Bio Pharma Dive
OCTOBER 27, 2023
In a wide-ranging interview, Bristol Myers’ Ken Rhodes talked biomarkers, diseases of interest and why the company is far from done with neuroscience-focused deals.
Pharmaceutical Technology
OCTOBER 27, 2023
The UK NICE has recommended the use of AbbVie’s foslevodopa–foscarbidopa (Produodopa) for the treatment of advanced Parkinson’s disease.
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Bio Pharma Dive
OCTOBER 27, 2023
The restructuring came as the French company forecast an earnings drop in 2024, prompting a stock selloff that erased about $20 billion in market value.
Pharmaceutical Technology
OCTOBER 27, 2023
(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.
Bio Pharma Dive
OCTOBER 27, 2023
Documents released ahead of a Tuesday advisory meeting show agency scientists to be generally convinced by the treatment’s benefit, a sign analysts read as positive.
Pharmaceutical Technology
OCTOBER 27, 2023
(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 27, 2023
Moderna's Senior Vice President of International Manufacturing discusses the impact of Covid-19 on mRNA applications and future trends in manufacturing.
Pharma Times
OCTOBER 27, 2023
Around 145,000 people in the UK are living with Parkinson’s disease - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 27, 2023
The US FDA has granted approval for Roche’s Vabysmo (faricimab) to treat macular oedema following retinal vein occlusion.
WCG Clinical
OCTOBER 27, 2023
Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We’ll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today.
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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
Pharmaceutical Technology
OCTOBER 27, 2023
China’s NMPA has approved Vocabria used along with the Rekambys to treat human immunodeficiency virus type-1 (HIV-1) infection.
Fierce Pharma
OCTOBER 27, 2023
Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. | Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. After unveiling the pivot alongside third-quarter earnings Friday, Sanofi’s stock plunged nearly 20%, with one analyst group suggesting the plan came “at the wrong time.
Pharmaceutical Technology
OCTOBER 27, 2023
Verily's molecular and real-world evidence offerings will be leveraged to develop Georgiamune's drug candidates
Pharma Times
OCTOBER 27, 2023
The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes
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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
Pharmaceutical Technology
OCTOBER 27, 2023
PY-314 is under clinical development by Ikena Oncology and currently in Phase I for Triple-Negative Breast Cancer (TNBC).
Fierce Pharma
OCTOBER 27, 2023
Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. | Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.
Pharmaceutical Technology
OCTOBER 27, 2023
Eftozanermin alfa is under clinical development by AbbVie and currently in Phase I for Refractory Multiple Myeloma.
Fierce Pharma
OCTOBER 27, 2023
With the FDA approval of Agamree (vamorolone) to treat Duchenne | Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy (DMD) is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat.
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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.
Pharmaceutical Technology
OCTOBER 27, 2023
The FDA did not originally approve the therapy earlier this year; it will now go undergo a second review.
Fierce Pharma
OCTOBER 27, 2023
Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from the introduction of BeiGene’s transformative oral treatment Brukinsa. | Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from BeiGene’s Brukinsa. But what about the impact of the Inflation Reduction Act? In August, Imbruvica was one of the 10 drugs identified by the CMS that will be subject to price negotiations in 2026.
Pharmaceutical Technology
OCTOBER 27, 2023
Ibrutinib is under clinical development by AbbVie and currently in Phase III for Mantle Cell Lymphoma.
Fierce Pharma
OCTOBER 27, 2023
Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. | Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate, midazolam and the nutrition additive Elcys—after inspections of leftover samples flagged silicone matter in some vials.
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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.
Pharmaceutical Technology
OCTOBER 27, 2023
Azacitidine is under clinical development by Bristol-Myers Squibb and currently in Phase III for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia).
Drug Channels
OCTOBER 27, 2023
Today’s guest post is from Dorothy Gemmell, Chief Commercial Officer at GoodRx. Dorothy explains the innovative new collaboration between GoodRx and Sanofi. Under the program, the out-of-pocket cost for Sanofi's Lantus will be capped at $35 at any pharmacy that accepts GoodRx. This program will increase affordabiliy and broaden access for people living with diabetes.
Pharmaceutical Technology
OCTOBER 27, 2023
Trametinib dimethyl sulfoxide is under clinical development by Novartis and currently in Phase II for Nongerminomatous (Nonseminomatous) Germ Cell Tumors.
pharmaphorum
OCTOBER 27, 2023
Join us on Wednesday 6th December 14:00 GMT / 15:00 CET / 09:00 EST as experts from the NIHR, Health Research Authority (HRA), and AstraZeneca delve beneath the surface to discuss the drivers behind the new NCVR process and its implications for commercial research sponsors.
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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.
Pharmaceutical Technology
OCTOBER 27, 2023
Lisaftoclax is under clinical development by Ascentage Pharma Group International and currently in Phase II for Chronic Lymphocytic Leukemia (CLL).
Drug Discovery World
OCTOBER 27, 2023
Diana Spencer catches up with Lorna Ewart , PhD, Chief Scientific Officer of Emulate, about the rise of organ-on-a-chip technology. Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials.
Pharmaceutical Technology
OCTOBER 27, 2023
Rhenium (186Re) obisbemeda is under clinical development by Plus Therapeutics and currently in Phase II for Triple-Negative Breast Cancer (TNBC).
Fierce Pharma
OCTOBER 27, 2023
After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population. | After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population.
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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.
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