Sat.Aug 29, 2020 - Fri.Sep 04, 2020

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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. This would see the UK mirroring decisions made by the European Medicines Agency, while also laying out a process should companies wish to file for a separate approval in the UK.

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PhIII US trial for AZ' coronavirus vaccine

Pharma Times

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa

Vaccines 122
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Trending Sources

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2 College Students Dreamed Up an A.L.S. Treatment. The Results Are In.

NY Times

A study of their therapy and clinical trials of other experimental treatments are offering glimmers of hope that paralysis from the disorder can be slowed.

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COVID-19 treatment study predicts adverse drug events

Outsourcing Pharma

Innovative research by Tabula Rasa Healthcare uses simulation technology to analyze potential adverse drug events of potential therapies for the virus.

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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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Mobio closes $1.8m seed fund to develop meditation app

pharmaphorum

Digital health firm Mobio Interactive has closed a $1.8 million seed fund to advance development of its meditation app Am Mindfulness. Mobio said that the app, known as Am for short, is the first and only meditation app to outperform placebo in randomised controlled trials. MI’s Seed raise was led by the Singapore-based Verge HealthTech Fund along with Atlas Asset Management , Creative Ventures and VC giant SOSV.

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Immunotherapies could target aggressive pancreatic cancer, research indicates

Pharma Times

Scientists have discovered that hard-to-treat pancreatic cancer hijacks a key immune system response

Immunity 135

More Trending

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Front-line physicians offer COVID-19 insights

Outsourcing Pharma

A recent study from healthcare insights company Sermo shares information and perspectives that trial and pharma professionals could learn from.

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10 reasons why virtual collaboration and medical education will persist in the new normal

pharmaphorum

While the effects of COVID-19 have been devastating for many industries, its positive impact on accelerating the uptake of digital health technologies and virtual collaboration solutions is undeniable. This has been a long time coming and there are countless reasons why I believe virtual collaboration and medical education are here to stay, long after there is a vaccine for COVID-19 and physical distancing guidelines have been lifted. 1.

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Janssen disappointed with second NICE no for Spravato

Pharma Times

NICE has concerns with the evidence submitted but Janssen insists the nasal spray is a cost-effective use of NHS resources

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For FDA and CDC and the Rest of Us – The Stakes Have Never Been Higher

Eye on FDA

Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week the President issued a tweet stating that people were operating within FDA to slow progress on a vaccine without supplying any evidence, credible or otherwise, to support that.

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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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COVID-19 report shares insights on potential therapies

Outsourcing Pharma

A new scientific report offers a comprehensive review of protein targets, associated COVID-19 drug candidates to date and other revealing information.

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Sanofi/Regeneron’s Kevzara fails again in serious COVID-19 cases

pharmaphorum

Sanofi has drawn another blank in its attempt to repurpose its IL-6 drug Kevzara to tackle the extreme immune reaction seen in serious cases of COVID-19. The French pharma and development partner Regeneron have been testing Kevzara (sarilumab) in patients severely or critically ill and hospitalised with COVID-19. In severe cases of COVID-19, patients suffer a “cytokine storm” where the immune system becomes overstimulated and attacks the body.

Immunity 109
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UK launch for Novo's new diabetes pill

Pharma Times

Rybelsus is the world’s first and only oral GLP-1 receptor agonist

Diabetes 142
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In Hard Times, a Barrage of Ads Promises Peace of Mind

NY Times

Meditation apps, tinctures, stress-busting gummies — spending on commercials for all of them is rising amid the pandemic’s climbing death toll and economic strain.

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Elligo: increasing diversity can elevate trials

Outsourcing Pharma

A company leader outlines the importance of increasing diversity in clinical trial patient populations, and how researchers can improve their results.

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Highlight Therapeutics trials second-line melanoma combo after immunotherapy fails

pharmaphorum

Cancer immunotherapy has set new standards in care, with some impressive responses in those patients lucky enough to respond. But many patients still do not respond to therapies such as Merck & Co’s anti PD-1 therapy Keytruda (pembrolizumab), or go on to develop progressive disease, and pharma companies are looking for new second-line therapies.

Immunity 105
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EU OKs paediatric use of Gilead's Epclusa

Pharma Times

The decision allows use of the therapy in the EU in children as young as six years of age

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Pfizer Expects Vaccine Results by End of October

NY Times

Pfizer’s chief executive, Dr. Albert Bourla, said the drug-making company is in a “very advanced stage” and should know by the end of October whether the coronavirus vaccine they are developing is safe and effective.

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Why Do CVS And Express Scripts Rely on Secretive Private Companies to Run Their Copay Maximizer Programs? (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I work on the forthcoming 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post and comments from June 2020. It was one of my most popular articles in 2020. One minor update: PrudentRx finally has a website! It's still uninformative and misleading, but I suspect that my original article shamed them into putting up a better placeholder.

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GSK opens £10m AI hub in London

pharmaphorum

GlaxoSmithKline is opening a £10 million artificial intelligence (AI) research hub in King’s Cross, London, according to a press report. The area is being reimagined as a life sciences and technology hub and is already home to the Francis Crick Institute biomedical research organisation. King’s Cross is also home to Google’s DeepMind artificial intelligence company, which has already been involved in life sciences projects such as using the technology to predict acute kidney injury.

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Kevzara fails in PhIII COVID-19 trial

Pharma Times

Sanofi and Regeneron do not anticipate carrying out further research on Kevzara in COVID-19

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Jacobson Pharma Collaborates with Fosun Pharma Group to Supply Potentially 10 Million Doses of BioNTech SE’s COVID-19 Vaccine Candidate in Hong Kong and Macau

Pharma Mirror

Jacobson Pharma Corporation Limited (“Jacobson Pharma” or the Group”; Stock Code: 2633.HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, announced the signing of a letter of intent (“Letter of Intent”) with Fosun Industrial Co.

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Copay Maximizers Are Displacing Accumulators—But CMS Ignores How Payers Leverage Patient Support (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I work on the forthcoming 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post and comments from June 2020. I'll have an update on accumulators in September. COVID-19 has not stopped the wheels of policy bureaucracy from grinding. Last week, the Centers for Medicare and Medicaid Services (CMS) released its final Notice of Benefit and Payment Parameters for the 2021 benefit year.

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Sanofi and GSK begin clinical trials of coronavirus vaccine

pharmaphorum

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction. Meanwhile GSK is producing the booster that reduces the amount of active ingredient necessary to produce an effect.

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Corticosteroids boost survival rates for COVID-19 patients

Pharma Times

Four papers have been published reinforcing evidence that steroids can significantly improve the outcomes for those critically ill with the virus

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Finding hidden treasures in old drugs: the challenges and importance of licensing generics

Drug Patent Watch

This paper was originally published by Melek Simsek, Berrie Meijer, Adriaan A. van Bodegraven, Nanne K.H. de Boer, and Chris J.J. Mulder in Drug Discovery Today under a Creative Commons…. The post Finding hidden treasures in old drugs: the challenges and importance of licensing generics appeared first on DrugPatentWatch - Make Better Decisions.

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Walgreens and CVS Top the 28,000 Pharmacies Profiting from the 340B Program. Will the Unregulated Party End? (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I work on the forthcoming 2020-21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post and comments from July 2020. I'm rerunning this post to provide context for manufacturers' recent actions regarding 340B contract pharmacies. The "SUBREGULATORY MISCHIEF" section below explains crucial background.

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England trials population testing for COVID-19

pharmaphorum

England is to trial population testing for COVID-19 in places such as schools, colleges and busy public spaces. Health secretary Matt Hancock said the government has earmarked an extra £500 million ($552 million) to scale up testing and capacity to launch community pilots as fears mount about as second wave of infections during the winter months. The population testing will be made possible by new test kits capable of giving results within 15 minutes or so.

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Sanofi, GSK launch early trial for COVID-19 vaccine

Pharma Times

Over 400 participants are being enrolled in the Phase I/II study after promising preclinical safety and immunogenicity data

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Video: A Major Driver of U.S. Digital Display Ad Spending Growth in 2020 and Beyond

Pharma Marketing Network

Despite the COVID-19 pandemic, digital display advertising will continue to grow this year with more investments in video ads. According to eMarketer, U.S. advertisers will increase investments in video by 11.3% this year to $35.45 billion, making it the only digital ad format to grow at a double-digit rate this year. For the first time ever, video will account for more than a quarter of all U.S. digital ad spending.

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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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How a flock of birds can help solve complex healthcare market research challenges

pharmaphorum

Bilal Babar from THE PLANNING SHOP tells us how the movement of birds and Swarm Technology have helped develop multiple market research tools. Flocks of birds wheeling, swooping and gliding in unison, as if choreographed, are a wonderful sight. The benefit to members of the flock are many including safety from predators, more eyes to spot food and natural selection – those that can’t keep up or fly in a very densely populated flock and make such sharp turns without colliding don’t survive.

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Roche to launch SARS-CoV-2 rapid antigen test

Pharma Times

The test can typically identify SARS-CoV-2 infection within 15 minutes

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IntelGenx, ATAI partner on film-based psychedelics

Outsourcing Pharma

The companies will join forces to use IntelGenxâs polymeric film technologies for development of pharmaceutical-grade psychedelic drug treatments.

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More Than 70,000 Covid-19 Patients Have Received Plasma. Does It Help?

NY Times

The idea behind convalescent plasma is attractively simple, but we just don’t know enough.

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