MedCity News
FEBRUARY 19, 2024
From diagnostics to treatment methodologies, BCI technology can unravel new dimensions of understanding and intervention, fundamentally altering the landscape of patient care.
pharmaphorum
FEBRUARY 19, 2024
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.
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MedCity News
FEBRUARY 19, 2024
HHS recently released a final rule that allows practitioners in Opioid Treatment Programs to start patients on methadone or buprenorphine via telehealth. However, the final rule does not apply to the broader range of providers, leading telehealth advocates to call for additional changes from the DEA.
Copyright Clearance Center
FEBRUARY 19, 2024
For nearly half a century, the Journal Citation Reports, or JCR, have been “must reading” in universities around the world. Dr. Nandita Quaderi, a senior vice president and the editor in chief for Web of Science at Clarivate, shares the latest developments in the JCR’s ongoing evolution.
MedCity News
FEBRUARY 19, 2024
In this episode, we’re joined by Régine Sitruk-Ware, a distinguished scientist at the Population Council’s Center for Biomedical Research (CBR), and Chelsea Polis, senior scientist of epidemiology at CBR. They talk about the effect upcoming male birth control products could have on women’s health.
pharmaphorum
FEBRUARY 19, 2024
AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 19, 2024
Almirall has signed a licensing agreement for the acquisition of worldwide rights to Novo Nordisk’s IL21-hindering antibody NN-8828.
MedCity News
FEBRUARY 19, 2024
During a recent panel, three health system executives shared some of the most important lessons they’ve learned from the digital initiatives they’ve worked on in the past couple years. Some of their nuggets of wisdom included starting with a problem instead of a solution and being sure not to use financial ROI as the only metric for success.
European Pharmaceutical Review
FEBRUARY 19, 2024
The World Health Organization (WHO) has launched a new Biomanufacturing Workforce Training Initiative to help overcome challenges within the biomanufacturing sector in low- and middle-income countries’ (LMICs). The programme aims to support the limited capacity within the industry in LMICs. Another goal of the initiative is to manage the shortage of a qualified workforce in the production of biological products, such as vaccines, and monoclonal antibodies (mAbs).
pharmaphorum
FEBRUARY 19, 2024
Ahead of landmark SCOTUS hearing, study finds telehealth access to abortion pill mifepristone is as safe and effective as in-clinic access
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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.
European Pharmaceutical Review
FEBRUARY 19, 2024
Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma” Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma.
PharmaTimes
FEBRUARY 19, 2024
Participants who received COMPASS showed a clinically significant improvement after 12 weeks
Pharmaceutical Technology
FEBRUARY 19, 2024
DYNE-251 is an antisense oligonucleotide commercialized by Dyne Therapeutics, with a leading Phase II program in Duchenne Muscular Dystrophy.
PharmaTimes
FEBRUARY 19, 2024
The study aims to improve the representation of ethnic diversity within Parkinson’s research
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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 19, 2024
PDS-01ADC is under clinical development by PDS Biotechnology and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).
pharmaphorum
FEBRUARY 19, 2024
FDA sets December date for decision on AstraZeneca and Daiichi Sankyo’s TROP2-directed ADC Dato-DXd as a therapy for lung cancer (NSCLC)
Pharmaceutical Commerce
FEBRUARY 19, 2024
Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.
PharmExec
FEBRUARY 19, 2024
The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Pharmacy Times
FEBRUARY 19, 2024
California's Stop Dangerous Pharmacies Act aims to improve patient safety by establishing new pharmacy staffing regulations and a medication error reporting system, arising from understaffed conditions.
Pharmaceutical Commerce
FEBRUARY 19, 2024
The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.
PharmExec
FEBRUARY 19, 2024
OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.
Pharmaceutical Technology
FEBRUARY 19, 2024
Iovance Biotherapeutics' Amtagvi has received accelerated US FDA approval for treating adults with metastatic or unresectable melanoma.
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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.
Pharmacy Times
FEBRUARY 19, 2024
The full scope of pharmacy practice offers a transformative approach to health care delivery, promising improved patient outcomes, greater access to care, and efficient utilization of health care resources.
Pharmaceutical Technology
FEBRUARY 19, 2024
The US Food and Drug Administration (FDA) has requested a partial clinical hold on all solid tumour trials for Gilead's magrolimab.
Pharmaceutical Commerce
FEBRUARY 19, 2024
Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.
Pharmaceutical Technology
FEBRUARY 19, 2024
Celltrion has announced that its Remsima SC has obtained approval for use as maintenance therapy for inflammatory bowel disease (IBD).
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Pharmaceutical Commerce
FEBRUARY 19, 2024
The lack of transparency in the pharmaceutical industry further exacerbates the challenges faced by consumers.
Pharmaceutical Technology
FEBRUARY 19, 2024
The US FDA has granted approval for AstraZeneca's Tagrisso regimen for EGFRm non-small cell lung cancer (NSCLC) in adults.
Pharmacy Times
FEBRUARY 19, 2024
Matthew Pianko, MD, outlines the logistical considerations involved when implementing bispecific antibodies for the treatment of multiple myeloma, including the roles of the project champion and other stakeholders as part of a multidisciplinary team.
Pharmaceutical Technology
FEBRUARY 19, 2024
Applied plans to submit a new drug application following the announcement of positive interim data from its Phase III 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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