World of DTC Marketing
FEBRUARY 21, 2022
Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. Merck’s molnupiravir, now approved for use in the U.K., costs about $700. Reportedly, the cost of production for molnupiravir stands at about $17.74.
pharmaphorum
FEBRUARY 21, 2022
Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels of HER2 – potentially making it an option for a much broader group of patients. It’s a key moment for the two companies, as expansion into HER2-low breast cancer has been held up as a key requirement for Enhertu (trastuzumab deruxtecan) if it is to achieve its multibillion-dollar sales expectations.
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Pharma Times
FEBRUARY 21, 2022
The UK government is urged to be more mindful of children and young people who have mental health issues, following the publication of the NHS Elective Recovery Plan
pharmaphorum
FEBRUARY 21, 2022
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy.
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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
XTalks
FEBRUARY 21, 2022
BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners.
pharmaphorum
FEBRUARY 21, 2022
The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. population was. . And then came COVID-19.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
FEBRUARY 21, 2022
Bacteria are known for breaking down lactose to make yogurt and sugar to make beer. Now researchers led by Northwestern University and LanzaTech have harnessed bacteria to break down waste carbon dioxide (CO2) to make valuable industrial chemicals. Credit: Justin Muir Bacteria are known for breaking down lactose to make yogurt and sugar to make beer. […].
Pharma Times
FEBRUARY 21, 2022
Study reveals that many with an increased risk of cancer were excluded from the potential for monitoring
Scienmag
FEBRUARY 21, 2022
Chinese chive (Allium tuberosum Rottler ex Sprengel) is a perennial herbaceous vegetable with medicinal qualities. Unfortunately, Chinese chive crops are severely damaged by the soil insect Bradysia cellarum Frey. B. cellarum are mainly found in the surface soil to a depth of 5 cm. Department of Plant Protection, Institute of Vegetables and Flowers, Chinese Academy […].
pharmaphorum
FEBRUARY 21, 2022
Swiss digital health company MindMaze has raised $105 million to help take its digital therapeutics (DTx) for neurological diseases like stroke onto the global stage, and fund the development of therapies for other diseases like Alzheimer’s and Parkinson’s. MindMaze takes a gaming approach to its DTx platform, but goes well beyond the use of a simple app on a mobile device to develop its therapies.
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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
FEBRUARY 21, 2022
LA JOLLA, CA—Every kind of T cell has a job to do. A healthy immune system makes sure no T cell oversteps. Credit: Published in Dolina et al., PNAS, and used with permission. LA JOLLA, CA—Every kind of T cell has a job to do. A healthy immune system makes sure no T cell oversteps. […].
pharmaphorum
FEBRUARY 21, 2022
An online doctor’s service operating in the UK has been fined after pleading guilty to providing online consultation and prescription services without being registered with the Care Quality Commission (CQC). The service – which provided powerful prescription medicines including high strength co-codamol, pregabalin and gabapentin to patients – exposed patients to “a significant risk of harm,” according to the CQC.
Scienmag
FEBRUARY 21, 2022
Studies comparing animal genomes generally focus on the DNA sequence itself. A new study by researchers at the University of California, Davis shows how the three-dimensional scaffolding of chromosomes is related across several species of carnivores, offering a new approach of “comparative scaffotyping” that could be used to identify related genes across species and place […].
pharmaphorum
FEBRUARY 21, 2022
Eli Lilly has reported phase 3 results with its ulcerative colitis challenger mirikizumab, as it waits for the readout of a second trial in the coming weeks that will allow it to file for regulatory approvals. The new data comes from the 1,162-subject LUCENT-1 trial – first unveiled last year – which compared induction treatment with the anti-IL-23p19 antibody to placebo in patients with moderately-to-severely active ulcerative colitis who had not tried a biologic therapy before.
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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
FEBRUARY 21, 2022
Roughly 35 million years ago, Earth cooled rapidly. At roughly the same time, the Drake Passage formed between South America and the Antarctic, paving the way for the Antarctic Circumpolar Current. Thanks to these two factors, Antarctica was soon completely covered in ice. As a study from the Alfred Wegener Institute now shows, this massive […].
Outsourcing Pharma
FEBRUARY 21, 2022
On February 23, five days ahead of the day of rare-disease awareness, OSPâs Rare and Orphan Diseases webinar will share insights from top industry experts.
Scienmag
FEBRUARY 21, 2022
HOUSTON ? Researchers at The University of Texas MD Anderson Cancer Center have developed a new radio-labeled molecule capable of selectively reacting with certain high-energy radicals that are characteristic of innate immune activity, which may allow a non-invasive approach to monitor inflammation in real time by positron emission tomography (PET) imaging.
The Pharma Data
FEBRUARY 21, 2022
Joint WHO/ILO. The World Health Organization (WHO) and The International Labour Organization (ILO) have published a new guide on developing and implementing stronger occupational health and safety programmes for health workers, as the COVID-19 pandemic continues to exert great pressure on them. “Even before the COVID-19 pandemic, the health sector was among the most hazardous sectors to work in,” said Dr Maria Neira, Director, Department of Environment, Climate Change and Health, WHO.
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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
FEBRUARY 21, 2022
CHAMPAIGN, Ill. — Embryonic stem cells and other pluripotent cells divide rapidly and have the capacity to become nearly any cell type in the body. Scientists have long sought to understand the signals that prompt stem cells to switch off pluripotency and adopt their final functional state. Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. […].
The Pharma Data
FEBRUARY 21, 2022
First HER2-low metastatic breast cancer Phase III results for AstraZeneca and Daiichi Sankyo’s Enhertu offer potential to redefine how the disease is classified and treated. Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast
Scienmag
FEBRUARY 21, 2022
According to the Global Burden of Disease study, neurological disorders are the leading cause of disability and the second leading cause of death after heart disease. Malfunctions in pentameric ligand-gated ion channels (pLGICs) have been linked to many of these conditions including Alzheimer’s and Parkinson’s diseases, epilepsy, anxiety disorders, pain, schizophrenia, atherosclerosis, diabetes, inflammatory bowel disease, […].
The Pharma Data
FEBRUARY 21, 2022
Robust pipeline with around 50 projects in clinical development / Cardiology portfolio poised for growth with launch products Kerendia™ (finerenone) and Verquvo™ (vericiguat) / Gearing up to become top-10 oncology company by 2030 with prostate cancer treatment Nubeqa™ (darolutamide) as a key driver for future growth / Expanding into the fast-evolving medical imaging AI market, building on leading expertise in radiology and medical understanding across various diseases / Leading portfolio and lon
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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
FEBRUARY 21, 2022
COLUMBUS, Ohio – A new study by researchers at The Ohio State University College of Medicine gives insight into what happens to the cardiovascular system of adolescents when they vape. In the mouse study, researchers found that vaping had a significant and long-term cardiovascular effect on adolescent males but not females. The results were published […].
Roots Analysis
FEBRUARY 21, 2022
Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. However, the conventional nucleotide library preparation process has several challenges, including requirement of huge amount of starting materials, inadequate throu
Scienmag
FEBRUARY 21, 2022
Researchers have created new materials that are very stretchable and extremely tough. Credit: Meixiang Wang, NC State University Researchers have created new materials that are very stretchable and extremely tough. “Materials that can be deformed, but that are difficult to break or tear, are desirable,” says Michael Dickey, co-corresponding author of a paper on the […].
BioPharma Reporter
FEBRUARY 21, 2022
Last week saw the WHO announce the first six countries that will receive the technology needed to produce mRNA vaccines on the African continent, as part of the global mRNA technology transfer hub project.
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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
FEBRUARY 21, 2022
Timing is key when treating developmental disorders. Blocking an overactive signaling pathway during the first five weeks of life prevents autism symptoms from ever developing in mice, according to new research published in JNeurosci. Credit: Gibson et al., JNeurosci 2021 Timing is key when treating developmental disorders. Blocking an overactive signaling pathway during the first […].
Outsourcing Pharma
FEBRUARY 21, 2022
The CRO is helping out on a project exploring the effects of the virus in children; other members of the research team include experts from Duke University.
Scienmag
FEBRUARY 21, 2022
Some people become seriously ill when infected with SARS-CoV-2 while others have only mild symptoms or no symptoms at all. In addition to risk factors such as advanced age and chronic diseases, like diabetes, our genetic heritage also contributes to our individual COVID-19 severity risk. Credit: Max Planck Institute for Evolutionary Anthropology Some people become […].
Outsourcing Pharma
FEBRUARY 21, 2022
The two companies, which have been collaborating for 15 years, reportedly will focus on elevating decentralized trial solutions to develop new therapies.
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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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