Fierce Pharma

APRIL 26, 2024

After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.

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pharmaphorum

APRIL 26, 2024

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.

Medical 113

Medical 113

Fierce Pharma

APRIL 26, 2024

AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.

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Sales FDA 290

MedCity News

APRIL 26, 2024

Johns Hopkins Hospital teamed up with Healthy.io, a company that offers smartphone-based technology to improve wound care management for diabetic patients. The partners are conducting a 120-person study to measure the impact of the startup’s technology. The post Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care appeared first on MedCity News.

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Patients Management 110

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Fierce Pharma

APRIL 26, 2024

GSK pulls Pfizer and BioNTech into another vaccine patent lawsuit, this time surrounding the partners' mRNA-based COVID shots fkansteiner Fri, 04/26/2024 - 10:07

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pharmaphorum

APRIL 26, 2024

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

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Manufacturing 109

MedCity News

APRIL 26, 2024

It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. The post BMI: A Flawed Measure of Health appeared first on MedCity News.

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Biopharma 114

pharmaphorum

APRIL 26, 2024

Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional surface.

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Pharmaceutical 103

European Pharmaceutical Review

APRIL 26, 2024

A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This method enables the number of administrations of the drug evaluated to be minimised, the researchers found. The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination.

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Medicine Pharmaceutical Pharmaceutical products Medical 96

MedCity News

APRIL 26, 2024

Addressing preventable harm starts with breaking down the data silos that exist within the healthcare landscape and pulling disparate systems together through connected healthcare operations. The post Driving Safer Care for All with Connected Healthcare Operations appeared first on MedCity News.

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Healthcare Healthcare Safety Patients 91

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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

European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ). Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine.

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Food and Drug Administration Medicine Marketing Food 87

MedCity News

APRIL 26, 2024

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. The post Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B appeared first on MedCity News.

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FDA Biopharma Pharma 87

European Pharmaceutical Review

APRIL 26, 2024

AbbVie has revealed positive topline results from the first head-to-head trial in atopic dermatitis assessing RINVOQ ® (upadacitinib) at a starting dose of 15mg daily versus DUPIXENT ® ( dupilumab ) at its labelled dose. The Phase IIIb/IV LEVEL UP study evaluated the efficacy and safety of these drugs in individuals 12 years old and older with moderate-to-severe atopic dermatitis.

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Safety Medical Patients Medicine 86

PharmaVoice

APRIL 26, 2024

Dr. Jeremy Levin, CEO of Ovid Therapeutics, explains how scientific advances have converged to create a new era of drug development potential.

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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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MedCity News

APRIL 26, 2024

This rapidly growing field marries bioinformatics and pharmacology and represents a transformative new era of precision medicine and highly personalized treatments. The post Revolutionizing Primary Care: The Role of Pharmacogenomics and AI in Personalized Medicine appeared first on MedCity News.

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Medicine Pharmacology 68

PharmaTech

APRIL 26, 2024

As breakthrough therapeutics in the pharma pipeline approach commercialization, pharmaceutical manufacturing facilities must evolve to meet demand.

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Pharmaceutical manufacturing Manufacturing Pharma Pharmaceutical 72

PharmaTimes

APRIL 26, 2024

The paper identifies the roles of LARP4A and LARP4B in sarcoma and carcinoma cancers

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MedCity News

APRIL 26, 2024

Check out news from Alpha Sophia, Handl Health, Alaffia Health, and Summer Health The post StartUPDATES: New Developments from Healthcare Startups appeared first on MedCity News.

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Healthcare Healthcare 59

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Safety

Pharmaceutical Commerce

APRIL 26, 2024

The latest news for pharma industry insiders.

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Pharma 102

PharmaTimes

APRIL 26, 2024

The new method could help to prevent severe side effects caused by enantiomer drugs

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Side effects Manufacturing 81

PharmExec

APRIL 26, 2024

Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.

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FDA Patients 52

Impetus Digital

APRIL 26, 2024

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. As we continue to transition towards and rely more heavily on artificial intelligence (AI) as a practical, day-to-day tool, an increasing number of sectors are choosing to implement this futuristic technology. This is no truer than in the healthcare sector.

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Healthcare Provider Healthcare Healthcare Patients 52

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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

PharmExec

APRIL 26, 2024

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

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Safety FDA Patients 52

PM360

APRIL 26, 2024

Healthcare advertising rarely demonstrates that it knows how to reward customers for their time, or shows what a smart creative idea can do. We need a better approach. Making memorable creative isn’t easy but it is possible in healthcare. There are just certain must haves. The first must have is obviously a talent for creative. Creative talent is the love child of imagination and a sense of humor.

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Healthcare Healthcare Media Sales goal 52

PharmExec

APRIL 26, 2024

In this Pharmaceutical Executive video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One, discusses what other tactics healthcare marketers can utilize to connect with diverse audiences on a deeper level

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Healthcare Healthcare Marketing Pharmaceutical 52

Pharmaceutical Technology

APRIL 26, 2024

The top 20 biopharmaceutical companies witnessed a promising first quarter (Q1) this year amid ongoing macroeconomic uncertainties, fluctuating interest rates, and evolving Medicare drug price negotiations.

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Biopharma Marketing 52

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Leads

PharmExec

APRIL 26, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization's pipeline.

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Pharmaceutical Technology

APRIL 26, 2024

Regeneron Pharmaceuticals has collaborated with Mammoth Biosciences to develop in vivo clustered regularly interspaced short palindromic repeats (CRISPR)-based gene editing therapies.

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Pharmaceutical 52

PharmExec

APRIL 26, 2024

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

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Pharmaceutical Technology

APRIL 26, 2024

Robotics company Multiply Labs has partnered with global life-sciences service provider GenScript Biotech to automate the cell isolation phase in cell therapy manufacturing.

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Manufacturing 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