Bio Pharma Dive
MARCH 6, 2023
Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.
Pharmaceutical Technology
MARCH 6, 2023
Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.
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Bio Pharma Dive
MARCH 6, 2023
The Swiss drugmaker's decision is the latest in a string of partnership announcements for the gene therapy maker, which aims to bounce back from past research failures.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 6, 2023
The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions. The product, faricimab 6mg/0.
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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
MARCH 6, 2023
A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.
Pharmaceutical Technology
MARCH 6, 2023
Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 6, 2023
The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. Verzenio along with endocrine therapy (ET) has received approval as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) adult patients who are at a high recurrence risk.
Bio Pharma Dive
MARCH 6, 2023
Kroger Health seeks to increase awareness among more eligible clinical trial participants.
NPR Health - Shots
MARCH 6, 2023
The last time this summit convened in 2018, the world was shocked to hear a scientist had created the first gene-edited babies. He was condemned, but gene-editing has continued, with some success.
Bio Pharma Dive
MARCH 6, 2023
The company says the findings could spur wider adoption of its pill Nexletol, though shares fell 20% as the data was short of Wall Street expectations.
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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
NPR Health - Shots
MARCH 6, 2023
Young Black adults, Mexican Americans and other Hispanic adults experienced the greatest cardiovascular risk factors, according to a study published in the Journal of the American Medical Association. (Image credit: M.
Bio Pharma Dive
MARCH 6, 2023
The results impressed analysts and suggest the biotech's drug could become a threat to BioMarin's Voxzogo, sending shares up about 60%.
FDA Law Blog
MARCH 6, 2023
By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.
Bio Pharma Dive
MARCH 6, 2023
Discover the data and metrics you should be tracking to evaluate patient access.
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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.
NPR Health - Shots
MARCH 6, 2023
Tuberculosis kills 1.6 million a year — the second deadliest infectious disease after COVID-19. Using immune cells and mRNA technology, scientists in South Africa are working on a new vaccine.
Medical Xpress
MARCH 6, 2023
Some cities fight gangs with ex-members who educate kids and starve gangs of new recruits. Stanford Medicine researchers have done something similar with cancer—altering cancer cells so that they teach the body's immune system to fight the very cancer the cells came from.
NPR Health - Shots
MARCH 6, 2023
Federal restrictions seemed to explain why many doctors weren't prescribing medication for opioid addiction. But some caution that removing those rules isn't enough to overcome hesitancy and stigma.
Medical Xpress
MARCH 6, 2023
For people with alcohol use disorder (AUD), there is a constant, vicious cycle between changes to the brain and changes to behavior. AUD can alter signaling pathways in the brain; in turn, those changes can exacerbate drinking.
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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.
STAT News
MARCH 6, 2023
LONDON — The first gene-edited children were born in China five years ago , but it’s unlikely to happen again there anytime soon. That was the message Chinese scientists delivered Monday on the opening day of the Third International Summit on Human Genome Editing in London. While the widely condemned experiment conducted by He Jiankui violated two existing Chinese regulations dating back to 2003 — which prohibit genetically altered embryos from being implanted into people fo
Medical Xpress
MARCH 6, 2023
A global team of researchers has created an algorithmic tool that can identify existing drugs in order to combat future pandemics. The work, reported in the Cell Press journal Heliyon, offers the possibility of responding more quickly to public-health crises.
STAT News
MARCH 6, 2023
It has been more than 11 years since Julia Young was diagnosed with advanced ovarian cancer, and two years since it spread to her lymph system. By her own account, she has already beaten the odds for how long most women survive the deadly disease. Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket
Medical Xpress
MARCH 6, 2023
Frequent socializing may extend the lifespan of older people, suggests a study of more than 28,000 Chinese people, published online in the Journal of Epidemiology & Community Health.
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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
MARCH 6, 2023
NEW ORLEANS — A new medicine represents a dramatic advance for patients with a rare condition called pulmonary arterial hypertension — and a return to heart disease for Merck, which long had a legendary presence in cardiology. The medicine, sotatercept, substantially increased the distance that patients could walk over the course of six minutes and reduced the risk that their condition would worsen, that they would die, and that they would need new treatments, according to data pre
Medical Xpress
MARCH 6, 2023
While it is generally accepted that exercise can benefit a person's overall health, a recently published paper has found a direct link between muscle contraction and a reduction in breast cancer.
STAT News
MARCH 6, 2023
Hospital systems are turning to cross-market mergers to satiate their thirst for growth and avoid antitrust heat. But hospitals are also still signing other lower-profile deals, which experts believe inevitably lead to higher insurance premiums and create more medical bill stress for people in those communities. “Smaller mergers just don’t get the attention they deserve because they affect fewer people,” said Vivian Ho, a health economist at Rice University who studies hospi
Medical Xpress
MARCH 6, 2023
Epilepsy is a chronic brain disorder characterized by recurrent seizures. About 30 percent of epilepsy patients are known to be drug-refractory, which means they do not respond to drug treatments. Temporal lobectomy of the epileptogenic zone can alleviate or terminate symptoms but surgical resection is not suitable for all patients and neurological damage after surgery can cause motor paralysis or speech impairment, so a new effective treatment is urgently needed.
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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.
STAT News
MARCH 6, 2023
Issues of fairness and justice echo across the health ecosystem, including drug development. Much of the conversation on improving equity in the development of novel therapeutics centers on increasing diversity in clinical trials. A key step in that direction begins with ensuring more equitable representation among clinical investigators. Engaging, recruiting, and retaining a diverse set of participants for clinical trials is critically important, as drugs can have different effects on people de
Medical Xpress
MARCH 6, 2023
New findings from researchers at Wake Forest University School of Medicine confirm that the rates of Type 1 and Type 2 diabetes continue to increase in children and young adults. Non-Hispanic Black and Hispanic children and young adults also had higher incidence rates of diabetes.
STAT News
MARCH 6, 2023
In opposing a fix to the 2022 Inflation Reduction Act, a leading voice in the effort to move the U.S. biopharmaceutical system toward European-style price controls cited “complicated details” in his reasoning for changing the law, adding that “getting it straight is critically important.” I couldn’t agree more.
Medical Xpress
MARCH 6, 2023
Getting tested for levels of HDL (the good) and LDL (the bad) cholesterol is part of the annual physical exam. But emerging research is showing that these standard tests may not be the most accurate way to test for heart disease risk.
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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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