Bio Pharma Dive
JULY 8, 2022
The biotech detailed the process that led to its take-private offer last month, aiming to win the support of shareholders, including two firms that have pushed for change.
Pharmaceutical Technology
JULY 8, 2022
Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The treatment is indicated as extended adjuvant treatment for adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.
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Bio Pharma Dive
JULY 8, 2022
While AbbVie is bailing on one of the two programs it paid Alector $205 million to acquire five years ago, work will continue on the second project. That drug, however, has shown safety signals.
Pharmaceutical Technology
JULY 8, 2022
Swedish Orphan Biovitrum AB (Sobi) has signed an exclusive licence agreement with ADC Therapeutics to develop and market Zynlonta (loncastuximab tesirine) for hematologic and solid tumour indications in Europe and mostinternational markets, for up to $435m. The deal, however, excludes the US, Greater China, Singapore and Japan. Zynlonta is a CD19-directed antibody-drug conjugate (ADC).
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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
JULY 8, 2022
The alliance comes on the heels of a change in leadership at ADC and will help ready the biotech to launch its lymphoma drug in Europe.
Pharmaceutical Technology
JULY 8, 2022
Over recent years, bispecific T-cell engagers (BiTEs) have attracted significant attention for their potential in treating a plethora of haematological and solid tumours by enhancing the anti-tumour responses of endogenous T-cells. BiTEs are a relatively nascent modality and have yet to benefit from the identification of robust biomarkers and novel combination approaches, such as in combination with anti-CD20 therapies, with the view to attenuate malignant B-cell survival and enhance clinical re
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 8, 2022
Europe was the fastest growing region for cloud hiring among pharmaceutical industry companies in the three months ending April. The number of roles in Europe made up 16.2% of total cloud jobs - up from 13.6% in the same quarter last year. That was followed by North America, which saw a 0.3 year-on-year percentage point change in cloud roles. The figures are compiled by GlobalData, who track the number of new job postings from key companies in various sectors over time.
ACRP blog
JULY 8, 2022
A recent survey by the Joint Task Force for Clinical Trial Competency (JTF) and the Multi-Regional Clinical Trials Center (MRCT) found that, for every domain in the JTF Competency Framework, clinical research professionals who were certified through either the Association of Clinical Research Professionals (ACRP) or SoCRA expressed much higher levels of self-assessed competency than did individuals without professional certification.
Pharmaceutical Technology
JULY 8, 2022
Digitalization related jobs that were closed during Q1 2022 had been online for an average of 34 days when they were taken offline. This was an increase compared to the equivalent figure a year earlier, indicating that the required skillset for these roles has become harder to find in the past year. Digitalization is one of the topics that GlobalData, our parent company and from whom the data for this article is taken, have identified as being a key disruptive technology force facing companies i
Antidote
JULY 8, 2022
When you head to the pharmacy to pick up medicine, you likely aren’t thinking about all the steps it had to take to get into your hands — but did you know that on average, it takes about ten years for a new medication to make it to market ? This includes the six to seven years that the medicine will go through clinical trial phases, plus a few others that we’ll discuss below.
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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
Pharmaceutical Technology
JULY 8, 2022
Xenetic Biosciences and Catalent Pharma Solutions have signed an agreement for the cGMP manufacturing of the Xenetic’s recombinant protein, Human DNase I. Under the deal, Catalent will use its biomanufacturing capabilities in Madison, Wisconsin to advance Xenetic’s DNase clinical development programme and progress it to first-in-human studies. The interventional DNase based oncology platform of Xenetic is intended to boost outcomes of current therapies, including immunotherapies.
XTalks
JULY 8, 2022
The US Food and Drug Administration (FDA) has issued a warning for Secura Bio’s Copiktra (duvelisib) after a clinical trial found the drug was associated with a higher risk of serious side effects including a “possible” increased risk of death. The trial found Copiktra was associated with a higher risk of infections, diarrhea, inflammation of the intestines and lungs, skin reactions and high liver enzyme levels in the blood.
Pharmaceutical Technology
JULY 8, 2022
In the first half of 2022 the number of deals relating to regenerative medicine decreased significantly by 40% from the same period in 2021. This marks a deceleration in growth from the 27.6% decrease in deals that occurred in H2 2021 relative to the same period a year earlier. GlobalData's deals database looks at mergers, acquisitions and venture capital and private equity investments taking place daily between thousands of companies across the world.
Scienmag
JULY 8, 2022
ATLANTA—A new universal flu vaccine protects against influenza B viruses, offering broad defense against different strains and improved immune protection, according to a new study by researchers in the Institute for Biomedical Sciences at Georgia State University. Credit: Georgia State University ATLANTA—A new universal flu vaccine protects against influenza B viruses, offering broad defense against different strains and improved […].
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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.
Pharma Times
JULY 8, 2022
The therapy will be used for specific muscle invasive urothelial cancer patients
Scienmag
JULY 8, 2022
Our visual perception of the world is often thought of as relatively stable. However, like all of our cognitive functions, visual processing is shaped by our experiences. During both development and adulthood, learning can alter visual perception. For example, improved visual discrimination of similar patterns is a learned skill critical for reading.
pharmaphorum
JULY 8, 2022
The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Preliminary research suggests that hybrid DCTs can reduce trial timing and resources , improve patient-centricity and patient engagement , and expand access and recruitment and increase diversity , mitigate bias, and re
Scienmag
JULY 8, 2022
East Hanover, NJ – July 8, 2022 – Employment increased slightly from May to June for people with disabilities, reaching an all-time high. The monthly increase in the labor force participation rate for people with disabilities may reflect their need for additional income because of inflation, according to today’s National Trends in Disability Employment – […].
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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.
Pharma Times
JULY 8, 2022
Preclinical data package details pharmacology and safety of VMX-C001
Scienmag
JULY 8, 2022
Data centers — dedicated spaces for storing, processing and disseminating data — enable everything from cloud computing to video streaming. In the process, they consume a large amount of energy transferring data back and forth inside the center. With demand for data growing exponentially, there is increasing pressure for data centers to become more energy […].
Pharmaceutical Commerce
JULY 8, 2022
How did the industry get here and what alternatives can be sought out?
Scienmag
JULY 8, 2022
Swans give up resting time to fight over the best feeding spots, new research shows. Credit: Paul Rose Swans give up resting time to fight over the best feeding spots, new research shows. Scientists studied the behaviour of mute and whooper swans, to see how they used their time and energy. Watching four key behaviours […].
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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.
Drug Discovery World
JULY 8, 2022
A Covid-19 lawsuit, a heart attack treatment developed using spider venom and a collaboration to fight antimicrobial resistance (AMR) are some of the theme’s of this week’s news round-up. . News round-up by DDW’s Reece Armstrong for 4 – 8 July. CureVac lawsuit against BioNTech over Covid-19 vaccine technology. Biopharmaceutical company CureVac has filed a lawsuit against BioNTech SE and two of its subsidiaries in relation to an alleged infringement of the company’s portfolio used in
Scienmag
JULY 8, 2022
Researchers at the University of Southampton have gained unprecedented new insight into the key properties of an antibody needed to fight off cancer. The interdisciplinary study, published in Science Immunology, revealed how changing the flexibility of the antibody could stimulate a stronger immune response. The findings have enabled the Southampton team to design antibodies to […].
Drug Discovery World
JULY 8, 2022
GSK’s annual Palio meeting is taking place with a focus on how preventative approaches to disease can help mitigate climate change. . GSK’s ‘Vaccines for a sustainable planet’ meeting is gathering 65 experts across immunology, vaccinology, epidemiology, and policy throughout 7-8 July. . The meeting will include a range of plenary sessions and working group discussions that cover topics on how vaccines can mitigate the effects of environmental change; vaccine development to prevent human-animal
Scienmag
JULY 8, 2022
Scientists have identified more than 1,500 genetic differences between migratory and non-migratory hoverflies. Credit: Will Hawkes Scientists have identified more than 1,500 genetic differences between migratory and non-migratory hoverflies. A team led by the University of Exeter captured migrating insects as they flew through a mountain pass, and sequenced active genes to identify which determine […].
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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.
Drug Discovery World
JULY 8, 2022
Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. . Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. . Immutep is looking to use IMP761 to address the root cause of autoimmune disease through its function to silence autoimmune memory T cells that accumulate at the diseas
Scienmag
JULY 8, 2022
Billions of people, in developed and developing nations, benefit daily from the use of wild species for food, energy, materials, medicine, recreation, inspiration and many other vital contributions to human well-being. The accelerating global biodiversity crisis, with a million species of plants and animals facing extinction, threatens these contributions to people.
Drug Discovery World
JULY 8, 2022
? Work has started on the first wholly speculative development of new multi-let laboratory and office space at Cambridge Biomedical Campus in the UK, which is specifically targeting a range of growing biotech and life science businesses. . The new building will form part of the campus’ growing ecosystem of clinical, academic, and commercial excellence and will provide a range of laboratory and office space. .
Scienmag
JULY 8, 2022
For centuries, people have been using mindfulness meditation to try to relieve their pain, but neuroscientists have only recently been able to test if and how this actually works. In the latest of these efforts, researchers at University of California San Diego School of Medicine measured the effects of mindfulness on pain perception and brain […].
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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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