Bio Pharma Dive
JANUARY 5, 2022
The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech.
Pharma Times
JANUARY 5, 2022
The test is a technological first in determining the metastatic status of a cancer without using prior insight of the primary cancer presented.
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Bio Pharma Dive
JANUARY 5, 2022
The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug as well as mark the start of a price battle in oncology.
pharmaphorum
JANUARY 5, 2022
A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2.
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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
JANUARY 5, 2022
Inflation in 2021 may have offered drugmakers a catalyst for taking slightly bigger increases on a list price basis. But rebates to insurers are still keeping net price rises lower.
pharmaphorum
JANUARY 5, 2022
The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JANUARY 5, 2022
GlaxoSmithKline places shingles vaccine Shingrix is among its top prospects, with peak sales potential of almost $6 billion. Now, Pfizer and BioNTech are joining forces to try to grab a slice of the market. Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a vaccine for shingles based on the same technology platform through clinical development, with trials due to start later this year.
Scienmag
JANUARY 5, 2022
For seven consecutive years, the U.S. National Science Foundation (NSF) has collaborated with the Center for the Advancement of Science in Space, Inc. (CASIS), manager of the International Space Station (ISS) National Laboratory, for a research funding opportunity focused on transport phenomena and nanoscale interactions in low Earth orbit. This year’s joint solicitation will award up […].
pharmaphorum
JANUARY 5, 2022
The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Despite an estimated 9.25 billion doses administered globally by 4th January, with 25 different vaccines either approved for use or under emergency use authorisation , 2022 starts on a more sombre note due to the rise of the Omicron variant.
Scienmag
JANUARY 5, 2022
BIRMINGHAM, Ala. – Immunologists have long been baffled by LPS, the bacterial lipopolysaccharide that helps form the cell walls of Gram-negative bacteria. Credit: UAB BIRMINGHAM, Ala. – Immunologists have long been baffled by LPS, the bacterial lipopolysaccharide that helps form the cell walls of Gram-negative bacteria. Many experiments show that exposure to LPS during exposure […].
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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
Eye on FDA
JANUARY 5, 2022
FDA has scheduled the first advisory committee meetings of 2022. One meeting of the Oncologic Drugs Advisory Committee is set for February 10 to discuss a new application for the proposed treatment of Non-Small Cell Lung Cancer (NSCLC. And a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee is meeting jointly with the Drug Safety and Risk Management Advisory Committee on February 15 to consider an NDA in the pain category.
Scienmag
JANUARY 5, 2022
SAN FRANCISCO, CA—January 5, 2021—Over the past decade, the CRISPR genome-editing system has revolutionized molecular biology, giving scientists the ability to alter genes inside living cells for research or medical applications. Now, researchers at Gladstone Institutes have fine-tuned an additional system for more efficient gene editing, using molecules called retrons.
Pharma Times
JANUARY 5, 2022
Pressure on care and NHS staff mounts with the spread of the latest Omicron variant of COVID-19.
Scienmag
JANUARY 5, 2022
Johns Hopkins Medicine researchers have developed a color-coded test that quickly signals whether newly developed nanoparticles — ultra small compartments designed to ferry medicines, vaccines and other therapies — deliver their cargo into target cells. Historically, nanoparticles have a very low delivery rate to the cytosol, the inside compartment of cells, releasing only about 1%–2% […].
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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.
NY Times
JANUARY 5, 2022
Two of the three parties in Germany’s new governing coalition support legalization, a potentially radical shift in the conservative country.
Scienmag
JANUARY 5, 2022
Colonizing Mars is no longer solely the work of science fiction but a potential future option for people who desire to live among the weightless. For headline grabbers like Jeff Bezos, NASA and Elon Musk, space colonization — or space settlement, a preferred term recommended by Bill Nye — is a big goal for the 21st century. Credit: Sarah Pack Colonizing Mars […].
Pharma Marketing Network
JANUARY 5, 2022
Tune in to this episode of the Pharma Marketing Podcast to hear from our guest, Chris Wasden, Head of Pharma Specialty Solutions & Corporate Strategy at Happify Health and Jennifer Ginest, Digital Marketing Manager of PMN , discuss the current role of Digital Therapeutics in Healthcare and were it is headed.
Scienmag
JANUARY 5, 2022
WASHINGTON – U.S. Naval Research Laboratory researchers in the Chemistry Division apply their knowledge of biology in conjunction with materials to improve understanding of how cells and tissues organize and apply new methods to affect cell communication. Advanced understanding in this field may make it possible to develop wearable technology with real-time wound monitoring capability. […].
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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 Marketing Network
JANUARY 5, 2022
If your New Year’s Resolutions include finally cracking the code to deliver Next Best Actions for every HCP engagement, these experts have some advice. Embedding data-driven practices into your organization requires resilience, persistence, and organization-wide governance and commitment. With large global organizations, how do you move toward one shared vision when the business is scattered around the world?
Scienmag
JANUARY 5, 2022
Very few proteins in the body have a change that makes them unique compared to the corresponding proteins in Neanderthals and apes. Researchers at the Max Planck Institute for Evolutionary Anthropology in Germany and Karolinska Institutet in Sweden have now studied one such protein, glutathione reductase, which protects against oxidative stress. They show that the […].
FDA Law Blog
JANUARY 5, 2022
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director. Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the Orphan Drug Act, biosimilars, and the Orange Book.
Scienmag
JANUARY 5, 2022
In a new publication from Opto-Electronic Advances; DOI 10.29026/oea.2021.210076, the research groups of Professor Zhong-Qun Tian from Xiamen University, Xiamen, China and Professor Huigao Duan from Hunan University Changsha, China discuss nanobridged rhombic antennas supporting both dipolar and high-order plasmonic modes with spatially superimposed hotspots in the mid-infrared.
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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.
XTalks
JANUARY 5, 2022
In the first episode of 2022, Ayesha provided updates on Omicron and COVID-19 vaccine boosters. The FDA expanded authorization of booster doses of Pfizer/BioNTech’s COVID-19 vaccine to youth between 12 and 15 years of age, authorized a third primary dose for immunocompromised children between five and 11 years old and a shorter wait time to get a booster for individuals 12 and older.
Scienmag
JANUARY 5, 2022
Understanding the surges and retreats of Alaska’s Malaspina Glacier is key if climate change models are to be applied to the glacier with confidence. Work by graduate student Victor Devaux-Chupin at the University of Alaska Fairbanks Geophysical Institute is providing some answers. The Malaspina consists of three lobes, each fed by its own glacier. The […].
Pharma Marketing Network
JANUARY 5, 2022
If your New Year’s Resolutions include finally cracking the code to deliver Next Best Actions for every HCP engagement, these experts have some advice. Embedding data-driven practices into your organization requires resilience, persistence, and organization-wide governance and commitment. With large global organizations, how do you move toward one shared vision when the business is scattered around the world?
Scienmag
JANUARY 5, 2022
Osaka, Japan – Acute myeloid leukemia (AML) is a common type of blood cancer that has a relatively low survival rate. It is particularly deadly for patients suffering from refractory and relapsed AML (R/R AML), meaning their cancer has stopped responding to treatment and has returned after a period of remission. In a recently published […].
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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 Patent Watch
JANUARY 5, 2022
Annual Drug Patent Expirations for GIAPREZA Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for La Jolla drug GIAPREZA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JANUARY 5, 2022
LOUISVILLE, Ky. – Researchers from the University of Louisville School of Dentistry and their colleagues have discovered details of how proteins produced by oral epithelial cells protect humans against viruses entering the body through the mouth. They also found that oral bacteria can suppress the activity of these cells, increasing vulnerability to infection.
Olympian Clinical Research
JANUARY 5, 2022
When a loved one is diagnosed with Alzheimer’s disease , it can be challenging to know what to do or how to cope. You may first want to understand this degenerative disease so that you can best support your loved one after their Alzheimer’s diagnosis. What is Alzheimer’s Disease? . Alzheimer’s disease is a progressive brain disorder that causes a gradual decline of a person’s mental functions, resulting in memory loss and an inability to think clearly.
Scienmag
JANUARY 5, 2022
Researchers have found a way to make AI-generated voices, such as digital personal assistants, more expressive, with a minimum amount of training. The method, which translates text to speech, can also be applied to voices that were never part of the system’s training set. Credit: University of California San Diego Researchers have found a way […].
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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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