Fierce Pharma

FEBRUARY 16, 2024

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

FDA 347

FDA 347

MedCity News

FEBRUARY 16, 2024

A new EY survey found that while 86% of health executives say that digital health solutions have the potential to reduce costs, 70% said they haven’t seen a return on investment so far.

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Fierce Pharma

FEBRUARY 16, 2024

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

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Food FDA Medicine Marketing 314

MedCity News

FEBRUARY 16, 2024

Offering safe affordable family-forming programs for everyone, including vulnerable or under-served employee populations, represents an opportunity for employers to build a caring culture that also will benefit the bottom line.

Competition 115

Competition 115

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Fierce Pharma

FEBRUARY 16, 2024

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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MedCity News

FEBRUARY 16, 2024

As more and more organizations integrate Generative AI with Configure, Price, Quote (CPQ) systems, they declare their belief that we can aspire to incredible advancements in human health and well-being through digital transformation.

Healthcare 114

Healthcare Healthcare 114

MedCity News

FEBRUARY 16, 2024

Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019.

Pharma 109

Pharma Biopharma 109

Fierce Pharma

FEBRUARY 16, 2024

While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.

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MedCity News

FEBRUARY 16, 2024

Moving from spreadsheets to automated data collection and processing is far from easy, but it could revolutionize drug development. It’s time for the biopharma industry to embrace end-to-end digitalization.

Biopharma 106

Biopharma 106

Fierce Pharma

FEBRUARY 16, 2024

Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chr | Four months after the FDA rejected Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria, Japan’s health regulators have signed off on the drug in the indication.

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FDA 210

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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

pharmaphorum

FEBRUARY 16, 2024

CAR-T therapies can achieve remarkable efficacy in the treatment of haematological cancers, but the risk of side effects means that the cell infusions are almost always administered to inpatients under close supervision in clinics.

Side effects 99

Side effects Safety 99

Fierce Pharma

FEBRUARY 16, 2024

After Elevidys scored an FDA approval in a restricted group of patients, Sarepta's attempt for a larger indication has snared a priority review.

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FDA Patients 160

MedCity News

FEBRUARY 16, 2024

Elation Health integrated Surescripts’ real-time prescription benefit tool — which gives clinicians immediate access to patient-specific medication coverage and cost data — into its EHR. The partnership aims to improve patients’ medication adherence by helping primary care physicians have more meaningful conversations with their patients about prescription affordability during visits.

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Prescription Physicians Medical Patients 97

Fierce Pharma

FEBRUARY 16, 2024

The scientific community has made tremendous progress against viral diseases.

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135

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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

Distribution

MedCity News

FEBRUARY 16, 2024

Equal parts networking and curated panels covering the latest trends in healthcare investment, MedCity INVEST 2024 is the ideal event to discuss health tech, biopharma, devices and diagnostics investment opportunities. Register today!

Healthcare 94

Healthcare Healthcare Biopharma Networking 94

pharmaphorum

FEBRUARY 16, 2024

Recent biotech financings include a $245m raise for cancer blood test company Freenome, plus big rounds for Cogent Biosciences, BioAge Labs, Latigo Biotherapeutics, ProfoundBio, and Firefly Bio

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94

Pharmaceutical Technology

FEBRUARY 16, 2024

This positive news comes after Otsuka’s Phase III Alzheimer’s agitation trial failed to meet its primary endpoint, announced earlier this week.

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FDA 98

pharmaphorum

FEBRUARY 16, 2024

Gilead Sciences has paused enrolment in clinical trials of its CD47 drug magrolimab in solid tumours, a week after dropping it for blood cancers.

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101

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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

Impetus Digital

FEBRUARY 16, 2024

A version of this article was previously published on PharmaPhorum. Whether we’re talking offices, medical congresses, or advisory board meetings , the term “hybrid” is often used to signal the ideal state. The place where everyone’s needs are being met. The best of both worlds. In the era of digital transformation, it is predicted that 2024 will be the year that finally cements hybrid meetings as the norm (1), with all-virtual meetings continuing to be a popular option.

Pharma 84

Pharma Healthcare Provider Healthcare Healthcare 84

pharmaphorum

FEBRUARY 16, 2024

Astellas has signed a deal with Kelonia Therapeutics that aims to push the boundaries of what can be achieved with CAR-T therapies in immuno-oncology

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95

Pharmaceutical Technology

FEBRUARY 16, 2024

GSK has successfully concluded the acquisition of Aiolos Bio in a deal that could reach $1.4bn, expanding its respiratory portfolio.

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95

European Pharmaceutical Review

FEBRUARY 16, 2024

Researchers have highlighted the potential of end-to-end continuous manufacture with column-free capture alternatives. The traditional batch process was compared with end-to-end continuous bioprocesses with either protein A (ProA) capture or column-free capture, employing aqueous two-phase extraction (ATPE) or precipitation from economic, environmental, and robustness perspectives.

Manufacturing 79

Manufacturing Biopharma Pharmaceutical Marketing 79

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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

Pharmaceutical Commerce

FEBRUARY 16, 2024

The financial commitment features construction of new warehouses in Pennsylvania and North Carolina.

Healthcare 103

Healthcare Healthcare 103

PharmaTimes

FEBRUARY 16, 2024

Cardiac quantitative susceptibility mapping successfully visualised iron deposits in patients

Patients 89

Patients 89

PharmaVoice

FEBRUARY 16, 2024

Belt tightening and streamlined portfolios are critical in 2024 amid continued economic uncertainty.

Pharma 86

Pharma 86

PharmaTimes

FEBRUARY 16, 2024

NRTX-1001 is being assessed for drug-resistant mesial temporal lobe epilepsy

Leads 86

Leads 86

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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

PharmExec

FEBRUARY 16, 2024

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

Food 52

Food Patients FDA 52

Rep-Lite

FEBRUARY 16, 2024

In healthcare, knowing how to grow a sales team can facilitate the success of any healthcare organization. The medical sales industry covers several sub-categories including, medical device sales rep, pharmaceutical sales rep, and medtech sales. Medical sales representatives build trust with medical professionals and offer insights into health care while navigating regulations.

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Medical sales Sales Medical Medical sales reps 52

Pharmaceutical Commerce

FEBRUARY 16, 2024

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

Food 52

Food FDA 52

PharmExec

FEBRUARY 16, 2024

Strategic and proactive thinking are vital in providing supply chain leaders with an opportunity to shift their focus to a more holistic, value-centered approach.

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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