Bio Pharma Dive
JUNE 5, 2023
The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
JUNE 5, 2023
The biotech, which has trimmed various research programs over the past year, cited the trial’s complexity and long timeline as reasons for its discontinuation.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 5, 2023
The “dissociative anesthetic” ketamine looks ever more promising as a safe and effective treatment for intractable depression. A new randomized trial from researchers in the United States has shown that injections of ketamine are at least as effective as electroconvulsive therapy (ECT) when treating non-psychotic forms of major depression.
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
Bio Pharma Dive
JUNE 5, 2023
Discover how medical affairs teams can overcome challenges to define and measure their impact, with a focus on KOL engagement, using a scientific journey approach and a comprehensive strategy.
Pharmaceutical Technology
JUNE 5, 2023
ITM (Isotope Technologies Munich) has announced a €255 million ($273.16 million) equity investment funding raise. According to ITM’s CEO Steffen Schuster, the raise is one of the largest private biotechnology financing rounds to date in the company’s home market, per the 5 June announcement. The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Deltaclinical
JUNE 5, 2023
Clinical trials are an indispensable part of medical research, testing new treatments and pharmaceuticals to improve health care. Traditionally, these studies were conducted in medical facilities, but today clinical studies with home visits are becoming increasingly popular. In this blog post, we will explore the benefits of clinical trials with home visits from the patient’s perspective. 1.
Bio Pharma Dive
JUNE 5, 2023
Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.
Deltaclinical
JUNE 5, 2023
Clinical trials are an indispensable part of medical research, testing new treatments and pharmaceuticals to improve health care. Traditionally, these studies were conducted in medical facilities, but today clinical studies with home visits are becoming increasingly popular. In this blog post, we will explore the benefits of clinical trials with home visits from the patient’s perspective. 1.
Bio Pharma Dive
JUNE 5, 2023
Biocorp’s “smart pen” technology could improve diabetes management and potentially be used in other areas Novo works in like obesity, one analyst said.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JUNE 5, 2023
Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report.
Bio Pharma Dive
JUNE 5, 2023
The biotech’s experimental NASH medicine, combined with drugs like Ozempic, helped to improve markers of the fatty liver disease.
Pharmaceutical Technology
JUNE 5, 2023
Results unveiled at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting indicate that some patients with locally advanced rectal cancer can be treated with chemotherapy alone and may not need radiation therapy before surgery. After five years, the treatment efficacy demonstrated in patients who received chemotherapy (and radiation as needed) versus patients who just received radiation therapy was found to be non-inferior.
Bio Pharma Dive
JUNE 5, 2023
As the lobbying group holds its annual meeting in Boston, BIO’s interim leader is trying to focus attention back on the industry’s most pressing priorities, like pushing back on the IRA.
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.
Pharmaceutical Technology
JUNE 5, 2023
China’s National Medical Products Administration (NMPA) has accepted Akeso’s new drug application (NDA) for ebronucimab (AK102) for two indications. Ebronucimab is intended to treat heterozygous familial hypercholesterolemia (HeFH), primary hypercholesterolemia and mixed hyperlipidemia. It is a fully human anti-PCSK9 monoclonal antibody co-developed by the company and AD Pharmaceuticals.
Antidote
JUNE 5, 2023
Hunter’s disease, also known as Hunter syndrome or MPS II, is an inherited disease that impacts the X chromosome. Though it is a rare condition, it is one that can significantly impact children and their families. Currently, there is no known cure for Hunter syndrome , but there are ways that care providers can help diagnosed individuals manage their symptoms.
Pharmaceutical Technology
JUNE 5, 2023
German biotechnology company Evotec has secured a $1.7m grant from a philanthropic funder, Open Philanthropy, to research RNA-targeting henipavirus therapeutics. The company will use the funding for the discovery and development of small molecule antivirals that target viral RNA in henipaviruses, a genus of zoonotic viruses that can cause fatal encephalitis in humans.
XTalks
JUNE 5, 2023
Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. Wegovy, in conjunction with diet and exercise, is authorized to assist adults and children aged 12 years and older struggling with obesity, or some adults grappling with excess weight alongside weight-related medical conditions, in their eff
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.
Pharmaceutical Technology
JUNE 5, 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Bristol-Myers Squibb’s mavacamten (Camzyos) as an add-on to standard care to control symptoms of obstructive hypertrophic cardiomyopathy (HCM). The symptoms of obstructive HCM include fatigue, palpitations and shortness of breath.
BioPharma Reporter
JUNE 5, 2023
BenevolentAI, a clinical-stage AI development company, has announced the successful delivery of its pre-clinical candidate for the potential treatment of amyotrophic lateral sclerosis (ALS), BEN-34712.
Pharmaceutical Technology
JUNE 5, 2023
PharmaEssentia has chosen Pint-Pharma as commercial partner for BESREMi (ropeginterferon alfa-2b-NJFT) in Latin America. The companies have entered into an exclusive licence agreement to register and promote BESREMi to treat polycythemia vera (PV), a rare type of blood cancer, in Ecuador, Chile, Mexico, Argentina, Brazil, Colombia and Peru. PharmaEssentia may be entitled to receive certain milestone payments along with royalties based on sales of the product.
Pharma Times
JUNE 5, 2023
New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes
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.
Pharmaceutical Technology
JUNE 5, 2023
AB-1003is under clinical development by Asklepios BioPharmaceutical and currently in Phase II for Limb-Girdle Muscular Dystrophy.
BioSpace
JUNE 5, 2023
A Kenilworth, NJ, R&D campus that formerly served as Merck’s global headquarters is now set to reopen and become the Northeast Science and Technology (NEST) Center.
Pharmaceutical Technology
JUNE 5, 2023
Camidanlumab tesirineis under clinical development by ADC Therapeutics and currently in Phase II for Myelodysplastic Syndrome.
Fierce Pharma
JUNE 5, 2023
After a postmarketing study of AstraZeneca's bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.< | The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug.
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.
Pharmaceutical Technology
JUNE 5, 2023
Darovasertibis under clinical development by Ideaya Biosciences and currently in Phase II for Colorectal Cancer.
BioSpace
JUNE 5, 2023
Biogen, and partner Denali, are discontinuing the Phase III LIGHTHOUSE study of BIIB122 in Parkinson’s disease due to the trial’s long timeline and complexity.
Pharmaceutical Technology
JUNE 5, 2023
GRWD-5769is under clinical development by Grey Wolf Therapeutics and currently in Phase II for Solid Tumor.
Pharma Times
JUNE 5, 2023
Company’s phase 3 study showed treatment with Tagrisso reduced risk of death by over half - News - PharmaTimes
Advertisement
The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
Expert insights. Personalized for you.
351 
Let's personalize your content