March, 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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Kite releases pivotal CAR T therapy Phase III study results

European Pharmaceutical Review

Primary overall survival (OS) analysis results from Kite’s Phase III ZUMA-7 study showed a statistically significant improvement for CAR T-cell therapy Yescarta ® in OS versus historical treatment. Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC).

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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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PulmCrit Hot Take: Steroid for severe pneumonia (CAPE COD trial)

EMCrit Project

Steroid is worthless for pneumonia! Wait, a new study shows it's beneficial! Hang on, a fresh meta-analysis shows that steroid it's useless! And wait, here's a fresh NEJM study showing mortality benefit!! This feels like a roller coaster. What's going on here? Several factors may explain this: Steroid is beneficial, but only in a subset […] EMCrit Project by Josh Farkas.

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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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More Trending

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11 Tips to Improve Epistaxis Management in the Emergency Department

ALiEM - Pharm Pearls

Managing epistaxis is often challenging, time-consuming, and takes practice. Even under the best circumstances, epistaxis often results in return visits for rebleeding and poor outcomes. Rarely should you do “nothing” for adults who present to the ED with or following epistaxis. If it produced enough blood to seek care (even without hemodynamic compromise), epistaxis frequently recurs even if currently resolved.

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Viral roots: A look at how modern outbreaks began

PharmaVoice

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

ID Stewardship

In this post a top 10 list of journal articles to read during an infectious diseases pharmacy rotation is provided. Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read.

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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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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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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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Three in four pharmacies experiencing a pharmacist shortage, MPs told

The Pharmacist

Almost three-quarters of pharmacies are experiencing a shortage of pharmacists, members of parliament were told at a roundtable event this week. MPs from across the political spectrum attended the event at parliament on Tuesday hosted by cross-sector campaign group Save Our Pharmacies. Community pharmacy leaders set out the challenges facing the sector, including early results […] The post Three in four pharmacies experiencing a pharmacist shortage, MPs told appeared first on The Pharmacis

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Targeting the new ‘Golden Girls’

PharmaVoice

With unprecedented buying power, women over 50 wield a lot of influence — but are still underserved by pharma. Urovant hopes to change that with its potential blockbuster drug.

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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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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

Vaccines 143
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Why Congress should prioritize fixing the 340B program

PhRMA

Nearly all Americans nationwide agree: Lowering out-of-pocket costs for health care should be a top priority for policymakers. Luckily, there are commonsense policies Congress could implement to meaningfully address the cost burdens Americans face. These include things like making sure patients aren’t paying more for their medicines than their health insurance company or requiring first-dollar coverage, so insurance companies cover the cost of certain lifesaving medicines from day one of the pla

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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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Opinion: How physician wellness programs keep doctors captive

STAT

The American College of Surgeons recently announced its new well-being initiative for surgeons. This wellness program has lofty goals: [The ACS] recognizes the need to foster well-being, resilience, and work-life integration for all surgeons, regardless of their career stage. Fostering the growth of both the surgical expertise and the person as a whole is paramount.

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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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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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‘The Last of Us’ might be fiction, but fungi are a looming threat

PharmaVoice

Fungal infections are a growing challenge for hospitalized patients, and new treatments are badly needed.

Hospitals 307
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Mass spectrometry software can link different data types

European Pharmaceutical Review

The latest version of software tool MZmine, which aids analysis of mass spectrometry data, has been released. Using this third generation software, scientists can analyse large volumes of data from mass spectrometry, processing thousands of samples within minutes to hours. [the newest version can process] thousands of samples within minutes to hours.” It is the first tool with an entire data processing pipeline that integrates liquid chromatography (LC)-ion mobility spectrometry (IMS)-MS a

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IRA Impacts: Cancer treatment research and development

PhRMA

Last month marked the one-year anniversary of the reignited Cancer Moonshot, the White House’s ambitious goal of reducing the death rate from cancer by at least 50% over the next 25 years. Much of the positive trends in declining cancer mortality, down 33% since peaking in 1991, is driven in large part by innovative medicines researched and developed by America’s biopharmaceutical companies.

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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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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+: SVB, biotech’s bank of choice, just failed. It could have ripple effects

STAT

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

Vaccines 114
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Janssen neuroscience leader takes on rare diseases one small ‘eureka’ at a time

PharmaVoice

Fueled by a fascination with the scientific process, Sindhu Ramchandren is exploring how a new drug could treat patients with a range of rare diseases.

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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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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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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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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

BioPharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

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Report: Obesity could cost the world over $4 trillion a year by 2035

STAT

The costs of obesity are projected to soar globally, in step with rising prevalence, according to a new report from the World Obesity Federation, the only group focused solely on tracking global obesity trends and a partner of the World Health Organization. Over half the world’s population will be either overweight or have obesity by 2035, the report projected, while the economic impact of a high BMI could reach $4.32 trillion annually, if current trends continue and policy inertia around

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Tapping into digital therapeutics to improve neurological outcomes

Pharmaceutical Technology

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation. Companies are testing the use of digital platforms along with pharmacological treatments.

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