Antidote

NOVEMBER 20, 2024

Being a caregiver is one of the most selfless and demanding roles you can take on. Whether you're looking after a parent, spouse, child, or loved one, juggling all of the daily responsibilities that come with it can quickly feel overwhelming. With so much focus on taking care of others, it’s easy to put yourself and your needs on the back burner. While your focus is understandably on your loved one, it’s important to remember that your own well-being matters too.

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Bio Pharma Dive

NOVEMBER 18, 2024

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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Gene Therapy Gene 336

Rethinking Clinical Trials

NOVEMBER 21, 2024

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

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Trials Clinical Trials Clinical Trials Doctors 316

Medical Xpress

NOVEMBER 22, 2024

An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.

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Research 115

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

NOVEMBER 6, 2024

The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.

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Marketing Drugs 263

pharmaphorum

NOVEMBER 11, 2024

Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.

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Drugs Development 127

Fierce Pharma

NOVEMBER 20, 2024

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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XTalks

NOVEMBER 27, 2024

World AIDS Day 2024 serves as a reminder of the ongoing fight against the human immunodeficiency virus, or HIV and acquired immunodeficiency syndrome, or AIDS. Marked each year on December 1, this day highlights progress in addressing one of the most significant public health challenges. This year’s theme , “Take the Rights Path to End AIDS,” emphasizes the importance of human rights in eradicating the epidemic.

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Trials Drugs Clinical Trials Clinical Trials 103

Medical Xpress

NOVEMBER 29, 2024

Emotional body odors may have the potential to enhance the anxiety-reducing effects of mindfulness. This is shown by a pilot study published in the Journal of Affective Disorders, co-authored by researchers from Karolinska Institutet.

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Research 120

Pharmaceutical Technology

NOVEMBER 27, 2024

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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Development Drugs 298

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pharmaphorum

NOVEMBER 8, 2024

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

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Drugs Sales 124

Bio Pharma Dive

NOVEMBER 21, 2024

Howard Chang will take over as chief scientific officer and senior VP of research as the biotech searches for more ways to overcome the looming loss of exclusivity for some of its top-selling medicines.

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Scientist Medicine Research 319

Fierce Pharma

NOVEMBER 14, 2024

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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Gene Therapy Gene FDA Approval Branding 143

XTalks

NOVEMBER 25, 2024

Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. Imkeldi introduces an accessible alternative to traditional tablets, particularly for those who struggle with swallowing or require customized dosing. Imkeldi’s innovative formulation provides consistent dosing accuracy while offering a palatable strawberry flavor and stable storage without refrigeration.

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In-Vivo FDA Approval In-Vitro Drugs 104

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Medical Xpress

NOVEMBER 29, 2024

"Tell a man he shouldn't think of a pink elephant and he can't get that beast out of his mind!

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Pharmaceutical Technology

NOVEMBER 27, 2024

In recent years, the evolution of biologic therapies for severe asthma has paralleled advancements in other chronic conditions such as rheumatoid arthritis and psoriasis, where biologics have also transformed treatment paradigms.

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pharmaphorum

NOVEMBER 6, 2024

Two players in medical extended reality (XR) – XRHealth and NeuroReality – have come together in a quest to build the biggest company in the sector.Boston, US-based XRHealth is leading the deal, acquiring NeuroReality of the Netherlands for an undisclosed sum, combining their products and expertise in the use of XR and virtual reality software for healthcare applications.

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Production 115

Bio Pharma Dive

NOVEMBER 22, 2024

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

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Drugs Marketing 312

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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.

Clinical Trials

Fierce Pharma

NOVEMBER 8, 2024

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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Licensing Licensing Antibody Drugs 143

XTalks

NOVEMBER 22, 2024

NewAmsterdam Pharma announced promising results from its Phase III TANDEM clinical trial, evaluating a fixed-dose combination of obicetrapib and ezetimibe. This therapy targets patients with high cardiovascular risk due to atherosclerotic cardiovascular disease (ASCVD), ASCVD risk factors or heterozygous familial hypercholesterolemia (HeFH). In the news release , John Kastelein, chief scientific officer of NewAmsterdam Pharma, said millions of people struggle to meet low-density lipoprotein chol

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Trials Clinical Research Clinical Trials Clinical Trials 105

Medical Xpress

NOVEMBER 29, 2024

Using a gene-screening method they created, Stanford Medicine researchers may have discovered why an effective chemotherapy damages heart cells—and they have identified a drug that could keep the heart cells beating.

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Gene Medicine Drugs Research 99

Pharmaceutical Technology

NOVEMBER 1, 2024

Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).

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Drugs 264

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

pharmaphorum

NOVEMBER 5, 2024

AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.

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Marketing 115

Bio Pharma Dive

NOVEMBER 15, 2024

At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.

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Fierce Pharma

NOVEMBER 13, 2024

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Production 142

FDA Law Blog

NOVEMBER 11, 2024

By Deborah L. Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.

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Containment Production Sales Medicine 109

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Velocity Clinical Research

NOVEMBER 20, 2024

For decades, research into respiratory health has centered on conditions such as asthma and chronic obstructive pulmonary disease (COPD), predominantly because of their high prevalence. However, the incidence of respiratory diseases is increasing globally, with lesser-researched but equally debilitating conditions such as interstitial lung disease, pulmonary sarcoidosis, and pneumoconiosis affecting health statuses worldwide.

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Clinical Trials Clinical Trials Trials Research 105

Pharmaceutical Technology

NOVEMBER 20, 2024

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

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Drugs 257

pharmaphorum

NOVEMBER 20, 2024

Streamline claims management in the healthcare industry by eliminating swivel chair processes. Learn how healthcare providers and biopharma companies can optimise efficiency.

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Bio Pharma Dive

NOVEMBER 21, 2024

The startup, Pep2Tango, is combining four methods of accelerating weight loss into one medicine in the hopes of developing a treatment that can improve upon drugs like Wegovy and Zepbound.

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Drugs Medicine Development 312

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