STAT

SEPTEMBER 22, 2022

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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European Pharmaceutical Review

SEPTEMBER 22, 2022

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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Pharmaceutical Technology

SEPTEMBER 22, 2022

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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PhRMA

SEPTEMBER 20, 2022

World Trade Organization (WTO) members, including the United States, are considering waiving commitments to honor certain intellectual property (IP) rights on COVID-19 treatments, following a harmful and unnecessary decision to do the same for COVID-19 vaccines. This is referred to as the TRIPS waiver.

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Vaccines 122

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

Communication

STAT

SEPTEMBER 21, 2022

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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pharmaphorum

SEPTEMBER 20, 2022

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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PhRMA

SEPTEMBER 23, 2022

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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STAT

SEPTEMBER 19, 2022

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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pharmaphorum

SEPTEMBER 21, 2022

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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Labelling 111

Pharmaceutical Technology

SEPTEMBER 19, 2022

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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Pharma Times

SEPTEMBER 21, 2022

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

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STAT

SEPTEMBER 20, 2022

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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Outsourcing Pharma

SEPTEMBER 19, 2022

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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European Pharmaceutical Review

SEPTEMBER 22, 2022

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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Pharmaceutical Manufacturing 105

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.

Med Ed 101

SEPTEMBER 22, 2022

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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STAT

SEPTEMBER 19, 2022

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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Pharma Times

SEPTEMBER 23, 2022

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

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European Pharmaceutical Review

SEPTEMBER 20, 2022

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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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.

Pharmaceutical Technology

SEPTEMBER 19, 2022

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.

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Adverse Reactions Labelling 98

STAT

SEPTEMBER 20, 2022

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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PharmaTech

SEPTEMBER 20, 2022

Experts from Umoja Biopharma dive into cell therapy development in this episode of the Drug Solutions Podcast, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point.

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European Pharmaceutical Review

SEPTEMBER 21, 2022

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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Vaccines Generic Medicine Biosimilars 98

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pharmaphorum

SEPTEMBER 22, 2022

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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STAT

SEPTEMBER 19, 2022

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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PharmExec

SEPTEMBER 20, 2022

Rohit Gupta is vice president of analytics strategy and transformation at Beghou Consulting - he works with biopharma leaders on all facets of drug commercialization, from market sizing strategies, to launch planning, to business analytics.

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European Pharmaceutical Review

SEPTEMBER 20, 2022

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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Biosimilars Diabetes 98

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Pharmacy Management

Pharmaceutical Technology

SEPTEMBER 23, 2022

Rivus Pharmaceuticals has raised $132m in a Series B funding round to clinically advance its lead candidate, HU6, for the treatment of obesity and cardio-metabolic disorders. RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech. Existing investors of the company, including Longitude Capital, Medicxi and RxCapital, also took part in the round.

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Diabetes 96

STAT

SEPTEMBER 23, 2022

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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Digital Pharmacist

SEPTEMBER 23, 2022

Pharmacies play a pivotal role in educating patients and caregivers about pain and the medications used to treat it. With September being National Pain Awareness Month, we thought this was the perfect time to discuss this initiative and how we can work together to bring awareness to it. American adults have or have had chronic pain. American adults have or have had high-impact chronic pain.

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European Pharmaceutical Review

SEPTEMBER 20, 2022

New data supports the potential use of Biogen’s and Sage Therapeutics’ zuranolone as a potential episodic treatment for people with major depressive disorder (MDD). Zuranolone is an investigational oral 14-day treatment under clinical development for adult patients with MDD and postpartum depression. In the ongoing open-label, longitudinal SHORELINE Study in MDD, the median time to the first repeat treatment course for those patients who responded to the initial 14-day treatment course was

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Labelling 98

Med Ed 101

SEPTEMBER 18, 2022

Over-the-counter medications provide easy access for patients to solve their own problems. Too often, patients lean on self-treatment without consulting a healthcare professional. One of my primary concerns with this is unforeseen drug interactions. I’ll break down my top 5 OTC drug interactions. NSAIDs NSAIDs make the top of the list when it comes to […].

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