Bio Pharma Dive
FEBRUARY 7, 2024
The new firm intends to carefully select its startups and fund them for the long haul. “We're not a company formation factory,” said Aaron Kantoff, the firm’s co-founder.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 7, 2024
People with bipolar disorder are four to six times more likely to die prematurely than those without the condition, according to a study that compared data on thousands of people with and without the disorder.
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Bio Pharma Dive
FEBRUARY 7, 2024
The company, a leading developer of cell therapies for autoimmune diseases, is the fifth drug startup to go public in 2024. All of them raised at least $100 million.
Pharmaceutical Technology
FEBRUARY 7, 2024
AstraZeneca is investing $300m in a facility in Rockville, US - a significant step in launching its cell therapy platforms in the country.
Rethinking Clinical Trials
FEBRUARY 7, 2024
In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.
Pharmaceutical Technology
FEBRUARY 7, 2024
Gilead Sciences has announced a 22.9% increase in net income of $5.61bn for FY23 as against $4.56bn in FY22.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 7, 2024
BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.
Bio Pharma Dive
FEBRUARY 7, 2024
The deal hands Kyowa Kirin rights in Japan to the drug, which is emerging as a potential rival to BioMarin’s marketed medicine Voxzogo.
Pharmaceutical Technology
FEBRUARY 7, 2024
Elotuzumab is under clinical development by AbbVie and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF).
Bio Pharma Dive
FEBRUARY 7, 2024
Analysts pressed company executives Tuesday on the potential of its GLP-1 drug for weight loss, early-stage results for which were published this week.
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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
FEBRUARY 7, 2024
Avadomide hydrochloride is under clinical development by Bristol-Myers Squibb and currently in Phase I for Follicular Lymphoma.
Rethinking Clinical Trials
FEBRUARY 7, 2024
Speaker Susan C. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated
Pharmaceutical Technology
FEBRUARY 7, 2024
Enfortumab vedotin is under clinical development by Astellas Pharma and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC).
Bio Pharma Dive
FEBRUARY 7, 2024
The UK drugmaker is adding a facility in Rockville, Maryland, after a spate of dealmaking in the therapeutic field.
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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
FEBRUARY 7, 2024
(Sacubitril + valsartan) is under clinical development by Novartis and currently in Phase II for Hypertrophic Cardiomyopathy.
FDA Law Blog
FEBRUARY 7, 2024
By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr
Pharmaceutical Technology
FEBRUARY 7, 2024
Irinotecan hydrochloride is under clinical development by Ipsen and currently in Phase II for Neuroendocrine Carcinoma.
BioPharma Reporter
FEBRUARY 7, 2024
Wedneday is Women in Science day and we have a fantastic interview with Hella who is co-founder and chief scientific officer of Immunic Therapeutics.
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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
FEBRUARY 7, 2024
Veru’s Ostarine has previously been investigated in five clinical studies in patients with muscle wastage caused by advanced cancer.
pharmaphorum
FEBRUARY 7, 2024
Stay updated on the latest clinical trials happening from January 15th to January 19th, 2024. Explore trials by ExeVir, NurixTx, Synendos Therapeutics, and Oxford BioTx.
Pharmaceutical Technology
FEBRUARY 7, 2024
Ligelizumab is under clinical development by Novartis and currently in Phase III for Food Allergy.
pharmaphorum
FEBRUARY 7, 2024
Jazz Pharmaceuticals has agreed another pipeline-building deal, this time paying $10 million upfront for rights to a KRAS inhibitor programme from UK biotech Redx Pharma, continuing a move into targeted cancer therapies. Under the terms of the deal, Jazz will acquire Redx’s KRAS inhibitor programme outright, including multiple preclinical-stage drug candidates, and will take responsibility for ushering the most promising compounds through clinical trials and onto the market.
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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
FEBRUARY 7, 2024
Elotuzumab is under clinical development by AbbVie and currently in Phase II for Myelofibrosis.
pharmaphorum
FEBRUARY 7, 2024
As the pandemic recedes and the global economy stabilises, are there promising signs for the biotech industry's financial outlook in 2024? Learn more about the potential for recovery, reducing bankruptcies, and attracting investors.
Pharmaceutical Technology
FEBRUARY 7, 2024
Abiraterone acetate is under clinical development by Tavanta Therapeutics and currently in Phase III for Hormone-Sensitive Prostate Cancer.
pharmaphorum
FEBRUARY 7, 2024
In this interview, Simon Arkell, co-founder and CEO of Ryght, discusses his vision whilst at JP Morgan 2024 and how generative AI is transforming the industry.
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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
FEBRUARY 7, 2024
The acquisition, which also includes Phase II asset AL101, closes gap to SpringWorks’ FDA-approved Ogsiveo.
Pharma Times
FEBRUARY 7, 2024
The HTA reported that Brainomix 360 improved access to treatment for stroke patients
Pharmaceutical Technology
FEBRUARY 7, 2024
When consent management processes are disconnected or poorly managed, it can have a detrimental impact on patient experiences.
pharmaphorum
FEBRUARY 7, 2024
GSK has revealed the data it hopes will allow a return to the US market for Blenrep, which was the first BCMA-targeting drug to launch there but was withdrawn from sale after it failed a confirmatory trial.
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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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