Sat.Sep 17, 2022 - Fri.Sep 23, 2022

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NIH launches the next stage of its ‘human genome project’ for the brain

STAT

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations. Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places.

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

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First patient dosed with HIV gene therapy

European Pharmaceutical Review

A breakthrough gene-editing therapy for human immunodeficiency virus type 1 (HIV) infection has entered first-in-human testing in what is being called “a major milestone in the search for a cure for HIV/AIDS”. EBT-101, a CRISPR-Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) has been administered to the first individual in a Phase I/II trial designed to establish its safety and efficacy.

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Micro-robots, smart toilets, and 3D bioprinted organs: the future of healthcare

Pharmaceutical Technology

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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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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STAT+: After early wins, CRISPR gene editing is about to get a lot harder

STAT

The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their liver last year, another six patients with a different strand of toxic liver DNA knocked out last week.   The next era of CRISPR may not be so smooth.

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LumiraDx Partners with British In Vitro Diagnostics Association

Pharma Times

Link up will involve reporting on role of rapid diagnostics in taking on antimicrobial resistance

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Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pharmaceutical Technology

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring Covid-19 therapies, personal protective equipment, tests and vital elements to bolster health systems.

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‘I’m deeply concerned’: Francis Collins on trust in science, how Covid communications failed, and his current obsession

STAT

Former NIH director and current White House science adviser Francis Collins told a group of journalists late last week about his passion for both the Cancer Moonshot and the new biomedical research agency known as ARPA-H. But he also revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.

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MSD’s pembrolizumab therapy gets NICE approval

Pharma Times

1,500 people set to receive new skin cancer treatment that reduces the risk of it returning

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AstraZeneca’s Tezspire for severe asthma gets green light in EU

pharmaphorum

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. Tezspire (tezepelumab) has been cleared for use in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal produ

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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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EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.

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A new study asks: Are we harming blood donors by taking blood from them?

STAT

One question has plagued the field of blood donation for as long as there have been transfusions: Are we harming blood donors by taking blood from them? Our iron stores are largely self-conserved: Our bodies recycle iron from old red blood cells to make new red blood cells. Iron that’s in use doesn’t tend to exit the body unless a person loses blood, whether through menstruation, bleeding from trauma, illness — or through donation.

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Recognizing National Sickle Cell Awareness Month

PhRMA

September is National Sickle Cell Awareness Month and a time for us to underscore the biopharmaceutical industry’s ongoing commitment to improve the lives of patients, families and communities affected by sickle cell disease.

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Hope for lupus sufferers with Feinstein Institutes-led phase 2 trial

pharmaphorum

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

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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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Novo Nordisk’s icodec therapy delivers positive data

Pharma Times

Data shows participants achieved greater treatment satisfaction when switching to icodec

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Medicare is using one of its biggest hammers to try to fix the dialysis system: how providers are paid

STAT

Chronic kidney disease, already a problem affecting millions of Americans , is only expected to become more prevalent as the country ages. For those with the disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine or their abdomen.

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Intranasal TIPs therapy study shows potential to reduce COVID-19 transmission

Outsourcing Pharma

Gladstone Institutes seek FDA approval for human clinical trial after single-dose, intranasal TIPs treatment for SARS-CoV-2 infection limits transmission in infected animals by decreased viral shedding.

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GSK requires supplier sustainability compliance from 2023

European Pharmaceutical Review

At Climate Week NYC GSK presented its new Sustainable Procurement Programme, announcing a fresh agenda, outlining how they will support their suppliers to succeed in their bold environmental objectives: have a net zero climate impact and a net positive impact on nature. This is an important move, as many GSK suppliers do not have easy geographical access to green infrastructure or green financing.

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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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AstraZeneca’s Tezspire approved in the EU for patients with severe asthma

Pharma Times

Tezspire is a maintenance therapy for patients with no phenotype or biomarker limitations

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STAT+: Minimal compliance, or meaningful change? Epic faces a crossroads as new rules put pressure on health data sharing

STAT

In the business of selling record-keeping software to hospitals, Epic Systems is breaking away from the pack. The Wisconsin-based company’s contracts now account for nearly half the nation’s hospital beds, and in recent months it has jumped out to a commanding lead over No. 2 Oracle Cerner, taking away dozens of customers. More than 253 million Americans, or 77% of the population, are estimated to now have data in the company’s software.

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Serotonin Syndrome Versus Neuroleptic Malignant Syndrome

Med Ed 101

Serotonin syndrome and neuroleptic malignant syndrome (NMS) are two commonly taught drug-induced syndromes but are rarely encountered in practice. I wanted to put together some important differences between these two syndromes because many of the symptoms overlap. Some of those classic overlapping symptoms include hyperthermia, hypertension, and tachycardia.

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Green HPLC method enables antipsychotic determination

European Pharmaceutical Review

In a recent paper, researchers demonstrated the comparability of a green high performance liquid chromatography (HPLC) for the determination and screening of typical antipsychotic drugs both in bulk and pharmaceutical formulation. Antipsychotics are used to treat a variety of serious mental disorders including schizophrenia and bipolar disorder, in which manic states may require management with multiple drugs.

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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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LEO Pharma receives positive CHMP opinion of Adtralza

Pharma Times

Therapy is for the treatment of adolescents with moderate-to-severe atopic dermatitis

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Opinion: FDA and USDA need to get on board with the CDC about reducing antibiotic use in raising animals for food

STAT

The overuse of antibiotics and other antimicrobials in raising farm animals for food may not be equivalent to Covid-19 and climate change as threats to human health, but it is right up there. This practice contributes to antibiotic-resistant infections, which are now a leading cause of death worldwide. The annual death toll from antimicrobial resistance could reach 10 million by 2050 — more people than currently die from cancer.

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NICE says yes to BeiGene’s Brukinsa after Scottish nay

pharmaphorum

BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has become the first drug in the class to be recommended for routine NHS use in England and Wales to treat Waldenström macroglobulinaemia (WM) – a rare form of non-Hodgkin lymphoma (NHL). The final appraisal document from health technology assessment (HTA) agency NICE says that Brukinsa can be used to treat WM in adults who have had at least one prior treatment, and only if bendamustine plus rituximab therapy is also suitable.

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EMA human medicines committee (CHMP) highlights, September 2022

European Pharmaceutical Review

In its first meeting since July, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended these 12 medicines for approval: Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season (when there is a risk of RSV infection in the community).

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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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Is Your Demand Side Platform (DSP) Ready for the Cookieless Future?

PharmExec

A cookieless future is on the horizon, so marketers across all industries are being forced to rethink their strategies and plan for the future. What does that entail?

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Surgeons often take a fifth of the lungs to remove a small tumor. There may be a better way.

STAT

Claudia Donohue was on the operating table first thing in the morning. It wasn’t where she wanted to end up when she first learned she had lung cancer. When she saw the constellation of white dots on her chest scan, she figured the last 59 years of smoking cigarettes had finally caught up to her. Plus, she’d already had cancer once before, in her bladder.

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Patient centricity is becoming business critical for pharma

pharmaphorum

New book sets the pharmaceutical industry on a course for bridging the patient centricity optimism gap. Bridging the gulf between patient centricity ambition and reality has never been more important for pharma – luckily, this seemingly insurmountable goal isn’t as far out of reach as many envision. That’s according to Sharon Suchotliff, patient centricity lead at consultancy firm ZS Associates, which has just published a book on the art of patient involvement.

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EMA approves biosimilar interchangeability in EU

European Pharmaceutical Review

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. Interchanging biosimilars is an acceptable practise already used by many Member States. However, the current lack of certainty whether interchangeability is acceptable EU-wide has prompted this decision.

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FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. Through certain Qualified Treatment Centers in the country, Skysona is anticipated to be made available commercially by the end of this year.