Worldwide Clinical Trials
DECEMBER 7, 2023
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.
Bio Pharma Dive
DECEMBER 7, 2023
The funding is indicative of investor interest in an area of drug research that involves at least a dozen startups and multiple publicly traded companies.
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Pharmaceutical Technology
DECEMBER 7, 2023
Japan has granted approval for the sBLA of Bristol-Myers Squibb (BMS) for Abecma to treat relapsed or refractory multiple myeloma (RRMM).
Antidote
DECEMBER 7, 2023
Chronic spontaneous urticaria, also called chronic idiopathic urticaria, is a type of chronic hives that come and go unexpectedly. These hives persist daily for a minimum of six weeks without a clear cause or trigger. While this condition can affect anyone at any point, women experience it twice as often as men , and it’s most common between the ages of 20 and 40.
Pharmaceutical Technology
DECEMBER 7, 2023
The FDA has granted fast track designation to Solid Biosciences’s gene therapy SGT-003 for the treatment of DMD.
Drug Discovery World
DECEMBER 7, 2023
A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials. NMRA-266, an allosteric modulator that works through a mechanism that has been clinically validated in the treatment of disorders like schizophrenia, will be developed by Neumora Therapeutics.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Outsourcing Pharma
DECEMBER 7, 2023
Virtual research organization, ObvioHealth, has just announced the launch of its application programming interface (API) which it says is tailored specifically for digital therapeutics (DTx) clinical trials.
Pharmaceutical Technology
DECEMBER 7, 2023
GlobalData’s report assesses the drugs in the Calcitonin Gene Related Peptide Type 1 Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
Fierce Pharma
DECEMBER 7, 2023
When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.
Pharmaceutical Technology
DECEMBER 7, 2023
The Bill & Melinda Gates Foundation grant will fund the development of dissolvable microneedle array patches for administering mRNA therapies.
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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
pharmaphorum
DECEMBER 7, 2023
AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.
Pharmaceutical Technology
DECEMBER 7, 2023
Sterile filling is a critical step in pharmaceutical primary packaging. However, during this process, some drug product loss is inevitable.
pharmaphorum
DECEMBER 7, 2023
In this latest instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with David Solomon, CEO of Mithra Pharmaceuticals, about the current women’s health landscape and what Mithra is doing on an international scale to ameliorate that.
Pharmaceutical Technology
DECEMBER 7, 2023
South Korean regulators approved Sosei’s brain injury drug Pivlaz despite previous negative Phase III results.
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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
Intouch Solutions
DECEMBER 7, 2023
We are fortunate that our leadership at EVERSANA INTOUCH strives to grow and develop forward-thinking and innovative teams, all while keeping an eye on business growth and providing top-notch services to our clients. Nathan Stewart, SVP, SEO & Content Strategy, is one of those leaders, and was recently highlighted in “20 to Know in Advertising in KC,” published by the Kansas City Business Journal.
Pharmaceutical Technology
DECEMBER 7, 2023
If approved in June 2024, Ipsen and Genfit’s elafibranor will compete with Intercept’s Ocaliva as second-line treatment options for PBC.
BioSpace
DECEMBER 7, 2023
As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.
Pharmaceutical Technology
DECEMBER 7, 2023
The companies presented positive Phase Ib data at the 2023 SABCS meeting, and announced plans to expand the protein degrader programme.
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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.
Outsourcing Pharma
DECEMBER 7, 2023
Today, world-leading generative artificial intelligence (AI) company for life sciences, Yseop, is celebrating its involvement in more than 150 clinical trials with pharma giants around the world.
Pharmaceutical Technology
DECEMBER 7, 2023
Dr Reddy's Laboratories has signed a licence agreement with Coya Therapeutics to develop and commercialise COYA 302 to treat ALS.
Pharma Times
DECEMBER 7, 2023
The disease is one of the leading causes of cancer deaths in the UK - News - PharmaTimes
Pharmaceutical Technology
DECEMBER 7, 2023
AbbVie has signed a definitive agreement for the acquisition of Cerevel Therapeutics for a deal value of nearly $8.7bn in cash.
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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.
Fierce Pharma
DECEMBER 7, 2023
In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. | In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little with Johnson & Johnson.
Pharmaceutical Technology
DECEMBER 7, 2023
Synplogen and Ginkgo Bioworks have signed an MOU to expedite DNA manufacturing and gene therapy platform services in Japan.
pharmaphorum
DECEMBER 7, 2023
Treatment with Eli Lilly’s JAK inhibitor Olumiant has been shown to preserve the function of insulin-producing pancreatic beta cells in patients with type 1 diabetes, potentially opening up a whole new avenue of therapy.
Pharmaceutical Technology
DECEMBER 7, 2023
GlobalData’s report assesses the drugs in the Alpha 2C Adrenergic Receptor pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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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.
Outsourcing Pharma
DECEMBER 7, 2023
Adults and children in the US with congenital thrombotic thrombocytopenic purpura (cTTP) can now access Adzynma for prophylactic and on-demand treatment.
Pharmaceutical Technology
DECEMBER 7, 2023
GlobalData’s report assesses the drugs in the Gamma-Aminobutyric Acid Receptor Subunit Alpha 2 pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
BioSpace
DECEMBER 7, 2023
The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.
Pharmaceutical Technology
DECEMBER 7, 2023
GlobalData’s report assesses the drugs in the Hepcidin pipeline by therapy areas, indications, stages, MoA, RoA, molecule type and the key players in the development pipeline.
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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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