Bio Pharma Dive
MARCH 30, 2022
A drug regimen including Roche's top prospect tiragolumab didn't outperform standard treatment in its first large trial, a setback for therapies aimed at a protein called TIGIT.
Pharma Times
MARCH 30, 2022
Report uses input from healthcare professionals to highlight training and support needs, while also warning about departures
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Bio Pharma Dive
MARCH 30, 2022
The biotech company plans to reduce its workforce by 30%, or by about 65 employees, in the latest example of a gene therapy developer restructuring.
pharmaphorum
MARCH 30, 2022
Data from a massive real-world study of asthma patients has suggested that overuse of inhalers is widespread and leading to an elevated risk of severe exacerbations. The results from the SABINA registry programme in more than a million people with the respiratory disease show that 40% of patients were over-using short-acting beta agonist (SABA) inhalers, which are used on demand to open up the airways.
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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 30, 2022
The biotech's experimental medicine, meant to be a convenient alternative to widely used injectable drugs like Aranesp, is the second of its kind to be knocked back by the agency due to safety concerns.
Pharma Times
MARCH 30, 2022
ProKnow was chosen to enable healthcare providers to benchmark treatment metrics against best practice and support clinical excellence
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MARCH 30, 2022
Plant-based food sales in the US hit $7.4 billion in 2021, growing by a whopping 54 percent since 2018 — significantly outpacing total food dollar sales, which only grew two percent in the last three years. This data was released in a new report by nonprofit Good Food Institute (GFI), which also noted that when it came to unit sales, the plant-based food industry experienced a six percent growth since 2018 while total food sales were stagnant. .
Bio Pharma Dive
MARCH 30, 2022
The panel of independent experts found clinical trial evidence generated by the drug's developer, Amylyx Pharmaceuticals, insufficient to establish the treatment's effectiveness.
Scienmag
MARCH 30, 2022
CHAPEL HILL, NC – The vast majority of people infected with the omicron variant of SARS-CoV-2 experience mild cold-like symptoms, moderate flu-like symptoms, or no symptoms at all, but the virus is so transmissible that it still spread deep into lung tissue to cause severe disease and death in thousands of people in the United […].
XTalks
MARCH 30, 2022
In this episode, Ayesha discussed Pfizer’s voluntary recall of several lots of its blood pressure medication Accuretic and two generic versions of it due to higher than acceptable levels of a carcinogenic nitrosamine compound. The recall affects lots produced between November 2019 and March 2022. The editorial team discussed the increasing frequency of recalls of commonly prescribed drugs like blood pressure and diabetes medications.
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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
Scienmag
MARCH 30, 2022
Finding the specific sound a rock makes when it cracks and breaks seems impossible when surrounded by other subsurface noises. But Texas A&M University researcher Dr. Siddharth Misra, the Ted H. Smith, Jr. ’75 and Max R. Vordenbaum ‘73 DVG Associate Professor in the Harold Vance Department of Petroleum Engineering, discovered a way to hear […].
pharmaphorum
MARCH 30, 2022
Roche has suffered a setback with its much-anticipated pairing of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq in small cell lung cancer (SCLC), in a blow to its ambitions in combination cancer immunotherapy. The SKYSCRAPER-02 showed that the combination of the two drugs given on top of chemotherapy was unable to improve progression-free survival versus Tecentriq (atezolizumab) plus chemo in extensive-stage SCLC – a notoriously hard-to-treat form of lung cancer.
Scienmag
MARCH 30, 2022
Acoustics researchers of Aalto University have improved the most common method for measuring the acoustics of a room, the sine sweep technique. The new approach will make it easier and faster to design a room so that the right sounds reach the right spots. Credit: Karolina Prawda / Aalto University Acoustics researchers of Aalto University […].
NY Times
MARCH 30, 2022
Taking these seven steps now can lower your risk and minimize the disruption to your family’s life.
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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.
Scienmag
MARCH 30, 2022
Finding the right ingredients to create materials with exotic quantum properties has been a chimera for experimental scientists, due to the endless possible combinations of different elements to be synthesized. Credit: © MPI CPfS Finding the right ingredients to create materials with exotic quantum properties has been a chimera for experimental scientists, due to the […].
NY Times
MARCH 30, 2022
“At some point it will become a waste of resources to continue studying an unpromising approach,” one expert said.
Scienmag
MARCH 30, 2022
Mineral systems: Their advantages in terms of developing holistic genetic models and for target generation in global mineral exploration Credit: GeoGeo Mineral systems: Their advantages in terms of developing holistic genetic models and for target generation in global mineral exploration [link] Announcing a new publication for Geosystems and Geoenvironment journal.
Eye on FDA
MARCH 30, 2022
Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in motion as well. It is a fundamental re-shifting of the landscape. And there are consequences. First, government funding supporting access to vaccination and treatment for COVID has run out and so far, is not replenished.
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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.
Scienmag
MARCH 30, 2022
AMHERST, Mass. – New research, led by the University of Massachusetts Amherst and published recently in the journal Climate of the Past, is the first to provide a continuous look at a shift in climate, called the Mid-Pleistocene Transition, that has puzzled scientists. Kurt Lindberg, the paper’s first author and currently a graduate student at […].
pharmaphorum
MARCH 30, 2022
Amazon’s latest push into the healthcare arena is focusing on one of the top new trends in clinical research – the shift towards decentralised trials. Amazon Web Services has teamed up with Thread, a US technology company that has developed a decentralised clinical trials (DCT) platform based on artificial intelligence and machine learning, to enhance and scale up the technology.
Scienmag
MARCH 30, 2022
The day after lead author Daniel Winstead approved the final proofs for a study to be published in Ambio, the journal of the Royal Swedish Academy of Sciences, Russia put its nuclear forces on high alert. Credit: Penn State The day after lead author Daniel Winstead approved the final proofs for a study to be […].
pharmaphorum
MARCH 30, 2022
CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. The first participants have been dosed in a new, second generation version – dubbed CV2CoV – which uses a different mRNA backbone and will be a key test of CureVac’s new vaccine design approach.
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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.
Scienmag
MARCH 30, 2022
Refining metals, manufacturing fertilizers and powering fuel cells for heavy vehicles are all processes that require purified hydrogen. But purifying, or separating, that hydrogen from a mix of other gases can be difficult, with several steps. A research team led by Chris Arges, Penn State associate professor of chemical engineering, demonstrated that the process can […].
XTalks
MARCH 30, 2022
Diversity and inclusion employment practices are in high demand. Integrating a diversity and inclusion framework into all sectors of a pharmaceutical organization will enhance leadership, employee engagement, company culture and behavioral competencies. One common misbelief is that diversity and inclusion is just for big pharma. When building innovative teams, small to mid-sized companies have also recognized its significance.
Scienmag
MARCH 30, 2022
In this round of funding, the SNSF Research Council decided to rank all NCCRs into three tiers based on cross-NCCR assessment results. We are delighted that MARVEL was ranked in the top tier and so will receive a bonus of 1.53 MCHF in addition to its regular budget of 10.8 MCHF. This brings the overall […].
pharmaphorum
MARCH 30, 2022
The organisation behind the iconic Canary Wharf development has said it plans to build one of the largest commercial laboratory facilities in Europe as part of a drive to make the east London site a hub for the life sciences sector. Canary Wharf Group has joined forces with science facility developer Kadans on the project, which will kick off with the construction of a 22 storey, 750,000 sq. ft. building dedicated to a combination of wet lab and office space.
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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.
Scienmag
MARCH 30, 2022
The New England Journal of Medicine (NEJM) today published final results of a nationwide multicenter study led by researchers at Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health that show plasma from patients who have recovered from COVID-19 and whose blood contains antibodies against SARS-CoV-2, the causative virus, is an effective […].
NY Times
MARCH 30, 2022
With a 6-4 vote, the group of independent advisers to the agency narrowly concluded that results from another clinical trial are needed to assess whether the therapy, called AMX0035, can help patients.
Scienmag
MARCH 30, 2022
For people with atrial fibrillation, one of our most common cardiac disorders, dementia risk is elevated. This is shown by a University of Gothenburg thesis based on research at population level. Credit: Photp by Josefin Bergenholtz For people with atrial fibrillation, one of our most common cardiac disorders, dementia risk is elevated. This is shown […].
Drug Patent Watch
MARCH 30, 2022
Annual Drug Patent Expirations for KLOXXADO Kloxxado is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. There are two patents protecting…. The post New patent for HIKMA drug KLOXXADO appeared first on DrugPatentWatch - Make Better Decisions.
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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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