Sat.Dec 18, 2021 - Fri.Dec 24, 2021

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Oxford and AstraZeneca aim to produce Omicron-targeted version of vaccine

Pharma Times

Calls for booster vaccinations in order to combat the rising cases brought about by winter and the recent Omicron variant have intensified, in the midst of record case rates.

Vaccines 121
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Sanofi buys US immuno-oncology biotech Amunix for $1 billion

pharmaphorum

Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing cancers – into the clinic next year.

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Time to put patient voice first in cancer research: GRYT Health

Outsourcing Pharma

The organization is working to give oncology professionals the chance to hear directly from patients about their unique experiences, concerns, and hopes.

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New patent for Amgen Inc drug CORLANOR

Drug Patent Watch

Annual Drug Patent Expirations for CORLANOR Corlanor is a drug marketed by Amgen Inc and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent for Amgen Inc drug CORLANOR appeared first on DrugPatentWatch - Make Better Decisions.

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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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Cancer researchers across the UK partner in new trial to find drugs for rare cancers

Pharma Times

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

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US health department backs 15 COVID-focused digital health startups

pharmaphorum

A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic. The PandemicX accelerator, launched by the Department of Health and Human Services, is focused on “using digital tools and publicly accessible data to eliminate disparities and tackle drivers of inequity exacerbated by COVID-19.” Companies that have been invited to take part will get “curriculum, mentor

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Watch: DHC Roundtable Discussion

Pharma Marketing Network

R.J. Lewis, Founder and CEO of eHealthcare Solutions and Tap Native and the Chief Collaborator at Pharma Marketing Network, moderated a deep dive discussion on the topic of physician-level data (PLD) with a focus around drivers for the tool, its usage, and successes learnings about its function in pharma, and the where it’s heading. Guests of the panel included experts from GSK, Ispen, BioPharm Communications, and CMI, who all spoke to the importance of incorporating and leveraging PLD ins

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Pfizer to provide UK with additional 2.5 treatment courses of Paxlovid

Pharma Times

With authorisation, Pfizer’s oral antiviral candidate Paxlovid is an investigational SARS-CoV-2 protease inhibitor could be prescribed at the first sign of COVID-19 infection.

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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease.

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Bias in artificial intelligence impacts drug development: AiCure

Outsourcing Pharma

According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments.

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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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New patent for Allergan Holdings drug VIBERZI

Drug Patent Watch

Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.

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Positive CHMP opinion for finerenone as new treatment for chronic kidney disease and type 2 diabetes

Pharma Times

It is estimated that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide.

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Leveraging augmented analytics to drive better business decisions

pharmaphorum

In early 2020, health officials were cautious about forecasting a COVID-19 vaccine timeline to the public, as vaccine discovery was a historically laborious process that took years (if not decades). Yet a successful COVID-19 vaccine gained emergency approval in just 11 months, a blistering pace that likely saved millions of lives. Such a fast turnaround would not have been possible without advanced analytics and the troves of intelligence that scientists had at their disposal.

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Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults

NY Times

The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”.

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Drug Channels News Roundup, December 2021: CAR-T Profits, UM Boom, Health Plans vs. Experts, Confused Physicians, and Health Insurance Explained

Drug Channels

Happy New Year, everyone! We made it through a challenging 2021. Ring in 2022 with these noisemakers from the Drug Channels party bag: Hospitals earn incredible markups on CAR-T therapies Utilization management booms Health plans often ignore clinical guidelines Benefit designs flummox physicians Plus: an awesomely concise summary of U.S. health insurance.

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CHMP recommend Saphnelo for systematic lupus erythematosus

Pharma Times

With approval, Saphnelo would be the first available treatment for systematic lupus erythematosus in Europe in over ten years.

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FDA sets out its stall on digital tools for remote clinical trials

pharmaphorum

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.

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Purchases, pandemic, and potential treatments: 2021’s greatest hits

Outsourcing Pharma

OSPâs list of the yearâs most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.

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F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older

NY Times

The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.

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COVID-19 vaccine should be offered to vulnerable children aged five to 11-years-old

Pharma Times

Government vaccine advisers have said vulnerable primary school children should be offered a low-dose of a COVID-19 vaccine.

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2021 in review: Building the framework of a patient-centric industry

pharmaphorum

Patient centricity and patient engagement have been hot topics in pharma for some time – but buzz words do not always translate into concrete action. However, we have seen a framework of guidelines and recommendations during the last year on everything from increasing diversity to producing lay summaries, start to take shape. As part of our 2021 in Review series, we look back over some of these developments.

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PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Pharma in Brief

Changes to the Patented Medicine Prices Review Board ( PMPRB ) regime, contained in pending amendments to the Patented Medicines Regulations , have been delayed until July 1, 2022. These amendments form the basis for new PMPRB Guidelines. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force of the amendments.

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Walgreens and CVS Limit Purchases of At-Home Coronavirus Tests

NY Times

The caps come as the rapid spread of the Omicron variant has customers flocking to testing sites and pharmacies, which are struggling to keep up.

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Xeris Biopharma’s glucagon injection becomes available in UK

Pharma Times

Tetris Pharma’s Ogluo is the first ready-to-use, pre-mixed and pre-measured glucagon injection.

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Insights from the WHO’s Global Strategy on Digital Health event

pharmaphorum

The World Health Organization (WHO) recently held a virtual panel discussion during Digital Health Week with speakers from around the world to talk about global strategy on digital health and collective opportunities for catalysing collaborative action. The panel focused on the objectives of the WHO’s Global Strategy on Digital Health 2020-2025 , which aims to develop partnerships at national, regional and global levels to align resources and investments to focus on sustainability and grow

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What Changes To Your Lifestyle Need To Be Done After Bariatric Surgery

Pharma Mirror

Getting bariatric surgery is a lifesaver for many people. It can dramatically improve the quality of life of those that are having problems because of their obesity. It reduces and even eliminates diabetes in many people and seriously reduces the risk of heart disease. The weight loss can be dramatic as well. Starting almost immediately after the surgery, the pounds fall away with ease.

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Family in Nigeria Lost 3 Daughters to Sickle Cell. Can They Save a Fourth?

NY Times

About 150,000 babies are born each year in Nigeria with sickle cell, a deadly disease. Tens of thousands of them die annually before their fifth birthdays.

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AstraZeneca and Novavax say their vaccines are effective against Omicron

Pharma Times

WHO officials remain cautious about claiming Omicron as a milder variant of the COVID-19 virus.

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Novartis bags elusive US approval for cholesterol drug inclisiran

pharmaphorum

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year after it was given a green light in Europe.

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December 24: The Weary World Rejoices

Pharma Packaging Solutions

So he came and proclaimed peace to you who were far off and peace to those who were near, for through him both of us have access in one Spirit to the Father. So then you are no longer strangers and aliens, but you are citizens with the saints and also members of the household of God. Ephesians 2:17-19 NRSV God’s purpose and longing for his creation has always been that we might not only be recipients of his great love and peace, but that we might be his partners in bringing that love and peace t

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Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles

NY Times

A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.

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New patent expiration for Pacira Pharms drug EXPAREL

Drug Patent Watch

Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent expiration for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.

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Novartis adds gene therapy for blindness with Gyroscope buy

pharmaphorum

Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. Just a few weeks France’s Sanofi made a $40 million investment in Gyroscope for first refusal rights on the gene therapy – called GT005 – but it is Novartis that has swooped on the company and its main asset.

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December 22: The Weary World Rejoices

Pharma Packaging Solutions

He has shown you, o mortal, what is good, and what does the Lord require of you? To do justice, to love Mercy, and to walk humbly before God. Micah 6:8 NRSV Requirements are placed on all of us from time to time. As a child, my family had morning prayer time at 4:00 a.m. At that time a bell was rung three times. Although I slept very near the living room, I didn’t always hear the bell immediately.

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2021 Highlights of Chronic Care Medicine

PharmD Live

1. Fee-for-service reimbursement falls as quality performance pay increases. A 3.75% cut in the 2022 Medicare conversion factor, which calculates reimbursement for procedures under fee-for-service, is mandated under a budget neutrality provision and comes after a pay bump from Congress that expires in 2022. Meanwhile, quality performance pay is increasing.