExec

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

Pharma 52
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Beacon secures $170m to advance ophthalmic gene therapies

Pharmaceutical Technology

Beacon’s lead candidate AGTC-501 is currently in a Phase II/III clinical trial for the treatment of X-linked retinitis pigmentosa (XLRP).

Leads 52
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PrimeRx Launches Digital Platform for Pharmacy Drug Ordering

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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Protecting your drug products: Strategies for preventing metal contamination in powders

Pharmaceutical Technology

Metal contamination in pharmaceutical products is a huge problem. Detection and removal of these contaminants is critical during milling.

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Publisher's Note: With Age Comes Wisdom

PharmaTech

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

FDA 52
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Moderna’s mRNA influenza vaccine receives $176m boost

Pharmaceutical Technology

Moderna has received a grant of $176m through the RRPV Consortium to expedite the development of mRNA-based pandemic influenza vaccines.

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Pharma Pulse 7/3/24: Reactions to New FDA Diversity Action Plan Guidance, Walgreens Strengthens Support for Children and Adults Living with Diabetes & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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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.