Sat.Sep 12, 2020 - Fri.Sep 18, 2020

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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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Oncology DTC: Opportunities

World of DTC Marketing

IN SUMMARY: According to a Takeda Oncology report “for people diagnosed with multiple myeloma, there can be an abundance of information, which can lead to confusion around the next steps in their diagnosis and treatment plan. Particularly, there appears to be a disconnect between what they understand and what they want to know about the treatment journey that lies ahead.

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Royal Society of Chemistry’s journal archives now available to companies for Text and Data Mining

Pharma Mirror

The Royal Society of Chemistry has launched its new Text and Data Mining (TDM) solution, making its full collection of research journals available to companies for AI and machine learning applications. With the volume of published research available growing hourly, access to the RSC’s collection in machine-readable format offers companies the opportunity to extract, pinpoint.

Research 243
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Vaxart's oral COVID-19 tablet vaccine to enter clinical trials

BioPharma Reporter

Vaxart will start a Phase 1 clinical trial for its oral COVID-19 vaccine candidate, having received Investigational New Drug (IND) clearance.

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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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AstraZeneca, Oxford vaccine study allowed to restart in UK

Bio Pharma Dive

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

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Our healthcare has failed us

World of DTC Marketing

IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason. The adult obesity rate passed 40 percent nationally for the first time according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES), a 26 percent jump from 2007–2008.

More Trending

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iBio’s FastPharming® Platform Produces Decoy Therapeutic to Bind to SARS-CoV-2

BioSpace

Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment.

Licensing 142
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Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial

Bio Pharma Dive

The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial.

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AbbVie doesn’t care about employees

World of DTC Marketing

THE BASICS: A “critical part” of pharmaceutical company AbbVie ‘s success is “face-to-face” interaction, CEO Richard Gonzalez explained in an Aug. 27 email outlining its process for bringing thousands of U.S.-based employees back to work. This is beyond irresponsible. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. employees and their families at risk.

Drugs 192
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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

NY Times

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine.

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

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Pfizer, BioNTech Say COVID-19 Vaccine Might Be Ready by End of October

BioSpace

In a weekend interview on CBS’ “Face the Nation,” Albert Bourla, chief executive officer of Pfizer indicated they may have key data from its Phase III trial of the vaccine to the U.S. Food and Drug Administration by the end of October.

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Moderna and Pfizer, having shown speed with coronavirus vaccines, see opportunity in seasonal flu

Bio Pharma Dive

Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.

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Online ads: Creative vs. media

World of DTC Marketing

TO THE POINT: When it comes to online advertising the creative is more important than the money you’re spending on media. DTC marketers need to create a “hook point” to lead to action. Consumers today are bombarded with so much information you have to grab their attention quick. In fact, you realistically only have 3-seconds or less.

Packaging 165
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Epilepsy gene therapy candidate moves closer to clinical study phase

BioPharma Reporter

Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01.

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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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BMS' Opdivo wins new NICE lung cancer backing

Pharma Times

The drug has been approved for routine NHS commissioning for squamous or non-squamous NSCLC

Drugs 133
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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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Stem Cells May Help COVID-19 and ARDS Patients Breathe Easier

BioSpace

One company working towards an ARDS treatment is Athersys, a biotech company focusing on regenerative medicine therapies for diseases with significant unmet need.

Medicine 132
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In the News: August 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 explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection. Fitbit recently posted a study that may indicate the company’s ability to create an algorithm that can flag cases of COVID-19 early.

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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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Access to coronavirus tests should be ‘top priority’, says NHS Confederation director

Pharma Times

Concerns over NHS Test and Trace system exacerbated by continuing rise in cases

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Merck pays Seattle Genetics $1.7B as antibody cancer drugs continue comeback

Bio Pharma Dive

Merck's deal for Seattle Genetics' antibody-drug conjugate comes as Gilead agreed to acquire rival developer Immunomedics in the biotech industry's largest buyout of 2020.

Genetics 312
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3 ways pharma marketers can draw inspiration from digitally-native brands

pharmaphorum

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. Companies like prescription glasses firm Warby Parker, shoe brand Rothy’s and tele-dentistry’s SmileDirectClub have grown up in today’s digitally native environment and can offer some key pointers for pharma.

Branding 130
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FIP Calls for a focus on Pharmacy Remuneration

Pharma Mirror

The Hague – “A common concern among pharmacy associations worldwide is the long-term financial viability of professional services delivered by pharmacists. These concerns are first and foremost triggered by the impacts of continued price and margin cuts in dispensing of medicines and the non-allocation of funding in many settings for extended professional services and social.

Pharmacy 130
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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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NICE unites with global health leaders to highlight evidence-based healthcare

Pharma Times

World Evidence-based Healthcare Day takes place on 20 October

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Seattle Genetics stays step ahead of rivals with bladder cancer data

Bio Pharma Dive

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

Genetics 307
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Lilly’s antibody therapy cuts hospitalisation rates in COVID-19

pharmaphorum

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. An interim analysis of the BLAZE-1 clinical trial showed a reduced rate of hospitalisation in patients treated with Lilly’s LY-CoV555, an antibody that neutralises the SARS-CoV-2 coronavirus, in a phase 2 trial.

Antibody 129
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NanoViricides Nominates a Novel Candidate for COVID-19 Treatment

Pharma Mirror

NanoViricides, Inc. (NYSE American:NNVC) (the “Company”) a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that it has nominated a clinical drug candidate for the treatment of COVID-19, thus further advancing its COVID-19 program closer to human clinical trials.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AZ picks up oral PCSK9 inhibitor programme from Dogma

Pharma Times

AZ will take the programme forward into clinical development

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Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

Bio Pharma Dive

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.

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BioNTech acquires German manufacturing site to boost COVID-19 vaccine production

BioPharma Reporter

BioNTech will acquire Novartisâ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.

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The Relationship Between Sleep and Chronic Illness

Pharma Mirror

For a state of such inactivity, sleep is actually one of the most important “activities” that you can undertake for long-term health and productivity. Indeed; one might argue that proper sleep (for the recommended amount of time) is the single most important thing that you can do in order to maximize your functionality. Many studies. The post The Relationship Between Sleep and Chronic Illness appeared first on Pharma Mirror Magazine.

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The New Age of Decentralized Clinical Trials

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.