March, 2023

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‘The Last of Us’ might be fiction, but fungi are a looming threat

PharmaVoice

Fungal infections are a growing challenge for hospitalized patients, and new treatments are badly needed.

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Congress Probes PBM Link to Higher Drug Prices

PharmExec

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

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IRA Impacts: Cancer treatment research and development

PhRMA

Last month marked the one-year anniversary of the reignited Cancer Moonshot, the White House’s ambitious goal of reducing the death rate from cancer by at least 50% over the next 25 years. Much of the positive trends in declining cancer mortality, down 33% since peaking in 1991, is driven in large part by innovative medicines researched and developed by America’s biopharmaceutical companies.

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

In this post a top 10 list of journal articles to read during an infectious diseases pharmacy rotation is provided. Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read.

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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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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response

STAT

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors. The bill is one of many that are currently being discussed in different states. Many politicians have cited doubts about the potential “harm” caused by puberty blockers and hormone therapies associated with gender-affirming care and concerns about incorrect treatment as major factors.

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Show 1335: Visual Thinking and the Value of Neurodiversity

The People's Pharmacy

This week, we talk with renowned author Temple Grandin. She reveals why she thinks visual thinking is underappreciated. Most importantly, she describes how we could change our educational system to better utilize a wide range of mental skills. Practical Applications of Visual Thinking: Most of us are not aware of how our brains work. Often, we assume that everyone thinks the same way we do.

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Why Congress should prioritize fixing the 340B program

PhRMA

Nearly all Americans nationwide agree: Lowering out-of-pocket costs for health care should be a top priority for policymakers. Luckily, there are commonsense policies Congress could implement to meaningfully address the cost burdens Americans face. These include things like making sure patients aren’t paying more for their medicines than their health insurance company or requiring first-dollar coverage, so insurance companies cover the cost of certain lifesaving medicines from day one of the pla

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Taxpayers shouldn't foot the bill for health systems' massive 2022 investment losses, health economists say

Fierce Healthcare

Taxpayers shouldn't foot the bill for health systems' massive 2022 investment losses, health economists say dmuoio Thu, 03/23/2023 - 17:25

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Cases of Marburg going unreported in Equatorial Guinea, WHO says

STAT

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

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Mass spectrometry software can link different data types

European Pharmaceutical Review

The latest version of software tool MZmine, which aids analysis of mass spectrometry data, has been released. Using this third generation software, scientists can analyse large volumes of data from mass spectrometry, processing thousands of samples within minutes to hours. [the newest version can process] thousands of samples within minutes to hours.” It is the first tool with an entire data processing pipeline that integrates liquid chromatography (LC)-ion mobility spectrometry (IMS)-MS a

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Lilly cuts insulin prices, caps out-of-pocket costs

Drug Store News

Lilly also will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.

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Key Trends: Patient experience data reveal how insurers and middlemen impose barriers in health care

PhRMA

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

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Cleveland Clinic, IBM unveil first quantum computer dedicated to biomedical research

Fierce Healthcare

Cleveland Clinic, IBM unveil first quantum computer dedicated to biomedical research hlandi Tue, 03/21/2023 - 11:49

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Opinion: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything

STAT

I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.

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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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Kite releases pivotal CAR T therapy Phase III study results

European Pharmaceutical Review

Primary overall survival (OS) analysis results from Kite’s Phase III ZUMA-7 study showed a statistically significant improvement for CAR T-cell therapy Yescarta ® in OS versus historical treatment. Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment compared to standard of care (SOC).

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Surprising Gabapentin Side Effects

The People's Pharmacy

The Food and Drug Administration first approved Neurontin (gabapentin) in 1993 to treat epilepsy. Anticonvulsants are not normally blockbuster drugs. Perhaps that is why the original manufacturer, Parke-Davis, promoted the drug off-label to treat pain. You will read about the mischief that caused shortly. The marketing campaign was incredibly successful, though.

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2023 IS the Year for OTC Naloxone!

The FDA Law Blog

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Walgreens won't sell abortion pills in GOP states after legal threats from state officials

Fierce Healthcare

Walgreens won't sell abortion pills in GOP states after legal threats from state officials agliadkovskaya Fri, 03/03/2023 - 17:18

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Opinion: There is no epidemic of autism. It’s an epidemic of need

STAT

On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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10 Favorite Wart Remedies That Work!

The People's Pharmacy

Warts are mysterious. They raise more questions than answers. We do know that warts are caused by a virus (human papilloma virus or HPV ). How that virus penetrates the skin on fingers, hands or knees is unclear. Why are children more vulnerable to warts than adults? Why are some people vulnerable and others resistant? How do warts usually disappear on their own accord and on their own timetable?

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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Uber Health rolls out same-day prescription delivery with plans to ship healthy food, OTC meds

Fierce Healthcare

Uber Health rolls out same-day prescription delivery with plans to ship healthy food, OTC meds hlandi Thu, 03/30/2023 - 12:54

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Marburg fever outbreak in Equatorial Guinea widens, WHO reports

STAT

The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a

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UK boosts life science innovation with £277 million funding

Pharmaceutical Technology

On March 28, the UK government announced that four UK life sciences companies will receive £277 million to help fund and advance manufacturing projects in medical diagnostics and human medicines. This funding comes from government and private investment with the aim of boosting the UK life sciences sector’s capacity for manufacturing and innovation.

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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

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Is it safe to buy prescriptions from Canada?

The Checkup by Singlecare

It’s no secret that prescription drugs cost more on average in the U.S. than they do anywhere else in the developed world. In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. Naturally, this has people looking beyond the border for more affordable alternatives, and Canada seems like an obvious choice.

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GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Fierce Pharma

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial fkansteiner Fri, 03/24/2023 - 10:05

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Idaho hospital to stop obstetrical services citing doc shortages, fewer births and 'political climate'

Fierce Healthcare

Idaho hospital to stop obstetrical services citing doc shortages, fewer births and 'political climate' hlandi Thu, 03/23/2023 - 16:12

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Polio cases derived from new oral vaccine reported for first time

STAT

Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one. The Global Polio Eradication Initiative announced Thursday that six children in the Democratic Republic of the Congo and one in Burundi have been paralyzed by viruses from the new vaccine, which is referred to as novel oral polio v

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BioNTech targets infectious diseases for vaccine development

Pharmaceutical Technology

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.

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HRG awards Nature's Truth No. 1 in Independent Pharmacy two years running

Drug Store News

The brand also earned accolades across several subcategories, including letter vitamins, herbals and botanicals, specialty supplements and mineral supplements.