Fri.Jun 24, 2022

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USP Expert: It’s Critical Pharmacists Have Conversations With Patients on Adherence, Storage Issues That Result in Antimicrobial Resistance

Pharmacy Times

Amy Cadwallader, PhD, director of Regulatory and Public Policy Development at US Pharmacopeia (USP), discusses how medicine quality and the medicines supply chain can affect antimicrobial resistance (AMR).

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Greece slaps Novartis with €214 million bribery suit

European Pharmaceutical Review

The Greek state has filed a lawsuit against Novartis , asking for € 214 million in compensation for non-pecuniary damages* the country may have suffered due to alleged illegal payments to government officials and healthcare providers. Commenting on the lawsuit , Greece’s Health Minister Thanos Plevris, stated that the country is seeking compensation for the damage it has suffered “from the actions that Novartis itself has admitted to in the USA that concerns payments to doctors.”.

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Pandemic Created Combat Like Trauma for Pharmacists

Pharmacy Times

The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.

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Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn

Pharmaceutical Technology

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. In addition to providing protection against the Omicron BA.1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 and BA.5.

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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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Oncology Overview: Abemaciclib, a CDK4/6 Inhibitor for Prostate Cancer

Pharmacy Times

Abemaciclib (Verzenio; Eli Lilly and Company) is an FDA-approved kinase inhibitor being investigated for new indications in individuals with hormone-sensitive prostate cancer and castration-resistant prostate cancer.

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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Pharmaceutical Technology

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-

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More Trending

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Data backs AZ’s Wilson disease drug, but with a question mark

pharmaphorum

Last year, AstraZeneca reported that a new drug to treat Wilson disease developed by its Alexion rare diseases unit had hit the mark in a phase 3 trial, setting it on course for regulatory filings. Now, the data has been revealed – and according to investigators could transform treatment. Wilson disease is a rare and progressive genetic condition in which the body’s process for removing excess copper is broken, allowing it to build to toxic levels and damage the liver, brain and other vita

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GSK Releases Positive Phase 3 Data for Its Respiratory Syncytial Virus Vaccine

Pharmacy Times

This is the first RSV vaccination candidate to show clinically meaningful and statistically significant efficacy in adults aged 60 years and older.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

2022 is probably the biggest year in EU pharmaceutical law that I have seen in 30 years. It is an exciting year… but whether the changes will be a net positive or a net negative is yet to be seen” Maarten Meulenbelt, Partner, Sidley Austin LLP. 2022 is undeniably a critical year for change in the pharmaceutical industry: for the first time in several decades, the European Union (EU)’s pharmaceutical legislation is up for review.

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Genentech Releases Positive Data from Broad Blood Cancer Portfolio

Pharmacy Times

Analysis results expand understanding of the impact of the company’s medicines in early stages with the goal or providing patients with durable and robust outcomes from their first treatment.

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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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Sarepta shares yo-yo as FDA places hold on Duchenne trial

pharmaphorum

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a serious safety incident. The FDA has ordered a clinical hold on Sarepta’s SRP-5051 (vesleteplirsen) drug candidate after one patient in the study developed very low levels of magnesium, a condition known as hypomagnesaemia, that can lead to muscle weakness and tremors, seizures, and irregular heart rhythms

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Expert: COVID-19 Vaccination Does Not Completely Protect Against the Virus’s Impact on Taste, Smell Function

Pharmacy Times

Kai Zhao, PhD, director of the Nasal Physiology and Therapeutic Center in the Department of Otolaryngology at Ohio State University College of Medicine, discusses his research investigating the persistence of taste and smell loss among patients who have been infected and reinfected with COVID-19.

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BioNTech launches African vaccine production in Rwanda

European Pharmaceutical Review

BioNTech has initiated construction of its first vaccine production facility in Africa. Located in Kigali, Rwanda, the mRNA manufacturing facility will be the first of three planned sites across the continent, with further factories to come in Senegal and South Africa. Together this network of factories will supply therapies and vaccines solely for people residing in member states of the African Union.

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Examining the Partnership Between Pharmacy and Public Health During the COVID-19 Pandemic

Pharmacy Times

Pharmacy and public health have a long history of collaboration during an emergency.

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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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invoX Pharma agrees to acquire biopharma firm F-star Therapeutics for $161m

Pharmaceutical Technology

invoX Pharma has signed a definitive agreement for the acquisition of all issued and outstanding shares of clinical-stage biopharma firm F-star Therapeutics, in a deal valued at nearly $161m or $7.12 for each share in cash. invoX Pharma is a fully owned Sino Biopharmaceutical subsidiary. The latest deal will expedite the strategy of invoX to develop the International Biopharmaceutical R&D Platform of Sino Biopharm outside of China to transform the lives of patients globally.

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HOPA Expert: To Mitigate the ‘Great Migration of Hematology/Oncology Pharmacists,’ First We Need to Understand Why

Pharmacy Times

Andrea Iannucci, PharmD, BCOP, member of the Board of Directors of the Hematology/Oncology Pharmacy Association (HOPA), discusses how HOPA works within and its impact on hematology/oncology pharmacy practice management.

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GSK to invest $1.2bn in infectious diseases R&D in lower-income countries

Pharmaceutical Technology

GlaxoSmithKline (GSK) has announced plans to invest $1.2bn (£1bn) over a decade to expedite research and development (R&D) for infectious diseases in lower-income countries. New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research.

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Opdualag From Bristol Myers Squibb

Pharmacy Times

Combination therapy with both nivolumab and relatlimab leads to increased T-cell activation compared with monotherapy with either agent alone.

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The benefits of in-person meetings for pharmaceutical microbiology

Pharmig

We’ve all become incredibly familiar with the various online platforms that have facilitated all of us staying in contact and being able to run organisations and businesses throughout the global pandemic. The post The benefits of in-person meetings for pharmaceutical microbiology appeared first on Pharmig.

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Pharmacist Moms: Coffee With Suzy - Episode 19

Pharmacy Times

Suzanne Soliman, PharmD, BCMAS welcomes Sonia T. Oskouei, PharmD, BCMAS, DPLA to discuss biosimilars within the pharmacy industry.

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Manicure Mishap Turned Obsession

The Luxe Pharmacist

My whole life I’ve loved getting my nails done but I’ve never been one to go consistently or maintain always having my nails done. It was partially a cost reason but also I just never felt like I had the time to go sit in the salon for an hour (thanks pharmacy school lol). When I graduated it was on my list of self care items that I wanted to get more into but then in residency I couldn’t have my nails done since I was in and out of the clean room making IV’s a lot, and t

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Daily Medication Pearl: Capecitabine (Xeloda)

Pharmacy Times

Capecitabine (Xeloda) is indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.

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Nitrosamine drug substance-related impurities (NDSRIs)

European Pharmaceutical Review

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). The latest recalls have centred on Orphenadrine Citrate ER Tablets 1 and Quinapril HCl/Hydrochlorothiazide 2 due to the presence of N -nitroso Orphenadrine and N -nitroso Quinapril, respectively. These NDSRIs can form during manufacturing or subsequent storage of the drug product.

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PBM Inquiry: Fresh Hope for HOSP

Pharmaceutical Commerce

The Health System Owned Specialty Pharmacy (HOSP) Alliance‘s Melissa Goff responds to the news of the FTC investigation into PBM practices news and outlines the alliance‘s vision for the integrated specialty pharmacy industry.

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Protected: Approaches to Reach, Recruit and Retain Atopic Dermatitis Patients for Clinical Trials

Pharma Marketing Network

This content is password protected. To view it please enter your password below: Password: The post Protected: Approaches to Reach, Recruit and Retain Atopic Dermatitis Patients for Clinical Trials appeared first on Pharma Marketing Network.

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New countries stockpile antiviral TPOXX as monkeypox outbreak continues

pharmaphorum

pharmaphorum editor in chief Jonah Comstock talks to Philip Gomez, CEO of Siga Technologies, about how his company’s antiviral drug can play a crucial role in addressing monkeypox cases. Although the World Health Organization is still rating the current monkeypox outbreak as a moderate threat , the disease has continued to spread , with 2,103 cases in 42 countries and one confirmed death, according to the latest WHO data.

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Daily OTC Pearl: Hydrogel Burn Pads

Pharmacy Times

Hydrogel Burn Pads provide cooling relief for minor burns and absorbs fluid to prevent infection.

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Fujifilm acquires AI tech to improve fertility treatment

pharmaphorum

Fujifilm’s Irvine Scientific unit has licensed rights to an artificial intelligence-powered technology developed to improve the success rate of in vitro fertilisation (IVF) techniques. The cell culture specialist, a player in assisted reproductive technologies (ART), has licensed the platform from Brigham and Women’s Hospital and Massachusetts General Hospital, where it was developed.

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FTC Probes Pharma and PBM Anti-Competitive Practices

PharmExec

Takes aim at actions that limit access to lower-cost drugs, calls for revamp of M&A-impact guidelines.

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Biogen and Happify partner on digital support for MS patients

pharmaphorum

Digital health company Happify has signed a partnership with another biopharma company, joining forces with Biogen on a toolkit to help people with multiple sclerosis manage their illness. The digital toolkit is designed to keep patients informed of new treatments, help them adhere to their prescribed therapies, encourage behaviours aimed at improving their wellbeing and connect to experts as well as other people with MS.

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Preparing for the 2023 DSCSA deadline

Pharma Manufacturing

Pharma can do better than 50% compliance

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Positive MHRA decision for Briviact

Pharma Times

MHRA extends UCB’s therapy for the treatment of partial-onset seizures

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GSK pledges £1bn drive for infectious disease R&D

pharmaphorum

GSK will invest around £1 billion ($1.2 billion) over a 10-year period to speed up R&D on infectious diseases that mainly impact lower-income countries. The initiative will focus on vaccines and medicines for diseases like malaria, tuberculosis, HIV and neglected tropical diseases (NTDs), which according to the drugmaker account for 60% of the disease burden in poorer regions of the world, as well as antimicrobial resistance.

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Sanofi and GSK report successful efficacy results against Omicron

Pharma Times

COVID-19 Beta-containing vaccine provides 75.