Sat.Mar 25, 2023 - Fri.Mar 31, 2023

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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response

STAT

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

Vaccines 364
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The Febrile Infant: Incorporating the 2021 American Academy of Pediatrics guidelines

ALiEM - Pharm Pearls

Can you trust a febrile infant? “No” has been, and continues to be, the resounding answer over the last 40 years as researchers and clinicians work to determine the optimal evaluation and management of the well-appearing young febrile infant [1]. The goal remains to identify infants with bacterial infections in this at-risk cohort of patients while also considering the balance of cost-effectiveness on a population scale and the potential for iatrogenic harm with evaluation such as unnecessary lu

Hospitals 360
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SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi

PharmaVoice

The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

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Mathai Mammen, former J&J executive, to become FogPharma CEO

BioPharma Dive

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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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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Cases of Marburg going unreported in Equatorial Guinea, WHO says

STAT

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Trick of the Trade: Chest tube rewarming with Foley tubing connector

ALiEM - Pharm Pearls

You have a pulseless hypothermic patient requiring aggressive internal rewarming. ECMO is not available, and you’ve made the decision to initiate thoracic lavage. After placing your chest tubes, you step back triumphantly, but in short order, the nurse hands you large diameter IV tubing with warmed fluids so that you can connect it to the chest tube.

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More Trending

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ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

BioPharma Dive

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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Focus Covid booster campaigns on high-risk people, WHO’s vaccine experts recommend

STAT

A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba

Vaccines 322
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Rapid microbiology testing market growth expected 2022 to 2027

European Pharmaceutical Review

A report has predicted the rapid microbiology testing market size is estimated to grow at a compound annual growth rate (CAGR) of 9.31 percent between 2022 and 2027. According to the data, the market is forecasted to increase by $2,487.91 million. The research includes historic market data from 2017 to 2021, using 2022 as the base year. It covers various testing methods such as growth-based, nucleic-acid-based and viability-based.

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Seamless clinical trials were created to make studies easier — instead, they’ve become more complex

PharmaVoice

Experts weigh in on how companies can design better trials that merge two phases into one.

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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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CMS removes 7 drugs from list marked for price hike penalties

BioPharma Dive

After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.

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STAT+: As AI promises to revolutionize medical note-taking, concerns mount about accuracy and harm

STAT

In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc

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Key Trends: Patient experience data reveal how insurers and middlemen impose barriers in health care

PhRMA

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

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Predator and prey: Harnessing phages to fight antibiotic resistance

PharmaVoice

Phages, bacteria’s natural predator, could help combat the growing threat of superbugs. But can these therapies rise above antibiotic market woes?

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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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BrainStorm files ALS drug application over FDA protest

BioPharma Dive

The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.

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STAT+: Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs

STAT

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

Vaccines 110
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Pharma’s salesforce is suffering — what does version 2.0 look like?

PharmaVoice

Ahead of turbulent market conditions, EY analyst Arda Ural encourages companies to rethink their sales strategy.

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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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Regeneron bets on ‘Treg’ cell therapy with Sonoma deal

BioPharma Dive

The biotech will work with Sonoma, a well-funded startup run by prominent immunologist Jeffrey Bluestone, to develop cell-based medicines for ulcerative colitis and Crohn’s disease.

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How the drug industry uses fear of fentanyl to extract more profit from naloxone

STAT

As the U.S. drug crisis has accelerated, the pharmaceutical industry has jumped into action — particularly when it comes to naloxone, the drug used to reverse opioid overdoses. In recent years, companies have introduced a dizzying array of ambitious new naloxone products. They include a mechanized injector that gives robotic voice commands , a prefilled syringe pen, an ultra-high-dose nasal spray, and an autoinjector that the Pentagon has purchased for use in the event of a terrorist atta

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BioNTech targets infectious diseases for vaccine development

Pharmaceutical Technology

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.

Vaccines 110
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Leaders wave a magic wand at pharma’s thorniest issues

PharmaVoice

The major challenges pharma leaders would solve with a quick flick of an imaginary wand.

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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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Pfizer returns cancer immunotherapy rights to Merck KGaA

BioPharma Dive

Analysts had speculated Pfizer might divest its Bavencio interest to help close its Seagen buyout. A Pfizer spokesperson said the move was “conceived independently” of any other deal, however.

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STAT+: Medical device companies now need to prove to FDA they’re protected against cyberattacks

STAT

Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid , lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan.

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Strategies to Overcome Anxiety with Hashimoto’s

The Thyroid Pharmacist

Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. It changed my life dramatically and made me feel like a shell of my former self. I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. I was scared.

Immunity 105
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Generic manufacturers sign sublicences to produce long-acting HIV medicine

European Pharmaceutical Review

The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). First sublicence agreement signed by MPP for a long-acting medicine Through the sublicences, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to requir

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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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After an ‘amazing year,’ SR One raises $600M to fuel more drug startups

BioPharma Dive

The former venture arm of GSK had several of its portfolio companies get acquired or go public in the past year, overcoming a tough environment for young biotechs.

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Genetic differences in breast tumors may contribute to racial disparities

STAT

Clinicians know the odds tend to be stacked against Black breast cancer patients. They get more dangerous and aggressive subtypes of breast cancer more frequently than white patients. Within breast cancer subtypes, Black patients tend to have worse outcomes compared to white negative patients, too. But what biological factors contribute to these disparities – and how much – is an open question.

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Viking’s weight loss drug enters an already crowded arena

Pharmaceutical Technology

Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.

Diabetes 105
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Episode 804: Faster Amiodarone is Better For Survival in Shock-Refractory Out-of-Hospital Cardiac Arrest

Pharmacy Joe

In this episode, I’ll discuss an article about timing of amiodarone for out-of-hospital, shock-refractory cardiac arrest. Episode 804: Faster Amiodarone is Better For Survival in Shock-Refractory Out-of-Hospital Cardiac Arrest Subscribe on iTunes , Android , or Stitcher A group of authors has hypothesized that the lack of clinically significant difference between amioadrone and lidocaine for out-of-hospital shock-refractory cardiac arrest is due to delayed timing of the administration of study m

Hospitals 105
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Vertex pays CRISPR to use its gene editing tech for diabetes drugs

BioPharma Dive

Vertex will license CRISPR technology to develop insulin-producing islet cells that are more resistant to immune rejection, adding to other efforts directed at Type 1 diabetes.

Diabetes 114