Bio Pharma Dive
AUGUST 19, 2020
BioMarin's hemophilia gene therapy Roctavian and Gilead's arthritis drug filgotinib were widely expected to win approvals from the FDA, which demanded more study data from both drugmakers.
World of DTC Marketing
AUGUST 19, 2020
R&D has been replaced with acquisitions. The latest is J&J’s deal to buy out Momenta for $6.5 billion. This week alone Sanofi, BMS, and other big pharma companies have spent billions on the purchase of smaller, promising companies who have drugs that could lead to happy investors. Drug companies have slowed their stock buybacks after the Covid-19 crisis and spent their money instead on buying each other.
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Bio Pharma Dive
AUGUST 19, 2020
Together, the companies expect to make three and a half times as many doses of Regeneron's antibody drug than the U.S. biotech could on its own.
Pharma Mirror
AUGUST 19, 2020
Edinburgh-based biotech company Ingenza Ltd. has made a significant breakthrough in the race to develop and manufacture a cost-effective vaccine against SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. Ingenza has been working closely with researchers at Oxford University and the UK CPI, Wilton, since the start of the outbreak, and the collaboration is.
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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
AUGUST 19, 2020
Mylan's launch of a generic copy of the multiple sclerosis drug Tecfidera comes earlier than expected, and risks a court siding with Biogen on a key patent.
NY Times
AUGUST 19, 2020
Government health leaders including Dr. Francis S. Collins and Dr. Anthony S. Fauci urged caution last week, citing weak data from the country’s largest plasma study.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 19, 2020
Researchers from the Salk Institute took a major step forward in developing a new insulin-producing pancreatic cell cluster as a potential treatment for type 1 diabetes patients.
XTalks
AUGUST 19, 2020
In March 2020, the world announced that the novel coronavirus outbreak was a pandemic, which, in turn, forced countries to take measures to flatten the curve and limit the spread of the virus among the population. Social distancing is one of the many ways to limit the spread of the virus. New research suggests that social distancing has deceased pediatric respiratory tract infections in Finland.
BioSpace
AUGUST 19, 2020
The study concludes that they can detect almost 50% of COVID-19 cases a day before enrollees in the study reported the onset of symptoms, and they do so with 70% specificity.
Pharma Times
AUGUST 19, 2020
Following a pause because of coronavirus, the company has now kicked off the second part of a trial assessing a pressurised metered-dose inhaler formulation of ensifentrine
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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
BioSpace
AUGUST 19, 2020
The U.S. FDA placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for COVID-19 over what was described as a lack of robust data supporting its use.
pharmaphorum
AUGUST 19, 2020
UK digital health company Sensyne Health has launched a new smartphone app to help people across the diabetes spectrum manage their condition. The app – called DBm-Health – can help users to monitor their blood glucose levels and send readings, notes and medication information to their healthcare practitioner to assess remotely. It is a follow-on to Sensyne ’s GDm-Health product, which is used for remote monitoring of diabetes during pregnancy and was recently made available for free to all NHS
Pharma Times
AUGUST 19, 2020
AZ says approval would “simplify and improve treatment by enabling continuity of care while minimising the risk of exposure to infection in the healthcare setting”
pharmaphorum
AUGUST 19, 2020
Johnson & Johnson is to buy Momenta Pharmaceuticals for $6.5 billion, adding potential inflammatory diseases blockbuster nipocalimab to the pipeline at its Janssen pharmaceuticals unit. J&J thinks that Momenta’s lead drug nipocalimab could be a kind of Swiss army knife drug that could be used across a range of inflammatory diseases including maternal-foetal disorders, neuro-inflammatory disorders, rheumatology, and autoimmune haematology.
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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
AUGUST 19, 2020
ELSI scientists find that small highly branched polymers which may have formed spontaneously on early Earth can mimic modern biological protein enzyme function. These simple catalytic structures may have helped jump start the origins of life. Credit: Tony Z. Jia, ELSI Most effort in origins of life research is focused on understanding the prebiotic formation […].
XTalks
AUGUST 19, 2020
The Consumer Goods Forum (CGF) launched the Coalition of Action on Food Waste, which aims to reduce the per capita global food loss by half at the retailer and consumer levels. The CEO-led initiative comprises 14 members representing the world’s largest retailers and manufacturers. The members include Ahold Delhaize, Barilla, Bel Group, General Mills, Kellogg Company, Majid Al Futtaim, McCain Foods, Merck Animal Health, Metro AG, Migros Ticaret, Nestlé, Sainsbury, Tesco and Walmart.
Scienmag
AUGUST 19, 2020
Credit: Sarah Kostick The majority of today’s plant-based food is a product of plant breeding. U.S. public plant breed-ing programs often focus on crops that are important to society but may be less profitable than crops that drive the bottom line for large businesses. Studies over recent decades have reported a reduction in capacity of […].
BioSpace
AUGUST 19, 2020
The drug company plans to combine its Cambridge operations at the laboratory and office building at the site by the end of the first half of 2023.
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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
AUGUST 19, 2020
A multi-site study finds that seniors are more concerned with being infected with COVID-19 than the effects of social isolation Credit: UCLA Health A study involving older adults with pre-existing major depressive disorder living in Los Angeles, New York, Pittsburgh, and St Louis found no increase in depression and anxiety during the COVID-19 pandemic.
Pharma Times
AUGUST 19, 2020
Plans have been announced to test 150,000 people per fortnight across the UK from October
Outsourcing Pharma
AUGUST 19, 2020
A leader from the clinical laboratory and diagnostic solution provider discusses how its research is fueled by partnerships and patient-centricity.
NY Times
AUGUST 19, 2020
A ruined economy and a broken health care system have left President Nicolás Maduro unable to fight the pandemic as other world leaders have. Instead, he’s detained thousands to try to halt the spread.
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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
AUGUST 19, 2020
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
NY Times
AUGUST 19, 2020
Una economía destruida y un sistema de salud colapsado han dejado al país sin capacidad para combatir la pandemia como lo han hecho otras naciones. En cambio, el gobierno ha desplegado sus fuerzas de seguridad para tratar de contener la propagación.
Scienmag
AUGUST 19, 2020
Using medical records of patients with COVID-19 in five countries, researchers create agile analytic tool for rapid disease insights More than a decade ago, electronic medical records were all the rage, promising to transform health care and help guide clinical decisions and public health response. With the arrival of COVID-19, researchers quickly realized that electronic […].
BioSpace
AUGUST 19, 2020
Pharmaceutical industry investors are betting on contract development and manufacturing organizations (CDMOs) this year, as they shift their focus from contract research organizations (CRO).
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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
AUGUST 19, 2020
New research has shown some of our least favourite vegetables could be the most beneficial when it comes to preventing advanced blood vessel disease. New research has shown some of our least favourite vegetables could be the most beneficial when it comes to preventing advanced blood vessel disease. Published in the British Journal of Nutrition […].
Outsourcing Pharma
AUGUST 19, 2020
An online patient community specializing in rare diseases has launched Xperiome, a knowledge platform aimed at speeding development of treatments.
Scienmag
AUGUST 19, 2020
Credit: Adam Toomes Unsustainable trade of species is a major pathway for the introduction of invasive alien species at distant localities and at higher frequencies. It is also a major driver of over-exploitation of wild native populations. In a new study, published in the peer-reviewed open-access scholarly journal Neobiota, scientists estimated the desire of Australians […].
Outsourcing Pharma
AUGUST 19, 2020
The precision study at the center of the partnership is geared toward identifying novel synergies across a broad variety of anticancer therapies.
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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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