Wed.Aug 31, 2022

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Current, Emerging COVID-19 Variants and the Testing Landscape

Drug Topics

Drug Topics® is joined by Joseph Mann, MSN, FNP-C, to discuss pharmacy’s fast-expanding role in COVID care, variant BA.5’s diagnostic impact, and the benefits of different tests available — including how technology behind a smartphone-integrated home test creates a fluid experience for patients.

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Pharmacists Can Fill Unmet Patient Care Needs for Mental Health, Substance Use Disorders

Pharmacy Times

Data have shown there is a rising need for mental health and substance use disorder services, yet there is a shortage of psychiatrists in the country that is estimated to worsen by 2024.

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Addressing and Preventing Fraud in the Pharmacy

Drug Topics

Drug Topics® sits down with George Euson, whose decades of experience in regulatory compliance for the pharmacy industry provide an insider's perspective on threats your business — and your patients — face today.

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Overview of New USP Chapters, Upcoming USP Chapters on Temperature Excursion Management for Drug Storage, Distribution

Pharmacy Times

Desmond Hunt, PhD, senior principal scientist at US Pharmacopeia (USP), discusses the standards and resources that USP has recently published or is looking at now on the subject of pharmacy in transit.

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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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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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FDA Authorizes Updated COVID-19 Boosters From Moderna, Pfizer-BioNTech

Pharmacy Times

With these bivalent vaccine authorizations, the monovalent mRNA COVID-19 vaccines are still not authorized as booster doses for individuals 12 years of age and older.

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Inflammatory Bowel Disease and C. difficile Infection (CDI)

Pharmacy Times

A gastroenterologist, Dr. Bincy Abraham, provides an overview of C. difficile infection (CDI) in patients with inflammatory bowel disease (IBD).

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Opinion: As hospitals raise their prices, U.S. workers and businesses suffer

STAT

Despite a recent taxpayer-subsidized boon , the hospital industry spent the last several months lobbying for additional federal dollars amid warnings about the continued spread of Covid-19 and inflation’s impact on the nation’s health care system. Those efforts bore fruit: Medicare recently granted hospitals the largest price increase since 1998.

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Expert: Another Pandemic Will Come Sooner Than the Last, Pharmacy’s Role Will Be Increasingly Pivotal

Pharmacy Times

Lawrence H. Summers, former US Secretary of the Treasury, explains that he is optimistic regarding pharmacy’s increasing role in fighting future pandemics.

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The Biden administration is pushing another round of Covid boosters. Who’s listening?

STAT

WASHINGTON — Federal health officials are starting to push new, variant-targeting vaccines that they say will curb a winter coronavirus wave and protect America’s most medically vulnerable people. The question is whether Americans feel any urgency to get them. The updated vaccines from Moderna and Pfizer and BioNTech, authorized Wednesday by the Food and Drug Administration, are tailored to fighting back the dominant BA.4 and BA.5 strains.

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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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Study: Smoking Is Worse for the Heart Than Previously Thought

Pharmacy Times

Some function is partially restored once smokers kick the habit, results presented at the European Society of Cardiology Congress 2022 show.

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STAT+: Pharmalittle: An emerging star in biotech investment; U.S. government expected to stop paying for Covid shots next year

STAT

Good morning from San Diego. I’m Jonathan Wosen, STAT’s West Coast biotech reporter, and I’m picking up the baton from Allison as we continue to fill in for Ed this week. I’m not a coffee drinker, but I’ve poured myself a cup of water. No ice, though, as I find it dilutes the flavor. Jokes aside, here are some newsy items for you to peruse this morning.

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FDA Approves Olipudase Alfa to Treat Acid Sphingomyelinase Deficiency

Pharmacy Times

The FDA approval makes olipudase alfa the first approved drug to target the physiological symptoms of the disease.

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How to Start a Pharma Company with a Low Budget in India?

Fossil Remedies

Do you think that India is a great place to launch a pharma business? Yes, indeed it is. In the past few decades, the Indian economy has done remarkably well. Many sectors have performed well, and the pharma sector is one of them. And the journey of growth has not ended yet. There is a great potential still, to prosper and flourish. Those, who don’t mind taking a risk in the business must reap the opportunity by launching a pharma company.

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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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Educational Opportunities to Combat C. difficile Infection (CDI)

Pharmacy Times

Drs. Lodise and Feuerstadt discuss educational opportunities to combat and reduce C. difficile infection (CDI).

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Football & Concussions: What You Need to Know

Board Vitals - Pharmacist

The NFL season is finally here. While the players prepare for the game on the field, another team is watching for something more important off the field. Four specially trained “spotters” watch every game from the stadium press box and pull players who may have been involved in concussion-causing collisions. The reason is clear; the National Football League (NFL) reported 224 concussions in 2019.

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Congenital Ichthyosis Treatment TMB-001 Yields Positive Results in 2b Trial

Drug Topics

Timber Pharmaceuticals’ CONTROL study evaluated the safety and efficacy of the topical isotretinoin.

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Woman of the Week: Thread’s Kim Boericke

PharmaVoice

Fresh off an eight-year tour of duty at ICON, the CRO industry veteran is stepping into a new role and a new title as chief delivery officer at Thread.

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FDA Updates Moderna, Pfizer-BioNTech EUA to Include Use of Bivalent Vaccine as Booster Dose

Drug Topics

These bivalent formulations include an mRNA component common to the BA.4 and BA.5 Omicron variant.

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Lifelong Statin Therapy May Benefit Quality of Life Among High-Risk Cardiovascular Disease Patients

Pharmacy Times

The benefits of taking a daily statin may improve as a patient grows older.

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Welly debuts OTC medicine, dietary supplements

Drug Store News

Welly Remedies is a line of over-the-counter medications and dietary supplements.

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Finerenone's Impact on Mortality in Patients with Type 2 Diabetes

Drug Topics

New research indicates the medication has cardioprotective properties.

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Expert Discusses Role of Pharmacist in Oncology Practices, Biosimilars

Pharmacy Times

Paul Forsberg, PharmD, BCOP, MHA, director of Pharmacy Services at Minnesota Oncology discusses how pharmacists can remain on top of shifts in the nature of biosimilar payer benefit design.

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August Month in Review: Top Stories on Drug Topics®

Drug Topics

Take a look back at our most popular news from August 2022.

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3 Drug Interactions With GLP-1 Agonists

Med Ed 101

Drug interactions don’t come to the top of my mind when I see GLP-1 agonists in use. We are fortunate that they do not have a lot of significant interactions, but I don’t think you should forget about them altogether. I’ve provided a list below of my top 3 drug interactions with GLP-1 agonists. Insulin […]. The post 3 Drug Interactions With GLP-1 Agonists appeared first on Med Ed 101.

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Phase 3 trial confirms Lumakras role in lung cancer

pharmaphorum

Amgen’s pathfinder KRAS inhibitor Lumakras has been shown to be effective in KRAS-mutated non-small cell lung cancer (NSCLC) in a phase 3 trial that should serve as a confirmation study for its earlier accelerated approval in this setting. The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with

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TG Therapeutics’ Ublituximab Shows Reduced Risk of Relapsing Forms of Multiple Sclerosis

Pharmacy Times

Investigational targeted B-cell therapy demonstrates superior efficacy compared with teriflunomide, a commonly prescribed treatment for MS.

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FDA clears bivalent Omicron shots from Pfizer, Moderna

pharmaphorum

As expected, the FDA has moved quickly to grant emergency use authorisation (EUA) to two new-generation COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna, both targeting the new Omicron subvariants BA.5 and BA.5. The US regulator has cleared a 30 µg booster dose of a new version of Pfizer’s Comirnaty shot – 15 µg encoding the spike protein of the original wild-type SARS-CoV-2 strain and 15-µg of mRNA coding for Omicron BA.4/BA.5 – for people aged 12 and over.

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Daily Medication Pearl: Ozanimod (Zeposia)

Pharmacy Times

Ozanimod (Zeposia) is indicated for the treatment of multiple sclerosis and moderately to severely active ulcerative colitis in adults.

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Forecyte Bio and Cytiva to Collaborate on Cell and Gene Therapy Manufacturing and Development

BioPharm

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

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Costa Rica’s commitment to developing talent in industry 4.0

Pharmaceutical Technology

Availability of labour is an important factor for foreign investors, with the education and skill sets found within that labour force being a decisive driver when it comes to FDI site selection. Data from the UN Conference on Trade and Development’s World Investment Report 2020 and the World Economic Forum’s Global Competitiveness Report 2019 indicates that countries with a higher-skilled and better-educated workforce attract more greenfield FDI projects, but how does a country ensure its workfo

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4 Benefits of Video for the Pharma Industry

Pharma Marketing Network

Video is, without a doubt, revolutionizing the pharmaceutical industry. It presents a tremendous opportunity for pharma and healthcare brands as it is one of the most effective mediums for delivering your message and results in high conversion rates. Why Video Works. We live in a fast-paced, short-lived world that is full of endless information. For digital users especially, this combination means drastically decreasing attention spans.

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Wearables: managing complexities in data privacy and consent in healthcare tech

Pharmaceutical Technology

Over the last few years, the trend for wearables has shown the potential benefits of transforming healthcare through digital technologies. Alongside fitness trackers and smartwatches, there are also medical devices used to monitor a patient’s vitals and some even contain SIM cards to enable two-way communication. Devices such as insulin pumps, heart pacemakers, and inhalers can track patient data in real-time and transmit to the user’s phone, an app, or their doctor, making the data immediately

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Futura eyes FDA filing as topical ED drug passes phase 3 test

pharmaphorum

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. The results of the FM71 trial of MED3000 showed that the topical gel formulation achieved a significant improvement in erectile function compared to baseline at 24 weeks, across the range of mild, moderate and severe ED.

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