2020

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Prescription Digital Therapeutics: When Software Is the Active Ingredient

Camargo

With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo.

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The sweeping biotech business model

World of DTC Marketing

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.

Drugs 217
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Research to bring more secure software for autonomous battlefield operations

Scienmag

Credit: U.S. Army Operational Test Command photo/Tad Browning WEST LAFAYETTE, Ind. — Drones and other unmanned machines can save human lives on the battlefield, but adversaries could hack into their artificial intelligence software. Purdue University will be leading research in partnership with Princeton University on ways to protect the software of these autonomous systems by […].

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How biotech and pharma companies pay their CEOs, and their workers

Bio Pharma Dive

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Scientists identify new gene involved in autism spectrum disorder

Scienmag

Forward genetics pinpoints gene linked to ASD involving severe speech impairment and opens door to search for more mutations, future treatments Credit: Photo taken by Brian Coats for UT Southwestern Medical Center DALLAS – Dec. 22, 2020 – UT Southwestern scientists have adapted a classic research technique called forward genetics to identify new genes involved […].

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Time to Reassess Tocilizumab’s Role in COVID-19 Pneumonia

JAMA Internal Medicine

In this issue of JAMA Internal Medicine, 3 important articles explore the use of tocilizumab in coronavirus disease 2019 (COVID-19) pneumonia. Tocilizumab is a humanized monoclonal antibody that binds human interleukin 6 (IL-6) receptors. It is used routinely in inflammatory arthritis, giant cell arteritis, and cytokine release syndrome after chimeric antigen receptor T-cell therapy.

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LabCorp Backs Resolution Bioscience’s Liquid Biopsy Test for NSCLC

XTalks

Clinicians and patients alike have long been hoping for liquid biopsy tests for cancer screening and diagnosis given their ease, convenience and ability to detect disease-specific mutations. LabCorp (NYSE:LH) may help lead the way with its backing of Resolution Bioscience’s new diagnostic blood test for lung cancer. The leading global life science company is set to introduce Resolution Bio’s ctDx Lung assay , a non-invasive liquid biopsy test for patients with non-small cell lung cancer (NSCLC).

Gene 105
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Lilly offers first evidence that its antibody drug may help treat COVID-19

Bio Pharma Dive

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear.

Antibody 328
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Could a COVID-19 breath test help UK out of lockdown?

pharmaphorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen in collaboration with Modern Water, Avacta and Aptamer Group, which had been working on test that identifies the SARS-CoV-2 coronavirus in waste water.

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Best Features of Mobile Workstations in Pharmaceutical Production

Pharma Mirror

The future of pharmaceutical manufacturing is mobile. Advances in cloud computing and the onset of Industry 4.0 has led to the proliferation of mobile IT solutions for manufacturing, including pharmaceuticals. Particularly, mobile workstations and tablets are becoming staples of the pharmaceutical manufacturing workflow due to their cost-effectiveness, particularly in demanding environments like cleanrooms, where even modular fixed human-machine interfaces (HMIs) can be exorbitantly priced and c

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Telehealth will be worth about $25 billion in 2021

World of DTC Marketing

SUMMARY: Deloitte predicts that the percentage of virtual video visits to doctors will rise to 5% globally in 2021, up from an estimated 1% in 2019. While 5% may not sound like much, consider that 8.5 billion doctor’s visits, worth a total of approximately US$500 billion. The most time-consuming task is to make an appointment with your doctor just to ask for a new Rx or an Rx renewal.

Doctors 309
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Merck signs $356M deal to supply US with experimental coronavirus drug

Bio Pharma Dive

The drugmaker spent $425 million a month ago to acquire the biotech developer of the treatment, which tamps down on the body's inflammatory response to viral infections.

Drugs 364
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Pfizer strikes a deal with newly formed China biotech

Bio Pharma Dive

The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Intellia, beginning treatment in CRISPR study, secures Gates Foundation backing

Bio Pharma Dive

The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.

In-Vivo 364
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The meeting that could change Alzheimer's treatment

Bio Pharma Dive

On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.

Drugs 363
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Moderna says its coronavirus vaccine sparks immune response in older people

Bio Pharma Dive

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

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A cure for hemophilia is closer than ever. For many patients, it could be just out of reach.

Bio Pharma Dive

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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AstraZeneca to buy Alexion for $39B

Bio Pharma Dive

The deal launches AstraZeneca, a company that has been growing mostly because of newer drugs for cancer and diabetes, into the market for rare disease treatments.

Marketing 362
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After a rare win, a biotech details long-awaited results for its ALS drug

Bio Pharma Dive

Data published Wednesday describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.

Drugs 363
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Record numbers of biotechs are going public. Here's how they're performing.

Bio Pharma Dive

Initial public offerings have fueled biotech's boom. A new database built by BioPharma Dive will help you keep track of them as they happen.

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Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Bio Pharma Dive

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.

Drugs 361
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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.

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CanSino, Canada abandon plans for a coronavirus vaccine trial

Bio Pharma Dive

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

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Pfizer pushes deeper into China with stake in cancer biotech

Bio Pharma Dive

The $200 million investment in CStone Pharmaceuticals puts Pfizer in charge of selling a cancer immunotherapy in the world's second largest drug market.

Marketing 358
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Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.

Bio Pharma Dive

An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.

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Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Biogen's all-important Alzheimer's drug enters the review gauntlet

Bio Pharma Dive

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.

Drugs 354
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Stem cell therapy for ALS fails a large clinical trial

Bio Pharma Dive

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.

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Moderna says it won't enforce coronavirus vaccine patents during pandemic

Bio Pharma Dive

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

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5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

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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