Sarepta, continuing its gene therapy push, helps launch a startup
Bio Pharma Dive
OCTOBER 22, 2020
The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million.
October, 2020
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10 Trends for online health seekers
World of DTC Marketing
OCTOBER 21, 2020
IN SUMMARY: Online health seekers are using the Internet differently since the pandemic. Treatment options are researched more, and people are using, but not relying, on social media to gather information on what’s best for THEM. I’ve spent the last three months gathering information on how online health seekers are using the Internet. My research points were Google, Twitter, and various websites that provide metrics on a variety of topics.
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Singapore Halts Dosing of Two Flu Shots After 59 Deaths in South Korea
BioSpace
OCTOBER 27, 2020
South Korea, on the other hand, indicated they would continue their state-run vaccination program because they did not find a direct link between the deaths and the vaccinations.
Novartis launches digital health hub in Canada
pharmaphorum
OCTOBER 23, 2020
Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers. The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019. Canada is the latest country to join a global network of hubs opened by Novartis.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
What cold lizards in Miami can tell us about climate change resilience
Scienmag
OCTOBER 21, 2020
Credit: Photo courtesy Day’s Edge Productions It was raining iguanas on a sunny morning. Biologist James Stroud’s phone started buzzing early on Jan. 22. A friend who was bicycling to work past the white sands and palm tree edges of Key Biscayne, an island town south of Miami, sent Stroud a picture of a 2-foot […].
Pharma Chatbots: Designing the Human Side of the Experience (Pt. One)
Intouch Solutions
OCTOBER 1, 2020
Robots are no longer the stuff of science fiction, and as more brands adopt conversational AI, some key considerations can enhance the chatbot user experience. In part one of this two-part series, we’ll talk about chatbots, human users, and live agents, and offer several tips for success. The post Pharma Chatbots: Designing the Human Side of the Experience (Pt.
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Web analytics should tell a story
World of DTC Marketing
OCTOBER 30, 2020
IN SUMMARY: Web analytics really has nothing to do with numbers. They have everything to do with what the numbers are telling you about your audience and messaging. DTC marketers need to get out of the mindset of using raw numbers and ask their web analytics people for insights instead. One of the services we often provide for clients is a deep-dive web analytics report.
IBM and Pfizer Believe Machine Learning Can Predict Alzheimer’s Risk
BioSpace
OCTOBER 22, 2020
Researchers with Pfizer and IBM developed an artificial intelligence (AI) model that they claim can predict eventual onset of Alzheimer’s disease with 71% accuracy based on a language sample. They published the research today in The Lancet eClinicalMedicine.
UK trials digital ‘health passport’ to help borders reopen
pharmaphorum
OCTOBER 19, 2020
Regular fliers are used to long queues to clear security – but a rigorous COVID-19 testing regime could be added to pre-flight checks backed by a digital “health passport” to prove passengers are free from the coronavirus. The UK is the latest country to test the scheme that allows passengers to demonstrate their coronavirus status as part of a global framework for COVID-safe air travel.
Pfizer to apply for COVID-19 vaccine EUA after mid-November safety data milestone
BioPharma Reporter
OCTOBER 16, 2020
Pfizerâs CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate âsoon afterâ a safety milestone is reached in the third week of November.
The New Age of Decentralized Clinical Trials
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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
Fats fighting back against bacteria
Scienmag
OCTOBER 19, 2020
Droplets of fat inside our cells are helping the body’s own defence system fight back against infection, University of Queensland researchers have discovered. Credit: Institute for Molecular Bioscience, University of Queensland Droplets of fat inside our cells are helping the body’s own defence system fight back against infection, University of Queensland researchers have discovered.
Early signs of survival benefit raise optimism around a small biotech's ALS drug
Bio Pharma Dive
OCTOBER 16, 2020
Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.
Clinical trials have ‘much work to do’ in boosting diversity
Outsourcing Pharma
OCTOBER 8, 2020
A veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.
Bayer Acquires AskBio for Up to $4 Billion to Expand Gene Therapy Platform
BioSpace
OCTOBER 26, 2020
Bayer is paying $2 billion upfront for AskBio's AAV-based gene therapy pipeline of treatments for Pompe disease, among others, and could pay an additional $2 billion in potential milestones.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Toxic positivity and grief: The reality of living through cancer
pharmaphorum
OCTOBER 22, 2020
Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase. No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with. Megan-Claire Chase , a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.
Finding and Evaluating Generic Drug Market Entry Opportunities
Drug Patent Watch
OCTOBER 6, 2020
Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.
COVID-19 vaccine manufacturing centre gains MHRA approval; ready to produce tens of millions of doses in the UK
BioPharma Reporter
OCTOBER 6, 2020
The UKâs Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's Oxbox centre.
Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire
Bio Pharma Dive
OCTOBER 8, 2020
Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
CBD helps reduce lung damage from COVID by increasing levels of protective peptide
Scienmag
OCTOBER 18, 2020
Credit: Kim Ratliff, Production Coordinator, Augusta University One way CBD appears to reduce the “cytokine storm” that damages the lungs and kills many patients with COVID-19 is by enabling an increase in levels of a natural peptide called apelin, which is known to reduce inflammation and whose levels are dramatically reduced in the face of […].
Vanquishing COVID-19 by Decreasing Viral Inoculum
BioSpace
OCTOBER 18, 2020
Dr. Monica Gandhi, MD, an infectious diseases doctor and professor of medicine at UC San Francisco, poses the hypothesis that masks and other social distancing measures may reduce the viral inoculum – or amount – of the SARS-CoV-2 we contract.
Careology teams up with private GP group on COVID-19 monitor
pharmaphorum
OCTOBER 1, 2020
A digital tool that allows doctors to monitor patients with COVID-19 remotely in real time and intervene when treatment is needed has been launched in the UK. The mobile app – developed by digital heath specialist Careology – provides advice on COVID-19 symptoms and links patients with doctors at the London General Practice, a private GP group with around 50,000 people on its books, via online video consultations.
IQVIA: tap the right talent to lead digital transformation
Outsourcing Pharma
OCTOBER 30, 2020
In order to effectively handle collection and analysis of huge volumes of vital data, a leader from IQVIA advises bringing on people up to the challenge.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
A Dose of Optimism, as the Pandemic Rages On
NY Times
OCTOBER 12, 2020
The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.
FDA releases coronavirus vaccine guidelines that White House resisted
Bio Pharma Dive
OCTOBER 6, 2020
The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely.
Giving the immune system a double boost against cancer
Scienmag
OCTOBER 30, 2020
Credit: CSHL, 2020 Cancer immunotherapies, which empower patients’ immune systems to eliminate tumors, are revolutionizing cancer treatment. Many patients respond well to these treatments, sometimes experiencing long-lasting remissions. But some cancers remain difficult to treat with immunotherapy, and expanding the impact of the approach is a high priority.
CRISPR Pioneers Doudna and Charpentier Win Nobel Prize in Chemistry
BioSpace
OCTOBER 6, 2020
There is little doubt that CRISPR gene editing is and will continue to revolutionize biology and medicine. The Nobel Committee confirmed their belief in that by awarding the Nobel Prize in Chemistry to Emmanuelle Charpentier and Jennifer A. Doudna for their discovery and development of CRISPR.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Pharma 2030: Will payers fund more preventive care programmes?
pharmaphorum
OCTOBER 26, 2020
Preventive care programmes are key to better health outcomes, but several factors are limiting their uptake. A new analysis looks at these barriers and asks how they could be overcome. Over the past decade, many healthcare systems have worked to expand their focus on health maintenance and disease prevention as several studies have indicated that preventive care services can play a significant role in improving general health while helping reduce long term healthcare costs.
WHO: remdesivir shows little effect on COVID-19
Outsourcing Pharma
OCTOBER 19, 2020
The agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.
Remdesivir Fails to Prevent Covid-19 Deaths in Huge Trial
NY Times
OCTOBER 15, 2020
An antiviral widely used to treat hospitalized patients did not lower the mortality rate in a multinational trial.
5 questions ahead of next week's FDA meeting on coronavirus vaccines
Bio Pharma Dive
OCTOBER 16, 2020
Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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