Bio Pharma Dive
NOVEMBER 2, 2020
While small in size, the collaboration gives AstraZeneca an entry point into radiopharmaceutical drug research, which was the focus of two Novartis buyouts in recent years.
pharmaphorum
NOVEMBER 2, 2020
The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.
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Bio Pharma Dive
NOVEMBER 2, 2020
The Dutch biotech labored for years developing a better stem cell transplant until 2019, when it switched focus to cancer-fighting cell therapies.
pharmaphorum
NOVEMBER 2, 2020
The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning. With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.
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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
NOVEMBER 2, 2020
The company hasn't determined whether its drug played a role in the deaths, but concerns over the treatment's safety could dim its chances for approval.
BioSpace
NOVEMBER 2, 2020
Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 2, 2020
Additional findings from Biogen’s Phase II LILAC study, announced today, show the company’s lupus drug candidate BIIB059 is superior to placebo for reducing joint disease activity in patients with systemic lupus erythematosus.
Scienmag
NOVEMBER 2, 2020
Credit: Micah Freedman, UC Davis North America’s beloved Monarch butterflies are known for their annual, multi-generation migrations in which individual insects can fly for thousands of miles. But Monarchs have also settled in some locations where their favorite food plants grow year round, so they no longer need to migrate. Micah Freedman, a graduate student […].
BioSpace
NOVEMBER 2, 2020
The life sciences industry is one of the fastest growing in the world. BioSpace provides a rundown of companies announcing facility and job expansions across the U.S. and beyond.
Pharma Times
NOVEMBER 2, 2020
Zejula is the first PARP inhibitor to be approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status
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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
BioPharma Reporter
NOVEMBER 2, 2020
A new multi-stakeholder group of experts has been set up to provide input and ideas in the context of the ongoing evaluation of the orphan medicinal products (OMP) regulation in Europe.
XTalks
NOVEMBER 2, 2020
The US Food and Drug Administration (FDA) recently announced the launch of a pilot program to assess whether services provided by third-party food safety auditors align with the requirements set out by the Food Safety Modernization Act (FSMA). The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety.
pharmaphorum
NOVEMBER 2, 2020
It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner, helping to reduce review time and facilitating cross-study analysis. Another content standard, the Analysis Data Model (ADaM), aims to perform a similar function for analysis datasets.
BioSpace
NOVEMBER 2, 2020
GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States.
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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.
XTalks
NOVEMBER 2, 2020
Fast food brands, such as Burger King, Tim Hortons and Popeyes, are planning on modernizing the drive-thru experience in more than 10,000 North American restaurants by 2022. The new technology will provide consumers with powerful predictive selling technology, integration with loyalty programs and contactless payment to support a more modern and efficient guest experience. “Our guests have sought out our drive-thru lanes for our iconic food and beverages throughout the COVID-19 pandemic –
pharmaphorum
NOVEMBER 2, 2020
Sanofi is to acquire Kiadis, a biotech specialising in therapies based around ‘off the shelf’ natural killer (NK) cells, for 308 million euros ($353 million). The French pharma is buying Kiadis for 5.45 euros per share in cash, an offer price representing a premium of 272% over the biotech’s closing price on Friday evening on Amsterdam’s Euronext market.
Scienmag
NOVEMBER 2, 2020
Credit: Mary Ann Liebert, Inc., publishers New Rochelle, NY, November 2, 2020–Cohen Veterans Bioscience (CVB), the Center for Biomedical Research Transparency (CBMRT), and Mary Ann Liebert, Inc., publishers, in their continued efforts to advance the publication of research with negative findings, announced today the launch of Neurotrauma Reports Null Hypothesis at the 10th Annual Traumatic […].
Pharma Times
NOVEMBER 2, 2020
The move gives the French drug giant access to Kiadis' natural killer cell technology platform
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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
NOVEMBER 2, 2020
Credit: Professor Luning Liu Researchers at the University of Liverpool have unlocked new possibilities for the future development of sustainable, clean bioenergy. The study, published in Nature Communications, shows how bacterial protein ‘cages’ can be reprogrammed as nanoscale bioreactors for hydrogen production. The carboxysome is a specialised bacterial organelle that encapsulates the essential CO2-fixing enzyme […].
BioSpace
NOVEMBER 2, 2020
Aptevo is a clinical-stage biotech company developing novel therapeutics built on its proprietary platform ADAPTIR™technology which is modular and includes bispecific molecules that recognize and bind to two unique target antigens simultaneously.
Scienmag
NOVEMBER 2, 2020
New research reports on discovery of 5-million-year-old honey badger-like animal from West Coast of South Africa Credit: Picture: Romala Govender Five million years ago, dangerous carnivores – such as giant wolverines and otters, bears, sabertooth cats, and large hyaenids – prowled the West Coast of South Africa. Today we can confirm that, among them, fearlessly […].
BioPharma Reporter
NOVEMBER 2, 2020
PerkinElmer will acquire UK cell engineering company Horizon Discovery, expanding its portfolio with gene editing and gene modulation tools.
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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
NOVEMBER 2, 2020
Credit: Takaki Maekawa Although profoundly different in terms of physiology, habitat and nutritional needs, plants and animals are confronted with one shared existential problem: how to keep themselves safe in the face of constant exposure to harmful microorganisms. Mounting evidence suggests that plants and animals have independently evolved similar receptors that sense pathogen molecules and […].
Drug Patent Watch
NOVEMBER 2, 2020
Annual Drug Patent Expirations for QVAR+REDIHALER Qvar Redihaler is a drug marketed by Norton Waterford and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for Norton Waterford drug QVAR REDIHALER appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
NOVEMBER 2, 2020
Mathematical modeling of electro-mechanical processes in neurons to assist the treatment of epilepsy and chronic depression by focused ultrasound Credit: Peter the Great St.Petersburg Polytechnic University Russian and British scientists study the approaches to mathematical modeling of electromechanical processes in neurons of the brain. Researchers from Peter the Great St.Petersburg Polytechnic University (SPbPU) in collaboration […].
BioSpace
NOVEMBER 2, 2020
The company announced positive topline results in its Phase III study of Xpovio (selinexor) in patients with advanced unresectable dedifferentiated liposarcoma, which sets up potential approval in this indication.
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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
NOVEMBER 2, 2020
Credit: David Albinsson/Chalmers University of Technology Are you affected by your neighbours? So are nanoparticles in catalysts. New research from Chalmers University of Technology, Sweden, published in the journals Science Advances and Nature Communications, reveals how the nearest neighbours determine how well nanoparticles work in a catalyst. “The long-term goal of the research is to […].
BioSpace
NOVEMBER 2, 2020
A new study suggests that pancreatic cancer cells avoid starvation by signaling to nerves. This encourages them to grow into dense tumors and release the nutrients the cells need to survive.
Scienmag
NOVEMBER 2, 2020
Credit: University of Texas at Austin AUSTIN, Texas — A new type of soil created by engineers at The University of Texas at Austin can pull water from the air and distribute it to plants, potentially expanding the map of farmable land around the globe to previously inhospitable places and reducing water use in agriculture […].
Pharma Times
NOVEMBER 2, 2020
The oral, once-daily therapy is designed to prevent attacks and reduce burden of therapy
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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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