August, 2020

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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

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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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Sophia Genetics launches AI tool to find COVID-19 ‘unknowns’

pharmaphorum

Swiss medical data specialist Sophia Genetics has launched a platform that will sift through data generated at more than 1,000 hospitals around the world to try to work out how the COVID-19 pandemic will evolve in the coming months and years. The data mining tool will be used to try to unearth some of the many unknowns with the virus, using next-generation sequencing (NGS) to see how the genome of SARS-CoV-2 changes over time, along with patient genetic information, results of lung and CT scans,

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Potential HIV cure Phase I trial gets FDA green light

Outsourcing Pharma

American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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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When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety.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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What Happens When 3rd-Party Cookies Expire?

Pharma Marketing Network

2022 will usher in the demise of third-party cookies—that means pharma brands must change their approach to targeting and measurement. For decades, the third-party cookie has been a core component of any digital marketing strategy, allowing advertisers to deliver targeted ads and measure their effectiveness. However, with increased consumer privacy concerns and regulations, third-party cookies are set to expire by 2022.

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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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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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CSafe, Cloudleaf partner on cold-chain tracking tech

Outsourcing Pharma

The firms are working to create a platform that gives the ability to monitor temperature-sensitive treatments, vaccines and other products.

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What They Said – A Look Back at FDA Press Releases First Half of 2020

Eye on FDA

Each year, midway through it all, I take a look back to see what FDA has been talking about and compare it to the year before to see how things may have changed. I’m a little late at getting to it this year due to all the COVID-19 distraction. But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Adapting Customer Engagement Strategies to the COVID Landscape

Pharma Marketing Network

The pharmaceutical industry has been under pressure for the past decade to change its go-to-market models. While the industry has attempted change, any change to its approach has been guarded. But the industry’s new challenge—marketing and selling in a COVID-19 environment—abruptly changes the customer interaction landscape, perhaps permanently. In office/in person sales promotion, the staple of pharmaceutical company activities, is simply not possible today with interactions reduced to the spor

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Researchers says hydroxychloroquine could still prevent COVID-19

Pharma Times

Scientists from the University of Oxford say the drug is being ‘discarded prematurely’

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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.

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Finding resilience after an HIV diagnosis

pharmaphorum

Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. He tells pharmaphorum about the importance of resilience in coping with a serious illness. John first began writing about HIV/AIDS as a journalist in 1986. “I had two friends of mine in their 20s die from AIDS while I was in journalism school in 1985 – a time when AIDS was always in the news and there was a lot

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Breaking FDA COVID-19 news

Outsourcing Pharma

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

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Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider

Drug Patent Watch

When drug patents expire, billions of dollars in revenues can disappear overnight as competitors enter the market. Accordingly, many investors focus on drug patents when evaluating drug companies. But, there…. The post Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider appeared first on DrugPatentWatch - Make Better Decisions.

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6 Key Takeaways from HBA’s “Virtual Best Practices: Clarity, Collaboration and Connecting”

Pharma Marketing Network

Recently, the Healthcare Businesswomen’s Association (HBA) held a webinar entitled, Virtual Best Practices: Clarity, Collaboration and Connecting , which dove into the topic of “Zoom fatigue,” a new, commonly used term defined by the draining feeling you experience after a day of long, unnecessary meetings. We are all facing new challenges in the rapidly changing work environment.

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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

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Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

NY Times

A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials.

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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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Novateur study points toward potential COVID-19 treatment

Outsourcing Pharma

Researchers at Novateur Ventures have released a strategy that examines leukotrienes as the cause for hyperinflammatory response in severe cases.

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Drug Repurposing: An Overview 

Drug Patent Watch

This article was originally published by Mahendra Saini, Nikhita Parihar, Shankar Lal Soni, and Vandana Sharma in the Asian Journal of Pharmaceutical Research and Development. 2020; 8(4): 194-212 under an…. The post Drug Repurposing: An Overview appeared first on DrugPatentWatch - Make Better Decisions.

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3 Key Takeaways: DHC Group Omnichannel Roundtable August 2020

Pharma Marketing Network

In the wake of the sales field disruption, DHC Group’s Mark Bard held a roundtable with several physician communication experts to discuss how marketers should move forward to insulate against channel dependence in the future. While the phrase “ Our expert panel focused on that reality and what the omnichannel of the future might look like.” is not new, the concept of building an HCP communication plan that isn’t significantly impacted by the loss of one channel or another is less developed.

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Verona progresses PhII trial of COPD inhaler

Pharma Times

Following a pause because of coronavirus, the company has now kicked off the second part of a trial assessing a pressurised metered-dose inhaler formulation of ensifentrine

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Inside Operation Warp Speed

NY Times

The goal of the initiative is admirable: getting a coronavirus vaccine out to Americans and saving lives as soon as possible. It is not, however, without its problems.

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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. .

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PRA: get ready for the RACE Act

Outsourcing Pharma

Experts from the CRO offers insight on preparing for the changes to the pediatric oncology research requirements, which take effect next week.

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How GoodRx Profits from Our Broken Pharmacy Pricing System

Drug Channels

On Friday, GoodRx filed its Form S-1 in preparation for going public. Link below. The company is insanely profitable. Its adjusted net income—earnings before interest, taxes, depreciation, and amortization (EBITDA)—is an astonishing 40%. Below, I provide my overview of how our crazy drug channel system enables GoodRx’s good fortune. You will admire the GoodRx management team’s business savvy in building a company that lowers out-of-pocket costs for consumers.

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FDA Credibility on the Line

Eye on FDA

In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments. That standard is even more important now, as we approach a time when critical clinical data will be emerging around the various vaccine candidates now being studied.

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Pfizer inks manufacturing deal with Gilead for COVID-19 med remdesivir

Pharma Times

Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment

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The Covid Drug Wars That Pitted Doctor vs. Doctor

NY Times

How much freedom should front-line clinicians have in treating Covid-19 patients with unproven drugs? The question opened up a civil war in some hospitals.

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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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Cerba Research: collaboration boosts rare-disease discoveries

Outsourcing Pharma

A leader from the clinical laboratory and diagnostic solution provider discusses how its research is fueled by partnerships and patient-centricity.

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Bad behaviour: why understanding human behaviour can improve outcomes

pharmaphorum

Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only ten minutes before I had a mental argument with myself, which I thought I had won, promising not to eat another one until tomorrow. The process that goes on inside our heads, affecting the good and bad choices we make regarding our health every day, is the focus of health psychology and the growing interest around behavioural change.

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Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

pharmaphorum

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.

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