Thu.Jul 28, 2022

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Abortion Ban Could Be Life-Threatening for Women With Neurological Conditions

Pharmacy Times

Researchers highlight how a lack of access to medications used to treat multiple sclerosis, migraines, and epilepsy, but not proven safe for pregnancy, threatens child-bearing aged women who live with these conditions.

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EMA task force begins review of Veru’s sabizabulin for Covid-19

Pharmaceutical Technology

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU). Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to hospital who are at incre

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Oncology Overview: Adagrasib (MRTX849) for Non-Small Cell Lung Cancer

Pharmacy Times

The FDA is evaluating the use of adagrasib (MRTX849) to treat patients with non-small cell lung cancer harboring a KRAS G12C mutation who have previously received at least 1 systemic therapy.

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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

Supply chain shortages have dominated headlines for several months, and the pharma industry has been no exception. While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems.

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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: Lowest Mortality Risk Found Among Adults Who Exceed Current Physical Activity Guidelines

Pharmacy Times

People who performed 2 to 4 times above the recommended amount of moderate physical activity (300-600 minutes/week) saw an overall 26%-31% lower risk of mortality from all causes.

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Late-stage ulcerative colitis pipeline continues to innovate

Pharmaceutical Technology

Ulcerative colitis (UC), an inflammatory bowel disease, is characterised by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life, including diarrhoea, abdominal pain and cramping, fatigue, weight loss and pain. While the exact cause of UC remains unknown, it is often associated with immune system malfunction.

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BMS reports 2% rise in total revenue in Q2 2022

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has reported a 2% rise in revenues to $11.9bn in the second quarter (Q2) of 2022 compared to $11.7bn in Q2 last year. The revenue growth was driven by in-line products, mainly Eliquis and Opdivo, as well as the company’s latest product portfolio comprising Abecma, Opdualag and Reblozyl. New LOE products, especially Revlimid and foreign exchange, impacts partially offset the increase in revenues.

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FDA Accepts New Drug Application for Tofersen as Treatment of SOD1-ALS

Pharmacy Times

Currently, there is no treatment targeted for superoxide dismutase 1 amyotrophic lateral sclerosis, which has a life expectancy of 3 to 5 years from time of symptom onset.

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Despite benefits, long-acting injectables remain underutilised for schizophrenia

Pharmaceutical Technology

Discontinuation or non-adherence to antipsychotic treatment is the most common cause of relapse in patients diagnosed with schizophrenia. As such, patients are typically offered continuous antipsychotic pharmacotherapy to prevent recurring episodes of psychosis. The use of long-acting injectable (LAI) formulations of these antipsychotics can help prevent hospitalisations related to symptom relapse, as these products are administered every fortnight or in one to six-month intervals, versus once o

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Second COVID-19 Booster Dose Improves Efficacy Against Omicron Subvariants

Pharmacy Times

After a second booster dose, efficacy against COVID-19 Omicron subvariants rose to 80% within the first 6 months, according to results of a study by the CDC.

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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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Personalized data could bring PhysIQ to the forefront of clinical trial evolution

PharmaVoice

The digital medicine company’s chief strategy officer, John Varaklis, explains how its analytic predictive platform could lead to safer and quicker clinical trials.

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Non-Alcoholic Fatty Liver Disease Increases Risk of Heart Failure

Pharmacy Times

Records from 11 million patients shows that non-alcoholic fatty liver disease could increase the risk of developing heart failure by 50%.

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Investment in decentralized clinical trials pays off: analysis

Outsourcing Pharma

A joint study conducted by analysts from Medable and the Center for the Study of Drug Development points toward shorter cycle times, cost savings, and more.

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What to Focus on When Speaking with Elected Officials in the Community

Pharmacy Times

The first thing is educating these folks, because it's hard for them to understand our challenges if they don’t understand what we do.

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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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Opdualag off to a flying start, says BMS CEO

pharmaphorum

Bristol-Myers Squibb’s new immune checkpoint inhibitor combination Opdualag has only been on the US market for a few weeks but is already off to a “great start”, according to chief executive Giovanni Caforio. Opdualag – a fixed-dose combination of LAG-3 inhibitor relatlimab and BMS’ PD-1 inhibitor Opdivo (nivolumab) – was approved as a first-line therapy for unresectable or metastatic melanoma by the FDA in March, and garnered $58 million in sales in the second quarter.

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Pharmacists Can Help Manage Patients With Parkinson Disease

Pharmacy Times

They can assess for adherence, identify drug-related problems, monitor pharmacotherapy, and provide education.

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OptimizeRx Extends Omnichannel Reach With Cooler Screens Partnership

PharmExec

Healthcare advertising agencies can now easily add retail pharmacies to their healthcare media buying strategies.

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FDA Approves Belimumab for Children with Active Lupus Nephritis

Pharmacy Times

Belimumab (Benlysta) the first FDA-approved therapy for pediatric lupus nephritis.

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Dupixent drives Sanofi to hike its full-year profit forecasts

pharmaphorum

Dupixent’s march towards becoming one of the world’s top-selling medicines continued at a healthy lick in the second quarter, allowing Sanofi to raise its full-year earnings forecasts. Sales of Dupixent (dupilumab) rocketed 43% to €1.96 billion ($2 billion) – ahead of analyst expectations – driven by buoyant demand in its atopic dermatitis and severe asthma indications fuelled by approvals in earlier age groups.

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Enfortumab Vedotin, Pembrolizumab Combo Maintains Strong Objective Response Rate Treating Urothelial Cancer

Pharmacy Times

The drug combination demonstrated a 64.5% confirmed objective response rate in individuals with unresectable locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-based chemotherapy.

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Melinta and Cidara sign licensing deal for rezafungin

Pharmaceutical Technology

Melinta Therapeutics has signed a licence agreement with Cidara Therapeutics to facilitate a strategic collaboration for marketing the latter’s rezafungin in the US. Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults. It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.

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Daily Medication Pearl: Argatroban Injection

Pharmacy Times

Argatroban is indicated for thrombosis in adult patients with heparin-induced thrombocytopenia and as an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention.

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Five largest chemical and pharmaceutical construction projects initiated globally in Q2 2022

Pharmaceutical Technology

Here are the largest chemical and pharmaceutical construction projects initiated globally in Q2 2022, according to GlobalData’s construction projects database. 1. Tuas Biomedical Park New Vaccine Production Facility – $467m. The project involves the construction of a new vaccine production facilities at Tuas Biomedical Park in Singapore.

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Daily OTC Pearl: EmuaidMax

Pharmacy Times

Topical symptomatic relief for resistant skin conditions, including severe boils, hemorrhoids, eczema, cold sores, fungal infections, psoriasis, poison ivy, oak and sumac, and other itchy, painful conditions.

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Ogilvy Health Bolsters Executive Leadership Team, Recruiting Tyler Montague as EVP, Client Leader

PharmExec

Montague will be responsible for developing and maintaining all relationships, activities and services for his client accounts while leading strategic and tactical planning initiatives for each of them.

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Advice for Pharmacists to Get Involved in Trade Associations, Working with Legislators

Pharmacy Times

Get involved, attend their sessions, attend their conferences, understand what they’re saying, make sure that we’re, again, speaking with that one common voice.

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Age-related macular degeneration market expected to grow to $22.8bn in 2031

Pharmaceutical Technology

The US Food and Drug Administration's (FDA) recent approval of Roche's Vabysmo (faricimab) for wet age-related macular degeneration (wAMD) in January this year, coupled with anticipated approval of pipeline therapies in the forecast period from 2021 to 2031, as well as potentially first-to-market therapies for geographic atrophy (GA), are all expected to drive the growth of the AMD market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan).

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Building a digital therapeutic for paediatric behavioural health – the pharmaphorum podcast

pharmaphorum

On the latest instalment of the pharmaphorum podcast, editor in chief Jonah Comstock hosts Dr Benny Alouf, chief medical officer at Limbix to discuss his company’s digital therapeutic for teen depression. Benny discusses SparkRx, Limbix’s product, and how it works, addressing the current regulatory landscape, how digital therapeutics interact with talk therapy and traditional therapeutics, and why it’s important to build a bespoke product for teens.

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Current and future players in the osteoarthritis market

Pharmaceutical Technology

Osteoarthritis (OA) is a slowly progressive joint disease that is a major cause of disability and pain among the elderly, second only to cardiovascular disease. The OA space is characterised by a high level of unmet clinical need driven by the limited effectiveness of currently available analgesics and the lack of disease-modifying OA drugs (DMOADs).

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July 2022: Generic Product News

Pharmacy Times

This month's featured products include iloperidone tablets, dabigatran etexilate capsules, and more.

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What factors are driving life sciences FDI in 2022?

Pharmaceutical Technology

Selecting a destination for a greenfield foreign direct investment (FDI) project is a long and sensitive process that no company takes lightly. By carefully weighing up a range of factors, businesses can ensure they are choosing a city or region where their company can access the resources needed to scale multinational operations smartly. In the life sciences sector, one country is significantly outstripping others for FDI.

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Harnessing the Potential of Data to Deliver the Future of Healthcare

Pharmaceutical Commerce

Faster approvals, more accurate and timely medicines monitoring—all enabled by harmonized, consistent and reliable data—will drive improved patient outcomes.

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Addressing Disparities in Clinical Trial Settings

Pharmacy Times

The panel highlights opportunities for inclusive populations within trials for HR+/HER2- breast cancer, as well as pharmacist-led initiatives in clinical trial settings.

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POCN Adds Bill Braswell as Business Unit President Amid Growth

PharmExec

Braswell joins the organization to play an integral role in expanding POCN’s strategic and channel partnerships and leading the Business Development team.

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