Thu.Apr 13, 2023

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5 Things To Know About Antimicrobial Stewardship Regulatory Standards

IDStewardship

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. difficile infection, adverse effects, antibiotic resistance, ho

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What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary

PhRMA

At the direction of the U.S. Trade Representative, the U.S. International Trade Commission (USTIC) is investigating the impact of a proposed waiver of intellectual property (IP) protections for COVID-19 diagnostics and therapeutics under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Public submissions to the USITC from experts across patient groups, academia, public health, labor and the private sector make clear that, much like the orig

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A Biosimilar Wave Looms Large Over US Biologics Market

Drug Topics

As more adalimumab biosimilars are poised to enter the market, manufacturers, payers, and patient advocates are preparing to navigate potentially turbulent waters.

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A guide to MedPAC’s Part B vote today

PhRMA

Today, the Medicare Payment Advisory Commission (MedPAC), an independent congressional agency that advises Congress on issues related to the Medicare program, will vote on draft recommendations related to Part B. Unfortunately, these recommendations include proposals that could give the Centers for Medicare and Medicaid Services (CMS) new authority to make one-size-fits-all value judgments based on flawed cost-effectiveness standards, and to come between doctors and patients in deciding which tr

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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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How Pharmacists Should Talk So Vaccine-Hesitant Parents Listen

Drug Topics

Vaccine hesitancy exists on a spectrum, but with the right tools, pharmacists can provide education and reassurance to parents and caregivers.

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Anakinra Found No Worse Than Standard of Care for Mortality Outcomes Among Patients with COVID-19 Pneumonia

Pharmacy Times

Patients administered anakinra did not meet a study’s primary endpoint of proportion of patients who did not need mechanical ventilation 15 days after starting treatment for severe COVID-19 pneumonia.

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Spontaneous Lobar Intracerebral Hemorrhage Associated With Higher Rate of Subsequent Major Cardiovascular Events

Pharmacy Times

The risk of a second stroke after intracerebral hemorrhage (ICH) did not differ by index hematoma location, and this risk was higher for ischemic stroke than ICH.

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Psychedelic medicines: are they gaining traction in Europe?

European Pharmaceutical Review

Psychedelics are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes. 1 Some psychedelics are found in nature, including psilocybin, a naturally occurring molecule found in almost 150 species of mushrooms which turns into psilocin once ingested, causing psychedelic effects. Other psychedelics are man-made, such as lysergic diethylamide (LSD), which was first synthesised in 1938 by Albert Hofmann at a laboratory in Switzerland. 2 LSD is wi

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Study: Vaping Show No Association With Increased Self-Reported Wheezing

Pharmacy Times

But analysis does suggest a small increase in risk for individuals who used cigarettes and electronic nicotine delivery systems together.

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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

Dyadic International has announced expansion of a licence agreement for its C1-cell protein expression platform with South African consortium Rubic One Health. The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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DEI-Focused Pharmacy Curriculum Paves the Way for Patient-Centered Care

Pharmacy Times

Pharmacy students must understand the intricacies of culture and health, but they first need to be aware of their biases and prejudices.

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Opinion: ‘Internist’ is a confusing, outdated term. It’s time for a new name

STAT

When my children were young, they repeatedly asked, “Dad, what does ‘internal medicine’ mean?” The term “internal medicine” is not intuitive to what we do as internal medicine physicians and continues to be an enigma to so many. Defining the role of internal medicine within the health care system has been a challenge since the field began in the late 1800s in Germany.

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Telemedicine Provides Paradigm Shift in Specialty Pharmacists' Role on the Care Team

Pharmacy Times

Remote services allow unrivaled opportunities for outreach to vulnerable populations and those in rural areas.

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What are the warning signs of clogged arteries?

The Checkup by Singlecare

You may take your arteries–and in fact, your whole cardiovascular system—for granted until they stop working properly. However, it’s important to pay attention to this set of organs because your arteries can develop deposits called plaque that build up and eventually restrict the flow of blood from your heart to your arms, legs, and other parts of your body.

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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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How Smarter Collaboration Helps Pharmacy Professionals Achieve Their Goals

Pharmacy Times

Pharmacy professionals can bring in the right people at the right time to identify needed changes and develop an action plan.

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Promising new malaria vaccine for kids approved in Ghana

STAT

DAKAR, Senegal — Ghana on Thursday became the first country to approve a new malaria vaccine for young children, one that officials hope will offer better protection against the disease that kills hundreds of thousands every year. Final results from late-stage trials have not yet been published, and the vaccine is under review at the World Health Organization.

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Reducing Consumption of Sugary Beverages Combats Negative Health Outcomes

Pharmacy Times

Limiting added or free sugar is recommended to reduce the adverse effects, especially in cardiometabolic disease.

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Appeals court restores access to abortion drug, but bars sending it through the mail

STAT

A federal appeals court is allowing continued access to a common abortion medication as a legal fight around its approval wages, but with some additional restrictions. Under the ruling from the 5th U.S. Circuit Court of Appeals in New Orleans late Wednesday, the drug, mifepristone, will remain available, but the judges said it could no longer be sent to patients through the mail and that it could only be used up to seven weeks into a pregnancy, not 10.

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How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle

ISPE

How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle Trudy Patterson Thu, 04/13/2023 - 13:13 iSpeak Blog iSpeak How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle Monica Lomeli, Dr. 13 April 2023 As the biopharmaceutical industry grapples with faster commercialization of new drugs, along with an increased focused on sustainability, process simulation has never been more relevant.

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Takeda discontinuing in AAV and rare haematology disease markets

Pharmaceutical Technology

Takeda has announced that it will be pivoting away from its discovery and preclinical programmes in adeno-associated virus (AAV) gene therapies. The company is aiming to refocus its efforts on its core therapeutic areas and current late-stage programmes such as the oral TYK2 inhibitor TAK-279, which is under development for several autoimmune disorders.

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No clinical benefit for nivolumab plus ipilimumab over nivolumab in recurrent/metastatic head & neck SCC

Hospital Pharmacy Europe

Nivolumab plus ipilimumab offers no additional benefit over nivolumab alone in recurrent or metastatic head & neck squamous cell carcinoma Nivolumab plus ipilimumab given first-line for patients with recurrent or metastatic head and neck squamous cell carcinoma (SCC), offers no clinical benefit over nivolumab alone. Head and neck squamous cell carcinomas (HNSCC) occur in the mouth, pharynx and larynx.

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Identify, Address Insomnia Causes to Prevent Health Complications

Pharmacy Times

For chronic cases, encourage patients to seek medical care from their primary health care providers.

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Regulatory Review: Legislative Actions Poised to Impact Pharmacy Inventory Management

Drug Topics

Recent legislation and regulatory updates will impact pharmacy inventory management in the coming months.

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Express Scripts rolls out new copay caps, PBM model with focus on transparency

Fierce Healthcare

Express Scripts rolls out new copay caps, PBM model with focus on transparency pminemyer Thu, 04/13/2023 - 15:33

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The JAK Inhibitor Pipeline Builds in Dermatology

Drug Topics

Eight JAK inhibitors are approved by the FDA to treat autoimmune, inflammatory, and allergic conditions.

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Listen: How the legal battle over abortion could thwart research, plus: the FDA ‘bully pulpit’ and Moderna’s future

STAT

Is pharma facing an existential threat? How do you get CEOs to speak out? And what’s going on with Sarepta Therapeutics? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Jeremy Levin, CEO of Ovid Therapeutics, joins us to discuss a judge’s decision to overturn the FDA approval of an abortion pill and why he believes it’s the biggest threat to the biopharma industry in 50 years.

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Walgreens, Prothena partner to increase access, enrollment in Alzheimer’s disease clinical trial

Drug Store News

The collaboration aims to support patient awareness, participation and representation in a clinical trial of Prothena’s Alzheimer’s drug candidate PRX012.

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Biotech company Prothena taps Walgreens to recruit patients for Alzheimer’s drug research

Fierce Healthcare

Biotech company Prothena taps Walgreens to recruit patients for Alzheimer’s drug research hlandi Thu, 04/13/2023 - 06:51

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INTERPHEX 2023 – experience science through commercialisation

European Pharmaceutical Review

INTERPHEX 2023 is right around the corner, taking place April 25-27 at the Javits Center in NYC. INTERPHEX is set to bring leading brands and professionals together once again with new features, a reimagined Show Floor and returning Show Floor favourites. From development to distribution, INTERPHEX is the leading global event that takes you through all stages of the pharmaceutical product development lifecycle.

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House oversight committee seeks answers on hospitals' COVID relief funds, improper Medicaid payments

Fierce Healthcare

House oversight committee seeks answers on hospitals' COVID relief funds, improper Medicaid payments dmuoio Thu, 04/13/2023 - 13:59

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Sickle cell disease gene therapies from Vertex, bluebird can be cost-effective at $1.9M: ICER

Fierce Pharma

Sickle cell disease gene therapies from Vertex, bluebird can be cost-effective at $1.

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Chutes & Ladders—Privia taps Parth Mehrotra as new CEO; Froedtert Health and ThedaCare merge, plan to shake up leadership

Fierce Healthcare

Chutes & Ladders—Privia taps Parth Mehrotra as new CEO; Froedtert Health and ThedaCare merge, plan to shake up leadership aburky Thu, 04/13/2023 - 17:30

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Fighting back against discount cards

Drug Store News

The programs claim to help consumers save money but only further line the pockets of PBMs while carving into pharmacies’ bottom lines.

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Justice Department seeks stay on parts of ACA preventive services ruling

Fierce Healthcare

Justice Department seeks stay on parts of ACA preventive services ruling rking Thu, 04/13/2023 - 16:29

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