Wed.Jan 31, 2024

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Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

Fierce Pharma

More than two years after Aduhelm's controversial and ill-fated FDA accelerated approval, Bi | Biogen is discontinuing its first Alzheimer's disease therapy, Aduhelm, after walking a rocky path. The company is taking a $60 million charge, halting sales and terminating a confirmatory trial.

FDA 307
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We’ve Actually Treated Tens of Thousands of People on Ozempic to Date – Here’s What Really Happens and What It Likely Means for Solving Our Obesity Epidemic

MedCity News

We and our collective organizations’ providers have treated 10,000’s of Americans, who suffer from obesity and/or Type 2 diabetes with GLP-1 drugs. And we believe we have important observations to share.

Biopharma 143
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GSK confirms Arexvy is a blockbuster but says the RSV battle has just begun

Fierce Pharma

Beaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arex | GSK's RSV vaccine Arexvy generated $1.5 billion in sales in 2023 compared to $890 million for Pfizer's Abrysvo. But the British pharma major says that the successful launch represents just one round of a boxing match, and much is still to be decided, especially with Moderna expected to joi

Pharma 293
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Biogen Says Goodbye to Beleaguered Alzheimer’s Drug Aduhelm

MedCity News

Biogen has returned its Aduhelm rights to Neurimmune, the company that initially developed the antibody Alzheimer’s disease drug. But Biogen isn’t abandoning Alzheimer’s, and its pipeline includes drugs that take other approaches to the neurodegenerative disorder.

Biopharma 110
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Teva's refresh under new CEO Francis moves into year 2 as Austedo, Ajovy and generics gain steam

Fierce Pharma

After charting a series of sales increases in 2023, Teva’s largely made good on the promise of its new CEO’s “Pivot to Growth” campaign. | After charting a series of sales increases in 2023, Teva’s largely made good on the promise of its new CEO’s “Pivot to Growth” campaign. With group revenues on the up-and-up, it’s all about maintaining momentum in the years to come, the company’s chief executive Richard Francis said in an interview.

Sales 217
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Immunotherapy changed the cancer treatment landscape. Is the gut microbiome the next frontier?

PharmaVoice

The president of L.A.’s City of Hope Cancer Center believes the current state of cancer treatments can be greatly improved with a peek into the gut’s many mysteries.

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More Trending

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Transforming Diagnosis and Treatment of Pediatric Pneumonia Through Point-Of-Care Lung Ultrasound

MedCity News

Point-of-care lung ultrasound – also known as lung POCUS – is a safer, more reliable alternative to X-ray in diagnosing pneumonia that provides information quickly. Yet it’s not widely considered the standard of care.

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Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

Fierce Pharma

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate.< | AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma keeps increasing its sales projections for the HER2-directed antibody-drug conjugate.

Sales 200
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ACO REACH Challenging to Succeed in First Year But Tools Can Help

MedCity News

To succeed in ACO Reach, groups need to accurately identify the social determinants of health (SDoH) barriers affecting their patient population and determine which barriers could be addressed effectively. Some technology can accurately note specific SDoH risk factors facing a given patient and offer targeted intervention recommendations based on that patient’s unique SDoH risk factors.

Patients 100
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After Novartis' radiotherapy Pluvicto disappoints, CEO touts 'compelling case' for future growth

Fierce Pharma

Even though Novartis grew sales and profits in the last quarter of 2023, the magnitude of the increases was not satisfactory to the Swiss pharma's investors. | Novartis grew sales and profits in the last quarter of 2023, but the magnitude of the increases was not satisfactory to the company’s investors. Among a portfolio of newer medicines, radiotherapy Pluvicto stuck out as a major drag.

Sales 141
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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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Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release

PharmaTech

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

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Novartis calls time on Tim3 drug sabatolimab in MDS

pharmaphorum

Novartis ends development of Tim3 antibody sabatolimab in myelodysplastic syndromes after failed phase 3 trial.

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Mental Health Startup Combining Psychiatry with Novel Treatments Launches with $5.4M in Funding

MedCity News

Being Health, a startup that launched last week, offers a care team that includes psychiatrists, psychotherapists, nurse anesthetists, functional medicine physicians, nutritionists, acupuncturists and care advocates. It serves patients both virtually and in person.

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Novo Nordisk sales surge drives value towards $500bn

pharmaphorum

A surge in 2023 sales and profits fuelled by diabetes and obesity drugs has driven Novo Nordisk's valuation toward $500bn

Sales 113
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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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ALULA Honors African American Leaders Who Led the Right Way (Part 2 of 4)

ALULA

This Black History Month, we celebrate African culture & history via Benjamin Banneker and Madam C. J. Walker for maintaining and pursuing a clear vision.

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CMS sets up negotiating framework for expensive sickle cell disease gene therapies

Pharmaceutical Technology

CMS’ CGT Access Model will see allow the agency to negotiate negotiate pricing and build a framework that expands access to treatments.

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ALULA Honors African American Leaders Who Led the Right Way (Part 1 of 4)

ALULA

African culture and history offer wisdom for the world. This Black History Month, we celebrate powerful leaders who achieved lasting positive impact.

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Healthcare Moves: A Monthly Summary of Hires and Layoffs

MedCity News

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.

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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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ALULA Honors African American Leaders Who Led the Right Way (Part 3 of 4)

ALULA

This Black History Month, we celebrate African culture & history via Althea Neale Gibson and Berry Gordy Jr for being great leaders by coaching others.

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AbbVie’s Tepkinly backed by NICE for DLBCL patients

pharmaphorum

AbbVie’s CD20xCD3 bispecific antibody Tepkinly has been recommended by NICE for NHS use as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive and fast-growing form of non-Hodgkin lymphoma. Tepkinly (epcoritamab) – the first medicine to emerge from AbbVie’s $3.9 billion alliance with Genmab signed in 2020 – can be used to treat adults with DLBCL whose cancer has returned or has not responded to at least two previous systemic treatments.

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Emerging Therapies Drive Analytical Advancements

PharmaTech

The emergence of mRNA vaccines and cell and gene therapies have pushed innovation in analytical methods.

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Digital health hit hard by VC slump in 2023, says report

pharmaphorum

Digital health investments has halved for the second year in a row, according to a new report from CB Insights

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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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NHS launches Pharmacy First to treat seven common conditions

PharmaTimes

Over 10,000 pharmacies in England will be offering the new advanced service

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GSK on top in RSV jab rollout, but is Pfizer closing the gap?

pharmaphorum

GSK's RSV vaccine Arexvy outsold Pfizer's Abrysvo last year, but fourth-quarter figures suggest the gap may be narrowing.

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Analyzing Exabytes

PharmaTech

Effective analytics will eliminate failures, deviations, and non-conformances.

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MRC Laboratory of Medical Sciences worth £120m opens on ICL campus

PharmaTimes

The institute is one of two UK laboratories wholly funded by the MRC

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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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Dissolution Testing Software

PharmaTech

Distek’s software update for the Opt-Diss–In-Situ Fiber Optic UV System for Dissolution Testing, Version 3.20, introduces enhancements designed to streamline the dissolution testing process and expand the system’s capabilities.

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Biogen Pulls Plug on Controversial Alzheimer Disease Drug Aduhelm

PharmExec

Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency's Peripheral and Central Nervous System Drugs Advisory Committee.

FDA 52
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ROSS Dual-Shaft Mixers

PharmaTech

Designed for processing high viscosity dispersions and suspensions, the ROSS line of Dual-Shaft Mixers are versatile systems utilized in the chemical, pharmaceutical, food, cosmetic, adhesive, coating, composite, and other industries.

Food 52
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Johnson & Johnson Files sBLA for Darzalex Faspro Combination in Multiple Myeloma

Pharmaceutical Commerce

FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

FDA 52
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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.