Bio Pharma Dive
JANUARY 25, 2022
The biotech raised the Series B round during "probably one of the worst biotech markets" emerging drugmakers have faced in some time, a Metagenomi executive told BioPharma Dive.
World of DTC Marketing
JANUARY 25, 2022
Clunky, costly, highly regulated health systems, often dominated by rent-seeking middlemen, are being shaken up by firms that target patients directly, meet them where they are—which is increasingly online—and give them more control over how to access care. Here is a summary of the article from The Economist. “Unicorns” are competing with incumbent healthcare companies and technology giants to make people better and prevent them from getting ill in the first place.
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Bio Pharma Dive
JANUARY 25, 2022
Despite sliding stock prices, biotechs aren't "on sale," J&J CFO Joe Wolk said Tuesday. "It's really hard to say whether there's been a capitulation, or a recognition, that values have come down.
Pharma Mirror
JANUARY 25, 2022
Waltham, Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma (“cSCC”).
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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 25, 2022
The trial, which will enroll nearly 1,500 people, could help determine whether a variant-specific shot is more effective than an additional booster of Pfizer's original vaccine.
Pharma Mirror
JANUARY 25, 2022
PRINCETON, N.J. and BANGALORE, India, Indegene, a technology-led healthcare solutions provider today announced it established new Global Development Centers in Mexico, Poland and Ukraine to enable life sciences organizations accelerate their digital transformation. The life sciences industry is witnessing tremendous change with a growing focus on personalization, transformation of go-to-market models, and rapid adoption of real-world data and evidence to improve health outcomes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JANUARY 25, 2022
The UCL study will evaluate the safety and effectiveness of MTL-CEBPA in combination with second line standard of care sorafenib versus the use of sorafenib in isolation
pharmaphorum
JANUARY 25, 2022
The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. To demonstrate how quickly the digital therapeutics space is developing, it is easiest to state that the first such therapy was approved in 2018 and since that point the annual investment in the space has more than doubled in the intervening years.
BioPharma Reporter
JANUARY 25, 2022
GlaxoSmithKline plc (GSK) says the US Food and Drug Administration (FDA) has approved its anti-IL-5 biologic Nucala (mepolizumab) in a 40 mg pre-filled syringe for children aged 6 to 11 years old with severe eosinophilic asthma (SEA).
pharmaphorum
JANUARY 25, 2022
Oskar Möbert, Vice President OpenData Europe at Veeva Systems, tells us how they are reimagining customer reference data to boost pharma rep productivity, enable more personalised engagement, and increase patient reach. The medical landscape is generally becoming more complex, both in terms of the range of stakeholders involved in patient care and the rapid explosion of engagement channels. “Our customers need to make decisions based on insights powered by a deep understanding of their tar
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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
Scienmag
JANUARY 25, 2022
In a new study, Empa researcher Dominik Brunner, together with colleagues from Utrecht University and the Austrian Central Institute for Meteorology and Geophysics, is investigating how much plastic is trickling down on us from the atmosphere. According to the study, some nanoplastics travel over 2000 kilometers through the air. According to the figures from the […].
pharmaphorum
JANUARY 25, 2022
The UK company behind a sleep mask that aims to treat sight-robbing complications of diabetes has secured $10 million in funding that will be used to run trials of the medical device. PolyPhotonix secured the money in a first-round financing led by Prevail InfoWorks, a company specialising in management of clinical trial data, with the cash injection due upon the start of a clinical trial in the US.
Outsourcing Pharma
JANUARY 25, 2022
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.
pharmaphorum
JANUARY 25, 2022
The FDA has limited the use of COVID-19 antibody therapies developed by Eli Lilly and Regeneron, on the back of data suggesting they have are “highly unlikely” to be effective against the now-dominant Omicron variant. The emergency use authorisations (EUAs) for Lilly’s bamlanivimab/etesevimab combination and Regeneron’s REGEN-COV (casirivimab and imdevimab) issued earlier on in the pandemic – when other variants were more common – has been revised to reflect the loss of e
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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.
BioPharma Reporter
JANUARY 25, 2022
Biotech EdiGene has announced an R&D collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology.
Pharma Times
JANUARY 25, 2022
Novartis UK has announced that the MHRA has given a positive scientific opinion for the investigational treatment, asciminib
Scienmag
JANUARY 25, 2022
Link to full release: Credit: Luther Davis/Alexey Merz/University of Washington Link to full release: [link] FROM: James Urton University of Washington 206-543-2580 jurton@uw.edu (NOTE: researcher contact information at end) For Immediate Release Jan. 25, 2022 Hungry yeast are tiny, living thermometers Membranes are crucial to our cells. Every cell in your body is enclosed by […].
Outsourcing Pharma
JANUARY 25, 2022
Am expert from the CRO discusses unique challenges associated with running clinical trials that stretch across national boarders and how to conquer them.
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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
JANUARY 25, 2022
It’s advice Logan Roy, the fictional patriarch from the TV program Succession, would not want to hear but must heed: family businesses must prepare the next generation or risk watching their businesses crumble. Credit: University of Ottawa It’s advice Logan Roy, the fictional patriarch from the TV program Succession, would not want to hear but […].
BioPharma Reporter
JANUARY 25, 2022
The construction of Yposkesiâs second facility is on track, the French CDMO has confirmed.
Scienmag
JANUARY 25, 2022
For governments and clean energy advocates looking to encourage people to use e-bikes for transportation, a new online tool from Portland State University researchers offers an overview of the existing incentive programs in the United States and Canada. Credit: Transportation Research and Education Center, Portland State University For governments and clean energy advocates looking to encourage people to use e-bikes for transportation, a new online […].
Drug Channels
JANUARY 25, 2022
Super Bowl LVI is on the horizon. Time for some blow-out beer commercials, occasionally interrupted by a football game. But who needs a Super Bowl party when you can tackle this month’s selection of notable news stories, intercepted for you from the Drug Channels gridiron: Offsides : A shocking update about the gross-to-net bubble for insulin Trick Play : OptumRx trolls us Fumble : High-deductible health plans foul out with patients Offensive Lines : The 340B program’s unstoppable growth Plus, t
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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
JANUARY 25, 2022
PULLMAN, Wash. – New research, led by Washington State University scientists, into how viral proteins interact and can be disabled holds promise to help plants defend themselves against viruses—and ultimately prevent crop losses. The study published in Frontiers in Plant Science found that viral proteins interact with each other to help a virus hijack its […].
pharmaphorum
JANUARY 25, 2022
What does the current picture of cardiovascular disease in Europe look like? Surprisingly for many, cardiovascular disease (CVD) is Europe’s leading cause of death – not cancer, as many people would assume. Last year, over 60 million people in the EU – more than the population of Italy – were living with CVD. While there has been some progress in understanding the prevention and treatment needs for CVD, it often does not receive the attention it duly deserves.
Scienmag
JANUARY 25, 2022
Amsterdam, January 19, 2022: The covid-19 pandemic still poses enormous social challenges. People with cognitive impairments (problems with, for example, memory and concentration) and dementia are doubly affected by this pandemic. On the one hand, they have direct risk of severe Covid-19 symptoms. And on the other hand, the restrictive measures hit them extra hard. […].
BioPharma Reporter
JANUARY 25, 2022
Pfizer and BioNTech expect to produce four billion doses of their COVID-19 vaccine in 2022: regardless of whether the current vaccine or a new Omicron specific vaccine is needed.
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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
JANUARY 25, 2022
DURHAM, N.C. — The Albemarle-Pamlico Peninsula covers more than 2,000 square miles on the North Carolina coastal plain, a vast expanse of forested swamps and tea-colored creeks. Many people would probably avoid this place, whose dense thickets of cane and shrubs and waterlogged soils can slow a hike to a crawl. Credit: Please credit Steve […].
ECRG Media's Clinical Research Podcast
JANUARY 25, 2022
When Clinical Research Sites Make You Mad 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 creati
Scienmag
JANUARY 25, 2022
A large study conducted in England found that, compared to the general population, people who had been hospitalized for COVID-19—and survived for at least one week after discharge—were more than twice as likely to die or be readmitted to the hospital in the next several months. Krishnan Bhaskaran and colleagues from the London School of […].
ECRG Media's Clinical Research Podcast
JANUARY 25, 2022
When Clinical Research Sites Make You Mad. 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.
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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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