August, 2022

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What is a 340B covered entity?

PhRMA

We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make appropriate decisions about their own health but also help enable constructive conversations on how we can support a regulatory and policy environment that helps patients access life-saving medications.

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Current, Emerging COVID-19 Variants and the Testing Landscape

Drug Topics

Drug Topics® is joined by Joseph Mann, MSN, FNP-C, to discuss pharmacy’s fast-expanding role in COVID care, variant BA.5’s diagnostic impact, and the benefits of different tests available — including how technology behind a smartphone-integrated home test creates a fluid experience for patients.

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Trending Sources

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Combination Flu, COVID-19, RSV mRNA Vaccine Could Change Immunizations Landscape

Pharmacy Times

Francesca Ceddia, MD, senior vice president of respiratory vaccines at Moderna, said the company is in early stages of development for a combined mRNA vaccine for influenza, COVID-19, and RSV.

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Digital health app linked to better outcomes in heart failure

pharmaphorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.

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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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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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Blister material as a source of nitrosamine impurities

European Pharmaceutical Review

Following numerous recalls, the industry is striving to investigate the causes, sources and ways to mitigate carcinogenic nitrosamine impurities. In a recent paper, published in the International Journal of Pharmaceutics , researchers identified nitrocellulose blister packaging as a potential source of N -nitrosodimethylamine (NDMA) and N -nitrosodiethylamine (NDEA) impurities.

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More Trending

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Leukemia Patients Turn to Online Pharmacies Due to Escape High Drug Prices

Drug Topics

Researchers report that half of the online pharmacies are rogue operations that may operate without a license or have other serious shortcomings.

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Study: Green Tea Extract Reduces Blood Sugar Levels, Improves Gut Health

Pharmacy Times

Investigators found that the health risks linked to the condition known as metabolic syndrome could be diminished by green tea’s anti-inflammatory benefits in the gut.

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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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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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The Price of Innovation: ‘Paying for a Cure’ Remains Costly Proposition

PharmExec

Curative-type therapies offer great hope in further transforming treatments for cancer and other diseases, but addressing the economics of these products—and ultimately the cost-benefit equation—is daunting. What is being done to smooth the path for pricing and reimbursement?

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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.

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Examining Lifelong Statin Therapy in Patients at Risk of Cardiovascular Disease

Drug Topics

New research looks at the potential benefits of long-term statin use in patients who are at increased risk of cardiovascular disease.

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Study: Myocarditis Risk Is Significantly Higher After COVID-19 Infection Vs After Vaccine

Pharmacy Times

Analysis includes nearly 43 million individuals aged 13 year and older who received at least 1 dose in England between December 1, 2020, and December 15, 2021.

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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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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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A World of Opportunity

PharmExec

Marie-France Tschudin, president, innovative medicines international, and chief commercial officer at Novartis, taps into life lessons to help bring therapies to people in novel ways­.

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Woman of the Week: COTA’s Miruna Sasu

PharmaVoice

Miruna Sasu is on a mission to use real world data to help wipe out cancer. She believes this audacious goal is within reach, and as president and CEO of COTA, she is inspiring her team to create a “path to care” for oncology patients.

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Inflation Reduction Act Benefits Medicare Patients

Drug Topics

Medicare users will see prescription drug pricing reform thanks to the Inflation Reduction Act.

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Hormone Therapy for Prostate Cancer May Increase Risk of Mortality From Cardiovascular Disease

Pharmacy Times

Use of hormone therapy to treat prostate cancer may require more consideration by health care providers as new study shows the therapy may increase the risk of heart disease.

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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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A Saga of 75 years journey of Indian Pharmaceutical Industry

Pharma Tutor

A Saga of 75 years journey of Indian Pharmaceutical Industry. Look back of growth drive for Indian pharmaceutical industry after 75 years of independence and future roadmap. admin. Sun, 08/14/2022 - 18:21. Tags. Pharmapedia. Articles.

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MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

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As Flu Season Approaches, Prepare to Vaccinate This Fall

Drug Topics

This National Immunization Awareness Month, prepare your pharmacy to offer important vaccines.

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Study Finds COVID-19 Vaccination During Pregnancy Does Not Increase Risk of Preterm Birth or Stillbirth

Pharmacy Times

New research indicates that COVID-19 vaccinations did not increase the risks of preterm births or gestational issues for pregnant women, despite prior conflicting evidence.

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UK first to approve Moderna’s Omicron booster jab

pharmaphorum

The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna’s mRNA-1273.214 shot. The new vaccine is an updated version of Moderna’s widely-use Spikevax vaccine, which includes sequences from the original Wuhan strain of SARS-CoV-2, as well as from the Omicron BA.1 subvariant.

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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Parexel joins pharmacy giants in quest to boost community health clinical trials

PharmaVoice

The Community Alliance Network is the latest industry initiative looking to the pharmacy counter to help improve trial recruitment diversity.

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Bristol Myers Squibb aims to improve disability diversity in clinical trials

European Pharmaceutical Review

Dubbed Disability Diversity in Clinical Trials (DDiCT), the initiative aims to provide recommendations on how to improve access, engagement, speed of enrolment and participation of people with disabilities in clinical trials. The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said.

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COVID-19: An Attack on the Brain

Drug Topics

What are the long term psychiatric and neuropsychiatric complications of COVID-19?

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Study to Evaluate Efficacy of Telehealth Cognitive Behavioral Therapy for Migraine

Pharmacy Times

Study will analyze whether cognitive behavioral therapy telehealth can lower headache days and disability as effectively as cognitive behavioral therapy plus a preventive medication for migraine.

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Pfizer vaults into sickle cell market as GBT deal confirmed

pharmaphorum

Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT) has been confirmed, with the $68.50-per-share deal valuing GBT at $5.4 billion. As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy.

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