Sat.Mar 18, 2023 - Fri.Mar 24, 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.

Hospitals 122
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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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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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Breast Cancer Detection Drug Up For FDA Approval

Drug Topics

The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection. An NDA has been submitted to the FDA.

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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: 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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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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How Inappropriate Antibiotic Prescribing Harms Patients

Drug Topics

According to a study, patients are frequently prescribed broad-spectrum antibiotics instead of narrowly tailored antibiotics, which would be more optimized to treat them.

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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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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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What we’ve learned from three years of fighting COVID-19

PhRMA

Three years ago, amidst an unprecedented public health crisis, biopharmaceutical industry made a commitment to fight COVID-19. Leveraging decades of research and investments in emerging technologies and scientific expertise, we dedicated ourselves to finding medical solutions to prevent, diagnose and treat those impacted by the coronavirus.

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Perrigo Recalls Gerber Good Start SoothePro Powdered Infant Formula

Drug Topics

Out of an abundance of caution, the infant formula giant has recalled one of their powdered infant formula products because of a potentially dangerous bacteria.

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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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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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PhRMA submits comments to OSTP on enhancing clinical trial diversity

PhRMA

The White House’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments. PhRMA shares OSTP’s recognition of the importance of having a clinical trial infrastructure that supports sites that are ready to respond to emergency situations like COVID-19.

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Initiation of Continuous Glucose Monitoring Reduced Hospitalizations for Diabetes, CKD

Drug Topics

According to 2 conference abstracts, CGM’s are effective in treating T2D and chronic kidney disease, but more data may be required to complete the picture.

Hospitals 187
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Opinion: Americans should be able to register to vote when they apply for health insurance on HealthCare.gov

STAT

The last time you renewed your driver’s license, you likely had the opportunity to register to vote at the same time. As former administrators at the Centers for Medicare & Medicaid Services in the Department of Health & Human Services, we believe Americans should have a similarly frictionless opportunity for voter registration when they submit an application for health insurance on HealthCare.gov, the federal government’s online health insurance marketplace.

Insurance 144
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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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U.S. biopharmaceutical exports support jobs, innovation

PhRMA

The U.S. Census Bureau and the U.S. Bureau of Economic Analysis recently published annual trade data indicating that U.S. exports of goods exceeded $2 trillion in 2022. According to the report, U.S. exports of pharmaceutical preparations exceeded $90 billion in 2022 — an increase of $7 billion over the previous year. Recent PhRMA comments to the U.S.

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Sanofi Cuts Insulin Prices, Joining Eli Lilly and Novo Nordisk

Drug Topics

The company also will establish a $35 out-of-pocket price cap for for all patients with commercial insurance that use Latnus

Insurance 187
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Tuberculosis cases nearly back to pre-pandemic levels, data show

STAT

Early in the Covid-19 pandemic, new diagnoses of tuberculosis dropped like a stone in the United States. Data released Thursday by the Centers for Disease Control and Prevention suggest the pandemic effect has pretty much worn off; TB is nearly back to pre-2020 levels. “We’re getting … close to where we were pre-pandemic; not quite back yet with increases in cases in the last two years,” Philip LoBue, director of the CDC’s division of tuberculosis elimination,

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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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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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PBM Transparency Bill Heads to Full Senate

Drug Topics

The proposed legislation, sponsored by Chuck Grassley and Maria Cantwell, aims to necessitate transparency from PBMs.

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Tanzania reports a Marburg outbreak, Africa’s second this year

STAT

Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.

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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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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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National Pharmacy Chain Opioid Settlements Poised to Affect Independent Pharmacies

Drug Topics

Stipulations of the settlements include data reporting, annual training, and an independent compliance officer.

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‘That scares me’: New childhood obesity guidelines still face a long road to consensus

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. The rise of childhood obesity in the United States did not happen quickly. But, to medicine, “it sort of cropped up overnight,” says Bob Siegel, a pediatric obesity specialist at Cincinnati Children’s.

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Biohaven licenses Hangzhou Highlightll’s BHV-8000 to treat brain disorders

Pharmaceutical Technology

Biohaven has purchased the exclusive global rights for oral, brain-penetrant dual Tyrosine Kinase 2 (TYK2)/Janus Kinase 1 (JAK1) inhibitor, BHV-8000 (previously TLL-041), which treats immune-mediated brain disorders , from Hangzhou Highlightll Pharmaceutical. The deal gives Biohaven global rights for the development of BHV-8000, excluding regions of China.

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Instacart reaches deal with Boston Children's to help deliver nutritious meals to patients

Fierce Healthcare

Instacart reaches deal with Boston Children's to help deliver nutritious meals to patients rking Fri, 03/24/2023 - 15:18

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Using Data Analytics to Manage Pharmacy Inventory

Drug Topics

Crunching the numbers can help pharmacies stay on top of their inventory.

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Opinion: Will there be any emergency doctors to see you in the future?

STAT

In the emergency room today, everyone is suffering. Many emergency medicine physicians are struggling to provide quality care amid staffing shortages, increased pressure to meet productivity metrics, and frustrated patients battling prolonged wait times. Their situation is compounded by a sense that they have been abandoned by hospital leadership, leading to increasing levels of physician burnout and attrition.

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RFID: The future of smart labelling?

Pharmaceutical Technology

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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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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Safety, Accuracy of Dexcom G7 CGM Evaluated in T1D and T2D

Drug Topics

The CGM provides accurate readings over 10.5 days of continuous wear.

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Study finds same small rise in breast cancer risk in many forms of hormonal birth control

STAT

Pills, patches, implants, and injections — the various forms of hormonal birth control have different formulations and doses of estrogen, progestin, or both. One might think, then, that they may have an unequal influence on breast cancer risk, but a new study in PLOS Medicine on Tuesday suggests that’s not so. The analysis found that most forms of hormonal birth control, regardless of their formulation, seem to confer roughly the same, small increase to breast cancer risk.

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