Sat.Apr 22, 2023 - Fri.Apr 28, 2023

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Q&A: Chronicling the failures of the U.S. response to Covid

STAT

A new book on the U.S. response to the Covid-19 pandemic paints a picture of a country ill-prepared to cope with a dangerous biological foe, riven by partisan politics, and led by people who saw little political gain in taking ownership of managing the crisis. It also describes a country that remains ill-equipped to battle the next pandemic or major disease threat, though it lays out changes that could strengthen the country’s position.

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Roy Vagelos is retiring and leaving a legacy of leadership lessons

PharmaVoice

The longtime pharma leader is stepping down from his role as chair of Regeneron’s board in June after decades in drug development.

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FDA approves new ALS medicine in precedent-setting decision

BioPharma Dive

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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IBCC – ABG, VBG, and pulse oximetry

EMCrit Project

The precise utilization of ABG, VBG, and pulse oximetry remains controversial. Unfortunately, there is little high-level evidence investigating whether these interventions affect patient outcomes (for example, there is precious little evidence to support most of the target values that we're chasing after). This chapter attempts to explore the strengths, weaknesses, and indications for various techniques. […] EMCrit Project by Josh Farkas.

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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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Opinion: Why involuntary treatment for addiction is a dangerous idea

STAT

As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders

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20 years on, the next stage of the human genome revolution is brewing

PharmaVoice

Two decades after the Human Genome Project, scientists are on the brink of uncovering its full potential for drug development.

More Trending

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Breathing easy: How digital inhalers are changing asthma treatment

Pharmaceutical Technology

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Led by students, a nascent climate movement is taking hold in medical education

STAT

When Cecilia Sorensen was an emergency medicine resident practicing at Denver Health in Colorado a few years ago, summer was known as “trauma season.” Gunshot and motor vehicle accident victims, people with heart attacks and COPD would stream into the ER. Later, on a fellowship, she witnessed the health impacts of drought in Syria. The common driver, she realized, was climate change and its impact, both locally and globally.

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A physician’s perspective on health equity, diversity and inclusion

PharmaVoice

Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

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Bristol Myers boosts cell therapy production with Novartis plant

BioPharma Dive

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

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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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Pioneering malaria vaccine gains regulatory clearance

European Pharmaceutical Review

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it

STAT

In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.

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5 minutes with — DTRA’s Dr. Amir Kalali

PharmaVoice

An industry veteran, innovator and curator, Dr. Amir Kalali’s vision for the future is patient-focused.

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Orbital raises $270 million in biotech’s largest Series A round this year

BioPharma Dive

Founded by Howard Chang, John Maraganore and others, the RNA-focused startup drew investment from a large group of blue-chip venture investment firms.

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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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Muscle Wasting and Hashimoto’s

The Thyroid Pharmacist

Years ago, I struggled just to get through each day. I had so many frustrating symptoms, including anxiety, irritable bowel syndrome (IBS) and acid reflux. I also had other seemingly odd symptoms for someone my age, like frequent muscle cramps, stiffness, carpal tunnel in both arms, and pain. (I’ve shared articles on pain and will be sharing one on carpal tunnel soon as well.

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STAT Wunderkinds discuss high-impact research, resilience, and social justice

STAT

Elenoe “Crew” Smith used to faint at the sight of blood. Still, she knew from a very young age that she wanted to help people living with sickle cell disease. Now, as a research director at Vertex Pharmaceuticals, she is working on potential sickle cell medicines. Smith was in STAT’s 2017 class of Wunderkinds , an annual selection of standout researchers who are launching their careers.

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Scientists could finally be closing in on a ‘pill’ for men

PharmaVoice

Drug developers have tried — and failed — to create a male contraceptive for decades. Now, one group of scientists might be on the verge of success.

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FDA approves Seres’ microbiota drug for recurrent gut infection

BioPharma Dive

The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff infections.

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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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Discussing Sterile Aseptic Connectors with Todd Andrews (INTERPHEX 2023)

PharmaTech

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

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To prevent preeclampsia, experts push for broader blood pressure testing at home

STAT

Eleni Tsigas likens her first experience with preeclampsia to a plane crash. She was in the midst of what she thought was a healthy first pregnancy, with low risk for complications. But at 29 weeks, she was rushed to the emergency room with what she now knows are classic signs of preeclampsia: very high blood pressure, a pounding headache, nausea, blurred vision.

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Immunotherapy to become standard treatment for infants with ALL

European Pharmaceutical Review

Immunotherapy treatment blinatumomab will now become standard treatment worldwide for babies with acute lymphoblastic leukaemia (ALL). This decision is based on new results from an international trial published in the New England Journal of Medicine. Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy.

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Lilly drug Mounjaro succeeds in second weight loss study

BioPharma Dive

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

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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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Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Vast sequencing project begins to unlock human genome’s secrets — by deciphering other mammals’ DNA

STAT

Despite decades of advancements in genomics, we still don’t know what most of our DNA does. But an ambitious international research collaboration is providing new answers about how genetics shapes human health and disease, with help from an unlikely source — a menagerie of mammals. The findings , reported in a set of 11 studies published on Thursday in the journal Science, come out of the Zoonomia Project, which compared the genomes of 240 mammalian species.

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Episode 812: Can You IV Push Piperacillin/Tazobactam?

Pharmacy Joe

In this episode, I’ll discuss an article about IV push piperacillin-tazobactam. Episode 812: Can You IV Push Piperacillin/Tazobactam? Subscribe on iTunes , Android , or Stitcher Article Safety and tolerability of i.v. push piperacillin/tazobactam within an emergency department Lead author: William Blake Hays Published in American Journal of Health-System Pharmacy May 2020 Background Piperacillin/tazobactam is typically administered via IV piggyback over 30 minutes or more increasingly common via

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AbbVie weathers first months of biosimilar challenge to top-selling Humira

BioPharma Dive

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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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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EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

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STAT+: Once bullish on digital health, Orexo hits a wall on reimbursement

STAT

After several quarters of promising to deliver concrete progress on key digital therapeutics projects, Swedish pharmaceutical company Orexo on Thursday reported the somber news that its efforts remained stalled. Orexo, which made almost all of its $60 million in 2022 revenues from U.S. sales of Zubsolv, a drug used to treat opioid use disorder, earned negligible income from its three software-based treatments in the first quarter of the year.

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European Pharmaceutical Review Issue 2 2023

European Pharmaceutical Review

Included in this issue of European Pharmaceutical Review : FOREWORD New quality requirements for tobacco products David Elder, David P Elder Consultancy QA/QC MASS SPECTROMETRY The benefits of mass spectrometry for expediting biologics to patients Ian Anderson, Mostafa Zarei and Qifeng Zhang, Lonza IN-DEPTH FOCUS: Bioprocessing/Bioproduction Realising the potential of AAV gene therapies Rajiv Vaidya, Andelyn Biosciences What gene therapy manufacturers can gain from collaboration Neil Almstead,

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.

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Ethnopharmacology: traditional medicine and modern drug discovery

Pharmaceutical Technology

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with cert