Bio Pharma Dive
MAY 16, 2022
The biotech company is searching for a permanent successor to Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO.
World of DTC Marketing
MAY 16, 2022
If You’re Short On Time: The U.S. Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. The approval for tirzepatide—which Lilly will market under the brand name Mounjaro—isn’t for weight loss but Type 2 diabetes. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?
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Bio Pharma Dive
MAY 16, 2022
Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination.
pharmaphorum
MAY 16, 2022
Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. Eli Lilly’s Mounjaro (tirzepatide) was given the green light by the US Food and Drug Administration after the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 glucagon-like peptide-1 (GLP-1 ) receptor agonist showed its effectiveness when used in conjunction with diet and exercise.
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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
MAY 16, 2022
New mRNA technology: identifying the right drug containment solution is more important than ever.
pharmaphorum
MAY 16, 2022
Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development (USAID), tells us what the agency focuses on to strengthen digital health infrastructure globally and improve and expand healthcare access. USAID learned a great deal from the Ebola outbreak in West Africa concerning effective digital health distribution and strategies for digital health implementation that were then applied to its COVID-19 response globally – alth
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 16, 2022
A digital health startup accelerator is launching in Italy, with more than €6 million backing the new enterprise. Called VITA, the accelerator will support up to 10 startups focused on digital transformation of the health system. The project is backed by asset management company CDP Venture Capital SGR, with help from digital health consultancy Healthware Group (pharmaphorum’s parent company) and Danish accelerator Accelerace.
Bio Pharma Dive
MAY 16, 2022
The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.
BioPharma Reporter
MAY 16, 2022
Vaccine company Valneva has received notice from the European Commission of its intent to terminate the Advanced Purchase Agreement for Valnevaâs COVID-19 vaccine.
XTalks
MAY 16, 2022
The partnership between Abbott and non-profit Women as One will train female and underrepresented physicians to help improve diversity in clinical trials. Research from recent years shows that representation of women and ethnic minorities, especially African Americans, still needs to be improved in most drug development programs approved by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
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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
MAY 16, 2022
Just as it’s hard to understand a conversation without knowing its context, it can be difficult for biologists to grasp the significance of gene expression without knowing a cell’s environment. To solve that problem, researchers at Princeton Engineering have developed a method to elucidate a cell’s surroundings so that biologists can make more meaning of […].
XTalks
MAY 16, 2022
Boochcraft, which claims to be America’s favorite hard kombucha brand, recently became a Certified Benefit Corporation (B-Corp), a label awarded to companies that voluntarily meet high social and environmental performance standards. Notably, Boochcraft is the first hard kombucha brand to achieve B-Corp status and will join more than 4,000 B-Corps across more than 70 countries and 150 industries.
Drug Patent Watch
MAY 16, 2022
Annual Drug Patent Expirations for ESBRIET Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty-one patents…. The post New patent for Genentech Inc drug ESBRIET appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MAY 16, 2022
Researchers from the Centenary Institute and the University of Technology Sydney have published the first study showing why people with chronic obstructive pulmonary disease (COPD) are at higher risk of developing severe COVID-19. Credit: Centenary Institute Researchers from the Centenary Institute and the University of Technology Sydney have published the first study showing why people […].
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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.
BioPharma Reporter
MAY 16, 2022
Gerresheimer has enhanced its manufacturing capabilities in India, in an effort to ensure consistent, local supply for pharma and healthcare operations.
Scienmag
MAY 16, 2022
Efficient and environmentally friendly solar cells are required for a transition to a fossil-free energy supply. Researchers at Linköping University have mapped how energy flows in organic solar cells, something that previously had been unknown. The results, which can contribute to more efficient solar cells, are published in Nature Communications. Credit: Thor Balkhed Efficient and […].
Pharma Times
MAY 16, 2022
Sarclisa is a monoclonal antibody which targets a specific epitope on the CD38 receptor on multiple myeloma cells
Scienmag
MAY 16, 2022
Ultra-powerful 7T MRI scanners could be used to help identify those patients with Parkinson’s disease and similar conditions most likely to benefit from new treatments for previously-untreatable symptoms, say scientists. Credit: University of Cambridge Ultra-powerful 7T MRI scanners could be used to help identify those patients with Parkinson’s disease and similar conditions most likely to […].
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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.
pharmaphorum
MAY 16, 2022
An albuterol/budesonide fixed-dose combination rescue medication has been shown to reduce severe exacerbations in patients with asthma for the first time, according to positive Phase 3 trial results announced by AstraZeneca and Avillion. Asthma affects as many as 339 million adults and children around the world. Regardless of severity, the condition means that these patients are at risk of severe exacerbations, with an estimated 176 million asthma exacerbations globally per year.
Scienmag
MAY 16, 2022
AMHERST, Mass. – Polymer scientists at the University of Massachusetts Amherst recently announced in the journal Nature Communications that they have solved a longstanding mystery surrounding a nanoscale structure, formed by collections of molecules, called a double-gyroid. This shape is one of the most desirable for materials scientists, and has a wide range of applications; […].
Pharma Times
MAY 16, 2022
PT027 is being developed through a partnership involving AstraZeneca and Avillion
Scienmag
MAY 16, 2022
Instead of relying on the cell’s repair mechanisms, the vaccinia virus MacGyvers a tool for DNA repair from one that it already uses to copy DNA, reports a team of researchers at the Medical University of South Carolina (MUSC) in the Journal of Virology. Blocking that tool – an enzyme known as polymerase – at […].
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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.
Outsourcing Pharma
MAY 16, 2022
The companyâs analysis of 2.5m patients worldwide suggest a growing proportion of younger patients, with implications for future study design and deployment.
Scienmag
MAY 16, 2022
Through a collaborative effort including the public, scientists from the Marine Megafauna Foundation and Murdoch University are reporting a large number of manta rays in the waters of Komodo National Park, an Indonesian UNESCO World Heritage Site, suggesting the area may hold the key to regional recovery of the threatened species. Credit: www.naturetripper.com Through a […].
The Pharma Data
MAY 16, 2022
Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.
Scienmag
MAY 16, 2022
New research modeling smoke from two recent megafires sets the stage for better forecasting of how emissions from these global-scale events will behave and impact temperatures. As huge wildfires become more common under climate change, increased attention has focused on the intensity and duration of their emissions, which rival those of some volcano eruptions.
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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.
The Pharma Data
MAY 16, 2022
WHO and UNICEF call on governments, industry, donors and civil society to fund and prioritize access to assistive products. A new report published today by WHO and UNICEF reveals that more than 2.5 billion people need one or more assistive products, such as wheelchairs, hearing aids, or apps that support communication and cognition. Yet nearly one billion of them are denied access, particularly in low- and middle-income countries, where access can be as low as 3% of the need for these life-chang
Scienmag
MAY 16, 2022
Exercise increases dopamine signaling in the motor areas of mice, according to research recently published in JNeurosci. Credit: Bastioli et al., JNeurosci 2022 Exercise increases dopamine signaling in the motor areas of mice, according to research recently published in JNeurosci. It’s no secret exercise is good for the brain — working out can improve mood, […].
The Pharma Data
MAY 16, 2022
The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics. It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7 million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths.
Scienmag
MAY 16, 2022
Recently, a research team from State Key Laboratory of Mechanical Transmissions, Chongqing University of China has found the coupling relationship between thermal control (TC) process and material removal (MR) process of precision machine tools. The research team believes that the coupling relationship of the two functional processes can affect the machining accuracy and energy efficiency […].
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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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