Bio Pharma Dive
DECEMBER 1, 2020
Working with University of Pennsylvania researcher Jim Wilson, Regeneron aims to develop a nasal spray version of the coronavirus treatment recently cleared by the Food and Drug Administration.
World of DTC Marketing
DECEMBER 1, 2020
Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. Want proof? Just look at any pharma product website that is nothing but a sales brochure in a majority of cases. ROI drives pharma companies. If it doesn’t add value to the bottom line, it’s not worth spending money on.
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Bio Pharma Dive
DECEMBER 1, 2020
Phase 3 results announced Tuesday boost chances that Agios' drug might not just win approval for a rare type of anemia, but also be useful in treating other blood diseases.
BioSpace
DECEMBER 1, 2020
Over a decade of research and billions of dollars have been poured into the Alzheimer’s industry. Experts are hopeful we could finally be headed towards a light at the end of the long dark tunnel.
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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
DECEMBER 1, 2020
Advisors on the CDC panel cited risk and disease burden as reasons for setting their priority list for the first vaccine doses to become available, supply of which will be extremely limited.
pharmaphorum
DECEMBER 1, 2020
Healthcare agency, consultancy and digital health group Healthware Group has acquired Finland-based digital service development and creative agency Make Helsinki. The acquisition builds on prior collaborations between the two organisations, including in best-in-class full-service agency offerings, digital transformation, technology/enterprise solutions and corporate venturing.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
DECEMBER 1, 2020
For so long the US healthcare system was built around the provider, with appointments and services set by the provider (along with insurance reimbursement systems). This structure relies on in-person visits of patients to operate and become profitable. But when the industry suddenly shifted due to COVID-19, so too did the power dynamics of the patient-provider relationship.
NY Times
DECEMBER 1, 2020
A C.D.C. advisory panel will decide on its recommendations on Tuesday afternoon. Here’s what we expect, along with answers to other questions about the new shot.
XTalks
DECEMBER 1, 2020
With the demand for plant-based meat and dairy alternatives growing worldwide, it’s no wonder that small startups and global food companies alike are positioning themselves to supply the goods. The latest company to join the trend is Unilever, which is setting a goal of achieving $1.2 billion (€1 billion) in sales from plant-based meat and dairy products in the next five to seven years.
Outsourcing Pharma
DECEMBER 1, 2020
Health tech specialists GoodCell are working with the New York Blood Center to identify COVID-19 patients with elevated risk of adverse clinical outcomes.
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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
DECEMBER 1, 2020
Pfizer/BioNTech and Moderna have each submitted formal applications for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their COVID-19 vaccines: completing the rolling review process.
BioSpace
DECEMBER 1, 2020
Upon the closing of the divestment, Grünenthal will make an upfront, non-contingent payment to AstraZeneca of $320 million.
BioPharma Reporter
DECEMBER 1, 2020
A neuroprotective drug which is already in development may be particularly effective for MND patients carrying a newly discovered genetic risk factor, helping to halt progression or even prevent the onset of the devastating degenerative disease.
Scienmag
DECEMBER 1, 2020
All-solid-state electrodes composed of graphite active material and no solid electrolyte. Energy density was improved by 150% through research on the particle diffusion process. Credit: Electronics and Telecommunications Research Institute(ETRI) South Korean researchers have developed a new type of electrode structure for all-solid-state secondary batteries.
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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
DECEMBER 1, 2020
US based scientists have hit upon a method to efficiently identify potential biological mechanisms underlying autism spectrum disorder (ASD); the Harvard and MIT based researchers say the approach is an important first step toward developing treatments for the disease.
Pharma Times
DECEMBER 1, 2020
Research conducted at Oxford University used new scanning method
pharmaphorum
DECEMBER 1, 2020
Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The filing for a conditional marketing authorisation completed the rolling submission process that began on October 6. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.
BioSpace
DECEMBER 1, 2020
Despite a number of anti-psychotic medications available, there are no approved drugs to address underlying cognitive development issues. Cerevance aims to change that.
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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.
Eye on FDA
DECEMBER 1, 2020
In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. But digging a little deeper, there are also questions to consider with respect to support for ensuring access to vaccines by communities of color.
Scienmag
DECEMBER 1, 2020
Credit: Penn State Geoscientists have long known that some parts of the continents formed in the Earth’s deep past, but the speed in which land rose above global seas — and the exact shapes that land masses formed — have so far eluded experts. But now, through analyzing roughly 600,000 mineral analyses from a database […].
pharmaphorum
DECEMBER 1, 2020
GPs in the UK have been urged to encourage patients to self-care, in advance of the anticipated roll-out of COVID-19 vaccines and the extra workload this will create. Findings of a survey from the digital self-care platform Healthily show GPs reported half of all appointments are for conditions that could have been managed by patients themselves. The medically-approved self-care platform is this month launching its #LiveHealthily campaign encouraging people from the UK to take control of their h
Scienmag
DECEMBER 1, 2020
Credit: Nationwide Children’s Hospital Seasons of change can be difficult to navigate emotionally, not only for adults, but also for children. The ongoing COVID-19 pandemic has undoubtedly impacted children’s mental health, and as families start planning for the holidays that may look very different this year, it’s important to build resilience in kids to prepare […].
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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.
pharmaphorum
DECEMBER 1, 2020
AstraZeneca is to sell European rights to its cholesterol drug Crestor (rosuvastatin) to Germany’s Grunenthal. Crestor is a statin and at its peak generated annual revenues of more than $7 billion but it lost patent protection in the US four years ago and sales have tumbled. Grunenthal will pay $320 million up front for rights to Crestor and associated medicines in over 30 countries in Europe, except for the UK and Spain.
Scienmag
DECEMBER 1, 2020
Coordinated by Politecnico di Milano, the project is funded by European Commission with a budget exceeding 5M€ Credit: Politecnico di Milano A breakthrough in microscopy and endoscopy will soon revolutionize the study of the cellular origin of diseases, advancing the field of precision medicine. This is the goal of CRIMSON, a trans-disciplinary and trans-national research […].
BioSpace
DECEMBER 1, 2020
Noema Pharma raised $59 million in a Series A financing round that will support the development of four clinical-stage assets the company licensed from Roche for the treatment of orphan neurological diseases with severe unmet needs.
Scienmag
DECEMBER 1, 2020
Credit: Michigan State University Michigan State University’s searchable database containing millions of records cataloging the lives of enslaved Africans and their descendants — Enslaved.org — is launching a second phase that will accept contributions from the public and from academic researchers. The one-of-a-kind hub, Enslaved.org: Peoples of the Historic Slave Trade, developed and maintained by […].
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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
DECEMBER 1, 2020
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
Scienmag
DECEMBER 1, 2020
Advanced imaging can diagnose nerve/muscle Credit: Northwestern University CHICAGO — After recovering from COVID-19, some patients are left with chronic, debilitating pain, numbness or weakness in their hands, feet, arms and legs due to unexplained nerve damage. A new Northwestern Medicine study shows how advanced imaging technology can pinpoint what may have caused patients’ nerve […].
BioSpace
DECEMBER 1, 2020
With two COVID-19 vaccines pending eminent FDA review, the biggest hurdle to widespread vaccinations is simply convincing people to be vaccinated.
Scienmag
DECEMBER 1, 2020
Credit: Matthew Boucher Historically credited as being the first bacterium ever characterized as a plant pathogen, fire blight is a bacterial disease that leads to significant losses of pear and apple. The role of insects in the spread of this disease has been long studied. In a new study, plant pathologists based at Cornell University […].
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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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