March, 2021

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5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

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America’s healthcare costs are in deep crisis

World of DTC Marketing

SUMMARY: The media loves to blame pharma companies for high healthcare costs, but unless we start to invest in healthy lifestyles, we’re headed for a healthcare crisis the likes of which we have never experienced. The media have targeted pharmaceutical companies for a long time because sensational headlines lead to clicks. Forget the fact that prescription drugs only account for $.10 of every healthcare dollar spent and that hospital chains are raking in cash with PBM’s and insurers

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DeepVerge’s nanochip-based COVID breath test could be ready this year

pharmaphorum

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. The company has already completed of the system that resembles a breathalyser in phase 1 and phase 2 studies with the SARS-CoV-2 virus in the safety of laboratories.

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U.S. Health Officials Question AstraZeneca Vaccine Trial Results

NY Times

According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated information.”.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Pfizer and BioNTech ramp up COVID-19 vaccine production to 2.5 billion doses

BioPharma Reporter

Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.

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Machine Learning Model Predicts Innovation’s Brilacidin Highly Effective Against COVID-19

BioSpace

A machine learning model that screened 1,482 compounds potentially effective for treating coronavirus disease 2019 (COVID-19) has ranked Innovation Pharma’s COVID-19 candidate brilacidin in the top 3% of compounds predicted to be most effective against the novel coronavirus.

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Why hasn’t pharma embraced email marketing?

World of DTC Marketing

SUMMARY : DTC marketers are spending tens of millions of dollars on programmatic ads that are full of fraud and have low click-through rates but they have yet to embrace email marketing which has an average click-through rate of 3.43%. There is no doubt that more people are using the Internet for online health searches, but the downside is that there is a lot of bad/false health information online. eMail represents an opportunity for pharmaceutical companies to get closer to their customers w

Marketing 289
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EU probes low platelet safety issue with COVID-19 shots

pharmaphorum

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety.

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Life-sciences pros believe in potential of AI, blockchain: survey

Outsourcing Pharma

A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data bias.

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Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’

BioPharma Reporter

The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could they be applied to vaccine development in the future?

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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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New Drug Approval Could Be on Horizon for Alzheimer’s after 17-Year Drought

BioSpace

A drug to halt the progression of Alzheimer’s disease will likely be approved within the next three years, and Alzheon’s ALZ-801 might be the leading candidate.

Drugs 144
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Takeda takes full control of drug for rare epilepsies

Bio Pharma Dive

A new agreement with Ovid Therapeutics has Takeda paying almost $200 million to secure global rights to soticlestat, an experimental treatment for certain brain diseases, including Dravet syndrome and Lennox Gastaut syndrome.

Drugs 345
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The right balance in DTC: Tv versus digital ads

World of DTC Marketing

SUMMARY: Television remains the most important medium for healthcare advertising , accounting for 54.7% of all spend in 2018, far higher than television’s 30.8% share of the advertising market as a whole. However, recent trends indicate that healthcare marketers are shifting more dollars to digital ads. The shift to digital advertising doesn’t make sense when pharma product websites don’t meet consumers’ needs.

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Gamification for patient care, medical education, and virtual engagement

pharmaphorum

“Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19. However, it is proving more than a mere buzzword. With diverse applications and approaches, it is quickly becoming a promising tool for patient adherence, chronic disease management, preventive medicine, rehabilitation, and paediatric care, as well as for medica

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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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New research adds to evidence that POTS may be an autoimmune disorder

Scienmag

Persistent work from scientists at The University of Toledo could aid in diagnosing and treating postural orthostatic tachycardia syndrome Credit: Daniel Miller / The University of Toledo The symptoms of postural orthostatic tachycardia syndrome, or POTS, can be as varied as they are confounding. There can be fatigue, pain, bleeding disorders and anxiety.

Research 133
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Valneva and Pfizer start new Phase 2 study for Lyme disease vaccine candidate

BioPharma Reporter

Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.

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India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials

NY Times

Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhi’s ambitious campaign to inoculate a vast population.

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Roche stops giving Huntington's disease drug in closely watched study

Bio Pharma Dive

A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals.

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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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Should doctors refuse to treat obese patients?

World of DTC Marketing

IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. One study found that only 50 percent of patients follow the instructions associated with taking their medication, and even fewer implement necessary lifestyle changes suggested by their doctor.

Doctors 250
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MPs slam £37bn NHS Test and Trace as UK endures third lockdown

pharmaphorum

There is no clear evidence that the UK’s £37 billion NHS Test and Trace programme (NHST&T) has an impact on the pandemic, according to a withering report from an influential committee of MPs. In its report the Public Accounts Committee (PAC) noted that Department of Health and Social Care justified the scale of the investment in part on the basis that an effective test and trace system would help avoid a second national lockdown.

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How Everyday Contact Lenses Could Help Monitor Ocular Disease

XTalks

Researchers at Purdue University have developed contact lenses with a new integrated technology that can monitor, and may even be able to diagnose, ocular disease progression. The novel technology has been applied to commercial soft contact lenses so they can be used as a bioinstrumentation tool for unobstructed ocular monitoring. Eye health and ocular disease screening and monitoring typically involve the use of an electroretinogram (ERG), which measures the electrophysical activity of the reti

Engineer 128
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New COVID-19 vaccine candidate leveraging nanotechnology is ‘promising’

BioPharma Reporter

Researchers from Cleveland Clinic's Global Center for Pathogen Research & Human Health, who have developed the nanotechnology based vaccine, say it has shown strong efficacy in preclinical disease models.

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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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Ocugen to Seek EUA for India-Developed COVID-19 Vaccine in the United States

BioSpace

Pennsylvania-based Ocugen has struck a deal to sell 100 million doses of a COVID-19 vaccine India’s Bharat Biotech in the United States later this year.

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The top drugs that could be impacted by an obscure provision in the pandemic relief law

Bio Pharma Dive

Elimination of the so-called penny rule in Medicaid could force drugmakers to pay larger rebates on a number of top medicines, including some HIV, diabetes and anti-inflammatory drugs.

Drugs 327
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VirTrial and uMotif Partner to Further Expand Decentralized Clinical Trial Capabilities

VirTrial

Scottsdale, AZ – (March 9, 2021) – VirTrial , the leading provider of telemedicine technology, and uMotif , the patient-centric data capture platform provider, are joining forces to combine their Decentralized Clinical Trial (DCT) technologies in one seamlessly integrated solution. VirTrial’s telemedicine platform provides robust and compliant video consultation capabilities to effortlessly connect site and patient.

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Health tech and digital transformation lessons from the NHS

pharmaphorum

In the year since the UK went into its first lockdown to limit the spread of COVID-19 the country’s health service has undergone an unprecedented digital transformation. . The NHS quickly scrambled to reduce face-to-face contact between patients and healthcare professionals, and manage demand for services that would soon be overstretched by dealing with the pandemic.

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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

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One and Done: Why People Are Eager for Johnson & Johnson’s Vaccine

NY Times

Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.

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AZ’s vaccine safety review shows ‘no evidence’ of an increased risk of blood clots

Pharma Times

Review included available safety data from over 17 million people vaccinated in the EU and UK with COVID-19 jab

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Why Mask-Associated Dry Eye Won’t Necessarily Boost Restasis Sales

XTalks

Dry eye disease may sound innocuous, but it’s a condition that affects between 25 and 35 percent of individuals in the US, and pandemic-related lifestyle changes may be pushing that percentage up. Reports of a new condition dubbed “mask-associated dry eye” have been coming out of vision care centers in the country, prompting researchers to look at the effects of face masks on the delicate tear film responsible for protecting the eye.

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Vertex begins human testing for diabetes cell therapy

Bio Pharma Dive

While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.