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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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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FDA Clears First Commercially Available Blood Test to Evaluate for TBI, Concussion

Drug Topics

The test is intended to complement the company’s TBI plasma test, which received FDA clearance in 2021.

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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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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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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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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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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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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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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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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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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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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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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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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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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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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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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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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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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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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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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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Strategies to Overcome Anxiety with Hashimoto’s

The Thyroid Pharmacist

Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. It changed my life dramatically and made me feel like a shell of my former self. I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. I was scared.

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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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QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

The FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.

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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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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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Andre Persaud departs Rite Aid

Drug Store News

Bill Miller, senior vice president of central retail operations, will serve as Rite Aid's acting head of retail operations, and Karen Staniforth, chief pharmacy officer, will oversee store pharmacy operations.

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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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Pfizer to acquire Seagen for $43 billion

European Pharmaceutical Review

Pfizer has announced it will acquire Seagen Inc. for a total enterprise value of $43 billion. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer.

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Occlutech launches FROST-HF study of heart failure device

Pharmafile

Occlutech has announced that it has recruited its first patient in the FROST-HF study, which aims to investigate the company’s atrial flow regulator (AFR) device to treat patients with heart failure. The study will include patients with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF), assessing the company’s AFR device for its safety and effectiveness.

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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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STAT+: SVB, biotech’s bank of choice, just failed. It could have ripple effects

STAT

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

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