Sat.Aug 15, 2020 - Fri.Aug 21, 2020

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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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5 Ways That Digital Signage Improves a Doctor’s Office

Pharma Mirror

When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety.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.

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Americans continue to neglect their health

World of DTC Marketing

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.

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First trial participant gets GSK's 5-in-1 meningitis jab

Pharma Times

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo

Trials 177
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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FDA shocks with rejections of high-profile therapies from BioMarin, Gilead

Bio Pharma Dive

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.

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Gates Foundation gives Dynavax COVID-19 grant to scale up adjuvant production

BioPharma Reporter

Dynavax gets Bill & Melinda Gates Foundation funding to scale up production of adjuvant for use in COVID-19 vaccines.

More Trending

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F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold

NY Times

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.

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Novartis set to take on Roche as FDA clears first at-home, injectable MS drug

Bio Pharma Dive

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.

Drugs 310
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Merck to Build $1.3 Billion Research Hub in London

BioSpace

The new research hub will be called the London Discovery Research Centre and is expected to open by 2025.

Research 140
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Working in pharma

World of DTC Marketing

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.

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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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Skin cancer deaths rocket 70% since the 1970s

Pharma Times

Melanoma incidence rates have more than doubled in the UK

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BioMarin's gene therapy rejection didn't shock everyone

Bio Pharma Dive

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.

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Researchers Develop Potential Breakthrough in Type 1 Diabetes Treatment

BioSpace

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.

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Pilot study backs Kaia Health app for back pain relief

pharmaphorum

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

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Survey reveals Britains welcome shift to virtual healthcare

Pharma Times

Findings also show increased trust in pharma and healthcare

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Gilead expands Tango alliance, continuing a busy year of cancer deals

Bio Pharma Dive

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.

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Fitbit COVID-19 Study Suggests Wearables Can Detect Disease Before Symptoms Arrive

BioSpace

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.

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Pharma improves HCP engagement during COVID-19 – report

pharmaphorum

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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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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Gov announces expansion of UK's ONS COVID-19 survey

Pharma Times

Plans have been announced to test 150,000 people per fortnight across the UK from October

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Coronavirus vaccine Pfizer, BioNTech chose for late-stage testing appears safer than first

Bio Pharma Dive

The companies' second experimental shot caused less fever, without compromising potency, when compared to an earlier version, according to preliminary data.

Vaccine 276
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Biotech Startup Codagenix Plans Human Trials for COVID-19 Vaccine

BioSpace

The 11-person team at Codagenix may be tiny, but it has big plans for the company’s new COVID-19 vaccine.

Vaccine 133
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Ingenza meets a key milestone in the deployment of novel cost-effective COVID-19 vaccine technology

Pharma Mirror

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.

Vaccine 130
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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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Swittons Introduces Smart IoT Devices for Pharmaceutical Lab Digital Transformation Initiatives

pharmaphorum

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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Lilly doubles down on Innovent cancer drug in immunotherapy push

Bio Pharma Dive

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.

Drugs 263
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FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis

BioSpace

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.

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Single radiotherapy shot proves effective in breast cancer

Pharma Times

The treatment, developed by UCL clinicians, allows for surgery and radiation therapy at the same time

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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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Sanofi adds BTK inhibitors to pipeline with $3.68bn Principia Biopharma acquisition

pharmaphorum

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.

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Commercial and regulatory strategy considerations for biotech

Bio Pharma Dive

Important considerations for biotech companies in early-stage development.

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Regeneron and Roche Partner to Increase Supply of COVID-19 Antibody Cocktail

BioSpace

Regeneron will distribute REGN-COV-2 in the U.S. and Roche will handle distribution outside the U.S.

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US expand use of Janssen's Darzalex

Pharma Times

The approval broadens the drug's label to include fifth treatment option in the relapsed/refractory multiple myeloma setting

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time