Bio Pharma Dive
MARCH 3, 2021
A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases, including Dravet syndrome and Lennox Gastaut syndrome.
World of DTC Marketing
MARCH 3, 2021
SUMMARY: According to Pew Internet “Despite antibiotics’ vital role in cancer care, companies have abandoned their development in favor of more profitable drugs. A pull strategy is needed with financial incentives to repair the broken market for antibiotics and make it worthwhile for the pharma industry to bring promising drugs to market. Drug resistance is a silent threat that could end up killing as many as 10m people in 2050.
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Bio Pharma Dive
MARCH 3, 2021
The NIH stopped enrolling patients hospitalized with coronavirus disease into a study of Vir's antibody drug after data monitors questioned its effectiveness.
BioPharma Reporter
MARCH 3, 2021
The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could they be applied to vaccine development in the future?
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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
MARCH 3, 2021
The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss. Safety concerns have diminished the drug's prospects in arthritis, however.
pharmaphorum
MARCH 3, 2021
Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks. The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation. Following an upbeat Q4 results announcement CEO Stanley Erck told CNBC that discussions with the FDA are ongoing but the hope is that the regulator will accept t
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MARCH 3, 2021
Rare disease families need to stand up and be counted if they want things to change said mum and advocate Christine Waggoner. She spoke to pharmaphorum as part of our Patients Insights series. Like many “rare disease mums”, Christine is an accidental advocate. After her daughter, Iris, was diagnosed with a rare disease at five, friends, family, and strangers donated so much to a research fund-raising campaign that she had to set up a non-profit to deal with it all.
BioSpace
MARCH 3, 2021
Shares of Five Prime Therapeutics were soaring this morning after Amgen announced it was acquiring the company and its Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion in cash.
pharmaphorum
MARCH 3, 2021
ISA Pharmaceuticals is planning to take its COVID-19 immunotherapy into the clinic, aiming to harness the power of T-cells to prevent the disease from becoming serious in infected patients. Based in Leiden, the Netherlands, ISA said it has completed preclinical work on ISA106 and is planning clinical trials with a phase 1 dose-finding study in healthy volunteers due in the next few months.
Scienmag
MARCH 3, 2021
Government of Canada’s COVID-19 Immunity Task Force funds $3.5 million University of Ottawa, Bruyère collaboration to research the immune response to vaccines Credit: University of Ottawa Long-term care facilities have been disproportionately burdened by COVID-19, accounting for about 60% of COVID-19 deaths nationwide, 70% if retirement homes are included.
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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
MARCH 3, 2021
The European Medicines Agency (EMA) has published guidance outlining the regulatory requirements for manufacturers planning to modify their COVID-19 vaccines against SARS-CoV-2 variants.
Scienmag
MARCH 3, 2021
Traffic significantly underestimated as cause of nitrogen oxide pollution in cities Credit: University of Innsbruck The far-reaching mobility restrictions at the beginning of the Corona pandemic in March 2020 created a unique situation for atmospheric sciences: “During the 2020 lockdown, we were able to directly investigate the actual effects of drastic traffic restrictions on the […].
BioSpace
MARCH 3, 2021
A career in regulatory affairs combines knowledge of law, science, economics and more. Those who follow this biotech career path aren't necessarily scientists, but they do need to understand the science behind the products that they need to regulate.
Scienmag
MARCH 3, 2021
A seemingly small difference in global warming levels could greatly impact wildfires worldwide, researchers have found Credit: Pexels Under the 2015 Paris Agreement, the United Nations Framework Convention on Climate Change agreed to pursue efforts to limit the temperature increase to 2.0°C and, ideally, to 1.5°C, over preindustrial levels. However, even before that treaty was […].
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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.
BioSpace
MARCH 3, 2021
Are you currently working full time and in school earning a master’s degree? If so, do you think you are giving the appropriate amount of time to your job, studies and personal life?
Scienmag
MARCH 3, 2021
Credit: National Park Service To investigate humans’ impact on freshwater resources, scientists have now conducted the first global accounting of fluctuating water levels in Earth’s lakes and reservoirs – including ones previously too small to measure from space. The research, published March 3 in the journal Nature, relied on NASA’s Ice, Cloud and land Elevation […].
BioSpace
MARCH 3, 2021
Biogen plans to build a new gene therapy manufacturing plant in Research Triangle Park, North Carolina. The site is on the company’s manufacturing campus.
Scienmag
MARCH 3, 2021
Credit: Image by Chenggong Wang, Program in Atmospheric and Oceanic Sciences, Princeton University A recent analysis of the latest generation of climate models — known as a CMIP6 — provides a cautionary tale on interpreting climate simulations as scientists develop more sensitive and sophisticated projections of how the Earth will respond to increasing levels of […].
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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.
Pharma Marketing Network
MARCH 3, 2021
We’ve talked before about how COVID-19 has upended our personal and business lives, and how the pharma industry was able to – impressively – shift gears to meet the challenges the pandemic brought. But what about patients? And what about the disrupted patient journey? What can our industry do to ensure patients maintain continuity of care at a time when good health is imperative?
Scienmag
MARCH 3, 2021
Credit: Sinai Health A robotics platform designed by Toronto researchers to screen thousands of COVID-19 samples at once has the potential to revolutionize how labs track the spread of viruses and other pathogens, according to new findings. The study, out Wednesday in Nature Communications, found that the next-generation, ultra-high-throughput sequencing platform, called C19-SPAR-Seq, designed by […].
XTalks
MARCH 3, 2021
For the first time in its 90-year history of being on store shelves, Reese’s has launched an all-peanut-butter version of their famous Reese’s Peanut Butter cups. The new product is called the Ultimate Peanut Butter Lovers Cups and is available nationwide for a limited time only. In 1963, The Hershey Chocolate Company acquired H.B. Reese Candy Company for $23.5 million.
Scienmag
MARCH 3, 2021
The source of potentially hazardous solar particles, released from the Sun at high speed during storms in its outer atmosphere, has been located for the first time by researchers at UCL and George Mason University, Virginia, USA. Credit: Source: NASA Goddard Space Flight Center Credit: NASA/GSFC/SDO The source of potentially hazardous solar particles, released from […].
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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.
BioSpace
MARCH 3, 2021
Lilly’s tirzepatide has been proposed as a potentially effective treatment option that may rival the efficacy of semaglutide.
Scienmag
MARCH 3, 2021
Credit: University of Pittsburgh PITTSBURGH, March 3, 2021 – Women who experience an accelerated accumulation of abdominal fat during menopause are at greater risk of heart disease, even if their weight stays steady, according to a University of Pittsburgh Graduate School of Public Health-led analysis published today in the journal Menopause. The study–based on a […].
BioSpace
MARCH 3, 2021
KemPharm announced this week that the U.S. Food and Drug Administration has approved its novel ADHD drug for use in patients six years and older.
Scienmag
MARCH 3, 2021
Credit: University of Sussex The models used to produce global climate scenarios may overestimate the energy and emission savings from improved energy efficiency, warns new research led by academics at the University of Sussex Business School and the University of Leeds. In a review of 33 studies, the researchers find that economy wide rebound effects […].
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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.
BioSpace
MARCH 3, 2021
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Scienmag
MARCH 3, 2021
Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — A smartphone app called Harbor, currently under development by researchers at the University of Illinois Urbana-Champaign, teaches young adults how to talk to a peer if they are concerned about that other person’s drinking or drug use. Designed for people ages 18-29, Harbor teaches young adults […].
pharmaphorum
MARCH 3, 2021
Numan has added to its digital health stable with the acquisition of Sweden’s Vi Health and its suite of tools including an artificial intelligence-powered symptom checker. . UK-based Numan is in the process of building a digital health platform to provide access to medical professionals as well as information on pharmaceutical products and health conditions, around its core focus of men’s health, wellness and fitness.
Scienmag
MARCH 3, 2021
Credit: Jacqui Lau. Scientists say outdated assumptions around gender continue to hinder effective and fair policymaking and action for climate mitigation and adaptation. Lead author of a new study, Dr Jacqueline Lau from the ARC Centre of Excellence for Coral Reef Studies at James Cook University (Coral CoE at JCU) and WorldFish, said gender–alongside other […].
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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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