Sat.Jul 30, 2022 - Fri.Aug 05, 2022

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ICYMI: Patients across the country are sharing concerns about government price setting

PhRMA

As members of Congress continue to push forward misguided government price-setting policies under the guise of “negotiation,” patient advocates across the country have been speaking out in local media outlets about the potential consequences.

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Notable Revisions in Diabetes Treatment According to ADA Guidelines

Pharmacy Times

American Diabetes Association updates recommendations regarding SGLT-2 inhibitors, GLP-1 RA, and finerenone for cardiovascular and renal comorbidities.

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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Myth vs. Fact: The Senate’s latest price setting proposal

PhRMA

The narratives being built around the Senate’s latest price setting proposal frame it as a bill intended to lower drug prices for patients and address rising inflation. But those narratives aren’t the facts. Here, we bust those myths.

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Updated NCCN Breast Cancer Screening Guidelines Help Clarify Risk for Patients

Pharmacy Times

Patients can better understand the most current recommendations for breast cancer screening with the new NCCN Guidelines for Patients®: Breast Cancer Screening and Diagnosis.

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More Trending

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Q&A With Court Horncastle, Vice President and Business Unit Head, Respiratory, US Commercial for GSK

PharmExec

Court Horncastle discusses how his career led him to work with treating COPD and asthma.

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An open letter to Congress: Stand with patients and future cures

PhRMA

I recently joined PhRMA board members in penning the letter below to Congress, urging them to abandon their latest drug pricing proposal.

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Tip of the Week: Use Mindfulness To Be An Effective Leader

Pharmacy Times

Effective pharmacy managers help everyone to see the proverbial forest through the trees.

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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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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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Editas, Real Chemistry and Compass blaze new trails with pivotal C-suite hires

PharmaVoice

How these latest executive personnel changes are impacting the industry.

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Celebrating Medicare’s 57th anniversary

PhRMA

In case you missed it, Saturday, July 30, marked the anniversary of Medicare. For 57 years, Medicare has helped pay for medical care for Americans over the age of 65, as well as younger Americans with certain medical needs. To celebrate, we are reflecting on the history of the program that benefits more than 60 million Americans. Unfortunately, some members of Congress are considering significant changes to Medicare that could have a devastating effect on millions of Americans.

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Resistant Starch in Foods Can Reduce Hereditary Cancer by 50%

Pharmacy Times

Findings in a new trial show that dietary supplementation of resistant starch has the potential to decrease people’s risk of certain types of gastrointestinal cancers.

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Roche scores phase 3 win for subcutaneous Tecentriq, eyes filings

pharmaphorum

Roche’s Tecentriq could become the first drug in the PD-1/PD-L1 inhibitor class to be approved in a subcutaneous formulation, after the new version matched the original intravenous formulation in a phase 3 trial. The results of the IMscin001 study found that an injection of Tecentriq under the skin taking just a few minutes was non-inferior to a 30 to 60-minute infusion with the IV version in terms of pharmacokinetics – how the active ingredient behaves in the body after administration.

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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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Taking probiotics where they’ve never gone before

PharmaVoice

How Seed Health is transforming the microbiome therapeutic market with its pharma-focused drug development approach.

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Pharmacopoeias to further support vaccine development and supply

European Pharmaceutical Review

Ph. Eur. The European Pharmacopoeia (Ph. Eur.) Commission has established the mRNAVAC Working Party to begin working on quality standards to support the emerging field of messenger RNA (mRNA) vaccines. The newly created Working Party’s first task will be to develop a consolidated strategy for future standards addressing these vaccines and their components.

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Is There Such Thing as Work-Life Balance in Pharmacy?

Pharmacy Times

Many companies overlook the power that workplace culture can have on employee wellness and instead, focus relentlessly on financial metrics.

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How the WHO hepatitis strategy measures up in the field

pharmaphorum

According to the World Health Organization (WHO), approximately 296 million people globally live with hepatitis B, with most unaware of their infection. Africa is the worst impacted region for hepatitis B with a prevalence of 7.5 percent compared to 0.5 percent in the Americas. Hepatitis C impacts an estimated 58 million people across the globe. Again, Africa is the worst-impacted region with a prevalence of 0.8 percent while the Americas see a prevalence of 0.5 percent.

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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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‘Death by 1,000 cuts:’ How emerging tech could change the journey for ALS patients

PharmaVoice

EverythingALS aims to speed drug development through improved diagnostics.

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Microparticles could form self-boosting vaccines

European Pharmaceutical Review

Researchers have developed microparticles that can be tuned to deliver their payload at different time points. According to the authors, the technology could enable the creation of “self-boosting” vaccines that only need to be administered once, which could be particularly beneficial for childhood vaccinations in regions with limited access to medical care.

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Regional Trends Reinforcing Breast Cancer Therapeutics Market

Pharmacy Times

Over the next few years, undiagnosed breast cancer cases may add to the demand for more rigorous end-stage treatments and therapeutics.

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Gilead Sciences’ push into oncology is paying off, as Veklury falters

pharmaphorum

Gilead Sciences’ investment in oncology has started to provide a solid return, with sales of cancer therapies breaching the $500 million threshold for the first time in the second quarter. Cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) for lymphoma and leukaemia together brought in $368 million, up 68%, while antibody drug conjugate Trodelvy (sacituzumab govitecan) rose 79% to $159 million thanks to increased uptake in triple-negative breast canc

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration. Subsequently, technology transfer as well as scale-up from the lab bench to the commercial facility of Samsung were carried out in a period of seven months.

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Big Data Steering Group to enhance data quality and discoverability under new workplan

European Pharmaceutical Review

The joint Big Data Steering Group of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has published a third workplan, setting actions to be delivered by 2025. According to EMA, the new plan will further enhance the efficient integration of data analysis into the regulatory evaluation of medicinal products. “Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes an

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Overdose Deaths Increased in Wave 4 of the Opioid Crisis, Coinciding with the COVID-19 Pandemic

Pharmacy Times

The suggested wave 4 of the opioid crisis saw high opioid-involved overdose death rates in urban counties and high acceleration of overdose deaths in rural counties, indicating that the opioid crisis worsened during the COVID-19 pandemic.

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-h

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The Senate’s latest price setting proposal will undermine U.S. economic growth

PhRMA

Last week, we examined ways the latest drug pricing proposal will undermine patient access to medicines , American medical innovation and our health care system as a whole. But there is another consequence that we can’t leave out: the impact this proposal will have on the biopharmaceutical industry’s contributions to American jobs and the economy.

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L9LS antibody safe and highly protective against malaria, finds study

European Pharmaceutical Review

A single injection of the investigational L9LS monoclonal antibody (mAb) has been found to be safe and highly protective in US adults exposed to the malaria parasite. The results of the Phase I US National Institutes of Health (NIH) study were published in The New England Journal of Medicine. In 2020, the World Health Organization (WHO) estimated that 240 million people had malaria, the mosquito-borne disease spread by Plasmodium parasites, and that it caused about 627,000 deaths.

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Facilities in Non-Hispanic Black, Rural Counties Less Likely to Administer Early COVID-19 Vaccines

Pharmacy Times

Health care facilities in counties with higher Black populations and in rural areas were less likely to serve as COVID-19 vaccination facilities during May 2021, indicating disparities in vaccine distribution.

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Sarepta says early filing for DMD gene therapy is back on

pharmaphorum

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023. The US biotech – which already has three antisense drugs for DMD on the market – had said earlier it was planning to delay the application into 2023, so the new announcement marks an acceleration of its plans.

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Generic subscription services like Mark Cuban’s promise cheaper drugs — but will it work?

PharmaVoice

Companies like Cost Plus Drugs and DiRx can bring generics directly to consumers at a fraction of the price, but whether it’s enough to fix the inflated U.S. healthcare system is yet to be seen.

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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

European Pharmaceutical Review

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. The Class 1 Medicines Recall Notification was published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Computationally Developed Cocktail for HIV Therapy Significantly Reduces Chance of Viral Rebound

Pharmacy Times

Using computational methods, the development of an HIV therapy cocktail based on the virus’ genetics was found to increase the efficacy of treatment.

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