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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Clinical Trials Clinical Trials Trials Scientist 306

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 280

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

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 294

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Clinical Supply

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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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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Trials Medicine Drugs 287

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

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

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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

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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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

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

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

AI remained one of the main talking points at CTS Europe, as the roadmap for generative AI was mapped out.

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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

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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

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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Marketing 130

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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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

Pharmaceutical Commerce

MARCH 7, 2024

In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, discusses the biggest roadblocks to the widespread adoption of novel modalities, and how new biotech companies can navigate the current funding slowdown while securing the capital crucial for their success.

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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

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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XTalks

MARCH 7, 2024

Earlier this week, the US Food and Drug Administration (FDA) took a significant step forward in regulating dietary supplements. The agency released a final guidance entitled “ Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” This pivotal document aims to streamline the process for manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements, providing a clear pathway for submitting new dietary ingr

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Regulation Manufacturing Compliance Marketing 105

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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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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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.

Clinical Supply

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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Drug Patent Watch

MARCH 7, 2024

Annual Drug Patent Expirations for ULORIC Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are three… The post New patent expiration for Takeda Pharms drug ULORIC appeared first on DrugPatentWatch - Make Better Decisions.

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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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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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Antibody Sales Trials Medicine 92

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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

Pharma Times

MARCH 7, 2024

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

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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 116

Pharma Times

MARCH 7, 2024

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

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Development Research Medicine 121

Pharma Tutor

MARCH 7, 2024

Indian Institute based research boosting pharmaceutical industrial R&D and revenue admin Thu, 03/07/2024 - 14:23 Pharmaceutical research conducted by institutes plays a crucial role in boosting industrial research and development (R&D) in the pharmaceutical sector. These institutes, often affiliated with universities or independent research organizations, contribute significantly to advancing scientific knowledge, discovering new drugs, and fostering innovation.

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Research Development Drugs 88

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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.

Clinical Supply