Sat.Aug 22, 2020 - Fri.Aug 28, 2020

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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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No digitization with HCP’s is not permanent

World of DTC Marketing

IN SUMMARY : When patients return to doctor’s offices will HCP’s have time to go online with every drug company that requests an online detail? Will patients be happy with telehealth once they feel it’s safe to return to physicians’ offices? After I read the Medscape report on the move to digitization I decided to reach out to some industry contacts to hear what they had to say.

Doctor 237
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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

NY Times

Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.

Scientist 145
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NIH Awards EcoHealth Alliance $7.5 Million Grant Despite Political Furor

BioSpace

EcoHealth had already developed a partnership with a WIV laboratory in Wuhan, China, under a five-year NIH grant. It was expected to run through 2024 but was canceled in April.

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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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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.

Vaccine 361
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Medscape on shift to digital

World of DTC Marketing

COVID-19 has disrupted traditional healthcare person-to-person communication and accelerated digital options, such as telehealth and remote patient-clinician contacts, digital therapeutics that deliver remote patient monitoring, and interventions through the use of software. But is this really the future? Medscape conducted some research in May to find out.

More Trending

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New Breast Cancer Drug Shows Promise in Halting Disease Progression

BioSpace

According to data from Phase I clinical trials, a new breast cancer drug developed by researchers at the University of Illinois Chicago can potentially stop disease progression without toxicity.

Drugs 142
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Moderna's vaccine may have an edge when immunization programs roll out

Bio Pharma Dive

A rival shot from Pfizer and BioNTech needs to be stored at colder temperatures and doesn't last as long in a refrigerator, which may limit its use.

Vaccine 347
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What Is the Difference Between Oxygen Generators and CPAP?

Pharma Mirror

A CPAP machine is a device that can replace or improve human breathing, increase lung ventilation, and improve respiratory function. It is generally used for lung failure or airway obstruction to breathing normally to help the patient complete the breathing process of inhalation and exhalation. It has a variety of breathing modes (various ways in. The post What Is the Difference Between Oxygen Generators and CPAP?

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AbbVie submits Rinvoq for ankylosing spondylitis

Pharma Times

In a pivotal Phase II/III study, twice as many patients receiving the drug achieved the primary endpoint of ASAS 40 response at week 14 versus placebo

Drugs 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA’s Hahn Apologizes for Overstating Benefit of COVID-19 Plasma Treatment

BioSpace

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.

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A new biotech forms to revive Amgen's old heart drug

Bio Pharma Dive

Founders of Dutch biotech Dezima have created NewAmsterdam Pharma and bought back the cholesterol drug they sold to Amgen in 2015.

Drugs 336
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Sharing oncology trial PROs to build the treatment of the future

pharmaphorum

Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes? . With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to assess products. .

Trials 128
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Two P.R. Experts at F.D.A. Have Been Ousted After Blood Plasma Fiasco

NY Times

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

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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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Abbott Wins $750 Million Contract with U.S. Government for Rapid COVID-19 Test

BioSpace

One day after Abbott secured Emergency Use Authorization for its $5 coronavirus test, the White House awarded the company a $750 million contract to deliver 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests.

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BioMarin's hemophilia gene therapy could have warranted a record price tag, ICER finds

Bio Pharma Dive

A draft report from the drug pricing watchdog concluded that, under the right conditions, Roctavian may be cost-effective at a price of $2.5 million.

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Pain-detecting tool for dementia patients rolls out in UK

pharmaphorum

Normal. 0. false. false. false. EN-GB. X-NONE. X-NONE. A smartphone-based app that uses facial analysis technology to spot chronic pain in people with dementia, called PainChek, is being rolled out in the UK by its Australian developer. The artificial intelligence-powered tool can help care workers and clinicians to identify and manage pain in patients with conditions like Alzheimer’s disease that can make it difficult for them to communicate.

Licensing 125
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Kidney cancer charity slams NICE rejection of Keytruda/Inlyta

Pharma Times

NICE says the combination's cost-effectiveness estimate is higher than what is considered acceptable for NHS use

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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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Biopharma Update on the Novel Coronavirus: August 28

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 28, 2020.

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Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

Bio Pharma Dive

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

Medicine 306
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COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts

pharmaphorum

Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry. The COVID-19 pandemic has brought about a radical transformation, with investors now eager to fund companies involved in the fight against the virus.

Vaccine 122
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Scancell receives funding for COVID-19 vaccine development

Pharma Times

It is hoped that the vaccine will generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future

Vaccine 112
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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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Case Report: 33-Year-Old Man Caught COVID-19 Twice

BioSpace

The genetic sequences of the two samples were markedly different, which strengthened the theory that the patient had been infected a second time.

Genetics 116
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Sarepta, after two dramatic approvals, gets an FDA review for next Duchenne drug

Bio Pharma Dive

Sarepta's first two medicines were both cleared in controversial fashion. Will its third attempt go more smoothly?

Medicine 296
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Humana lawsuit exposes fraud risk in high-growth telehealth market

pharmaphorum

Health insurer Humana has filed a lawsuit against telemedicine company QuivvyTech that it says resulted in fraudulent prescriptions worth millions of dollars being written for duped customers. According to the complaint, QuivvyTech hired telemarketers to cold-call Humana members, whose details were obtained using “illegal means,” and encouraged them to talk about common ailments, claiming to be calling from Humana.

Marketing 122
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The Blanc Mask for COVID-19 and Beyond: A New Generation of PPE

XTalks

To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. Xtalks spoke to one of the co-founders of Blanc, Philipp Egorov, to learn more about the mask.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves First Acne Treatment with New Mechanism of Action in 40 Years

BioSpace

The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1%).

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AstraZeneca broadens coronavirus vaccine manufacturing deal with Catalent

Bio Pharma Dive

Catalent, which is already helping the British pharma make its vaccine, will now add key services from a Maryland gene therapy plant.

Vaccine 290
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Moderna’s COVID vaccine works in older people, according to new data

pharmaphorum

Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19. An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.

Vaccine 111
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What Do We Really Know About Macrophage Programming?

XTalks

Macrophages are white blood cells that specialize in the detection, phagocytosis and destruction of bacteria and other harmful organisms. They can also present antigens to T cells and initiate inflammation by releasing cytokines, which activate other cells. In other words, when fighting bacteria, the macrophages are programmed to be pro-inflammatory.

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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.