Fierce Pharma

FEBRUARY 20, 2024

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.

Manufacturing 255

Manufacturing 255

Salesforce

FEBRUARY 20, 2024

For many people, a sudden tingling in the leg or a feeling of numbness in the arm isn’t too much cause for alarm. The tingling or the numbness goes away after a little while, and they go on with their lives. But for Brooke Eby, an abrupt limp on her way to a conference one day ultimately led to a diagnosis of amyotrophic lateral sclerosis (ALS) at the age of 33.

Patients 137

Patients Pharma Consulting Leads 137

Fierce Pharma

FEBRUARY 20, 2024

AstraZeneca, having surpassed its long-term $45 billion revenue goal last year, has handsomely rewarded its chief executive. | AstraZeneca CEO Pascal Soriot’s compensation package makes him the current top contender for 2023’s highest-paid pharma CEO in Europe. Still, as in years past, not everyone is pleased with Soriot’s 2023 windfall.

Pharma 251

Pharma 251

MedCity News

FEBRUARY 20, 2024

About 57% of patients have gone to a doctor’s appointment to discover that the provider was not the right one for their condition, according to new research from Zocdoc. Because of this, the company launched a new tool called Guided Search that helps pair patients with the correct provider.

Patients 111

Patients Healthcare Healthcare 111

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Fierce Pharma

FEBRUARY 20, 2024

On AbbVie’s latest earnings call, analysts were curious whether long-time CEO Richard Gonzalez was weighing a succession plan now that Humira’s loss of U.S. exclusivity has passed. | Robert Michael, AbbVie’s current president and chief operating officer, has been tapped by the company’s board of directors to take over Richard Gonzalez’s CEO post on July 1.

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MedCity News

FEBRUARY 20, 2024

There is growing and coordinated momentum behind the goal of ensuring connected medical devices improve people’s lives without introducing them to cybersecurity threats and associated safety risks. There also is a proven playbook for implementing the type of multi-layered, security-by-design strategies these initiatives advocate.

Safety 111

Safety Medical 111

MedCity News

FEBRUARY 20, 2024

There are plenty tools and data sharing standards available to foster a more cohesive and integrated approach to healthcare interoperability. However, providers aren’t really adopting these tools, experts said during a recent panel.

Healthcare 110

Healthcare Healthcare 110

Fierce Pharma

FEBRUARY 20, 2024

GSK’s long-acting HIV regimen Cabenuva has already shown it works as well as daily oral therapies in patients who have the virus under control. | GSK’s long-acting HIV regimen Cabenuva has already shown it works as well as daily oral therapies in patients who have the virus under control. Now, the injection has beaten daily drugs in individuals who’ve faced issues adhering to their medications.

Patients 191

Patients Medical 191

pharmaphorum

FEBRUARY 20, 2024

The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).

FDA 103

FDA 103

Fierce Pharma

FEBRUARY 20, 2024

This week on “The Top Line,” we’re speaking with Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled indiv | This week, we’re speaking with Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled individuals to lead longer and healthier lives by taking and staying on medication.

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Leads Medical 154

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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.

Safety

PharmaVoice

FEBRUARY 20, 2024

A significant growth is predicted for both AI and IoT in healthcare. By 2030, the AI market is expected to reach $187.95 billion USD, while the IoT market is projected to climb even higher to $312.7 billion USD.

Healthcare 104

Healthcare Healthcare Marketing 104

Fierce Pharma

FEBRUARY 20, 2024

AstraZeneca is celebrating a trio of recent advancements for its portfolio in non-small cell lung cancer (NSCLC). | AstraZeneca is celebrating a trio of advancements for its portfolio in non-small cell lung cancer, including an “overwhelming efficacy benefit” for Tagrisso in early-stage disease. Besides the trial result, AZ touted an FDA approval for Tagrisso's chemo combo in metastatic tumors, plus an application acceptance for a Daiichi Sankyo-partnered TROP2 antibody-drug conjugate in a

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FDA Patients 152

MedCity News

FEBRUARY 20, 2024

Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target.

Leads 103

Leads Biopharma Pharma 103

Fierce Pharma

FEBRUARY 20, 2024

It’s been 15 years since Genzyme began rationing the Fabry disease treatment Fabrazyme after a shortage caused by contamination at a manufacturing site, marking the start of many years of litigatio | Sanofi's Genzyme was accused of causing injuries after contaminated doses of its Fabry disease drug led to a shortage, during which the company rationed the drug.

Manufacturing 141

Manufacturing 141

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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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Pharmaceutical Commerce

FEBRUARY 20, 2024

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

FDA 101

FDA 101

MedCity News

FEBRUARY 20, 2024

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

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FDA Patients Safety Biopharma 102

pharmaphorum

FEBRUARY 20, 2024

The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.

Marketing 95

Marketing 95

MedCity News

FEBRUARY 20, 2024

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

Healthcare 100

Healthcare Healthcare Medical 100

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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.

Safety

European Pharmaceutical Review

FEBRUARY 20, 2024

A report from Data Bridge Market Research has predicted that the upstream bioprocessing market will value $14,256.78 million by 2029. Additionally, the research calculated that market is anticipated to undergo a CAGR of 6.85 percent between 2022 and 2029. The rising productivity of cell lines has improved the performance of upstream processing with low cost and high process reproducibility, the report explained.

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Marketing Manufacturing Media Pharmaceutical 81

Pharmaceutical Technology

FEBRUARY 20, 2024

Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.

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Food FDA 94

pharmaphorum

FEBRUARY 20, 2024

Bayer takes anti-alpha2 antiplasmin antibody BAY3018250 into phase 2 as a deep vein thrombosis treatment, hoping to improve on thrombolytics.

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MedCity News

FEBRUARY 20, 2024

The conference, scheduled for May 21-22 at the Ritz Carlton in Chicago, is the premier boutique healthcare investment event in the U.S.

Healthcare 93

Healthcare Healthcare 93

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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.

Specialization

pharmaphorum

FEBRUARY 20, 2024

Google DeepMind and Owkin scientists have joined forces to create Bioptimus, an AI startup that aims to develop a foundation model for biology

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PharmaVoice

FEBRUARY 20, 2024

While buzz builds around “off the shelf” CAR-T cell therapies, Kite is staying competitive with a shorter manufacturing turnaround and a focus on broadening applications.

Competition 69

Competition Manufacturing 69

PharmaTimes

FEBRUARY 20, 2024

The nanogels, in combination with rolipram, contributed to the recovery of injured tissue

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Evolve Your Success

FEBRUARY 20, 2024

In the dynamic realm of medical device sales, the possibilities are limitless. Dive into the role of a Diabetes Sales Specialist and explore the diverse opportunities that await. In this episode for Black History Month, Samuel Adeyinka interviews District Sales Trainer & Diabetes Sales Specialist, O’Neal Ford , to shed light on his role. Discover the importance of curiosity and adaptability in the field as O’Neal discusses the evolving landscape of endocrinology and the impact of

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Sales Medical sales Medical Education 59

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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

Leads

pharmaphorum

FEBRUARY 20, 2024

AbbVie reveals its CEO succession plan, as COO Robert Michael prepares to take over from Richard Gonzalez on July 1

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PharmaTimes

FEBRUARY 20, 2024

The new programme will engage with children and young people under the age of 18 years

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Patients 82

Clarify Health

FEBRUARY 20, 2024

Since July 2022, CMS has required most group health plans and issuers of group or individual health insurance to post price information for covered items and health services. For most, the concept of price transparency has been approached as a compliance necessity. However, it offers far more than just adherence to regulations. Price transparency stands as a strategic asset with the power to significantly help payers.

Competition 52

Competition Healthcare Healthcare Marketing 52

Pharmaceutical Commerce

FEBRUARY 20, 2024

When identifying a third-party service provider for ground transport of pharmaceutical freight, it is essential that the shipper partner with a company equipped with the expertise and technologies to plan for and monitor necessary shipments as well as respond to issues that may compromise the freight along its journey.

Transportation 52

Transportation Pharma Pharmaceutical 52

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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.

Management