Rethinking Clinical Trials

MARCH 7, 2024

Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

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Bio Pharma Dive

MARCH 7, 2024

The startup, which has raised nearly $254 million privately, is in early testing with drugs designed to target particularly tough-to-treat tumors.

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Drugs 312

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) and current […]

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Bio Pharma Dive

MARCH 7, 2024

Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

Could Alzheimer’s disease one day be treated by flashes of light and clicks of sound? Scientists have now demonstrated how stimulating high-frequency brain waves in mice can clear out the amyloid protein clumps associated with Alzheimer’s.

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Protein Scientist Research Clinical Trials 229

Bio Pharma Dive

MARCH 7, 2024

The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.

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Drugs 299

Pharma Mirror

MARCH 7, 2024

Presented by BetterHelp. Accessing affordable mental health services can significantly impact overall well-being. Learning how to connect with a therapist and access the kind of mental health care that you can afford can pave the way to a more satisfying and successful life. Even the WHO launched an initiative surrounding this issue in 2019. Launched in 2019, the WHO Special Initiative for Mental Health aims to ensure universal health coverage involving access to quality and affordable care for

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Pharmaceutical Technology

MARCH 7, 2024

Sionna could have four candidates in clinical trials in 2024, amidst a cystic fibrosis landscape that is dominated by Vertex.

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Pharma Mirror

MARCH 7, 2024

Presented by BetterHelp. With a veritable world of research and information in our pockets, the internet is a vast repository of knowledge. The online medical space offers valuable resources for individuals seeking to improve their health and well-being. From reputable websites to informative articles, online platforms provide accessible health education and empowerment avenues.

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Research 130

Pharmaceutical Technology

MARCH 7, 2024

Gilead Sciences has entered an agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies.

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Antibody 162

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Clinical Supply

Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. One key decision is whether to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) or a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) and respective regulatory agencies of its member states.

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Clinical Trials Clinical Trials Trials Development 130

Pharmaceutical Technology

MARCH 7, 2024

Alumis secured $259m in a Series C funding round to develop its clinical-stage pipeline of therapies designed to address immune dysfunction.

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Development 147

Pharma Times

MARCH 7, 2024

Ovarian high-grade serous carcinoma is the most common form of aggressive ovarian cancer

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Pharmaceutical Technology

MARCH 7, 2024

Taletrectinib is one of the first agents to provide segmented efficacy data on ROS1-positive NSCLC patients based on their line of therapy.

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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

Fierce Pharma

MARCH 7, 2024

As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.

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Pharmaceutical Technology

MARCH 7, 2024

Citius Pharmaceuticals’ CEO detailed plans to launch its lymphoma therapy Lymphir in Autumn 2024, as it awaits a PDUFA date.

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Pharma Times

MARCH 7, 2024

Secondary breast cancer is an important risk factor after receiving radiotherapy for Hodgkin lymphoma

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Pharmaceutical Technology

MARCH 7, 2024

Merck has reported a 15.1% decline in net income attributable to shareholders to €2.82bn in 2023 versus €3.326bn in 2022.

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Fierce Pharma

MARCH 7, 2024

GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. | GSK has more trial evidence to support a potential comeback for its withdrawn antibody-drug conjugate Blenrep. And analysts are already assigning blockbuster sales figures to the medicine.

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Pharmaceutical Technology

MARCH 7, 2024

The challenges and opportunities surrounding Africa becoming a clinical trials global force were discussed on day one of CTS Europe.

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Clinical Trials Clinical Trials Trials 130

pharmaphorum

MARCH 7, 2024

On today’s podcast, host Jonah Comstock welcomes Jane Reed, director of life sciences at IQVIA NLP, the new name for recent IQVIA acquisition Linguamatics. Reed talks through some of these different technologies and use cases and describes how natural language processing has exciting potential in translating real-world conversations on social media into pharmaceutical adverse event reports.

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Life Science 118

Pharmaceutical Technology

MARCH 7, 2024

The UK NICE has declined to recommend Daiichi Sankyo's Enhertu for the treatment of advanced HER2-low breast cancer in adults.

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

pharmaphorum

MARCH 7, 2024

Gilead and MSD showcase once-weekly oral HIV regimen at CROI congress, as ViiV presents new data on injectable Cabenuva in patients with low adherence to daily oral therapy

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XTalks

MARCH 7, 2024

International Women’s Day 2024 is Friday, March 8, and this year’s theme is “ Inspire Inclusion ,” which encourages a collective effort to understand, value and advocate for women’s inclusion across all spheres of life. This also includes highlighting some of the issues that women face, including women’s health issues, and working collectively to address them.

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pharmaphorum

MARCH 7, 2024

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug conjugate (ADC), given in a regimen with pomalidomide plus dexamethasone (PomDex), was shown to be more effective at preventing disease progression or death than Johnson & Johnson’s $10 billion-a-year anti-CD38 antibody Darzalex (daratumumab) with PomDex in the head-to-head DREAMM-8 trial.

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BioPharma Reporter

MARCH 7, 2024

In the realm of modern medicine, few advancements have inspired and challenged the industry quite like gene therapy.

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Gene Therapy Gene Medicine 112

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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

Clinical Research

pharmaphorum

MARCH 7, 2024

Digital tools must be used in pharma manufacturing to keep pace with drug discovery and clinical development Mike.

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Clinical Development Manufacturing Development Drugs 115

Drug Patent Watch

MARCH 7, 2024

LACTOSE-Free Medicines, 2024 is part of DrugPatentWatch’s deep library of business intelligence on biopharmaceutical drugs. Buy Lactose-Free Medicines from Amazon This guide is designed to provide information for healthcare providers to… The post LACTOSE-Free Medicines: Which Drugs Contain LACTOSE? appeared first on DrugPatentWatch - Make Better Decisions.

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Containment Medicine Drugs 111

Fierce Pharma

MARCH 7, 2024

With the swelling popularity of Eli Lilly’s diabetes med Mounjaro and its weight loss counterpart Zepbound, unauthorized copycats continue to emerge, posing a growing safety risk. | The company republished an open letter reiterating its commitment to taking legal action against scam sellers after discovering bacteria and impurities in some of the fraudulent meds.

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Bacteria 110

FDA Law Blog

MARCH 7, 2024

By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Clinical Trials Trials Regulation 105

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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