Sun.Jul 02, 2023

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New patent expiration for Bayer Hlthcare drug LEVITRA

Drug Patent Watch

Annual Drug Patent Expirations for LEVITRA Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph… The post New patent expiration for Bayer Hlthcare drug LEVITRA appeared first on DrugPatentWatch - Make Better Decisions.

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Automation Aids Cell and Gene Therapy Production

PharmaTech

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

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Marketing in the AI Age

PharmExec

Here in New Jersey, our home base, summer is officially upon us, and the Canadian wildfire smoke has just cleared from the air. I’m sure the bird watchers would attest to the eager chirping as both wildlife and humans greedily enjoy the beautiful weather. But even as the seasons change, so does the technology that drives innovation, as coverage in the July issue of Pharmaceutical Executive® attests.

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Update: Pharmacists’ Scope of Practice, CMS, and Physicians

Med Ed 101

Pharmacists’ scope of practice has been expanding and that growth has been done on the state level. The federal level has been stagnant for quite some time. CMS did make news in June and recently announced a new, voluntary primary care model called “Making Care Primary (MCP)” Model. Sadly, they missed the mark and did […] The post Update: Pharmacists’ Scope of Practice, CMS, and Physicians appeared first on Med Ed 101.

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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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CMS tweaks Medicare price negotiation but remains defiant

pharmaphorum

CMS tweaks Medicare price negotiation but remains defiant Phil.

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Gaining a Deeper Understanding of Aseptic Needs

PharmaTech

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

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In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

PharmaTech

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

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In search of consistent quality

Express Pharma

The theme for the Indian Pharmaceutical Alliance’s flagship event, the Global Pharmaceutical Quality Summit, was Patient Centricity and the Future of Manufacturing and Quality. A pertinent choice, given the reverberations from children’s deaths across at least seven countries, which have been linked to Made-in-India cough syrups and other formulations.

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New patent expiration for Eyepoint Pharms drug DEXYCU KIT

Drug Patent Watch

Annual Drug Patent Expirations for DEXYCU+KIT Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. It is available from one supplier. There are seven… The post New patent expiration for Eyepoint Pharms drug DEXYCU KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Magnesium to the Rescue; Part 1

Fusion Pharmacy

Common Signs and Symptoms of a Magnesium Deficiency In recent years and especially since the start of the pandemic, I have noticed a trend in articles found in medical journals, medical case studies, and trusted health blogs where the topic seems to be focused on a “deficiency” of some sort: a deficiency of nutrients (vitamins, minerals, amino acids), sleep, focus, and even time!

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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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New tentative approval for Mylan Labs drug posaconazole

Drug Patent Watch

[![posaconazole structure]([link] Posaconazole is the generic ingredient in three branded drugs marketed by Msd Merck Co, Merck Sharp Dohme, Par Sterile Products, Schering, Hikma, Actavis Labs Fl Inc, Aet Pharma,… The post New tentative approval for Mylan Labs drug posaconazole appeared first on DrugPatentWatch - Make Better Decisions.

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Understanding Nitrosamine Impurities in the Pharmaceutical Industry

PharmaTech

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

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Pharmaceutical Executive, July 2023 Issue (PDF)

PharmExec

Click the title above for a link to open the Pharmaceutical Executive June 2023 issue in an interactive PDF format.

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Navigating the Formality Spectrum in ICH Q9(R1)

PharmaTech

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

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AHFS Drug Information

RX Note

Introduction American Hospital Formulary Service Drug Information (AHFS DI) from the American Society of Health-System Pharmacists (ASHP) is a comprehensive source of drug information for health professionals with therapeutic guidelines and off-label uses. It was first published in 1959 as an adaptation from the Hospital Formulary of Selected Drugs by Don E.

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The Inspection Result: Warning Letters and Form 483s

PharmaTech

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

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Sanford Guide

RX Note

Introduction Since 1969, Sanford Guide has been a leader in point-of-care recommendations for the treatment of infectious diseases. It is published annually in hard copy and also available as a mobile app. Mobile Application The mobile app is a convenient way to access Sanford Guide content. It is searchable and includes activity spectra, which can helpful for determining the best antibiotic to treat a particular infection.

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Overcoming Analytical Challenges in High Potency Formulation

PharmaTech

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

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Ghost-Pill

RX Note

Introduction A patient who is taking Glucophage XR 500 mg came to the pharmacy concerned that she had seen some tablet-like structures in her stool. She asked if she was still getting the full dose of medication if the tablet was not dissolving. Facts With some controlled-release formulations, it is expected that the empty intact shell that housed the medicine ("ghost-pill" or "ghost-tablet"), or other insoluble formulation parts will appear in the stools.

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Top 10 Considerations when Meeting with Regulators

PharmaTech

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

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Augmentin 228 mg/5 ml Syrup

RX Note

Introduction Once, I received a prescription for a child requiring Augmentin syrup at a dosage of 25 mg/kg three times daily. I decided to intervene regarding the frequency of dosing. Surprisingly, both the prescriber and I consulted the same reference, Frank Shann Drug Doses , which states the following: Dose as amoxicillin, oral. 4:1 (non-Duo products) 15-25 mg/kg (adult 500/125 mg) 8H; 7:1 (Duo) 20-30 mg/kg (adult 875/125 mg) 12 H; or 16:1 (XR) 30-50 mg/kg (adult 2000/125 mg) 12H.

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Drug Shortages Continue to Plague FDA and Manufacturers

PharmaTech

Problems continue despite actions by regulators to better prevent and address drug shortages.

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Which pharmaceutical companies have the most film dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most film dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most film dosed drugs… The post Which pharmaceutical companies have the most film dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Monitoring for Microbes

PharmaTech

Data from environmental monitoring can assist in keeping sterile environments sterile.

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Magnesium to the Rescue; Part 2

Fusion Pharmacy

Incorporating Magnesium Into Your Diet With Food & Supplementation In this article, I’ll explore options for increasing magnesium in your diet, and I will give some suggestions about which magnesium supplements you might use. Please keep in mind that these articles are touchstones for your own research, and as always, you are welcome to come into my pharmacy where we are happy to help guide you.

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Innovation Idolatry

PharmaTech

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

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Laboratory Data

RX Note

Introduction Clinical laboratory tests are valuable tools used to Differentiate among possible diagnoses Confirm a diagnosis Assess current status Evaluate the response to therapy when history and physical exam alone are insufficient Related tests may be grouped together into a set called a profile or a panel, although small differences may exist between institutions panels.

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New Deal on the Horizon

PharmaTech

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

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Schwartz Formula

RX Note

Introduction The Cockcroft-Gault equation is not used to estimate creatinine clearance in paediatric patient because it was developed using data from adults. Cockcroft-Gault equation is a formula developed from 249 patients aged 18 to 92 years old in a 1976 study. NOTE: Recent guidelines are suggesting CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation as the preferred method for estimating adult GFR.

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Improvements to EMA’s PRIME Designation Scheme

PharmaTech

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

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Drug Pricing’s Static Changes

PharmaTech

The debate surrounding drug pricing changes rages on.

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Good Practices for Data Integrity

PharmaTech

Automation can be balanced with operator oversight.

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