Pharmaceutical Technology
SEPTEMBER 21, 2023
The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.
Bio Pharma Dive
SEPTEMBER 21, 2023
More than $50 million in venture funding has now gone into Seraxis, which is among a series of biotechs trying to fundamentally alter diabetes treatment.
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Pharmaceutical Technology
SEPTEMBER 21, 2023
Kezar and Everest Medicines have signed a deal for the development and commercialisation of zetomipzomib for lupus nephritis.
Bio Pharma Dive
SEPTEMBER 21, 2023
The Novo Nordisk Foundation’s planned manufacturing facility will help both private companies and academic researchers develop new cell therapies.
Pharmaceutical Technology
SEPTEMBER 21, 2023
The collaboration will use Evaxion’s EDEN platform to bring an AI-designed gonorrhea mRNA vaccine to the market.
Bio Pharma Dive
SEPTEMBER 21, 2023
The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.
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Fierce Pharma
SEPTEMBER 21, 2023
Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.
Pharmaceutical Technology
SEPTEMBER 21, 2023
On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.
Rethinking Clinical Trials
SEPTEMBER 21, 2023
Speaker Pasquale Rummo, PhD, MPH Associate Professor NYU Grossman School of Medicine Slides Keywords Randomized clinical trial; Food insecurity; Nutrition; Online retailer; Equity Key Points Supplemental Nutrition Assistance Program (SNAP) provides nutrition assistance benefits to supplement food budgets with the goal of mitigating food insecurity.
Pharmaceutical Technology
SEPTEMBER 21, 2023
Novo Nordisk is to invest $136m to develop the Cellerator facility in Lyngby, Denmark, to manufacture cell therapies for 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
BioSpace
SEPTEMBER 21, 2023
In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.
Pharmaceutical Technology
SEPTEMBER 21, 2023
AbCellera and Regeneron have extended their current multi-target collaboration to discover therapeutic antibodies for up to eight targets
Antidote
SEPTEMBER 21, 2023
Antidote’s podcast, Talk of the Towne , hosted by Antidote’s Senior Clinical Informatics Manager, Dr. Richard Towne, is an interview series featuring members of Antidote's partner network. During each episode, Rich and his guests take a closer look at particular therapeutic areas, the latest research developments, and specific pain points that impact the patient population.
Pharmaceutical Technology
SEPTEMBER 21, 2023
The European Commission granted approval for The Menarini Group’s Orserdu to treat patients with ER positive, HER2-negative breast cancer.
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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
Pharma Times
SEPTEMBER 21, 2023
The report outlines ways the government can help patients with Parkinson’s disease - News - PharmaTimes
Pharmaceutical Technology
SEPTEMBER 21, 2023
The licence grants Meitheal marketing rights for insulin aspart, lispro, and glargine following FDA approval.
BioSpace
SEPTEMBER 21, 2023
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
Pharmaceutical Technology
SEPTEMBER 21, 2023
Regulatory applications in EU and the UK will follow a potential filing in the US in early 2024.
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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.
Drug Discovery World
SEPTEMBER 21, 2023
A research team from VIB-KU Leuven and the UK Dementia Research Institute has discovered how neurons die in Alzheimer’s disease, opening new pathways for potential future treatments. A new research paper published in Science illustrates how neurons initiate a programmed form of cell death, known as necroptosis, when they are exposed to amyloid plaques and tau tangles.
Pharmaceutical Technology
SEPTEMBER 21, 2023
Fresh Tracks is planning to seek approval for liquidation and dissolution from stakeholders pending a better offer.
BioSpace
SEPTEMBER 21, 2023
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Pharma Times
SEPTEMBER 21, 2023
The investment will support research into cancer treatments and diagnosis - News - PharmaTimes
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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.
Outsourcing Pharma
SEPTEMBER 21, 2023
Built upon seven years of real-world patient journey data, Belong.Life has recently announced the launch of its software as a service (SaaS)-based conversational artificial intelligence (AI) cancer clinical trial matching platform.
BioSpace
SEPTEMBER 21, 2023
The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.
Outsourcing Pharma
SEPTEMBER 21, 2023
Therapeutic candidates and patient samples can be analyzed âin a fraction of the time it would normally takeâ thanks to newly patented single-molecule imaging technology.
BioSpace
SEPTEMBER 21, 2023
The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
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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.
Fierce Pharma
SEPTEMBER 21, 2023
Long categorized as a takeover target, autoimmune disease specialist Aurinia Pharmaceuticals has remained independent, to the frustration of some investors who believe the Canadian company has not | Aurinia has responded to criticism from some investors who believe the company has not maximized its opportunity with lupus nephritis drug Lupkynis. The company named its founder and former CEO Robert Foster to its board of directors in an agreement with major stockholder MKT Capital.
BioSpace
SEPTEMBER 21, 2023
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
Outsourcing Pharma
SEPTEMBER 21, 2023
A study of MedRhythmâs MR-001 neurorehabilitation system designed to improve walking and ambulation in adults with chronic stroke walking impairment will use Curavit Clinical Research as its virtual contract research organization (VCRO).
Fierce Pharma
SEPTEMBER 21, 2023
Even after Eli Lilly missed its first swing at the lucrative U.S. market with ulcerative colitis drug mirikizumab, the company’s launch is gaining steam overseas. | Lilly's mirikizumab is one of several launches the company is counting on for growth in the near term. Even after an FDA rejection, the launch is gaining steam overseas.
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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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