Fri.Jul 21, 2023

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The Senior Citizen Vote Is Feared With Good Reason

Drug Topics

Despite the increase in drug costs outpacing inflation, Pennsylvania seniors are still paying the same amount for prescriptions that they did in 1990.

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Study Findings Urge Use of Personalized Hearing Aids for Older Individuals

Pharmacy Times

Individuals with age-related hearing loss should not be treated with “standard” hearing aids, but fitted to their personal needs, while avoiding settings that add distortion.

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Reaching The APEX: American Pharmacies Annual Meeting Showcases the Importance of Community

Drug Topics

Chuck Waters, vice president of marketing, communications, and data strategy at American Pharmacies, shared why collaboration is so important for the company’s annual APEX event.

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Search Engines Provide Higher Quality Information on HIV PrEP Compared to Virtual Assistants

Pharmacy Times

For adolescents and young adults affected by HIV, Google yielded higher quality information on pre-exposure prophylaxis more frequently compared to other search engines.

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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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Addressing Misconceptions, Concerns Around Biosimilar Use

Drug Topics

Researchers at the 2023 American Academy of Dermatology Association Annual Meeting discussed the effects of product complexity on preclinical testing, among other topics.

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Absence of Sleep Apnea Associated with Better Cognition Over 5-Year Follow-Up

Pharmacy Times

The findings showed that interventions to improve sleep could be key to maintaining cognitive function, with investigators calling for further studies.

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More Trending

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Do Pharmaceutical Brand Colors Affect Consumer Buying Decisions?

Pharmacy Times

A company’s choice of color for branding and logo design may impact how consumers feel about the brand and could influence buyer decision-making.

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Pharmacists Can Take Shots at Vaccine-Preventable Diseases

Drug Topics

By educating patients and administering vaccinations, these key health care providers can help prevent new cases from occurring.

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Optimizing Clinical Pathways and Analyzing Quality of Life for Patients with MM

Pharmacy Times

Multiple myeloma clinical pathways and factors affecting patient quality of life are explored by an expert panel.

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Misdiagnoses cost the U.S. 800,000 deaths and serious disabilities every year, study finds

STAT

Diagnostic errors — that is, overlooking a disease, or diagnosing it erroneously or late — are a known occurrence in health care, and one that can have tragic effects. Yet so far there have been few attempts to quantify misdiagnoses in terms of deaths and permanent disability, and the full scale of their impact has been underestimated by the medical community, according to a 2015 report by the National Academy of Medicine.

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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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Atezolizumab, Bevacizumab Combination May Increase Risk of Cardiac Toxicity in Patients with Liver Cancer

Pharmacy Times

Quitting treatment may significantly improve severe hypertension in patients with hepatocellular carcinoma.

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Regulators warn hospitals and telehealth companies about privacy risks of Meta, Google tracking tech

Fierce Healthcare

Federal regulators are warning hospital systems and telehealth providers about the data privacy risks of using third-party tracking technologies. | Federal regulators sent letters to 130 hospital systems and telehealth providers warning them about the data privacy and security risks related to the use of online tracking technologies integrated into their websites or mobile apps.

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STAT+: White House launches permanent pandemic office

STAT

WASHINGTON – The White House on Friday launched its pandemic preparedness office, half a year after Congress instructed the administration to set up a new arm in the wake of the coronavirus pandemic. The Office of Pandemic Preparedness and Response Policy is a now-permanent installment in Washington and will first be led by retired Major General Paul Friedrichs, a longtime biosecurity official.

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Providers improperly collected $784M from a fund for uninsured COVID patients. Now, the government wants it back

Fierce Healthcare

A pandemic program that distributed funds for uninsured patients’ COVID-19 testing and treatment made nearly $784 million in improper payments to healthcare providers, money the government should b | A recent audit estimated that COVID testing and treatment payments for millions of uninsured patients shouldn't have happened. The government agency responsible for the program says it's now working to claw those funds back from providers.

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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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Providers still hesitate to prescribe buprenorphine for addiction, despite ‘X-waiver’ removal

STAT

Significant challenges remain before most American clinicians feel comfortable treating patients with buprenorphine , according to a new study. While the federal government’s recent moves to deregulate buprenorphine have led to a bump in new prescribers, it didn’t lead to a significant bump in overall prescribing volume. Many health care providers still see prescribing buprenorphine as difficult, or simply have little interest in using the medication, according to the study.

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After FDA snub, Daiichi's Vanflyta gains US approval and tees up AML clash with Novartis, Astellas

Fierce Pharma

If at first you don’t succeed, try, try again. That’s the lesson Daiichi Sankyo likely took home Friday after scoring a long-awaited U.S. | Some four years after Daiichi Sankyo's quizartinib scored its initial green light in Japan—and suffered a slap-down from drug regulators stateside—the acute myeloid leukemia medicine has won the FDA’s blessing.

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FTC votes to withdraw previous guidance around PBMs as probe continues

Fierce Healthcare

As it continues a broad probe into the operations of pharmacy benefit managers, the Federal Trade Commission has voted to rescind longstanding advocacy statements on this sector. | As it continues a broad probe into the operations of pharmacy benefit managers, the Federal Trade Commission has voted to rescind longstanding advocacy statements on this sector.

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Opinion: Gain-of-function research is about much more than dangerous pathogens

STAT

In the wake of the Covid-19 pandemic, we’ve heard a lot about gain-of-function research, and some of its risks, particularly regarding the possible creation of dangerous pathogens. But there’s a lot more to this field than that, including research that could potentially be quite beneficial to human society. If we focus solely on the risks, we may miss those benefits.

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ICH Q9 (R1): The Next Frontier

ISPE

ICH Q9 (R1): The Next Frontier Trudy Patterson Fri, 07/21/2023 - 11:53 iSpeak Blog iSpeak ICH Q9 (R1): The Next Frontier Christopher John Potter, PhD 21 July 2023 A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023. Professor Anne Greene of TU Dublin and Marty Lipa, Merck & Co., co-chaired the seminar.

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Opinion: Stanford President Marc Tessier-Lavigne and the new standards of scientific conduct

STAT

Stanford President Marc Tessier-Lavigne , who will step down from his position Aug. 31, was initially accused of scientific misconduct, but that’s not why he lost his job. He lost it because he failed to adequately lead his labs, and because of the repercussions that failure had for his leadership of a premier research institution. In his own words, Tessier-Lavigne resigned because Stanford “needs a president whose leadership is not hampered” by discussions of problems with

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Industry Voices—Bringing drug price cost transparency directly to patients

Fierce Healthcare

This is the fourth in a series of articles that looks at the current state of drug cost transparency for prescribers, pharmacists, and patients, and how to improve it based upon savings and ROI | Until the introduction of real-time prescription benefit tools, patient-specific drug costs surfaced only at the pharmacy counter.

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Europe recommends the approval of Pfizer’s RSV vaccine for older adults and in pregnancy

STAT

LONDON — European regulators on Friday recommended the approval of Pfizer’s RSV vaccine both for older adults and for use in pregnancy, which could extend protection against the common respiratory virus to newborns. The Pfizer vaccine, called Abrysvo, is already approved in the United States for people 60 and older. The Food and Drug Administration is scheduled to weigh in on its use for pregnant people next month.

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Mortality Rate of Individuals With Alzheimer Disease, Dementias Increased During COVID-19 Pandemic

Pharmacy Times

The research narrows the most at-risk populations and how to mitigate the impacts on adults with ADRD.

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STAT+: Pfizer says most tornado damage at key plant hit warehouse, but finished drugs also impacted

STAT

Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines. The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel.

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ADC Therapeutics pulls the plug on Zynlonta study after partial FDA hold

Fierce Pharma

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether fol | After severe respiratory events and seven deaths held up ADC's Zynlonta study in unfit or frail patients with previously untreated diffuse large B-cell lymphoma, the company has scrapped the trial altogether.

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.

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Catalent facing board shake-up pressure from activist investor Elliott: WSJ

Fierce Pharma

Catalent’s onerous year just got even more complicated. | Proxy battler and shareholder dissident Elliott Management has acquired a stake in Catalent in a bid to shuffle the drugmaker’s board, The Wall Street Journal reported Thursday. Elliott has been in talks with potential director candidates in an effort to build a Rolodex of nominees for a potential proxy contest, according to the news outlet.

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Determining accurate estimation of true endotoxin concentration

European Pharmaceutical Review

A semi-quantitative limulus amebocyte lysate (LAL) gel clot test with a narrow dilution range can be valuable for relatively accurate estimation of endotoxin in biopharmaceutical products, research shows. The paper published in Vaccine Research demonstrated the compatibility and benefits of LAL gel clot tests in a semi-quantitative manner compared to the LAL chromogenic assay.

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STAT+: European regulator will review study data from contract research organization due to ‘serious concerns’

STAT

In the latest melee over the safety of prescription medicines, the European Medicines Agency is reviewing studies conducted by Synapse Labs, a contract research organization, due to questions about its study data. The review comes in response to an inspection of Synapse facilities by Spanish regulators, who raised “serious concerns about the validity and reliability” of clinical trial data generated by the company.

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VR helps brain tumor patients overcome “scanxiety” before brain scans, study finds

Fierce Healthcare

Virtual reality therapy has been shown to help primary brain tumor patients overcome “scanxiety” before brain scans, according to a new study published in the Journal for Neuro-Oncology. | Virtual reality therapy has been shown to help primary brain tumor patients overcome “scanxiety” before brain scans, according to a new study published in the Journal for Neuro-Oncology.

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STAT+: Major pharma companies call on their suppliers to reduce carbon footprints

STAT

As anxiety mounts over climate change, seven of the world’s largest drugmakers urged dozens of their suppliers to outline targets they expect them to reach over the next few years in order to reduce carbon footprints. In explaining their action, the companies — GSK, Sanofi, Roche, AstraZeneca, Novo Nordisk, Samsung Biologics, and Merck KGaA — noted that the health care sector contributes approximately 5% of global greenhouse gas emissions, with around half of this coming fro

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Sandoz to build Slovenian biosimilar development facility

European Pharmaceutical Review

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. With this financial boost, the Ljubljana site is set to become a key location for biosimilar product development at Sandoz. “The new Biosimilar Development Center in Ljubljana will …[help] Sandoz

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STAT+: European regulatory panel weighs against approval of Mirati’s KRAS-targeted lung cancer drug

STAT

A European regulatory panel has recommended against approval of a lung cancer drug made by Mirati Therapeutics, the company said Friday. Mirati said it will appeal the negative opinion of the drug, called Krazati, issued by a committee of the European Medicines Agency that met this week. But for now, the adverse decision is likely to be adopted by European regulators and prevent the company from marketing the pill in Europe.

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'The Top Line': A special episode on Narcan, the life-saving nasal spray

Fierce Pharma

In this episode of 'The Top Line' we replay an important show from April 28, 2023 regarding Narcan. | This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.

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