PharmaFocus Today – Page 169 – media

Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said: “The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.” The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by ...
- Source: drugdu
- 124
- March 22, 2024
Blood Test Identifies Individuals at Highest Risk of Dying From Heart Failure

Heart failure is a serious condition where the heart is unable to pump blood effectively throughout the body, leading to frequent hospital stays and a decline in quality of life. A protein known as neuropeptide Y (NPY) is produced by nerves in the heart under severe stress. NPY can cause dangerous heart rhythms and narrow the heart’s smallest blood vessels, forcing the heart to work harder and narrowing the arteries that supply blood to the heart. Now, a new study has found that measuring NPY levels could predict the progression of heart failure, paving the way for a blood test to assist in managing heart failure treatment within the next five years. The collaborative study by researchers at the University of Oxford (Oxford, UK) and University of Glasgow (Scotland, UK) found that patients with the highest NPY levels had a 50% greater chance of dying from heart complications within three ...
- Source: drugdu
- 105
- March 21, 2024
Improved Microneedle Technology Speeds Up Extraction of Sample Interstitial Fluid for Disease Diagnosis

Interstitial fluid has many similarities with blood, and its secrets are still being uncovered. A microneedle offers a minimally invasive method to sample this fluid directly under the skin. This tool allows for real-time and continuous monitoring of biomarkers circulating in the body. Despite their small size, just two to three times the width of a human hair and around a millimeter in length, microneedles can make a significant difference in early infection diagnosis and personal health monitoring. Now, researchers have developed improved microneedle technology that enhances the extraction of interstitial fluid by collecting more sample quantities in less time. Sandia National Laboratories (Albuquerque, NM, USA) is leading the way in microneedle research through collaboration with different partners to enhance this technology. Sandia has achieved a breakthrough in interstitial extraction, moving from using multiple needle arrays to a single microneedle technique that collects enough fluid for analysis in just about ...
- Source: drugdu
- 94
- March 21, 2024
AstraZeneca Joins Radiopharma Deals Spree With $2B Fusion Acquisition

AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer. By FRANK VINLUANAstraZeneca is following in the footsteps of some of its big pharmaceutical company peers, plunking down $2 billion to acquire its radiopharmaceuticals partner Fusion Pharmaceuticals. More than adding a pipeline of targeted radiation therapies, AstraZeneca gains the crucial supply chain and manufacturing infrastructure to support them. The sum is an upfront payment. According to the deal terms announced Tuesday, AstraZeneca will pay $21 cash for each Fusion share, representing a 97% premium to Fusion’s closing stock price on Monday. Shareholders of the radiopharmaceutical company could get even more. The deal includes a contingent value right that will pay an additional $3 per share upon achievement of a regulatory milestone. That ...
- Source: drugdu
- 160
- March 21, 2024
FDA Grants Accelerated Approval to Takeda’s Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
- Source: drugdu
- 180
- March 21, 2024
BIO-THERA Signs License and Commercialization Agreement with SteinCares for Two Investigational Biosimilars

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has signed license and commercialization agreements with SteinCares for two investigational biosimilars. The Company today announced that it has entered into a license and commercialization agreement with SteinCares for two investigational biosimilars. Under the terms of the agreements, SteinCares will have exclusive distribution and marketing rights for the two biosimilars in Brazil and the rest of Latin America. Under the terms of the agreements, BIO-THERA will be responsible for the development, manufacturing, commercial supply and filing of marketing applications with the U.S. FDA and the European EMA for the two biosimilars, and SteinCares will be responsible for the filing of marketing applications for the two biosimilars in Brazil and the rest of Latin America, and for their commercialization. SteinCares is familiar ...
- Source: drugdu
- 213
- March 21, 2024
ALS Association partners with myTomorrows to improve clinical trial accessibility

The fatal motor neurone disease currently does not have a cure available to treat patients The ALS Association and myTomorrows have partnered to improve the accessibility of future clinical trials for patients living with amyotrophic lateral sclerosis (ALS). The aim of the partnership is to ensure that patients living with the condition and physicians are up-to-date with information about pre-approval treatment options and clinical trials. ALS is a fatal motor neurone disease that is characterised by the progressive degeneration of nerve cells in the spinal cord and brain, affecting the voluntary control of arms and legs. Usually fatal within five years with no cure available, searching for clinical trials for ALS patients is challenging due to its day-to-day implications and rapid escalation. The US-based ALS Association and myTomorrows aim to tackle these challenges and make it easier for patients and their families to participate in clinical trials. The ALS Association ...
- Source: drugdu
- 188
- March 21, 2024
KCL researchers develop pipeline to create customisable cell culture device creations

The SOL3D pipeline addresses research challenges in relation to equipment, expertise and cost Scientists from King’s College London’s (KCL) UK Dementia Research Institute’s (UK DRI) have developed a process to enable custom cell culture device creation. Published at PLOS Biology, the soft-lithography on 3D vat polymerised (SOL3D) pipeline is cheaper, versatile, highly reproducible and modifies the microfabrication of cell culture devices to produce customised systems. Cell culture devices are designed to support physical environments for cells within the laboratory setting, enabling scientists to observe cell growth and how they interact with each other under different test conditions. Currently, wet labs use commercially developed microdevices, which are expensive and do not allow for customisation, ultimately narrowing the scope of research that can be done. The SOL3D pipeline, instead, offers the potential to create bespoke designs and addresses challenges in relation to equipment, expertise and cost. Researchers used bioengineering and microfabrication expertise ...
- Source: drugdu
- 114
- March 21, 2024
March 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
- Source: drugdu
- 122
- March 21, 2024
New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don’t cause any problems. However, for individuals with certain underlying health conditions, these bacteria can lead to lung infections, showing symptoms similar to those of tuberculosis. Such infections can lead to chronic coughing, sometimes with blood, and scarring that increases susceptibility to respiratory infections like bronchitis and pneumonia. Diagnosing and treating these infections is a lengthy process due to the slow growth rate of the bacteria. With the number of NTM infection cases rising each year, partly due to climate change, there’s a pressing need for quick and precise diagnostic methods. Researchers have now introduced a CRISPR-based testing platform capable of identifying NTM infections using blood samples, providing results in as little as two hours. Researchers at Tulane University (New Orleans, LA, ...
- Source: drugdu
- 162
- March 20, 2024

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