Pharmaceutical Technology
APRIL 21, 2023
Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.
Bio Pharma Dive
APRIL 21, 2023
The company has chosen to stop an extension portion of a key study after an external group of advisers reviewed the data available and concluded further treatment with the drug was unwarranted.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharmaceutical Technology
APRIL 21, 2023
Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.
Bio Pharma Dive
APRIL 21, 2023
With cash running low and a search for a buyer underway, GenSight wants advice from regulators on the type of data that would support an approval.
Pharmaceutical Technology
APRIL 21, 2023
The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.
Bio Pharma Dive
APRIL 21, 2023
The stay suspends a Texas judge’s order that had invalidated the FDA’s approval of mifepristone, keeping it avaliable while a circuit court hears the case.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
APRIL 21, 2023
A decision by the Supreme Court could have far-reaching effects on the lucrative market for antibody drugs, spurring responses from many of the industry’s top companies.
Pharmaceutical Technology
APRIL 21, 2023
Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinical development. The Series B1 financing comes after the company raised equity and debt financing worth $68m in a Series B round in December 2022. It brings the total capital raised by the company to $175m. Led by new investor Kinnevik, the Series B1 financing round has also seen participation from another new investor, Henry R Kravis, co-founder of private
STAT News
APRIL 21, 2023
A medical student spoke emotionally about grappling with a diagnosis his classes told him little about. A young queer man took one test, got a different result on the next, and is now saving up the money needed for the most advanced diagnostics, which insurers rarely cover. A young woman tested positive, got little guidance from her doctor and found information on government sites that she interpreted as pushing abstinence.
Pharmaceutical Technology
APRIL 21, 2023
In a statement emailed to Endpoints News , AstraZeneca (AZ) disclosed intentions to terminate its clinical program for its daily glucagon-like peptide-1 receptor glucagon co-agonist (GLP-1RA/GCGR) cotadutide, in favour of focusing on the development of AZD9550, its once-weekly injectable GLP-1RA/GCGR. In parallel, the company will also shift its focus from the non-alcoholic steatohepatitis (NASH) market to the ever-growing diabetes and obesity market in lieu of the increase in the utilisation of
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Medical Xpress
APRIL 21, 2023
Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage.
Pharmaceutical Technology
APRIL 21, 2023
On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine.
Fierce Pharma
APRIL 21, 2023
In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35
Pharmaceutical Technology
APRIL 21, 2023
US-based biopharmaceutical company Blue Water Vaccines has signed an asset purchase agreement with Veru to buy its Entadfi (finasteride and tadalafil) capsules business, for a total consideration of $100m. The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. It will pay another $10m in instalments through to September 2024.
Advertisement
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
Rethinking Clinical Trials
APRIL 21, 2023
Intervention Complexity Calculator The Intervention Complexity Calculator was developed as a standard tool to capture intervention complexity with the intent to enhance communication challenges of intervention delivery. This version of the tool is most likely to be useful to the trial team and its health care system partners during trial planning and conduct.
Pharmaceutical Technology
APRIL 21, 2023
Samyang has entered into a strategic partnership agreement with LG Chem to develop new cancer therapeutics using Samyang’s technology, NanoReady. Samyang will provide LG Chem non-exclusive rights to the NanoReady technology, along with a supply of its key components. LG Chem will use the technology for the development of innovative mRNA-based cancer therapeutics with maximised therapeutic efficacy.
Medical Xpress
APRIL 21, 2023
A study led by the University of St Andrews suggests that a frequently used medical test for heart injury could one day be used to help COVID-19 patients avoid hospitalization.
Pharmaceutical Technology
APRIL 21, 2023
Orphan drug development company Orphalan has introduced Cuvrior, a new trientine tetrahydrochloride (TETA-4HCl), for commercial use in the US for Wilson disease. Wilson disease is a rare inherited disorder of copper transportation in the body and chiefly affects the liver and brain. The therapy is intended for treating de-coppered adult patients who have stable disease and are tolerant to D-penicillamine.
Advertisement
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.
STAT News
APRIL 21, 2023
Medicine is a calling. But far too often, trainees — residents and fellows — at hospitals don’t receive the support necessary to deliver the best clinical care. Overworked, underpaid, and under-appreciated in an era of skyrocketing paperwork requirements and historic inflation, trainees sometimes struggle to make ends meet, care for themselves and loved ones, and even find joy in the day-to-day grind of learning to be an independent physician.
Medical Xpress
APRIL 21, 2023
Just over a century has passed since the discovery of insulin, a time period during which the therapeutic powers of the hormone have broadened and refined. Insulin is an essential treatment for type 1 diabetes and often for type 2 diabetes, as well. Roughly 8.4 million Americans use insulin, according to the American Diabetes Association.
STAT News
APRIL 21, 2023
As a third-year neurology resident at Mass General Brigham, I started my career at the height of the Covid-19 pandemic. Now Covid numbers may be down, but hospitals continue to overflow. On a 28-hour shift, I cared for more than 40 patients, 11 of whom were newly admitted to the hospital overnight. Stretched too thin, I skimmed through the patients’ medical charts and did a quick physical exam to make sure each person was stable.
Medical Xpress
APRIL 21, 2023
Alcohol consumption increased substantially across the United States during the COVID-19 pandemic, but the impact was greatest among American Indian and Alaska Native (AIAN) populations, where deaths from alcohol-associated liver disease were six times those of white people, according to a study by Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB).
Advertisement
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.
STAT News
APRIL 21, 2023
WASHINGTON — Amid a scramble to assemble a health care policy package in the Senate, a pair of key senators have significantly changed a proposal to cap insulin costs. The new legislation by Senate Diabetes Caucus co-chairs Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) would cap insured patients’ insulin costs at $35 per month for at least one insulin of each type and dosage form, and require pharmacy benefit managers to pass through rebates they collect from insulin ma
Medical Xpress
APRIL 21, 2023
Using powerful sequencing technology, researchers have identified specific biomarker patterns in the blood that are unique to severe COVID-19 infection, as well as others unique to Multisystem Inflammatory Syndrome in Children (MIS-C), a severe complication of COVID-19 infection in children.
Drug Discovery World
APRIL 21, 2023
New study results have demonstrated the potential of a new drug to reprogramme the immune profile in the tumour microenvironment (TME) and convert resistant tumours to responders to Immune Checkpoint Blockage (ICB) therapies. Purple Biotech shared the new results at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Florida, US.
Medical Xpress
APRIL 21, 2023
By looking at where people were born instead of where they ultimately move to and die, geographic disparities in mortality look different than previously assumed, according to a new study published on April 1, 2023, in the journal Demography.
Advertisement
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.
XTalks
APRIL 21, 2023
Cerner Enviza, an Oracle-owned company, and John Snow Labs are now supporting the US Food and Drug Administration’s (FDA) drug safety Sentinel Initiative. By using novel artificial intelligence (AI) tools for drug safety and real-world evidence (RWE) studies, the two companies will help the FDA improve the understanding of the effects of medicines on real-world populations.
Medical Xpress
APRIL 21, 2023
The life-saving drug "Narcan" is expected to be available over-the-counter later this year, but its price tag is expected to put it out of reach for many below the poverty line.
Pharma Times
APRIL 21, 2023
Companies will collaborate to boost novel treatments for individuals with geographic atrophy
Medical Xpress
APRIL 21, 2023
University of Pittsburgh researchers have identified a type of immune cell that drives chronic organ transplant failure in a mouse model of kidney transplantation and uncovered pathways that could be therapeutically targeted to improve patient outcomes. The findings are published in a new Science Immunology paper.
Advertisement
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.
Expert insights. Personalized for you.
246 
Let's personalize your content