Bio Pharma Dive
JANUARY 16, 2024
The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.
Pharmaceutical Technology
JANUARY 16, 2024
XNK Therapeutics has received scientific recommendation from the EMA's Committee for Advanced Therapies (CAT) for its product evencaleucel.
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Bio Pharma Dive
JANUARY 16, 2024
Relationships with Speaker Bureau faculty are among the most important that a biopharmaceutical company nurtures.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 16, 2024
A feral kitten in Omaha, Nebraska, tested positive for rabies in November 2023. It died of the raccoon variant of the virus, which is typically found only in the Appalachian Mountains.
Bio Pharma Dive
JANUARY 16, 2024
While investment remains lower than in other areas of drug R&D, executives and VCs speak of growing momentum for a field that’s been overlooked in the past.
Pharmaceutical Technology
JANUARY 16, 2024
As the deadline nears for the government to reveal its proposed prices, pharmaceutical companies are continuing to fight regulation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
JANUARY 16, 2024
Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulat
Bio Pharma Dive
JANUARY 16, 2024
A stock market run and a flurry of dealmaking have buoyed a sector that spent much of 2023 in a downturn. Can the momentum last?
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 16, 2024
Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, and the Japanese Foundation for Cancer Research (JFCR), the first and leading non-profit cancer research organization in Japan, has announced a strategic alliance to accelerate access to oncology clinical trials in Japan.
Pharmaceutical Technology
JANUARY 16, 2024
Oskar Möbert, vice president of Veeva OpenData, discusses how standardizing data across an organization can help biopharmas deliver a superior customer experience, scale globally, and become more agile in their business.
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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
XTalks
JANUARY 16, 2024
To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. Many of the validated cognitive assessments today are paper based, introducing the potential for bias and limiting ethnic and geographic diversity in clinical studies. Additionally, blood biomarkers only provide a snapshot in time and do not provide insight into cognitive function.
Pharmaceutical Technology
JANUARY 16, 2024
Roche has received marketing authorisation from the EC for Tecentriq SC for subcutaneous administration to treat cancers.
Bioengineer
JANUARY 16, 2024
The presence of the T790M mutation during first or second-generation EGFR-TKI treatments is observed in 50-60% of patients. This mutation hinders the drug’s binding to the mutant EGFR protein. Osimertinib, however, can covalently bind to the T790M and cysteine-797 (C797) residue at the protein’s ATP binding site, overcoming resistance mechanisms.
Pharmaceutical Technology
JANUARY 16, 2024
The US FDA has granted orphan drug designation to Neuraptive Therapeutics’ NTX-001, a treatment kit for peripheral nerve injury repair.
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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
Drug Patent Watch
JANUARY 16, 2024
A recent article published in the Journal of Cheminformatics addresses the challenge of confirming the patent status of newly developed compounds, particularly in the pharmaceutical industry, where generating novel structures… The post An AI Approach to Generate Novel Pharmaceuticals using Patent Data appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JANUARY 16, 2024
Santhera Pharmaceuticals has announced the introduction of AGAMREE to treat Duchenne muscular dystrophy (DMD) patients in Germany.
Fierce Pharma
JANUARY 16, 2024
Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FD | Vertex Pharmaceuticals and CRISPR Therapeutics have scored an FDA approval for their gene-editing therapy Casgevy (exa-cel) to treat transfusion-dependent beta thalassemia (TDT). The approval came more than two months ahead of the FDA's March 30 decision date.
Pharmaceutical Technology
JANUARY 16, 2024
The updated binding term sheet for an oral arsenic trioxide therapy sees Phebra take on more duties and BioSenic given royalties.
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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
JANUARY 16, 2024
Biotech company ExeVir Bio has revealed new data demonstrating that its antibodies are effective in neutralising currently circulating Covid-19 Omicron variants. The company says that all authorised SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralisation potency against the currently circulating variants.
Pharmaceutical Technology
JANUARY 16, 2024
Antimicrobial resistance is the third leading cause of death globally, with no major advances in the field in the past 50 years.
Outsourcing Pharma
JANUARY 16, 2024
An alliance between KBI Biopharma Inc., and Argonaut Manufacturing Services Inc., has been formed so biopharma clients can receive end-to-end drug substance and drug product manufacturing solutions.
Pharmaceutical Technology
JANUARY 16, 2024
Allakos’ stock price has plummeted following the announcement of two Phase II studies failing to meet their primary endpoints.
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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.
pharmaphorum
JANUARY 16, 2024
In addition to bringing treatment and hope to patients without alternatives, early access programmes provide further information on a product’s safety and efficacy data in real-world conditions.
Pharmaceutical Technology
JANUARY 16, 2024
The MHRA said that males planning a family in the next year should consult their healthcare professional before valproate use.
BioPharma Reporter
JANUARY 16, 2024
TrakCel, a provider of cellular orchestration systems to the cell and gene therapy (CGT) industry, has launched its own consultancy services to share its process development knowledge with the broader community of CGT developers.
Pharmaceutical Technology
JANUARY 16, 2024
Disco has built a protein mapping platform for cancer cell surfaces, to unlock targets for the antibody-based therapy market.
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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.
pharmaphorum
JANUARY 16, 2024
Roche’s Tecentriq has become the first PD-1/PD-L1 inhibitor to be cleared in the EU in a subcutaneous form that will make dosing easier for patients and healthcare providers
Pharmaceutical Technology
JANUARY 16, 2024
Patients play their cards close to their chest when it comes to sharing their personal information.
Fierce Pharma
JANUARY 16, 2024
As British pharma giant AstraZeneca looks abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next t | As other British drugmakers like AstraZeneca look abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next two years.
pharmaphorum
JANUARY 16, 2024
In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Carl Hansen, CEO of AbCellera, for a conversation on the discovery and acceleration of antibody therapeutics.
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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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