Sat.Jul 16, 2022 - Fri.Jul 22, 2022

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Review Finds No Link Between Serotonin Levels, Chemical Imbalance and Depression

Pharmacy Times

A review of decades of research concluded that there is no evidence of an association between serotonin levels and depression, calling the function of antidepressants into question.

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Connecting your Digital Health Strategy from Clinical to Commercial

PharmExec

Thursday, July 21st 2022 at 11am EST, 8am PST, 5pm CEST Join this webinar to hear industry thought leaders discuss how data and experiences serve clinical and commercial needs, explore which platforms and technologies can enable a robust digital health ecosystem, and share recommendations for building a digital health strategy fit for your business.

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Twill taps YourCoach for DtX-health coaching integration

pharmaphorum

Health coaching ecosystem YourCoach Health and digital therapeutics company Twill (formerly Happify Health ) are teaming up to offer access to YourCoach’s cross-specialty health coaches via Twill’s Duet platform, the companies announced today. “Digital therapy has been around for a really long time,” YourCoach Cofounder and CEO Marina Borukhovich told pharmaphorum.

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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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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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How to Promote a Culture of Belonging in Pharmacy

Pharmacy Times

Companies that incorporate Diversity, Equity, and Inclusion (DEI) into their everyday operations will be instrumental in shaping a new standard in their workforce and ultimately in society.

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NA to NAM ratio as a biomarker for cell therapy sterility

European Pharmaceutical Review

Researchers have shown that ratio of nicotinic acid (NA) to nicotinamide (NAM) in cell cultures significantly increases with the presence of live microorganisms within 24 hours, acting as a useful biomarker for the detection of early-stage microbial contamination in cell therapies. Cell therapies are emerging as promising therapeutic modalities across a range of indications, with mesenchymal stromal cells (MSCs) the most clinically studied cell therapy platform worldwide; however, the nutrient r

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

A key factor of Pfizer’s Covid-19 antiviral Paxlovid efficacy has been early intervention, but getting it in time has proven to be a challenge. On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .

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Patients with Diabetes on Medicare Advantage More Likely to Have Worse Health Outcomes Despite Preventive Care Access

Pharmacy Times

Patients with diabetes on Medicare Advantage were also less likely to be prescribed newer, more expensive medicine than patients on Medicare Fee-For-Service plans, indicating potential disparities in care.

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Largest-Ever Industry Report Reveals Video Meetings 3x More Effective and Companies Using Them Most Gain Advantage

PharmExec

Data from over 130 million quarterly HCP-field interactions across 80% of global biotech and pharma companies unveiled in Veeva Pulse Field Trends Report - industrywide data shows frequent use of key digital channels is vital for effective HCP engagement.

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Roche CEO Severin Schwan to stand down after 14 years

pharmaphorum

Long-serving Roche chief executive Severin Schwan is stepping down, to be replaced next March by Thomas Schinecker, currently head of diagnostics at the Swiss group. Schwan (pictured above) has been nominated as chair of Roche’s board of directors however, to succeed Christoph Franz will not seek re-election after more than eight years in the role, so will still be intimately involved in the company’s affairs.

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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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Gladstone and UCSF scientists discover BET protein role in Covid-19

Pharmaceutical Technology

Researchers at Gladstone Institutes and UC San Francisco (UCSF) have discovered in a study that bromodomain and extraterminal (BET) proteins are vital for the body to fight Covid-19 infection. . The research also found that BET proteins play two distinct roles in affecting how the SARS-CoV-2 virus interacts with human cells. . They provide the virus with a pathway into cells while aiding cells to defend themselves.

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Putting an End to the Opioid Epidemic in Emergency Medicine

Pharmacy Times

What we're seeing as a trend is this significant increase in synthetic opioids, specifically fentanyl, being contaminated and causing severe overdoses.

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How digital health is changing the relationship between patients and health providers

PharmaVoice

The pandemic has forced the pharmaceutical industry to look at digital in a new way - and it’s driving better health outcomes

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UK scientists say they have found cancer driver in junk DNA

pharmaphorum

It has suspected for many years that some diseases may be linked to non-coding or ‘junk’ DNA, but the mechanism behind the pathology hasn’t been worked out. Now, scientists in the UK think they have found a culprit implicated in cancer. Junk DNA is a term used to describe the 97% of the genetic sequence in human cells found between the 3% coding for our 20,000 genes, once thought to be inert.

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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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AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. Tixagevimab and cilgavimab are two long-acting antibodies (LAABs) obtained from the B-cells of patients convalescing following Covid-19.

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Daily Medication Pearl: Privigen Immune Globulin Intravenous (Human)

Pharmacy Times

Privigen is indicated for the treatment of primary humoral immunodeficiency, chronic immune thrombocytopenic purpura in patients 15 years of age and older, chronic inflammatory demyelinating polyneuropathy in adults.

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Grünenthal to buy NebidoTM testosterone treatment from Bayer for €500m

European Pharmaceutical Review

Grünenthal has agreed to acquire testosterone treatment Nebido TM and its associated brands from Bayer AG, for up to €500 million. The long-acting injectable treatment for testosterone deficiency has been commercially approved in more than 80 countries. Nebido is also patented until March 2024 in the European Union and until May 2027 in the United States.

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Pfizer, Flynn fined £70m in resurrected epilepsy drug pricing probe

pharmaphorum

Drugmakers Pfizer and Flynn Pharma have been fined £70 million ($84 million) by the UK Competition and Markets Authority (CMA) for overcharging the NHS for a widely-used epilepsy drug. The CMA delivered a preliminary judgment in the case last year which concluded that Pfizer and Flynn abused a dominant position in phenytoin sodium capsules, causing NHS spending on the drug to balloon from around £2 million a year in 2012 to £50 million the following year.

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ASRS conference reveals hopeful outcomes for gene therapy RGX-314 in retinal diseases

Pharmaceutical Technology

Pipeline therapies within the diabetic macular oedema (DME) space have recently gathered interest following the American Society of Retina Specialists (ASRS) Annual Meeting, which took place on 13–16 July. The spotlight was placed on many up-and-coming pharmacotherapies for retinal diseases, one of which was AbbVie’s/Regenxbio’s gene therapy RGX-314.

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Methotrexate Access Becomes Challenging for Some Patients Following Supreme Court Decision on Abortion

Pharmacy Times

Donald Miller, PharmD, discussed how the recent Supreme Court decision overturning Roe v. Wade has created confusion around access to methotrexate for patients in some states that are limiting abortion access.

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How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. 1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health. Our research paper, which is being submitted for publication this summer, aims to create an evidence-based medicine (EBM) methodology that can assess this positive impact, to further help re

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Amazon ratchets up its health ambitions, buying US primary care group

pharmaphorum

Amazon has accelerated its expansion into the healthcare sector with an all-cash deal to acquire One Medical, a US group that provides virtual and in-person primary care services using a subscription fee model. Amazon is buying One Medical for $18 per share, valuing the company at around $3.9 billion and making it one of the online retail giant’s largest-ever acquisitions – and by far its biggest within the health category.

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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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Study: Gabapentin-Related Overdose Deaths Increasing, Associated with Opioid Use

Pharmacy Times

The increase in gabapentin-related overdose deaths follows a rising trend in overall overdose deaths during the COVID-19 pandemic.

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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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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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ESG Top Trends: Technology trends

Pharmaceutical Technology

The pharma industry has deeply rooted environmental, social, and governance (ESG) issues that challenge sustainability. Overcoming these challenges requires collaborative, proactive steps to achieve sustainability goals and turn the reputation of this industry around. Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData.

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Simultaneous Administration of COVID-19 Booster, Influenza Vaccine May Increase Likelihood of System Reaction

Pharmacy Times

Individuals vaccinated simultaneously with COVID-19 booster and influenza vaccines may be more likely to experience systemic reactions and adverse health impacts.

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Woman of the Week: Vaxxinity's Mei Mei Hu

PharmaVoice

Mei Mei Hu is looking to lead a third biologic ‘revolution’ by developing vaccines for chronic diseases.

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Ex-GSK vaccine chief to lead new UK biotech Vicebio

pharmaphorum

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. The London-based company was founded by venture capital firm Medicxi in 2019, but has now come out of stealth mode with financial backing of €18 million and a platform based on a ‘molecular clamp’ technology developed by researchers at the University of Queensland (

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Top 10 Thyroid Tests and How to Interpret Them

The Thyroid Pharmacist

In my clinical experience, I’ve seen many cases of thyroid problems go undiagnosed (or misdiagnosed) because most doctors don’t perform a comprehensive test panel. I spent almost a decade undiagnosed because I only had one marker tested. My thyroid condition was missed completely, leading me to deal with needless “mystery” symptoms like chronic fatigue, depression, anxiety, and many others, for far too long!

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Comparing Front-Line Renal Cell Carcinoma Combination Regimens Without Head-to-Head Studies

Pharmacy Times

With a lack of head-to-head studies comparing combination regimens in frontline metastatic renal cell carcinoma, deciding on how to choose the right regimen can pose a challenge.

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With big changes ahead for J&J and Novartis, here's what the companies' execs are talking about

PharmaVoice

Both J&J and Novartis are making — or considering — big shifts in their fundamental company makeup.

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Bid to expand Keytruda use in head and neck cancer therapy fails

pharmaphorum

While immunotherapies have transformed treatment of many types of cancer, they do sometimes fail to have an impact – as Merck & Co has just observed in a study of Keytruda in head and neck cancer. The PD-1 inhibitor missed the mark in the phase 3 KEYNOTE-412 trial in 780 newly-diagnosed patients with head and neck squamous cell carcinoma (HNSCC), a notoriously hard-to-treat form of cancer.