Mon.Nov 13, 2023

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Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Fierce Pharma

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. | Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack.

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Report: Workers Trust Employers More Than Insurers With Their Health

MedCity News

Just 37% of employees trust their insurer to suggest high-quality care regardless of cost, while 53% trust their employer with their health, according to a survey released by Included Health.

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Trending Sources

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Half a year later, Teva's 'pivot to growth' strategy appears to be bearing fruit

Fierce Pharma

Six months on, Teva’s new “pivot to growth” strategy appears to be paying off. | In 2023’s third quarter, the Israeli-American generics giant reported global sales of $3.9 billion, up 7% from the same period in 2022. The company credited that growth to the strong momentum behind its branded meds Austedo and Ajovy, plus a “stable and sustainable generics business” in the U.S. that’s also seen “continued growth” in Europe and other international markets.

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Report: Many Found Renewing Medicaid Coverage Easy, But Some Faced Barriers

MedCity News

New KFF focus groups revealed that some thought the process of renewing Medicaid coverage during the unwinding of the continuous enrollment provision was simple. Others, however, faced challenges with communication from state Medicaid agencies, and some weren’t aware their coverage had been terminated.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Teva draws $100M from Royalty funding to bankroll long-acting schizophrenia drug

Fierce Pharma

To fuel CEO Richard Francis’s “pivot to growth” plan, Teva has turned to royalty financing to fuel the accelerated development of a pipeline antipsychotic drug in its innovation portfolio. | To fuel CEO Richard Francis’s “pivot to growth” plan, Teva has turned to royalty financing to fuel the accelerated development of a long-acting antipsychotic drug.

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Healthcare Doesn’t Need More Big Tech; It Needs Specialized Tech

MedCity News

It’s easy to oversimplify and say, “These big tech companies are now doing healthcare and they’re going to solve everything.” But the reality is that often, the solutions are not going to come from big tech.

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Novartis to Pay Legend Biotech $100M in Pact Bringing Cell Therapy to Solid Tumors

MedCity News

Novartis gains global rights to Legend Biotech cell therapies that address DLL3, a promising target for lung cancers and other types of solid tumors. The pharmaceutical giant may make these therapies using T-Charge, its next-generation CAR T-cell therapy manufacturing technology.

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Humans can’t shake the mosquito threat. Here’s what pharma has in the pipeline.

PharmaVoice

The arsenal against the world’s deadliest creature is growing and a universal vaccine is in the works.

Pharma 116
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Loneliness and its Impact on Alzheimer’s Patients: Harnessing Companion Animal Digital Technology

MedCity News

A significant healthcare crisis looms as Baby Boomers age, which will contribute to a rise in Alzheimer’s cases. Combined with a shortage of geriatricians and caregivers, we will soon have more lonely seniors in America. We must open our minds to new solutions, such as robotic companions.

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Could GSK myelofibrosis treatment gain EU-first approval?

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. The Committee deemed it beneficial as a treatment for disease-related splenomegaly (enlarged spleen) or symptoms in adults with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor n

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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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Ajinomoto Adds Gene Therapy to CDMO Scope via $554M Forge Bio Buyout

MedCity News

Ajinomoto’s Forge Biologics acquisition brings contract development and manufacturing organization capabilities in gene therapy. Forge specializes in manufacturing AAV vectors used to deliver these therapies.

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Medical Debts in America: Collections, Aggressive Tactics, and Consequences

PharmExec

The growing issue of medical debt has caused stakeholders to reevaluate tactics as the cost of pharmaceutical healthcare continues to rise.

Medical 98
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Psychiatry’s Future Progress Depends on Innovation, Collaboration, and Access

MedCity News

We are on the edge of rapid innovation in psychiatry. Now is the time to break out of our silos and take advantage of the promise the future holds.

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UK announces $326.4m funding to improve drug and alcohol treatment

Pharmaceutical Technology

The UK government has announced £267m ($326.4m) funds for developing treatments for drug and alcohol misuse.

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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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OmniLife Health’s Clinical Workflow Solution Focuses on Complex Care [Sponsored]

MedCity News

OmniLife Health’s initial focus with its complex care coordination platform is organ transplant care.

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BIO-Europe 2023: Barriers remain in the AI pharma revolution

Pharmaceutical Technology

At the BIO-Europe conference, experts discussed remaining challenges in AI healthcare interventions.

Pharma 98
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Equity for Women in Healthcare: 131 Years is Too Long to Wait

PharmExec

Closing the gender gap in pharma—and how we get there together.

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Welcome New Board Member: Jeanne Miller

MedTechVets

NOV 14th – We were proud to interview and welcome new MedTechVets Board Member, Jeanne Miller. She is the Area Vice President of Sales for Biosense Webster , a division of Johnson & Johnson MedTech and a proud wife and mother of four. Jeanne began her service in the U.S. Marine Corps as an Aviation Supply Officer after graduating from the United States Naval Academy.

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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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Victoria Atkins replaces Barclay as UK health secretary

pharmaphorum

Victoria Atkins replaces Barclay as UK health secretary Phil.

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Digital Hollywood Focus on AI and Copyright

Copyright Clearance Center

The post Digital Hollywood Focus on AI and Copyright appeared first on Copyright Clearance Center.

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Sandoz opens new antibiotic and biosimilar facilities in Austria and Germany

PharmaTimes

Antimicrobial resistance is considered one of the top ten global public health threats - News - PharmaTimes

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UCB on course for approval of gMG drug Rystiggo in EU

pharmaphorum

UCB on course for approval of gMG drug Rystiggo in EU Phil.

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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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IO Biotech enrols 380 patients with advanced melanoma in phase 3 trial

PharmaTimes

The trial is evaluating an investigational cancer vaccine in combination with Keytruda - News - PharmaTimes

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e-Data and the Biopharmaceutical Supply Chain

PharmExec

MilliporeSigma’s Stephen Wing, head of Analytical and Logistical Services, discusses the ways in which digital transformation and data transparency dramatically enhance supply chains, and how manufacturers are using the company’s eMERGE™ platform to improve overall efficiencies.

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Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

PharmaTech

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.

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FDA Approves Expanded Nerve Block Indications for Pacira BioSciences' Exparel

PharmExec

FDA expands indications for bupivacaine liposome injectable suspension (Exparel; Pacira BioSciences, Inc.) for use in adult patients as an adductor canal block and a sciatic nerve block in the popliteal fossa.

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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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FDA approves Takeda’s targeted therapy for advanced colon cancer

Pharmaceutical Technology

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The global Clarivate clinical outcome assessment team is comprised of health psychologists and outcomes researchers who have extensive methodological and commercial experience.

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Akili says OTC switch for ADHD DTx leads to sales rise

pharmaphorum

Akili says OTC switch for ADHD DTx leads to sales rise Phil.

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CHMP provides positive opinion for Merck’s Keytruda

Pharmaceutical Technology

The EMA CHMP provided a positive opinion for granting approval to Merck’s Keytruda combination therapy to treat biliary tract cancer.

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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.