August, 2023

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No longer brushed off: A Minnesota clinic tries to rewrite medicine’s approach to miscarriage

STAT

WOODBURY, Minn. — By the time Taylor Teske came to be sitting on an exam table in an obstetrician’s office in Minnesota, her medical records marked a devastating journey: nine pregnancies, one baby, eight miscarriages. The first miscarriage happened in June 2018, almost as soon as she found out she was pregnant. Teske told her boss at the vascular clinic where she worked that she was pregnant, and he asked if she wanted to sneak a look using the clinic’s ultrasound.

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PEM POCUS Series: Pediatric Lung Ultrasound

ALiEM - Pharm Pearls

Read this tutorial on the use of point of care ultrasonography (POCUS) for pediatric lung ultrasound. Then test your skills on the ALiEMU course page to receive your PEM POCUS badge worth 2 hours of ALiEMU course credit. Take the ALiEMU PEM POCUS: Pediatric Lung Ultrasound Quiz Module Goals List indications for performing a pediatric lung point-of-care ultrasound (POCUS).

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‘We need to do better:’ A biotech CEO on standing apart from the crowd

PharmaVoice

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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Sanofi appoints a venture investor to R&D head as executive team expands

BioPharma Dive

Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.

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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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BenevolentAI doses participants in BEN-8744 study

Pharma Times

The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes

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Stem cell therapy delivers potential for sickle cell disease

European Pharmaceutical Review

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Based on new data from the Novartis Phase I/II clinical trial , which used the first therapy to target a new genetic area and use cryopreserved stem cells, trial participants reported a decrease in vaso-occlusive events.

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More Trending

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Antidote dispensing drones get government funding

The Pharmacist

Antidote dispensing drones or artificial intelligence that detects an overdose could be used to prevent drugs deaths, as a result of government funding awarded to 12 technology projects. The projects are the winners of the Reducing Drug Deaths Innovation Challenge, funded by the Office for Life Sciences and support the government’s Addiction Mission.

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What pharma companies are getting wrong about drug repositioning

PharmaVoice

Children’s Tumor Foundation president Annette Bakker is working to teach the industry the crucial difference between drug repurposing and drug repositioning.

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Bristol Myers gets key FDA approval for bone marrow disease drug

BioPharma Dive

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

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UCB announces approval of Bimzelx

Pharma Times

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes

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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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Guidance for medicine packaging under Windsor Framework

European Pharmaceutical Review

The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. In preparation for the implementation of these requirements under the Windsor Framework, new guidance for the industry was published by the MHRA on 28 July 2023.

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Medicaid rebukes states for mistakenly disenrolling children

STAT

Medicaid warned states Wednesday that they could be mistakenly removing children from government insurance programs in a post-pandemic review of millions of enrollees. States may be unnecessarily disenrolling children from Medicaid or the Children’s Health Insurance Program because they are reviewing families as a whole despite there being a higher threshold to remove children from the programs.

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Researchers develop novel chemosensor-based method for rapid detection of bacterial toxin

Express Pharma

A research team from Japan developed an innovative methodology to detect Lipopolysaccharide (LPS). Based on a novel fluorescent chemosensor, the proposed system detects the endotoxin in a matter of minutes, making it suitable for on-site testing in hospitals and pharma manufacturing facilities. LPS, largely known as “endotoxins”, is a molecule which is found in the outer membrane of Gram-negative bacteria, and can be very harmful to humans.

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Finding the right flu vaccine is hard. Getting people to take it is harder.

PharmaVoice

Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

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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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Sage, reeling from depression drug decision, to lay off 40% of workforce

BioPharma Dive

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

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MTHFR, Hashimoto’s and Nutrients

The Thyroid Pharmacist

You may have heard of the term “MTHFR gene mutation” and may be wondering what it is. First, I’d like to say that I prefer the term “MTHFR gene variation” rather than “mutation.” The word mutation makes it sound like there’s something wrong with the person, while variation is more empowering – and in my opinion, also more accurate. While the word “mutation” implies an occurrence that is rare, unnatural, or flawed, the MTHFR gene variation is common.

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CPE slams 'shambolic' vaccination U-turn despite additional funding

The Pharmacist

Community pharmacies will get additional payments to deliver Covid vaccinations in September and October as the government brings forward the autumn programme in light of a new Covid variant. But the sector’s negotiator has criticised the government’s ‘shambolic start’ to the vaccination programme, which it said has a ‘seemingly endlessly changing timetable’ that leaves community […] The post CPE slams 'shambolic' vaccination U-turn despite additional funding appeared first on Th

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Opinion: It’s long past time for a more comprehensive Covid treatment approach

STAT

Because Covid cases and hospitalizations are no longer front-page news, many Americans might be surprised to learn that we are in the midst of a mini-surge. The latest data from the Centers for Disease Control and Prevention, from Aug. 12, confirm a 21.6% increase in Covid-19 hospitalizations from the prior week and a 21.4% increase in Covid-related deaths, demonstrating that Covid is not over and that Latinos and Blacks have reason to be concerned.

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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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IMA: the all-in-one solutions provider for complete vaccines lines

European Pharmaceutical Review

In the wake of the COVID-19 pandemic, we have now acquired a much clearer understanding of how fast a virus spreads. Even with extremely rapid vaccine development, limitations in production capabilities can have real-life implications. This has led pharmaceutical equipment manufacturers to react quickly, while maintaining due levels of diligence and social responsibility.

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How an AstraZeneca exec is leading the charge in the next immuno-oncology era

PharmaVoice

The pharma giant’s head of immuno-oncology is now charging toward the next step in the cancer fight with long-term survival and precision.

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Medicare names first 10 drugs for price negotiations

BioPharma Dive

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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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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Cybersecurity dominates pharma industry discussions during Q2 2023: GlobalData

Express Pharma

Amid the push for digital transformation, the pharma industry finds itself navigating a critical intersection of concerns—data protection, regulations, and the threat of data breaches. This pivotal juncture has thrust cybersecurity into the spotlight in the discussions of companies during Q2 2023, revealing its paramount significance in safeguarding sensitive information, with regulation mentions getting on par with data protection, reveals the Company Filing Analytics Database of GlobalData.

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STAT+: Departing Stanford president retracts two widely cited papers, against lead author’s wishes

STAT

After an expansive investigation found manipulated data and other issues with papers co-authored by Stanford’s now ex-president Marc Tessier-Lavigne , the prominent neuroscientist on Thursday retracted two studies published in the journal Science in 2001 — over the objection of a former postdoctoral researcher who played a leading role in both projects.

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CGT manufacturing QC market to value $2.8b by 2031

European Pharmaceutical Review

According to a report by Transparency Market Research Inc, the global cell and gene therapy (CGT) manufacturing quality control (QC) market is anticipated to value $2.8 billion in 2031. It is projected to expand at a CAGR of 24.6 percent from 2023 to 2031. Comparatively, the market is expected to value $463.1 million by the end of 2023. With increasing research and development in the cell and gene therapy field, the demand for optimal quality control is needed to ensure the safe and efficient ma

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A rare disease research aims to tackle disability discrimination in new lawsuit

PharmaVoice

How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

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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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Apellis finds faulty needles in probe of rare eye drug side effects

BioPharma Dive

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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STAT+: Sly CAR-T strategy evades ‘fratricide’ problem to aim at all blood cancers

STAT

The problem with the plan was fratricide, among other wanton cellular murders. Saar Gill and Carl June, cell therapy researchers at the University of Pennsylvania, wanted to make a single treatment that could tackle virtually all blood cancers. It was an audacious goal. Most cell therapies, such as CAR-T, involve removing a patients’ T cells, arming them with GPS coordinates for that tumor, and then reinfusing them into the battlefield.

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siRNA therapy shows long-term potential in lowering LDL-C

European Pharmaceutical Review

Novartis has announced that Leqvio ® (inclisiran) , the first and only small interfering RNA (siRNA) therapy indicated to reduce low-density lipoprotein cholesterol (LDL-C), has demonstrated promising long-term results. This is based on three-year follow up data from a Phase III trial, presented at the European Society of Cardiology (ESC) Congress 2023.

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