Bio Pharma Dive
OCTOBER 18, 2022
At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2022
In 1906, Alois Alzheimer, a psychiatrist and neuroanatomist, reported “a peculiar severe disease process of the cerebral cortex” to a gathering of psychiatrists in Tübingen, Germany. The case was a 50-year-old woman who suffered from memory loss, delusions, hallucinations, aggression, and confusion – all of which worsened until her untimely death five years later.
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Bio Pharma Dive
OCTOBER 18, 2022
The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.
Pharmaceutical Technology
OCTOBER 18, 2022
Oculis has signed a definitive business combination agreement with special purpose acquisition company (SPAC) European Biotech Acquisition (EBAC). The merged business is anticipated to have an enterprise value of nearly $220m following the closing of the transaction. The deal is also expected to offer proceeds comprising nearly $127.5m held in the trust of EBAC and nearly $80m in upsized private investment in public equity (PIPE) and private investment.
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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
Bio Pharma Dive
OCTOBER 18, 2022
Like with Prevail Therapeutics, Lilly’s first gene therapy acquisition, the pharma’s planned buyout of Akouos includes a contingent value right that could hike the deal’s overall cost.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2022
With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority. In a relief to the Centre, 12 out of […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 18, 2022
Moderna has entered an agreement with Gavi, the Vaccine Alliance, with regard to the delivery of Covid-19 vaccines to lower-income countries supported by the Gavi COVAX Advance Market Commitment (AMC). According to the deal, the parties will cancel pending orders under the existing Covid-19 vaccine supply agreement for this year. Additionally, Moderna and Gavi will create a new approach aiding lower-income countries to gain access to updated variant-specific Covid-19 vaccine doses starting next
Bio Pharma Dive
OCTOBER 18, 2022
The biotech survived multiple drug rejections, shareholder lawsuits and a federal investigation before winning approval of Fotivda, the centerpiece of its $566 million buyout on Tuesday.
STAT News
OCTOBER 18, 2022
A fourth-year medical student, Tema, faced an abrupt interruption to her education earlier this year. A state law banning abortion after six weeks went into effect hours after the U.S. Supreme Court overturned Roe v. Wade, and two days later, the clinic where her school provided first-hand abortion experience shut down. “I’d do my patients a great disservice if I’m not trained in abortion,” said Tema, who is planning to become a family planning doctor, and asked that
Rethinking Clinical Trials
OCTOBER 18, 2022
Rachel Richesson, cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core , will present this week at IMPACT Collaboratory Grand Rounds. The virtual session, “Developing Standards and Quality Metrics for Clinical Phenotyping Using EHR Data in Pragmatic Clinical Trials,” will be held on Thursday, October 20, 2022, at 12:00 pm eastern.
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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
STAT News
OCTOBER 18, 2022
The director of a Boston University laboratory that conducted potentially controversial research on the viruses that cause Covid-19 said his institution didn’t clear the work with the National Institutes of Health because it wasn’t funded by the federal agency. Ronald Corley said the research, which was designed to explore what makes some SARS-CoV-2 viruses more or less pathogenic, was funded with money from the university itself.
NPR Health - Shots
OCTOBER 18, 2022
The World Health Organization has issued an alert about the deaths in the West African nation of Gambia. For context, we speak to the authors of The Truth Pill: The Myth of Drug Regulation in India.
STAT News
OCTOBER 18, 2022
WASHINGTON — Biden health officials are bracing for the prospect that the country’s sole preventive Covid-19 treatment for immunocompromised people could be ineffective this winter. AstraZeneca’s Evusheld, the only monoclonal antibody authorized as a periodic injection to prevent infection, has become an essential shot for roughly 17,000 Americans with weakened immune systems.
XTalks
OCTOBER 18, 2022
A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Medpace is a top-10, full-service CRO providing comprehensive Phase I to Phase IV clinical development services to support global research and the development of life-saving therapeutics and devices.
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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.
Pharma Times
OCTOBER 18, 2022
Therapy is based on ACD856's indicative disease modifying effects against the condition
STAT News
OCTOBER 18, 2022
Amid ongoing controversy over the cost of insulin, a new analysis finds that approximately 1.3 million people, or 16.5% of all adults with diabetes in the U.S., rationed their use of the life-saving treatment in the past year, raising the prospect of harmful and increasingly expensive health consequences. Among all insulin users, the most common rationing tactic was to simply delay purchases, with 14.5% of people with diabetes making this decision in response to the cost.
BioPharma Reporter
OCTOBER 18, 2022
GSKâs respiratory syncytial virus (RSV) vaccine for adults aged 60+ has demonstrated overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD) - and a 94.1% reduction in severe RSV - in Phase 3 trials.
STAT News
OCTOBER 18, 2022
The Biden administration on Tuesday unveiled a new national biodefense strategy, aiming to adapt lessons drawn from the rocky response to the Covid-19 pandemic as it prepares the country for future public health emergencies. The strategy, which has been long anticipated, includes such goals as strengthening public health workforces both in the United States and globally, and establishing international mechanisms to bolster laboratory safety.
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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.
XTalks
OCTOBER 18, 2022
In order to prosper, life science organizations need innovators, strategists, researchers, visionaries and more to build a workforce that demonstrates real value for patient outcomes. Disruption is very commonly witnessed in the life sciences industry hence human resources (HR) departments need to continuously come up with new talent strategies and recruitment practices to stay progressive. .
BioSpace
OCTOBER 18, 2022
Advaxis and Ayala Pharmaceuticals entered a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer.
Pharma Times
OCTOBER 18, 2022
First treatment in 30 years to improve second-line treatment of DLBCL
BioSpace
OCTOBER 18, 2022
PD-L1 expression is not the static, “yes/no” predictor of tumor response for which researchers hoped. Surface Oncology, Immutep and Corbus are each taking a different approach to immuno-oncology.
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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.
STAT News
OCTOBER 18, 2022
Expansions to social safety net programs during Covid-19 have been essential for low-income Americans hit hard by the pandemic. But the stabilizing impact of these expansions will be at risk when the federal Covid-19 Public Health Emergency , which was initially declared on January 31, 2020, comes to an end, possibly by Jan. 11, 2023. Ending the public health emergency will end expansions to Medicaid and the Supplemental Nutrition Assistance Program (SNAP), the nation’s flagship programs
pharmaphorum
OCTOBER 18, 2022
Now that the COVID-19 pandemic has provided the industry with a solid foundation of experience with decentralised trials, it is appropriate to reflect and ask whether DCT studies are truly helping to address long-standing issues in research and development for sponsors, study teams and, most importantly, patients. IQVIA conducted a thorough analysis of 12 global DCT studies across three therapeutic areas and seven indications to compare DCTs’ value to key stakeholders with traditional trials.
STAT News
OCTOBER 18, 2022
When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes. Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility tr
XTalks
OCTOBER 18, 2022
Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain. According to Nevro, the Senza HFX iQ is the first and only artificial intelligence (AI)-based SCS system that “learns from patients.”. It delivers personalized care through its digital capabilities and collection of patient data, which together help guide the patient through a customized trea
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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.
Drug Discovery World
OCTOBER 18, 2022
An international team of researchers has discovered a new antibiotic by computational analysis and deciphered its mode of action. . The researchers also found that Dynobactin kills Gram-negative bacteria, which include many dangerous and resistant pathogens. . The team were led by researchers from the Northeastern University in Boston, together with Prof Sebastian Hiller from the Biozentrum of the University of Basel. .
BioSpace
OCTOBER 18, 2022
Editas is reportedly in "advanced discussions" regarding the sale of its preclinical cancer lineup. The company told BioSpace it has undertaken a strategic review to inform opportunities.
Outsourcing Pharma
OCTOBER 18, 2022
Walmart joins rival retailers by launching its service for clinical trial recruitment, stating that it will focus on older, rural, women and minority populations.
BioSpace
OCTOBER 18, 2022
???????Ambrx Biopharma Inc. announced it will lay off 15% of its workforce and suspend development of its lead candidate in a strategic realignment initiative.
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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.
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