Bio Pharma Dive
DECEMBER 15, 2020
A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.
World of DTC Marketing
DECEMBER 15, 2020
SUMMARY: Deloitte predicts that the percentage of virtual video visits to doctors will rise to 5% globally in 2021, up from an estimated 1% in 2019. While 5% may not sound like much, consider that 8.5 billion doctor’s visits, worth a total of approximately US$500 billion. The most time-consuming task is to make an appointment with your doctor just to ask for a new Rx or an Rx renewal.
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Bio Pharma Dive
DECEMBER 15, 2020
The acquisition marks a significant bet by Lilly on gene therapy's potential to address tough-to-treat neurological disorders like Parkinson's disease.
Camargo
DECEMBER 15, 2020
Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. The product may be based on an elegant and compelling scientific premise, but if it does not provide a set of benefits that could change current behaviors, or if it is not accessible to patients, it might be best to consider alternatives.
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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
DECEMBER 15, 2020
The developer of "off the shelf" cell therapies has become the second company in two days to form a joint venture with Overland Pharmaceuticals, a new biotech aiming to bring innovative drugs to Asia.
Pharma Times
DECEMBER 15, 2020
A new report launched by Takeda has found that just 17% of UK adults surveyed felt their perception of pharma had improved based on the industry's response to COVID-19
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 15, 2020
After four people in the Pfizer-BioNTech's and three people in Moderna’s COVID-19 vaccine trials developed temporary facial weakness or paralysis, some people became concerned that it could happen to them. But experts suggest that the condition, known as Bell’s palsy, is fairly prevalent in the p.
NY Times
DECEMBER 15, 2020
The positive review likely ensures that the F.D.A. will grant emergency authorization for a second coronavirus vaccine this week for millions of Americans.
BioSpace
DECEMBER 15, 2020
The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.
NY Times
DECEMBER 15, 2020
The U.S., Britain, Canada and others are hedging their bets, reserving doses that far outnumber their populations, as many poorer nations struggle to secure enough.
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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
Pharma Times
DECEMBER 15, 2020
The trial is expected to begin next month, with first data anticipated in the second quarter of 2020
BioSpace
DECEMBER 15, 2020
A little more than one year after Gilead Sciences and Galapagos NV announced intentions to seek regulatory approval for Jyseleca (filgotinib) as a treatment for rheumatoid arthritis, the companies have pulled the plug on that goal.
BioPharma Reporter
DECEMBER 15, 2020
Following the announcement yesterday by the UKâs Health Secretary Matt Hancock that a new strain of SARS-COV-2 could be responsible for faster spread of the virus in the South East of England, Shore Capital analysts give their perspective on what is known about that to date.
BioSpace
DECEMBER 15, 2020
Novartis' Iptacopan isn’t the only drug to receive Breakthrough Therapy designation this week. Several other experimental treatments were also awarded the designation.
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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
DECEMBER 15, 2020
Syneos Health (Nasdaq:SYNH) has completed its previously announced acquisition of biopharma CRO Synteract. With the acquisition, Syneos will add to its burgeoning portfolio that makes it the only fully integrated biopharmaceutical solutions organization in the biotech and pharma space. As a full-service CRO serving the biopharma segment, Synteract will help complement and further Syneos’ goals of leading as a purpose-built organization committed to accelerating customer performance in the delive
BioSpace
DECEMBER 15, 2020
Detecting the presence of SARS-CoV-2 in asymptomatic individuals has been a challenge not even PCR – the gold standard of testing – can adequately address. Now two companies have developed novel solutions with the sensitivity and specificity needed to provide ample warning.
BioPharma Reporter
DECEMBER 15, 2020
The European Medicines Agency has brought forward a key meeting to assess the Pfizer/BioNTech COVID-19 vaccine: with its committee now convening a week earlier than scheduled.
BioSpace
DECEMBER 15, 2020
Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. BioSpace has captured some key efforts.
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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.
XTalks
DECEMBER 15, 2020
2020 has been a year full of unexpected events and changes for the food and beverage industry. Some challenges included supply chain disruptions due to country-wide lockdowns, shortages of various grocery products, bankruptcy and closures of our favorite local restaurants and moving from in-restaurant dining experiences to enjoying food flavors at home.
BioSpace
DECEMBER 15, 2020
Some semblance of a work-life balance is already a challenge to maintain, but doing so when you’re working and living in the same space takes effort and one (or more!) of these strategies.
Scienmag
DECEMBER 15, 2020
Credit: Tallinn University In the present world we are witnessing headlines which regularly chronicle technology-based issues such as security hacks, inappropriate or illegal surveillance, misuse of personal data, spread of misinformation, algorithmic bias, and lack of transparency. Siddharth Nakul Gulati finds these aspects about trust important: “Quite recently, elections in the US have sparked debate […].
pharmaphorum
DECEMBER 15, 2020
Graeme Duncan from ADVANZ PHARMA explores how successful cross-industry collaboration between pharma and generics companies has helped support supply challenges during the pandemic. While the world has had to come together to fight COVID-19, so too has the pharmaceutical industry in ensuring that essential medicines reach patients in need. Surges in demand have created challenges throughout the supply chain, from production line capacity to managing the shipment of products from one country to a
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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
DECEMBER 15, 2020
Sub-culture and supply fuel drug-related violence: study Credit: Flinders University A community or sub-culture encouraging young men’s exposure and obsession with guns – as well as ready access to firearms and drugs – can make gun violence ‘all too easy’, with Flinders University experts promoting a new direction on managing the global problem.
Pharma Times
DECEMBER 15, 2020
The Russian Direct Investment Fund has released a new analysis of data obtained 21 days after administering the first dose of the vaccine, showing efficacy of 91.
Scienmag
DECEMBER 15, 2020
New study suggests waters will become more turbulent as Arctic loses summertime ice. Credit: Courtesy of: Gianluca Meneghello Eddies are often seen as the weather of the ocean. Like large-scale circulations in the atmosphere, eddies swirl through the ocean as slow-moving sea cyclones, sweeping up nutrients and heat, and transporting them around the world.
BioSpace
DECEMBER 15, 2020
Novartis’ Entresto is well on its way to receiving approval as a treatment for heart failure patients following overwhelming support from a U.S. Food and Drug Administration (FDA) advisory committee.
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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
DECEMBER 15, 2020
Unusual conditions in 2018 analyzed to improve Arctic sea ice forecast Credit: Photo by Jun Inoue, National Institute of Polar Research, CC BY-SA. Experts in Japan recently discovered that atmospheric conditions near Alaska can affect sea ice conditions in the Arctic Ocean months later. The team used various data, including ship-based data from 2018, to […].
Pharma Times
DECEMBER 15, 2020
PHE says it is investigating more than a thousand cases of the new strain
Scienmag
DECEMBER 15, 2020
PNNL research explores how urban land and anthropogenic aerosols interact with and intensify thunderstorms Credit: (Photo by 12019 | Pixabay.com) RICHLAND, Wash.–Urban landscapes and human-made aerosols–particles suspended in the atmosphere–have the potential to not only make gusts stronger and hail larger; they can also start storms sooner and even pull them toward cities, according to […].
BioSpace
DECEMBER 15, 2020
vTv Therapeutics, based in High Point, North Carolina, announced that its Phase II Elevage study of azeliragon in mild Alzheimer’s disease and type 2 diabetes failed to hit its primary objective.
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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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