Bio Pharma Dive
FEBRUARY 23, 2022
Jeffrey Marrazzo has led Spark since its founding in 2013, through the historic FDA approval of Luxturna and the company's $4.3 billion buyout by Roche.
pharmaphorum
FEBRUARY 23, 2022
Takeda has forged another alliance as it continues a push into gene therapy, agreeing a deal worth up to $2 billion with Code Biotherapeutics for opt-in rights to four candidates for rare diseases. The Japanese drugmaker will get access to Code Bio’s 3DNA non-viral genetic medicine delivery platform, initially for a liver-directed programme, and is also interested in deploying the technology for central nervous system disorders.
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Bio Pharma Dive
FEBRUARY 23, 2022
The companies' vaccine provided strong protection against severe illness in a large clinical trial, a long awaited result that could position it as a booster for people who have received other shots.
XTalks
FEBRUARY 23, 2022
Cakes, cookies and brownies, among other confectionary delicacies, tend to be packed with the most common allergens, including cow’s milk, eggs and tree nuts. While we all deserve a treat, those with allergies can often be excluded from satisfying their sweet tooth without planning and forethought. That’s where Partake Foods comes in. . Founded in 2016 by Denise Woodard, Partake Foods was created out of necessity for allergen- and gluten-free cookies and baking mixes.
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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 23, 2022
Data from a Phase 3 trial showed Kodiak's experimental treatment didn't match up to Eylea in wet AMD, spurring questions from analysts about its potential.
pharmaphorum
FEBRUARY 23, 2022
Nothing quite compares to the level of solace patients find in connecting with others who share similar health experiences. These interactions have become so fundamental to people living with chronic conditions that a recent Health Union survey of 2,371 patients revealed 95% use online social resources for health reasons. In 2022, social health – the dynamic, real-time actions people take to find meaningful connections and share information throughout the health journey – is more relevant tha
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 23, 2022
Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. Ben Hargreaves takes a look at why uptake began slowly in both the EU and the US, and then began to accelerate to see biosimilars take a large portion of market share away from originator products.
Scienmag
FEBRUARY 23, 2022
Space travel can be agonizingly slow: For example, the New Horizons probe took almost 10 years to reach Pluto. Traveling to Proxima Centauri b, the closest habitable planet to Earth, would require thousands of years with even the biggest rockets. Now, researchers calculate in ACS’ Nano Letters that low-power lasers on Earth could launch and maneuver small […].
Pharma Times
FEBRUARY 23, 2022
New company Haleon will become standalone venture as GSK's strategy for the future unfolds
Scienmag
FEBRUARY 23, 2022
Researchers at the RIKEN Center for Sustainable Resource Science (CSRS) in Japan have developed a way to improve crop quality without needing to create special genetically modified plants. Rather that changing plant genomes, the new technique relies on a spray that introduces bioactive molecules into plant cells through their leaves. The new technology could be […].
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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
Clinical Trial Podcast
FEBRUARY 23, 2022
A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run. To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more, I invited our guest, Kristi Etchberger, on the show.
Scienmag
FEBRUARY 23, 2022
The rate of increase in serious allergic reactions to food among children has flattened since changes to Australian infant feeding guidelines, a new study has found. Credit: Kamran Aydinov The rate of increase in serious allergic reactions to food among children has flattened since changes to Australian infant feeding guidelines, a new study has found. […].
pharmaphorum
FEBRUARY 23, 2022
Manufacturing problems seem to have scuppered Mallinckrodt’s hopes of bringing the first approved drug to market in the US for hepatorenal syndrome (HRS), a life-threatening condition that causes scarring and fluid build-up in the kidney, at least for now. The FDA has issued a complete response letter to Mallinckrodt for terlipressin, on the grounds that the company had been forced to change its packaging and labelling manufacturing facility for the drug.
Scienmag
FEBRUARY 23, 2022
A chemical used in electric vehicle batteries could also give us carbon-free fuel for space flight, according to new UC Riverside research. Credit: NASA/Bill Ingalls A chemical used in electric vehicle batteries could also give us carbon-free fuel for space flight, according to new UC Riverside research. In addition to emission reductions, this chemical also […].
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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
FEBRUARY 23, 2022
Releasing data from both Phase 3 and booster trials, Sanofi and GSK have announced they will submit the results as the basis for regulatory applications for their COVID-19 vaccine.
Scienmag
FEBRUARY 23, 2022
An analysis of data from more than 11,000 older Japanese adults suggests that seniors who own a dog may be at lower risk of disability than those who have never been dog owners. Yu Taniguchi of the National Institute for Environmental Studies in Tsukuba, Japan, and colleagues present these findings in the open-access journal PLOS […].
The Pharma Data
FEBRUARY 23, 2022
New report details exploitative practices employed by $55 billion formula industry, compromising child nutrition, violating international commitments. More than half of parents and pregnant women (51 per cent) surveyed for a new WHO/UNICEF report say they have been targeted with marketing from formula milk companies, much of which is in breach of international standards on infant feeding practices.
Scienmag
FEBRUARY 23, 2022
Sexual harassment in secondary schools is pervasive: two in three teens (64.7 percent) surveyed in Scotland reported visual and verbal harassment, and one in three (34.3 percent) reported personally invasive behaviors, in the last three months. Students are uncertain about the acceptability of many behaviors, and some are normalized, according to the research, published in […].
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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.
The Pharma Data
FEBRUARY 23, 2022
Bangladesh, Indonesia, Pakistan, Serbia and Vietnam to receive mRNA technology from the technology transfer hub. The World Health Organization (WHO), the Republic of Korea and the WHO Academy today announced the establishment of a global biomanufacturing training hub that will serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments.
Scienmag
FEBRUARY 23, 2022
BIRMINGHAM, Ala. – University of Alabama at Birmingham researchers are calling for a wider study of racial differences in high blood pressure after finding two clinical measures that are significantly greater in Blacks with resistant hypertension, as compared to whites with resistant hypertension. Credit: UAB BIRMINGHAM, Ala. – University of Alabama at Birmingham researchers are […].
The Pharma Data
FEBRUARY 23, 2022
* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: * 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease * 57.9% efficacy against any symptomatic COVID-19 disease, in line with expect
Scienmag
FEBRUARY 23, 2022
Breast cancer is the second type of cancer with the highest mortality in women and around 30,000 cases are diagnosed in Spain every year. The most aggressive type, which accounts for approximately 15% of cases, is known as triple-negative. It was given this name because it does not have any of the therapeutic targets that […].
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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.
The Pharma Data
FEBRUARY 23, 2022
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVac TM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. populations: For persons who travel or move to TBE endemic areas: TBE vaccine is recommended for persons who are moving or traveling to a TBE-endemic area and will
Scienmag
FEBRUARY 23, 2022
Common traits of the species vulnerable to extinction identified in new analysis of mammals, birds and plants Credit: Jacob Plumb, Unsplash, CC0 ([link] Common traits of the species vulnerable to extinction identified in new analysis of mammals, birds and plants ### Article URL: [link] Article Title: Demographic and life history traits explain patterns in species […].
The Pharma Data
FEBRUARY 23, 2022
Autoimmune diseases are triggered when the immune system malfunctions and attacks the body’s own structures. Although there is not, as yet, any cure for such diseases, their progression can be slowed down by therapeutic measures. Researchers at MedUni Vienna’s Center for Physiology and Pharmacology have now discovered a central signaling pathway in immune cells that may help in the development of a new therapeutic approach.
Scienmag
FEBRUARY 23, 2022
Patients with both a high lipoprotein(a) and high coronary artery calcium score (CAC) face a more than 20% risk of heart attack or stroke over the following 10 years, according to findings from a multicenter study led by preventive cardiologists at UT Southwestern Medical Center. Credit: UT Southwestern Medical Center Patients with both a high lipoprotein(a) and […].
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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.
BioPharma Reporter
FEBRUARY 23, 2022
Semarion Ltd, a University of Cambridge spin-out company combining materials engineering and cell biology to tackle unmet drug screening needs, has just closed a Â2.14m (US$2.89m) seed funding round.
Scienmag
FEBRUARY 23, 2022
Scientists at UCL have developed a new technique that uses microscopic magnetic particles to remotely activate brain cells; researchers say the discovery in rats could potentially lead to the development of a new class of non-invasive therapies for neurological disorders. Credit: Yichao Yu and Mark Lythgoe at UCL Scientists at UCL have developed a new […].
Roots Analysis
FEBRUARY 23, 2022
NGS has emerged as an evolutionary technology in modern biotechnology and healthcare research, enabling researchers to develop a better understanding of the cause and consequences of disease. Over the past few years, several companies have started offering a diverse range of genome sequencing products and services using various second and third generation sequencing technologies.
Scienmag
FEBRUARY 23, 2022
Researchers from The University of Texas at Dallas and Oklahoma State University have developed an innovative terahertz imager microchip that can enable devices to detect and create images through obstacles that include fog, smoke, dust and snow. Credit: The University of Texas at Dallas Researchers from The University of Texas at Dallas and Oklahoma State […].
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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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