Bio Pharma Dive
FEBRUARY 8, 2022
In documents released Tuesday, FDA staff gave a cool review to an immunotherapy developed by Eli Lilly and Innovent Biologics. An advisory meeting this week to review it could have broader implications for cancer drug development in the U.S.
World of DTC Marketing
FEBRUARY 8, 2022
According to the Lancet, a medical journal, the incidence of depression and anxiety has soared in the pandemic—by more than 25% globally in 2020. That, combined with more people using online services, has led to a boom in mental-health apps. But are they safe and effective? Now that big companies prioritize employees’ mental health, some apps work with them to help entire workforces.
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Bio Pharma Dive
FEBRUARY 8, 2022
The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5%.
NY Times
FEBRUARY 8, 2022
A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory.
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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
FEBRUARY 8, 2022
Sandrock's appointment to Verge Genomics' board of directors follows about a week after the executive took up a similar post with Voyager Therapeutics.
pharmaphorum
FEBRUARY 8, 2022
Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 8, 2022
Glasgow, UK (24th November, 2021) – Formedix , a leading provider of clinical trial software solutions, announces the launch of the Formedix ryze Community, to provide their customers with a location to collaborate, expand their knowledge and share information. Through a range of tools, the ryze Community will support the pharmaceutical industry to streamline and enhance clinical trial set-up and build.
BioPharma Reporter
FEBRUARY 8, 2022
WuXi Biologics Cayman Inc suspended trading of its Hong Kong shares today after its inclusion of two of its units on the US governmentâs so-called unverified list of exporters triggered a record selloff, noted financial media outlets.
pharmaphorum
FEBRUARY 8, 2022
Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. The massive windfall revenues will drive its sales up towards the $100 billion mark – it’s estimating a range of $98 to $102 billion – up from $81.3 billion in 2021, which was almost twice revenues in the prior year.
Outsourcing Pharma
FEBRUARY 8, 2022
The latest in the Diversity in Oncology series, taking place February 9, will discuss ways academia and community collaboration can narrow representation gaps.
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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
XTalks
FEBRUARY 8, 2022
For the US Food and Drug Administration (FDA), the new year brings along a new set of food safety tasks to tackle. The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) recently released a list of draft and final guidance topics that are a priority for the agency’s Foods Program to complete in 2022.
BioPharma Reporter
FEBRUARY 8, 2022
Pfizer forecasts $32bn in revenue for COVID-19 vaccine Comirnaty, and $22bn for oral COVID-19 treatment Paxlovid, in 2022.
Scienmag
FEBRUARY 8, 2022
Highlights Credit: Zhe Jia and AGU Highlights A 47 km-deep, magnitude 7.5 earthquake that struck the south Atlantic in 2021 and caused a global tsunami was actually a sequence of five earthquakes. A shallow, “almost invisible” magnitude 8.2 quake accounted for 70% of the energy released during the event. Global earthquake monitoring needs to improve […].
ProRelix Research
FEBRUARY 8, 2022
A lot has changed over the past few decades in the way clinical trials are conducted. Advances in data management systems, risk-based monitoring, pharmacovigilance, electronic databases, and application of complex […]. The post Clinical Trial Outsourcing and Management in USA appeared first on ProRelix Research.
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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 8, 2022
A long-term study in the Southern Ocean reveals a clear correlation between warming waters, decreased sea ice, and reduced abundance of Antarctic silverfish. These small, abundant fish are important prey for penguins, seals, and other regional marine life, in a role similar to that played by anchovies or sardines in more temperate waters. Credit: © […].
Pharma Times
FEBRUARY 8, 2022
NICE recommends appetite suppressing drug which can reduce a patient’s by more than 10%
Scienmag
FEBRUARY 8, 2022
Drugs which are commonly-used as the first line of treatment for colorectal cancer cause the tumour cells to oversecrete proteins known as mucins, according to a new study published today in the journal eLife. The proteins alter the mucous layer, forming a physical barrier that prevents drugs from reaching their intended target. Credit: Lluís Espinosa/IMIM […].
pharmaphorum
FEBRUARY 8, 2022
The rise in the use of decentralised clinical trial (DCTs) designs forced by COVID-19 looks set to outlast the pandemic, and digital health company Seqster has formed another partnership to tap into the shift from traditional site-based studies. The latest agreement is with contract research organisation United BioSource (UBC), which will use Seqster’s expertise in collecting and analysing data from electronic health records (EHRs), genomic studies, wearables, and other sources in remote t
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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 8, 2022
As we have experienced during the COVID pandemic, loneliness, or perceived social isolation, is a major stress for social animals and increases the risk of various mental and physical health issues such as depression, substance abuse, obesity, and premature death. In efforts to understand the neural basis for loneliness, Kansai Fukumitsu and others at the […].
Pharma Times
FEBRUARY 8, 2022
Greater urgency for kidney cancer treatments as 40% of UK patients wait 84 days for a diagnosis
Scienmag
FEBRUARY 8, 2022
The Breakthrough Agenda agreed at COP26 could help trigger positive tipping points to tackle the climate crisis, researchers say. Credit: John Ambler The Breakthrough Agenda agreed at COP26 could help trigger positive tipping points to tackle the climate crisis, researchers say. At the summit in Glasgow, leaders of countries covering 70% of world GDP pledged […].
Clairnes
FEBRUARY 8, 2022
The post Tackling barriers to diversity, equity, and inclusion in clinical trials appeared first on Clinical Trial Recruitment & Management Services.
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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 8, 2022
For the first time, researchers have found a cost-effective and convenient way to apply a silver-based antimicrobial clear coating to new or existing textiles. Their method uses polyphenols, commonly found in food items notorious for staining clothes such as wine and chocolate. A range of textile types can be treated by the researchers’ method, and […].
pharmaphorum
FEBRUARY 8, 2022
Covid-19 has lit a fire under the medical industry, driving them to re-evaluate and incorporate digital engagement models. Now, healthcare companies have a unique opportunity to continue this momentum beyond the pandemic bubble as Healthware Group CEO Roberto Ascione tells Dr Paul Tunnah at the 2021 Frontiers Health conference in Milan. Digital health has undergone a dramatic transformation over the past few years.
Scienmag
FEBRUARY 8, 2022
KNOXVILLE, Tenn. – For the last two years, Extension specialists with the University of Tennessee Institute of Agriculture have led the USDA’s Southeast Dairy Business Innovation Initiatives (SDBII) program across Tennessee, Kentucky, and North Carolina. A new round of funding is expanding the program’s reach to all 12 southeastern states, including Kentucky, Tennessee and North […].
pharmaphorum
FEBRUARY 8, 2022
An oral drug developed by RedHill Biopharma has reduced mortality in severe COVID-19 patients when added to therapy with corticosteroids and Gilead Science’s intravenous antiviral Veklury, setting up regulatory filings. The phase 2/3 trial also showed that opaganib – an oral sphingosine kinase-2 (SK2) inhibitor – improved survival by 70% by day 42 compared to placebo when given on top of standard care, and improved the chances of recovery at day 14 by a third, from 27.9% to 37.4%.
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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 8, 2022
New research reveals that items in litter typically originate less than two miles from where they’re found — and unless humans remove them, most of these items will never leave the environment. Credit: Win Cowger/UCR New research reveals that items in litter typically originate less than two miles from where they’re found — and unless […].
Drug Channels
FEBRUARY 8, 2022
More than four years ago, I warned about the emerging trend of copay accumulators and outlined the costly consequences for patients. The latest data reveal that copay accumulator adjustment programs are now in the word list for a growing share of pharmacy benefit designs. What’s more, adoption of copay maximizers now exceeds that of copay accumulators.
Scienmag
FEBRUARY 8, 2022
High-resolution 3D study of pine pollen reveals nanofoams are key to surviving mass extinctions Credit: ESRF/Stef Candé High-resolution 3D study of pine pollen reveals nanofoams are key to surviving mass extinctions Scientists from the Natural History Museum, London (United Kingdom), and the ESRF, the European Synchrotron, Grenoble (France), have found that some pollen has survived […].
ECRG Media's Clinical Research Podcast
FEBRUARY 8, 2022
Should CRAs Have Sky Club Access Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short is a content creating conglo
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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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