Tue.Jul 19, 2022

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FDA Approves Zonisamide Oral Suspension as Adjunctive Therapy For Epilepsy

Pharmacy Times

Zonisade is the first and only FDA-approved oral liquid formulation of zonisamide, which helps patients with epilepsy who have difficulty swallowing tablets.

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US FDA grants approval to Incyte’s Opzelura cream for vitiligo treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor. With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval.

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Trending Sources

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Patients in Appalachia Face Unique Disparities, Obstacles to Care

Pharmacy Times

Organizations such as the Appalachian Community Cancer Alliance are working to leverage technology and improve barriers to care.

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Engaging change: Connecting patients and regulators can move the dial on drug development

pharmaphorum

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. In the United States, learning how to navigate forums such as the FDA’s listening sessions and patient-focused drug development (PFDD) meetings could be the key to “truly moving the dial”.

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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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Study: Y Chromosome Loss in Men Increases Risk of Heart Failure, Death From CVD

Pharmacy Times

Results are first to show causal relationship between losing mLOY in the blood and development of cardiovascular disease.

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FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current use in atopic dermatitis. The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months.

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More Trending

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Filings buzz in pharmaceuticals: 65% increase in cloud computing mentions in Q1 of 2022

Pharmaceutical Technology

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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The Changing Role of Pharmacy Technicians Over the Next Several Months

Pharmacy Times

Pharmacies are so much more attuned to being able to use that technician to the top of his or her license and credential.

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Biotech R&D spending has skyrocketed, and so have opportunities for savings

PharmaVoice

With R&D costs on the rise, biotechs are embracing new strategies and technologies to make spending more efficient.

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Trilaciclib Protects Against Chemotherapy-Induced Myelosuppression

Pharmacy Times

Treatment's approval marks exciting new development for patients with ES-SCLC to prevent CIM.

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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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ESG Top Trends: Healthcare ESG Impact

Pharmaceutical Technology

All aspects of environmental, social, and governance (ESG) are important, and in the healthcare industry, companies must excel across all three. Listed below are the impact of ESG on healthcare, as identified by GlobalData. ESG needs to be at the core of any healthcare company or institution that wants to continue to provide quality care and services.

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Clinical Overview: Cyletzo, a Biosimilar Version of Adalimumab

Pharmacy Times

Indications for adalimumab include ankylosing spondylitis, Crohn disease, chronic plaque psoriasis, juvenile idiopathic arthritis, moderate to severe rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

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Job Options for Acute Care Nurse Practitioners 

Board Vitals - Pharmacist

One of the best and, sometimes, most confusing characteristics of becoming a nurse practitioner (NP) is the ability to work in many types of jobs. However, knowing where you want to work after school can help you to distinguish what type of NP you want to become. Acute care nurse practitioners (ACNP) can work in a wide array of areas, which are typically related to short-term, serious incidences of illness.

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Limitations, Barriers from Lack of Cultural Competency

Pharmacy Times

We spend a lot of time harping on vaccine hesitancy, but one thing we don't talk about is vaccine access, and that is really a very key indicator to a lack of cultural competency.

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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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Sunlight and Sleep: A Natural Remedy to Sleep Better

Compounding Pharmacy of America

A good night’s sleep can often feel like a luxury hard to come by. Work, kids, social pressures/obligations, as well as other distractions such as technology may keep you awake far longer than they should, making you sacrifice something that is detrimental to the overall health of your body: sleep. Effects of Sleep Deprivation The […]. The post Sunlight and Sleep: A Natural Remedy to Sleep Better appeared first on The Compounding Pharmacy of America.

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Eight-Year Data Show Pertuzumab Regimen Reduces Risk of Recurrence, Death for Patients with HER2-positive Breast Cancer

Pharmacy Times

Patients at highest risk of cancer recurrence, including people with lymph node-positive disease, saw the greatest reduction in the risk of recurrence or death with the pertuzumab-based regimen.

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Glowy Summer Make Up

The Luxe Pharmacist

I’ve gotten so many requests for make up tutorials and what products I use on repeat, and while I don’t have a tutorial up yet this is the next best thing! I absolutely love having glowing and bright skin especially in the summer which means I’ve learned to not be afraid of my two best friends…blush and highlighter. I’ve been wearing the below combo all summer long on repeat.

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Patients Should Consult Pharmacy Staff Before Taking OTC Medication

Pharmacy Times

Logan Franck, PharmD, BCACP, a clinical associate professor in the College of Pharmacy at the University of Nebraska Medical Center, discuses his American Association of Pharmacy Technicians session on over-the-counter medications.

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Asia-Pacific is seeing a hiring boom for robotics roles in pharma

Pharmaceutical Technology

Asia-Pacific was the fastest growing region for robotics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Asia-Pacific made up 2.6% of total robotics jobs - up from 0.7% in the same quarter last year. That was followed by Europe, which saw a 0.1 year-on-year percentage point change in robotics roles.

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Disappointment as Lynparza fails colorectal cancer test

pharmaphorum

AstraZeneca and Merck’s PARP inhibitor Lynparza has carved out blockbuster revenues across uses in breast, ovarian, prostate and pancreatic cancer, but colorectal cancer won’t be added to the list. Merck said the LYNK-003 rial of Lynparza (olaparib) given as either a monotherapy or in combination with Roche’s CD20-targeting antibody Avastin (bevacizumab) in advanced colorectal cancer has been halted, as a look at the unblinded data showed little chance of a positive result.

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Behind the Creative…Inspiring Award Winning Creative Carolyn O’Neill

PharmExec

Carolyn O’Neill, Chief Creative Officer of Centron discusses their APEX-award winning global disease awareness campaign for both HCPs and patients, “Dimensionalizing the Patient Experience in PNH.” PNH or paroxysmal nocturnal hemoglobinuria is a rare immune disorder that attacks a person’s red blood cells. The campaign was meant to build on it is not an inherited disease and people’s symptoms don’t exhibit externally, usually appearing in mid-life and portray the feelings of a PNH sufferer.

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AbbVie seeks EMA marketing authorisation for preventive migraine therapy

Pharmaceutical Technology

AbbVie has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for its atogepant for prophylaxis of migraine in adults who experience a minimum of four migraine days each month. An oral CGRP receptor antagonist (gepant), atogepant is developed as a preventive migraine treatment. The application is based on the Phase III ADVANCE and PROGRESS clinical trial analysing the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine a

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AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu

pharmaphorum

AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up the treatment pathway. The green light from the European Commission means that Enhertu (trastuzumab) deruxtecan) can now be used for patients whose disease has progressed after first-line therapies such as Roche’s Herceptin (trastuzumab) plus chemotherapy, a standard regimen for this type of cancer.

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The Evolution of Pneumococcal Vaccines and Current Guidelines

Pharmacy Times

Pharmacists are in an excellent position to educate and counsel patients on current recommendations.

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Worldwide Clinical Trials, Invitae join to accelerate rare-disease studies

Outsourcing Pharma

The CRO and medical genetics company will collaborate to accelerate trials centered on rare diseases, using real-world data and genetic testing technology.

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Pfizer's former R&D head takes on drug pricing misconceptions in new book

PharmaVoice

John LaMattina has something to say about the industry — and he hopes patients are listening.

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Patient advocacy foundation holds listening session with FDA

Outsourcing Pharma

The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.

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Lumeon Engages Amendola for Strategic PR and Marketing Services

PharmExec

Award-winning healthcare, digital health and life sciences PR agency and care orchestration leader partner to raise awareness of automating manual tasks and empowering care teams.

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UPS Healthcare Logistics Expands Premier Service, Plans New Warehousing and Delivery Capacity

Pharmaceutical Commerce

Three levels of service—Silver, Gold and Platinum—are rolling out globally.

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Consumer Confidence in Health Information from Non-Health Care Provider Sources on the Rise in The Harris Poll's 2022 Health Information Trends Study

PharmExec

Trust in information from secondary sources like Internet searches, pharma companies, patient advocacy groups, and more has grown since 2019 Survey; Consumers need help making sense of online health information.

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Monkeypox cases prompt governments to order vaccine supply

Pharma Times

Imvanex is a non-replicating smallpox vaccine developed in collaboration with the US government

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SPAG, Leading Asian Integrated Health Communications and Marketing Agency, Joins FINN Partners

PharmExec

The move makes FINN one of the world's largest agencies in health innovation and Increases SPAG global service capabilities and offerings for clients.

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AstraZeneca and Daiichi Sankyo’s Enhertu receives EU approval

Pharma Times

Specifically engineered antibody treats HER2-positive metastatic breast cancer

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Two Labs Adds Medical Affairs & Communications to Suite of Services

PharmExec

Aimed at small and emerging biopharma/biotech manufacturers, this service fills a gap in the market.