Novavax seeks FDA approval for updated Covid-19 vaccine
Pharmaceutical Technology
JUNE 17, 2024
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.
Mon.Jun 17, 2024
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New data showcase promise, growing pains of CAR-T in autoimmune disease
Bio Pharma Dive
JUNE 17, 2024
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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TC-110 by Adaptimmune Therapeutics for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
TC-110 is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia).
Abortion pill ruling offers measure of relief for FDA, biotech
Bio Pharma Dive
JUNE 17, 2024
One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.
Equecabtagene autoleucel by Nanjing IASO Biotherapeutics for Refractory Multiple Myeloma: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Equecabtagene autoleucel is under clinical development by Nanjing IASO Biotherapeutics and currently in Phase II for Refractory Multiple Myeloma.
Syncona melds two gene therapy biotechs for better shot at new nervous system treatments
Bio Pharma Dive
JUNE 17, 2024
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.
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Mysterious, Rare Syndrome Causes The Human Body to ‘Brew’ Alcohol
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 17, 2024
(hiroyuki nakai/Getty Images) Imagine you turn up to the hospital looking for help because you feel dizzy and can’t stop slurring your speech – only to be told that you’re simply drunk. Yet, you haven’t had a drop of alcohol.
DFV-890 by Novartis for Coronary Artery Disease (CAD) (Ischemic Heart Disease): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
DFV-890 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).
The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials
Bio Pharma Dive
JUNE 17, 2024
Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.
MAS-825 by Novartis for Coronary Artery Disease (CAD) (Ischemic Heart Disease): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
MAS-825 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).
The New Age of Decentralized Clinical Trials
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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
June 17, 2024: This Week’s PCT Grand Rounds to Feature Trial of Electronic Cigarettes for Smoking Cessation
Rethinking Clinical Trials
JUNE 17, 2024
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.
OCT-461201 by Oxford Cannabinoid Technologies for Neuropathic Pain (Neuralgia): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Neuropathic Pain (Neuralgia).
Report recommends ways to improve availability and affordability of essential medical devices
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 17, 2024
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.
Olanzapine ER by Teva Pharmaceutical Industries for Schizophrenia: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Olanzapine ER is under clinical development by Teva Pharmaceutical Industries and currently in Phase III for Schizophrenia.
Takeda drug for rare types of epilepsy misses goal in late-stage trial
Bio Pharma Dive
JUNE 17, 2024
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.
OCT-461201 by Oxford Cannabinoid Technologies for Visceral Pain: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
OCT-461201 is under clinical development by Oxford Cannabinoid Technologies and currently in Phase I for Visceral Pain.
Early patient engagement can improve medication adherence. Here’s how.
Bio Pharma Dive
JUNE 17, 2024
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.
Olanzapine by Neurelis for Bipolar Disorder (Manic Depression): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Olanzapine is under clinical development by Neurelis and currently in Phase I for Bipolar Disorder (Manic Depression).
The New Age of Decentralized Clinical Trials
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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.
Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults
Fierce Pharma
JUNE 17, 2024
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.
Mometasone furoate by Lyra Therapeutics for Rhinosinusitis: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Mometasone furoate is under clinical development by Lyra Therapeutics and currently in Phase III for Rhinosinusitis.
From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep
Fierce Pharma
JUNE 17, 2024
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.
Orforglipron calcium by Eli Lilly and Co for Obesity: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Orforglipron calcium is under clinical development by Eli Lilly and Co and currently in Phase III for Obesity.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies
Drug Patent Watch
JUNE 17, 2024
The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.
MEDI-0618 by AstraZeneca for Migraine: Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
MEDI-0618 is under clinical development by AstraZeneca and currently in Phase I for Migraine.
Merck Wins FDA Approval for First Pneumococcal Vaccine Designed for Adults
BioSpace
JUNE 17, 2024
Merck on Monday secured the FDA’s green light for its 21-valent pneumococcal vaccine Capvaxive, which covers serotypes responsible for around 84% of invasive pneumococcal disease cases.
Daxdilimab by Amgen for Chronic Cutaneous Lupus Erythematosus (CCLE) / Discoid Lupus Erythematosus (DLE): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Daxdilimab is under clinical development by Amgen and currently in Phase II for Chronic Cutaneous Lupus Erythematosus (CCLE) / Discoid Lupus Erythematosus (DLE).
How Machine Learning Drives Clinical Trial Efficiency
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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.
BIOSECURE’s Surprise Absence, the $100+ Billion Future Weight-Loss Market, DIA and More
BioSpace
JUNE 17, 2024
This week’s news ranged from BioSpace’s on-the-ground updates from DIA to safety concerns in clinical trials to BIOSECURE Act updates to new projections that the GLP-1 market could top $100 billion within 10 years.
Apalutamide by Johnson & Johnson for Metastatic Castration-Resistant Prostate Cancer (mCRPC): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
Apalutamide is under clinical development by Johnson & Johnson and currently in Phase III for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Innovative Approaches to Extend the Life of Drug Patents
Drug Patent Watch
JUNE 17, 2024
Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs. Here are some key approaches with examples: New Formulations One common strategy is to develop and patent new formulations of the existing drug compound to provide benefits like reduced dosing frequency, easier administration, improved bioavailability, or reduced side effects.
MAS-825 by Novartis for Coronary Artery Disease (CAD) (Ischemic Heart Disease): Likelihood of Approval
Pharmaceutical Technology
JUNE 17, 2024
MAS-825 is under clinical development by Novartis and currently in Phase II for Coronary Artery Disease (CAD) (Ischemic Heart Disease).
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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