Sat.Mar 04, 2023 - Fri.Mar 10, 2023

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FDA Sets Target Date To Expand Dwarfism Care Voxzogo To Younger Children

Drug Topics

Voxzogo is already available for patients over 5 years with a genetic cause of dwarfism. The PDUFA date is set for Oct. 21, 2023, and will potentially expand the drug to children 5 and under.

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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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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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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

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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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Pharmacists Are Crucial in Managing Endometriosis Symptoms

Drug Topics

Endometriosis has been linked with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease, but more definitive research is needed

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Pfizer CEO Albert Bourla maxed out campaign contributions to Dr. Oz ahead of midterm elections

STAT

WASHINGTON — Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records. Oz is well-known for spreading medical misinformation , including touting astrology as a legitimate medical tool and the myth that apple juice contains unsafe levels of arsenic — a surprising political ally for Bourla, who runs one of the largest pharmaceutica

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

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The Role of the Pharmacist in Cannabis Legalization

Drug Topics

Now that more states are legalizing cannabis for medical and recreational use, pharmacists must step up to educate and counsel customers on safe use

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STAT+: ‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments

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. “Anne” is sitting in a small, wood-paneled consultation room, at the Mayo Clinic in Rochester, Minn., about to embark on yet another weight loss journey.

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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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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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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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PBM Formulary Exclusions List Reaches All-Time High

Drug Topics

Critics of PBM's say that the high number of exclusions narrows patient options and make medications financially inaccessible.

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Opinion: Ranked to fail: Does gatekeeping affect diversity in The Match?

STAT

For graduating medical students hoping to secure a residency training position — and that’s virtually all of them — Match Day is the most anticipated day of the year. The Match is the culmination of medical school, application preparation, interviews, and recruitment events. It’s like a traditional job search but without the room for negotiation since it is based on an algorithm that announces job placement once a year, on the third Friday of March, for all participat

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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.

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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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An Inside Look at Pharma Revenue Management

PharmExec

According to the 2023 State of Revenue Report, pharma companies are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

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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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Opinion: How cross-state licensure reform can ease America’s mental health crisis

STAT

Teletherapy has made mental health care more accessible than ever before, making care possible for people who otherwise would never have been able to get it. But the antiquated system of licensure in the United States is creating a huge barrier to realizing the potential for telehealth. I’ve seen the benefits of teletherapy firsthand. As the founder and CEO of Alma, a mental health company that helps independent mental health providers run their private practice and accept insurance, we s

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Biden administration urged to take more aggressive steps to relieve medical debt

Fierce Healthcare

Biden administration urged to take more aggressive steps to relieve medical debt dmuoio Tue, 03/07/2023 - 10:09

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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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Cancer Risk Associated With UV Nail Dryers

Drug Topics

The safety of gel manicures is under renewed scrutiny after a new study suggested they can cause DNA damage

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Biden administration requests $20 billion cash infusion to bolster public health

STAT

WASHINGTON — The Biden administration is calling for a big boost for public health funding across the federal health department, but left out specific funding for Covid-19 activities. In its budget request to Congress on Thursday, the White House asked for $20 billion over five years to support pandemic preparedness efforts at the Administration for Strategic Preparedness and Response, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Adminis

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Wegmans enhances in-store capabilities for shoppers with sensory disabilities

Drug Store News

The retailer introduced enhanced in-store pharmacy auxiliary aids and accessibility options for customers with sensory disabilities.

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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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FDA Accepts Biologics License Application for Proposed Denosumab Biosimilar

Drug Topics

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

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How one medical school became remarkably diverse — without considering race in admissions

STAT

The diversity of medical school classes has barely budged in recent decades, even with the ability to consider an applicant’s race as one factor in admissions. Now, many medical school leaders fear a looming U.S. Supreme Court decision to restrict or ban race-conscious admissions policies could lead to precipitous declines, imperiling efforts to fight the nation’s stark racial and ethnic health disparities.

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NACDS commends intro of PBM reform legislation in Florida

Drug Store News

Steve Anderson, president and CEO of the National Association of Chain Drug Stores, said HB 1509/SB 1550 will finally hold PBMs accountable.

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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

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Show Them The Money

Drug Topics

The role of the pharmacy technician has evolved over the past 45 years—but pay hasn’t caught up

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FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt

STAT

Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems. Now the FDA has released a rare comment clarifying what happened during its authorization process.

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How providers like UAB, Parkland Hospital are supporting at-risk mothers using a device already in their pockets

Fierce Healthcare

How providers like UAB, Parkland Hospital are supporting at-risk mothers using a device already in their pockets aburky Mon, 03/06/2023 - 12:22

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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

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Show Me the Way: Technician-Led Pharmacy Services

Drug Topics

Pharmacy technicians can play an important role in leadership at the pharmacy.

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STAT+: Many doctors spend their days battling insurers. Why do some go to work for ‘the dark side’?

STAT

Gastroenterologist Alin Botoman had been on hold for almost an hour. The drone of muzak taunted him on speaker phone. It was the second day in a row he’d spent trying to get insurance to cover a dual CT/PET scan he’d already performed for his patient with esophageal cancer. The day before, after the insurance company unexpectedly denied the request, he’d called to contest the decision and spent an hour on hold.

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Does caffeine raise your blood pressure?

The Checkup by Singlecare

If you find yourself reaching for a cup of coffee every morning or swigging an energy drink each afternoon, you’re not alone. Caffeine is the world’s most-consumed drug—found in the leaves and fruits of some plants, and a key ingredient in caffeinated beverages like coffee, energy drinks, soft drinks, and black or green tea. It’s also found in energy snacks and some non-prescription drugs.