Mon.Jul 25, 2022

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Unvaccinated First Responders Have Higher Risk, Incidence of COVID-19 Infection

Pharmacy Times

Unvaccinated first responders were more likely to doubt the safety and efficacy of COVID-19 vaccines than vaccinated counterparts, reporting low trust in the government.

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Philips on designing innovation and cultivating partnerships – part one

pharmaphorum

Sachin Grover, lead of solutions vertical at Philips India, tells me about the company’s innovations during India’s COVID outbreak and how they’ve led to increased healthcare access in the region. There is a vast difference in India’s healthcare system between rural and urban areas, but Philips’ team in the region is working hard to close that gap and improve access to healthcare. “It’s been 75 years since India’s independence.

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Trending Sources

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Holistic Psoriatic Arthritis Care: Why Well-Being Should Be Incorporated Into the Treatment Paradigm

Pharmacy Times

People living with psoriatic arthritis deserve to be informed about ways to approach disease management holistically and with a personalized approach.

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Embracing digitalization in the pharmaceutical supply chain

Pharmaceutical Technology

The COVID-19 pandemic triggered significant changes to the way healthcare operates. Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. “There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.

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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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Vitamin B6 Supplements Reduces Anxiety, Depression in New Study

Pharmacy Times

Participants took about 50 times higher than the recommended daily allowance every day for a month, investigators say.

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Human element important for decentralized trial advancement

Outsourcing Pharma

During the Decentralized Trial Technology event, experts from CVS Health, University of Chicago, and ACRP shared insight on what can increase DCT success.

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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The Regulation will cover all SoHO (eg, blood, tissues, cells, breast milk and microbiota) except solid organs. A major aim of the proposal is to enhance the protection of recipients of SoHO therapies, as well as donors of SoHO and offspring from medically assisted reproduction.

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Facing Challenges of Burnout, Pharmacies Seek Ways to Support Staff

Pharmacy Times

Along with expanding responsibilities, pharmacies must have the infrastructure and pharmacy staff must have sufficient support.

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Behind Pfizer's new quest to target a 'transformation' in pharma

PharmaVoice

A combined venture with Roivant — called Priovant Therapeutics — is looking to be a forerunner in the burgeoning autoimmune disease market.

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Proposed Changes of USP Strengthens Documentation Requirements

Pharmacy Times

Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.

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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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A 'total waste'? Drug developers worry if two decades of Alzheimer's research were pointed at the wrong targets

PharmaVoice

The latest trial failures in Alzheimer's have shown cracks in the foundation of ingrained theories like amyloid plaque clearance. What will it take to move forward?

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Biosimilar Adoption: Patient and Provider Considerations

Pharmacy Times

From a patient perspective, the lack of awareness of biosimilars is the biggest barrier to adoption.

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Machine learning hiring levels in the pharmaceutical industry rose in June 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for machine learning related positions rose in June 2022 compared with the equivalent month last year, with 26.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 24.1% of companies who were hiring for machine learning related jobs a year ago and an increase compared to the figure of 26.3% in May 2022.

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USP Will Become Enforceable for Facilities Once Revisions of , Approved

Pharmacy Times

Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said once the 2 compounding chapters, and become enforceable, there will be a 6-month grace period before USP becomes enforceable.

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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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Roche’s fast-growing eye drug Vabysmo set for EU approval

pharmaphorum

Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the US – and could soon start making inroads against its rival in Europe. Vabysmo (faricimab) has been recommended by the EMA’s human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricin

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Digital Engagement is Only as Good as the First-Party Data It Provides

PharmExec

First-party insights bridge marketing and sales to deliver better HCP experiences.

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The earlier the better: New consortium leverages infant screening to accelerate treatment

PharmaVoice

Inozyme Pharma has joined a genomic sequencing program developing a novel rapid test for 388 genetic diseases.

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Education, Thirst for Knowledge Emerges from Health Mart University

Pharmacy Times

Health Mart University also offers "basic technician training programs," to allow pharmacies to bring those new technicians on board, help them meet the PTCB examination standards, and really get that new technician ready to go.

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FDA verdict on Enhertu in HER2-low breast cancer due before year-end

pharmaphorum

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory. The two partners said this morning that the FDA will review Enhertu (trastuzumab deruxtecan) under its real-time oncology review process as well as Project Orbis – a project run by the FDA and other regulators that aims to allow patients faster access to new cancer

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Daily Medication Pearl: Piperacillin and Tazobactam (Zosyn)

Pharmacy Times

Piperacillin and tazobactam (Zosyn) is indicated for treatment of intra-abdominal infections, skin and skin structure infections, female pelvic infections, community-acquired pneumonia, and nosocomial pneumonia.

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EMA CHMP recommends Moderna’s Covid-19 booster for adolescents

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an update to the conditional marketing authorization (CMA) to include Moderna ’s 50µg booster dose of Covid-19 vaccine, Spikevax, for usage in adolescents aged 12 to 17 years. As per the recommendation, the booster shot is indicated for use in people of this age group a minimum of three months after they receive the initial vaccine regimen.

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Study Results Indicate Increase in Early-Onset Colorectal Cancer

Pharmacy Times

Delayed diagnosis in younger individuals and presentation of advanced disease highlights need for awareness.

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How Does Apple’s iOS 14 Update Affect Facebook Advertising in 2021 – BLOG #70

The Social Pharmacist

The recent iOS 14 updates resonated with the immense significance of digital privacy among its users from the past years. Its implementation gave consumers more control over the data they unknowingly share with advertisers and publishers. . In response to the upcoming changes, Facebook has indicated that they expect the amount of data available for ad targeting and measurement to decrease as users “opt-out” of tracking.

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Drug Shortages Update: July 2022

OctariusRx

This week we are once again providing an update on the most recent drug shortages. Drug shortages currently remain at over 100 different medications, with the Food and Drug Administration (FDA) noting 118 products as being unavailable. Some of these shortages are short term, or limited availability, while others are completely unavailable with unknown release dates.

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Apptronik Launches Humanoid Robot

Pharmaceutical Technology

Concept: Austin-based robotics startup Apptronik has unveiled a humanoid robot named Astro. It is a general-purpose robot that can work alongside humans. Nature of Disruption: Astro is a human-centered robotic system that includes vision-based grasping. It leverages ML technology to find, grab and pick up objects. The robot has modern actuation packed into a small form factor.

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Ginkgo buys Zymergen, but may shed drug discovery business

pharmaphorum

Zymergen’s brand new plan to shift from a synthetic biology specialist to a drug discovery player has come to an early end, with the sale of the company to rival Ginkgo Bioworks. The all-stock transaction values Zymergen at an approximately $300 million, a fraction of the $1 billion it raised in venture funding with another $530 million from its initial public offering in April 2021.

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AstraZeneca-Daiichi Sankyo’s breast cancer ADC gets FDA priority review

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults. The treatment is intended for HER2-low immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative breast cancer patients who have previously received treatment in the metastati

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Bavarian Nordic monkeypox jab cleared in EU, as WHO declares emergency

pharmaphorum

The EMA has extended the approved indications of Bavarian Nordic’s smallpox vaccine Imvanex for monkeypox, which has now infected tens of thousands of people across dozens of countries worldwide. Imvanex has been approved in the EU since 2013 for smallpox, a virus related to monkeypox , and according to the CHMP should not be approved to protect adults from monkeypox disease.

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EC extends marketing authorisation for Bavarian Nordic’s smallpox vaccine

Pharmaceutical Technology

The European Commission (EC) has extended Bavarian Nordic ’s smallpox vaccine Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) marketing authorisation to offer protection from monkeypox. A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government. The move to expand the marketing authorization for Imvanex to include protection from monkeypox and disease caused by the vaccinia virus comes after the European Medicines Agency (EMA) Committee for Medic

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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer. Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – an

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July 2022: Rx Product News

Pharmacy Times

This month's featured products include viloxazine extended-releast capsules, lumateperone, and more.

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Incorporating patient preference vital to study success: ICON

Outsourcing Pharma

A leader from the CRO discusses how capturing the perspective of trial participants can help ensure development of treatments that meet the patientsâ needs.

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Know Your Salary Range

Pharmacy Times

This is important to establish when deciding on a pharmacy focus or making a career change.

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How Does Apple’s iOS 14 Update Affect Facebook Advertising in 2021 – BLOG #70

The Social Pharmacist

The recent iOS 14 updates resonated with the immense significance of digital privacy among its users from the past years. Its implementation gave consumers more control over the data they unknowingly share with advertisers and publishers. . In response to the upcoming changes, Facebook has indicated that they expect the amount of data available for ad targeting and measurement to decrease as users “opt-out” of tracking.

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