Mon.Jun 17, 2024

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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New data showcase promise, growing pains of CAR-T in autoimmune disease

Bio Pharma Dive

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

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OCT-461201 by Oxford Cannabinoid Technologies for Neuropathic Pain (Neuralgia): Likelihood of Approval

Pharmaceutical Technology

OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Neuropathic Pain (Neuralgia).

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The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials

Bio Pharma Dive

Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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MAS-825 by Novartis for Coronary Artery Disease (CAD) (Ischemic Heart Disease): Likelihood of Approval

Pharmaceutical Technology

MAS-825 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).

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Syncona melds two gene therapy biotechs for better shot at new nervous system treatments

Bio Pharma Dive

The new company, Spur Therapeutics, is getting another $50 million from Syncona to support its broadened pipeline, which targets Parkinson’s disease as well as heart conditions.

More Trending

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Report recommends ways to improve availability and affordability of essential medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

Incentivising domestic production of essential medical devices, building a robust logistics infrastructure and supplier network with stringent quality control measures and certification standards, and proper pricing policies are some of the ways to grow the medical devices sector in the country and to improve availability and affordability across the country, according to a recent report.

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MEDI-0618 by AstraZeneca for Migraine: Likelihood of Approval

Pharmaceutical Technology

MEDI-0618 is under clinical development by AstraZeneca and currently in Phase I for Migraine.

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June 17, 2024: This Week’s PCT Grand Rounds to Feature Trial of Electronic Cigarettes for Smoking Cessation

Rethinking Clinical Trials

Dr. Reto Auer In this Friday’s PCT Grand Rounds, Reto Auer of the University of Bern will present “Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes.” The Grand Rounds session will be held on Friday, June 21, 2024, at 1:00 pm eastern.

Trials 173
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OCT-461201 by Oxford Cannabinoid Technologies for Visceral Pain: Likelihood of Approval

Pharmaceutical Technology

OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Visceral Pain.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Takeda drug for rare types of epilepsy misses goal in late-stage trial

Bio Pharma Dive

Called soticlestat, the drug had seemed promising in earlier studies for people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to take on full rights to the drug.

Drugs 162
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Olanzapine by Neurelis for Bipolar Disorder (Manic Depression): Likelihood of Approval

Pharmaceutical Technology

Olanzapine is under clinical development by Neurelis and currently in Phase I for Bipolar Disorder (Manic Depression).

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Early patient engagement can improve medication adherence. Here’s how.

Bio Pharma Dive

Research shows that 20% of patients have failed to fill a script in the past, and one-third aren’t confident managing their illness. Engaging patients as soon as a medicine is prescribed can help.

Medicine 162
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Ferric carboxymaltose by Vifor Pharma Management for Restless Legs Syndrome: Likelihood of Approval

Pharmaceutical Technology

Ferric carboxymaltose is under clinical development by Vifor Pharma Management and currently in Phase III for Restless Legs Syndrome.

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The New Age of Decentralized Clinical Trials

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

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Leuko device to remotely monitor cancer patients during chemotherapy

Pharma Times

Cancer was estimated to be responsible for more than 18 million cases worldwide in 2020

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Daxdilimab by Amgen for Idiopathic Inflammatory Myopathy (IIM): Likelihood of Approval

Pharmaceutical Technology

Daxdilimab is under clinical development by Amgen and currently in Phase II for Idiopathic Inflammatory Myopathy (IIM).

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Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults

Fierce Pharma

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

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Dabrafenib mesylate by Novartis for Follicular Thyroid Cancer: Likelihood of Approval

Pharmaceutical Technology

Dabrafenib mesylate is under clinical development by Novartis and currently in Phase II for Follicular Thyroid Cancer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep

Fierce Pharma

Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all. | Two back-to-back pivotal trial wins have rekindled hopes at GSK that once-failed multiple myeloma drug Blenrep could reach more than 3 billion pounds sterling in peak sales after all.

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Apalutamide by Johnson & Johnson for Metastatic Castration-Resistant Prostate Cancer (mCRPC): Likelihood of Approval

Pharmaceutical Technology

Apalutamide is under clinical development by Johnson & Johnson and currently in Phase III for Metastatic Castration-Resistant Prostate Cancer (mCRPC).

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Ten-minute brain scan could improve diagnosis for paediatric brain cancer

Pharma Times

Medulloblastoma is responsible for around 52 new cases in children in the UK every year

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Daxdilimab by Amgen for Chronic Cutaneous Lupus Erythematosus (CCLE) / Discoid Lupus Erythematosus (DLE): Likelihood of Approval

Pharmaceutical Technology

Daxdilimab is under clinical development by Amgen and currently in Phase II for Chronic Cutaneous Lupus Erythematosus (CCLE) / Discoid Lupus Erythematosus (DLE).

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The New Age of Decentralized Clinical Trials

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.

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Could Amazon or Google hold the key to the future of public health diagnostics?

pharmaphorum

Discover how leading tech giants such as Amazon, Google, Apple, and Microsoft are shaping the future of public health diagnostics through MedTech innovations. Explore the potential impact on healthcare and stay informed on the latest developments.

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Olanzapine ER by Teva Pharmaceutical Industries for Schizophrenia: Likelihood of Approval

Pharmaceutical Technology

Olanzapine ER is under clinical development by Teva Pharmaceutical Industries and currently in Phase III for Schizophrenia.

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Upscaling your brand strategy: New ways of planning

pharmaphorum

Learn how to upscale your brand strategy with new and innovative ways of planning. Discover effective brand planning strategies to take your brand to the next level.

Branding 114
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EHA 2024: AstraZeneca’s Calquence plus chemoimmunotherapy offers new standard for MCL

Pharmaceutical Technology

If Calquence receives FDA label expansion in MCL, it will achieve a unique position in the treatment-naive MCL market share.

Marketing 130
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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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New data at EHA backs Sanofi, Innate’s NK cell engager

pharmaphorum

Sanofi and Innate Pharma NK cell engager therapy SAR443579 shows promising efficacy in AML patients in a phase 1/2 trial reported at EHA.

Trials 114
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Feladilimab by GSK for Metastatic Melanoma: Likelihood of Approval

Pharmaceutical Technology

Feladilimab is under clinical development by GSK and currently in Phase II for Metastatic Melanoma.

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Address the impact of trending health information with conversation data

pharmaphorum

Explore the impact and influence of trending health information, like Ozempic and the Eddy Effect on platforms like TikTok, through conversation data analysis. Learn more about these trends and their implications.

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Feladilimab by GSK for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Feladilimab is under clinical development by GSK and currently in Phase II for Solid Tumor.

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How Machine Learning Drives Clinical Trial Efficiency

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.