Sat.Aug 27, 2022 - Fri.Sep 02, 2022

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Your questions on the new Covid vaccine boosters answered

STAT

Sometime this weekend or early next week, pharmacies and doctors’ offices are going to start to receive Covid-19 boosters that have been reformulated to include protection against one of the sub-variants of Omicron. These boosters, from Pfizer and its partner BioNTech as well as from Moderna, are bivalent shots. They target two strains of the SARS-CoV-2 virus, both the original strain that all previous vaccines have protected against, and the Omicron sub-variants BA.4/BA.5.

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Parexel joins pharmacy giants in quest to boost community health clinical trials

PharmaVoice

The Community Alliance Network is the latest industry initiative looking to the pharmacy counter to help improve trial recruitment diversity.

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Managing the next pandemic: the role of nasal vaccine administration

European Pharmaceutical Review

The COVID-19 pandemic has reminded the pharmaceutical industry of several key lessons. It has highlighted the value of cutting-edge technologies, such as messenger RNA (mRNA) vaccines, and reinforced the industry’s understanding of the power of collaboration, including with contract partners such as contract development and manufacturing organisations (CDMOs).

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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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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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A third Covid autumn is upon us. Here’s a look at where we stand

STAT

As the country heads for its third autumn and winter with Covid-19, the forecasts are not auspicious. Given how transmissible the SARS-CoV-2 virus is, models anticipate more than 100,000 additional deaths by the time next summer rolls around. The toll will depend on whether new variants emerge and how humans behave. Will many Americans, for example, decide to get the new, Omicron-tailored booster that could be available as soon as this weekend?

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The ‘long COVID’ nightmare: Data-driven alliance offers understanding of the lasting viral impact

PharmaVoice

A collaboration between Stanford University researchers and Komodo Health aims to advance knowledge of lingering COVID symptoms, health disparities and intervention strategies.

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More Trending

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Novo Nordisk agrees to acquire biopharma firm Forma for $1.1bn

Pharmaceutical Technology

Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.

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Opinion: People with terminal cancer need to know they are dying. Doctors shouldn’t withhold that information

STAT

I have worn many hats professionally. The most uncomfortable one is “doctor friend.” At best, it’s a request for a recommendation for a gynecologist or for advice on which antihistamine works best for allergies. But other times I have found myself in the role of interpreter between a friend and their physician, navigating serious health problems.

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Leading the industry’s next potential game-changer in drug discovery

PharmaVoice

Rachel Meyers, chief scientific officer at Faze Medicines, is helping guide the company towards the development of biomolecular condensates — an emerging field that could transform drug discovery.

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What is a 340B covered entity?

PhRMA

We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make appropriate decisions about their own health but also help enable constructive conversations on how we can support a regulatory and policy environment that helps patients access life-saving medications.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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FDA grants EUAs for Moderna and Pfizer-BioNTech’s bivalent Covid-19 boosters

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. According to the amended EUA, the vaccines are indicated to be administered at a minimum of two months after the initial or booster dose. These 'updated boosters' comprise the SARS-CoV-2 virus’ two messenger RNA (mRNA) components, one from the initial strain and the other one common between the BA.4 and BA.5 lineage o

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FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains

STAT

The Food and Drug Administration on Wednesday authorized new Covid booster shots from Moderna and Pfizer that more closely match the strains of the coronavirus that are currently circulating in the U.S. Pfizer’s booster, made with partner BioNTech, is being authorized for people as young as 12 years old. The Moderna booster is being authorized for people ages 18 and up.

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First 90 Days: Adaptive Biotech’s Tycho Peterson

PharmaVoice

A long-time analyst, Tycho Peterson brings his business savvy to the C-suite at Adaptive, where he began as CFO in June with a knowledge of what works and what doesn't in the diagnostics space.

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Boehringer bags first approval for rare skin disease drug

pharmaphorum

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. The FDA has cleared the IL-36 receptor inhibitor under the Spevigo brand name to treat the devastating eruptions of painful blisters, known as flares, that are a characteristic of GPP.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Why Balancing Blood Sugar is Vital for Hashimoto’s Health

The Thyroid Pharmacist

I often get asked if there is one thing that people with Hashimoto’s should do right away to feel better. My answer is always, “There are two! Get off gluten and balance your blood sugar levels!”. Balancing blood sugar levels should be one of the top priorities for anyone who is hoping to overcome autoimmune thyroiditis (and adrenal fatigue). It was one of the first interventions I tried when working to heal my own thyroid condition, and it made a big difference for me.

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A Q&A with WHO’s Maria Van Kerkhove on Covid — and fatigue over the pandemic

STAT

Maria Van Kerkhove gets it. Truly, she knows you’re over Covid. The World Health Organization’s technical lead for Covid-19, Van Kerkhove understands that the world is struggling with a lot right now. Devastating flooding in Pakistan, famine in the Horn of Africa, war in Ukraine, monkeypox around the globe — there are too many demands for our attention and concern, for philanthropic and government funding.

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Moderna’s lawsuit against Pfizer and BioNTech explained in 10 quotes

PharmaVoice

The biotech says that its competitors’ COVID-19 vaccine copied proprietary mRNA technology. Here’s a breakdown of the case.

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Hungary will deploy Brainomix AI stroke software nationwide

pharmaphorum

UK medtech company Brainomix has claimed its first national contract – from Hungary – for its artificial intelligence-based platform used to improve diagnosis and treatment of people with suspected stroke from medical images. The platform – called e-Stroke – is already deployed in hundreds of hospitals across the UK, other countries in Europe and Asia as well as the US but this is the first time that it has been the subject of a nationwide tender, according to the Oxford-based company.

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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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Drug Digest: Sterilization’s Horizon: Improving Automation, Single-Use Technologies, and Annex 1

PharmaTech

Pharmaceutical Technology editors interview aseptic and sterilization experts from Watson-Marlow Fluid Technology Solutions and Cherwell—diving into sterilization, aseptic processing, and the revised EU GMP Annex 1 guidance.

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Opinion: ‘Food is medicine’ interventions should be the main course at White House nutrition conference

STAT

Much of the public’s perceptions around food as an intervention for health are dated. So are the U.S. government’s perceptions and its health care policies. Not by a matter of years, but by decades. The last time the nation focused on food — from the top — was the 1969 White House Conference on Food, Nutrition, and Health.

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Woman of the Week: Thread’s Kim Boericke

PharmaVoice

Fresh off an eight-year tour of duty at ICON, the CRO industry veteran is stepping into a new role and a new title as chief delivery officer at Thread.

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Europe approves first gene therapy for treatment of haemophilia A

European Pharmaceutical Review

The European Commission has granted conditional marketing authorization to BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe haemophilia A in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). The EC also endorsed the European Medicines Agency’s (EMA’s) recommendation for Roctavian to maintain orphan drug designation, thereby granting a 10-year period of market ex

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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DeltaV™ Spectral PAT: Achieve Real-Time, Closed-Loop Control in PAT Manufacturing

PharmaTech

In a new podcast titled, “DeltaV™ Spectral Process Analytical Technology (PAT): Achieve Real-Time, Closed-Loop PAT in Manufacturing,” find out how embedding PAT directly into the control system enables life sciences manufacturers to take a simplified approach to achieving real-time manufacturing, compliance with confidence, greater ROI and delivery of quality treatments to market faster.

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Rahul Gupta, first physician to serve as drug czar, says stigma among doctors is key culprit in addiction crisis

STAT

WASHINGTON — Rahul Gupta is no stranger to the nationwide addiction crisis. Drug use and overdose defined his tenure as the top health official in West Virginia, arguably the state hardest hit by the epidemic, and before that as the health officer in the state’s largest county.

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Hurdles remain in biosims market — but Alvotech is undeterred

PharmaVoice

The biosimilar developer is advancing a pipeline with high growth potential, including a copycat of Humira.

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Overdoses come in many forms

PharmD Live

By Marshall Eidenberg, DO, PharmD Live. Medication: everything in moderation. There is horror and harm in acknowledging the estimated 107,622 drug overdose deaths in 2021. We have seen the scourge of opioids, synthetic opioids, methamphetamines, and cocaine overdose deaths across the country. Yet there is an additional problem of overdoses due to limited information and understanding by physicians working inside their practices.

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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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Personalised culture media solutions support timely biopharmaceutical manufacturing

European Pharmaceutical Review

What are the clients’ goals in seeking out a personalised culture media solution? Oftentimes, our clients’ goals are to increase cell growth, improve protein titers and optimise product quality attributes. Biopharmaceutical manufacturers find that custom media can provide tailored solutions. What are some of the challenges manufacturers face? Discussion often exposes significant problems with lot-to-lot consistency with current media suppliers and scale-up to supply all their manufacturing sites

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Opinion: As hospitals raise their prices, U.S. workers and businesses suffer

STAT

Despite a recent taxpayer-subsidized boon , the hospital industry spent the last several months lobbying for additional federal dollars amid warnings about the continued spread of Covid-19 and inflation’s impact on the nation’s health care system. Those efforts bore fruit: Medicare recently granted hospitals the largest price increase since 1998.

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Pharma’s renewed sickle cell investment lifts a once-shirked disease

PharmaVoice

Pfizer's $5.4 billion deal to acquire Global Blood Therapeutics invigorated the fast-growing market, and patients are fit to be the benefactors.

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Moderna files lawsuits against Pfizer and BioNTech over mRNA technology

Pharmaceutical Technology

Moderna has f iled patent infringement lawsuits in the US District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany against Pfizer and BioNTech over messenger ribonucleic acid (mRNA) technology. Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, is said to have infringed patents filed by Moderna between 2010 and 2016 for its mRNA technology.

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Pfizer’s RSV vaccine effective in older patients

European Pharmaceutical Review

Pfizer has announced positive top-line data from a Phase III clinical trial (NCT05035212) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. Based on the results, Pfizer said it intends to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF “in fall 2022”.