Bio Pharma Dive
AUGUST 18, 2020
Approval of BioMarin's Roctavian, should it come as expected this week, would deliver on decades of unfulfilled hopes for a gene therapy fix to one of the earliest identified inherited diseases.
World of DTC Marketing
AUGUST 20, 2020
QUICK READ: The belief that the development of a vaccine for coronavirus is being dangerously rushed, in part to improve Donald Trump’s prospects ahead of the presidential election in November are very real. In addition, Avaaz discovered that”global health misinformation spreading networks” had generated roughly 3.8 billion views for their content on Facebook.
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Pharma Mirror
AUGUST 17, 2020
When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety. Offices with old decor prevent patients from visiting the doctor regularly and feeling relaxed. But what if there was a way to modernize the office affordably to make it more. The post 5 Ways That Digital Signage Improves a Doctor’s Office appeared first on Pharma Mirror Magazine.
Pharma Times
AUGUST 20, 2020
The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo
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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
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 21, 2020
As the NY Times recently reported , obesity is the leading cause of mortality in the United States. Obesity costs the nation $1.72 trillion every year. In the United States, where at least 4.6 million people have been infected and over 165,000 have died, the promise of a vaccine is hampered by a vexing epidemic that long preceded Covid-19: obesity.
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.
Bio Pharma Dive
AUGUST 20, 2020
Kesimpta, a new multiple sclerosis drug from Novartis, works the same way as Roche's blockbuster Ocrevus, but patients can take it without leaving home.
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.
pharmaphorum
AUGUST 18, 2020
Pharma companies have improved how they engage with healthcare providers as a result of COVID-19, according to a new survey of HCPs. This has resulted in pharma companies being more relevant and providing more value in closing the care gap, the report says. The Accenture survey of 720 general practitioners, oncologists, cardiologists and immunologists globally found that this is in turn helping HCPs better serve patients.
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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 20, 2020
The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Bio Pharma Dive
AUGUST 18, 2020
A $145 million payment to broaden a partnership with Tango Therapeutics is the latest in a series of deals Gilead has made to grow its oncology business.
World of DTC Marketing
AUGUST 16, 2020
Here is a copy of a talk I recently gave via Zoom to my European colleagues. Those of you who know me know that I am a frequent contributor to Hedley Rees books as well as the author of a blog that gets close to 100,000 reads a month. I have been and continue to be critical of the pharma industry but it’s not out of spite or hate. I am critical because I love this industry.
pharmaphorum
AUGUST 21, 2020
An app developed by Kaia Health to help people suffering from back pain who may not want to take painkillers has shown its worth again in a study conducted with a health benefit plan in the US. The pilot study of the app – which combines physical therapy, relaxation exercises and medical information to help back pain sufferers manage their condition – showed it was able to reduce self-reported pain and sleep quality.
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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
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.
Bio Pharma Dive
AUGUST 20, 2020
The FDA's decision not to approve Roctavian raises the question of why BioMarin was able to submit the hemophilia A therapy in the first place.
BioPharma Reporter
AUGUST 17, 2020
Dynavax gets Bill & Melinda Gates Foundation funding to scale up production of adjuvant for use in COVID-19 vaccines.
pharmaphorum
AUGUST 17, 2020
Sanofi is to buy Principia Biopharma for up to $3.68 billion, adding a potential multiple sclerosis drug to its pipeline. The French pharma said it will pay $100 per share in cash for San Francisco-based Principia, which specialises in Bruton’s kinase (BTK) inhibitor drugs, after the deal was unanimously agreed by both boards of directors. Sanofi’s acquisition builds on a partnership to develop central nervous system drugs that began in late 2017.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
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.
Bio Pharma Dive
AUGUST 20, 2020
The companies' second experimental shot caused less fever, without compromising potency, when compared to an earlier version, according to preliminary data.
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.
pharmaphorum
AUGUST 21, 2020
Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.
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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
AUGUST 20, 2020
Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.
Bio Pharma Dive
AUGUST 20, 2020
A deal being negotiated would provide EU countries with 225 million doses of CureVac's experimental shot, which relies on similar technology as those developed by Moderna and BioNTech.
XTalks
AUGUST 21, 2020
Food fraudsters have found countless ways to trick shoppers – from cheap horsemeat sold as beef to conventional apples labeled as organic. But new rapid testing and tracing technologies may help turn the tables on food crime. The stakes are high for producers of expensive foods, which are particularly vulnerable to fraud. These include extra virgin olive oil, saffron and organic produce.
pharmaphorum
AUGUST 20, 2020
David Keene looks at the difficulties faced in treating mental health patients and how digital technologies are changing the game. In 1919 a young Dwight Eisenhower participated in a cross-country road trip to deliver tanks from Fort Meade in Maryland to San Francisco. Most of the roads on the journey were muddy, rut filled trails, and after 62 days at an average speed of 5 miles per hour, the convoy finally arrived.
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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.
BioSpace
AUGUST 17, 2020
“Joining the board will allow me to help guide and influence the development of a product from bench to bedside,” Franchimont told BioSpace. “I look forward to contributing to ongoing discussions on translation from bench science to the clinic, and ultimately to making real differences in the liv.
Bio Pharma Dive
AUGUST 18, 2020
The Indianapolis pharma paid $200 million to gain most of the rights to Tyvyt, a checkpoint blocker that could help it compete with Merck, Roche and others.
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
pharmaphorum
AUGUST 16, 2020
Swittons , a P360 company, has announced a new line of Internet of Things (IoT) enabled smart devices built specifically for pharmaceutical labs. The fully customizable devices align with strategic Lab of the Future (LoTF) initiatives and help automate various laboratory workflows between people and existing digital lab equipment, systems and solutions.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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