Tue.Mar 14, 2023

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VA To Cover Alzheimer's Drug, With Some Exceptions

Drug Topics

Per VA regulations, anyone who has had a stroke or seizure within the last year, as well as those with MRIs showing microhemmorrhages, aneurysms, lesions or tumors would be excluded from coverage of the drug, called Leqambi

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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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Novo Nordisk To Cut Insulin Prices Up To 75%

Drug Topics

According to a company press release, the price reductions will go into effect at the start of 2024

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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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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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FDA Grants De Novo Approval to Non-Invasive Tinnitus Treatment Device

Drug Topics

The product, called Lenire, uses bimodal stimulation and will be available in April 2023

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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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‘This is a nonpartisan issue’: Planned Parenthood’s Alexis McGill Johnson on fighting for reproductive rights

STAT

In the wake of the Supreme Court’s decision to overturn Roe v. Wade, the news has been full of stories about patients crossing state lines in order to access reproductive care. What often gets left out is the accompanying confusion created by abortion restrictions. “I had a patient travel all the way from Mississippi,” said Sarah Traxler, an OB-GYN in Minnesota, “only for me to have to say, ‘It’s not safe for me to see you here in this clinic.

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Sandoz to build new biologics production plant in Slovenia to support biosimilars

Drug Store News

The Sandoz investment is expected to be at least $400 million, supporting the company’s ambition to drive the future growth of its global biosimilars portfolio.

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EPA announces proposed drinking water limits for six ‘forever chemicals’

STAT

The Environmental Protection Agency for the first time on Tuesday proposed enforceable regulations for “forever chemicals,” also called PFAS, in Americans’ drinking water. The six PFAS are the first new contaminants to be regulated under the Safe Drinking Water Act’s 1996 amendments. The EPA set a threshold of 4 nanograms per liter for the chemicals PFOA and PFOS in drinking water.

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End-Of-Life Management for Single-Use Products in Bioproduction

ISPE

End-Of-Life Management for Single-Use Products in Bioproduction Trudy Patterson Tue, 03/14/2023 - 09:49 iSpeak Blog iSpeak End-Of-Life Management for Single-Use Products in Bioproduction 14 March 2023 Users Perspective on End of Life Management for Single-Use Products used in Bioproduction Part 1 Introduction Single-Use products utilized in the production of biologics provide flexibility that was unimaginable a few years ago.

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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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STAT+: Novo Nordisk to lower insulin prices by up to 75% amid growing pressure

STAT

Under mounting pressure, Novo Nordisk plans to cut U.S. list prices for several insulin products by up to 75%, the latest big drugmaker to take such a step in response to a years-long outcry over the cost of the diabetes treatments. The company plans to cut the list price of its NovoLog insulin by 75%, and the prices for Novolin and Levemir by 65% starting in January 2024.

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How Pharmacists Can Help Patients Manage Seasonal Allergies

Digital Pharmacist

Allergy season comes every year and pharmacies need to ensure that patients know how to identify and treat their symptoms accurately. Nearly 15% of Americans (over 24 million) deal with diagnosed hay fever, according to the CDC. Close to 10% of children have some sort of respiratory allergy. Altogether, seasonal allergies cause around 12 million primary care visits each year.

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National Academies calls for transforming use of racial and ethnic labels in genetics research

STAT

Saying genetics researchers inconsistently and inappropriately use racial and ethnic labels that fail to capture the complex patterns of human genetic variation, the National Academies of Sciences, Engineering, and Medicine issued a report Tuesday calling for a transformation in how such descriptors are used. Outdated methods of grouping people may result in poor scientific results and misguided interpretations, said the report.

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Erythritol use in cardiac patients linked to higher subsequent MACE risk

Hospital Pharmacy Europe

A greater intake of erythritol in patients undergoing cardiac evaluation increases the subsequent risk of a major cardiovascular adverse event Higher plasma levels of the artificial sweetener erythritol, in those undergoing cardiac risk assessment is associated with an increased 3-year risk of a major cardiovascular event according to the findings of an analysis by an international research group.

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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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Opinion: NRC: be straight about when clinicians need to report errors that lead to radiation exposure

STAT

A recent action by the U.S. Nuclear Regulatory Commission (NRC) should have protected patients who are inadvertently exposed to potentially high doses of radiation due to faulty injections or infusions. But it instead preferentially protects the nuclear medicine practitioners who are subject to its regulations and oversight. At issue is the NRC’s policy that exempts practitioners of nuclear medicine — clinicians who use radioactive pharmaceuticals to diagnose or treat disease

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'Podnosis': Trends that should be on every hospital exec's radar, and the outlook for rural hospitals in 2023

Fierce Healthcare

'Podnosis': Trends that should be on every hospital exec's radar, and the outlook for rural hospitals in 2023 tcarey Tue, 03/14/2023 - 12:38

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STAT+: PhRMA chief dings health insurers over drug prices at their own conference

STAT

WASHINGTON — The head of the brand drug lobby used an in-person health insurance industry conference to blame insurers for making people pay too much for drugs. America’s Health Insurance Plans CEO Matt Eyles, interviewing PhRMA President Stephen Ubl, asked for examples of policies that would benefit both industries. Ubl responded by suggesting that insurers lower cost sharing for drugs.

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Suave Pink caters to lush, coily hair care needs

Drug Store News

The Lush & Coily collection is infused with natural shea butter to moisturize and pure coconut oil to enhance shine and reduce breakage, the company said.

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STAT+: Setting aside the thorniest issues around CRISPR babies, scientists say embryo-editing research should proceed

STAT

LONDON — The Francis Crick Institute is a glimmering chameleon of a building, spanning four acres of downtown London, that took 10 years and cost nearly $850 million to build. The curves of its vaulted twin roofs manage to resemble the hull of an alien spacecraft while still echoing the steel and glass forms found at the bustling St. Pancras train station across the street.

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SXSW 2023: How retailers like Walgreens and healthcare startups aim to make inroads in underserved markets

Fierce Healthcare

SXSW 2023: How retailers like Walgreens and healthcare startups aim to make inroads in underserved markets hlandi Tue, 03/14/2023 - 15:49

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STAT+: Pharmalittle: Novo to cut some insulin prices by up to 75%; Veterans Administration to cover new Alzheimer’s treatment

STAT

Rise and shine, everyone, another busy day is on the way. The Pharmalot campus, in fact, is humming thanks to some repair work to the castle, although our short person is sleeping in, since this constitutes a spring break on the calendars kept by some institutions of higher learning. As for us, we can see a steady flow of flurries outside our window, and we are keeping warm with another cup of stimulation.

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A rising oncology powerhouse in China, BeiGene looks to strengthen its international punch

PharmaVoice

To expand its reach, Christiane Langer, the company’s head of medical affairs, is leaning on connections and singularity over fitting in a box.

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STAT+: Amylyx’s ALS drug launch starts strong. That could be trouble for the FDA

STAT

Behind the stellar commercial launch of Amylyx Pharmaceuticals’ treatment for ALS lies an uncomfortable question: Does early success of the drug, called Relyvrio, make it more complicated, perhaps impossible, to pull it from the market if we find out next year that it doesn’t work? On Monday night, Amylyx said Relyvrio sales totaled $22 million in 2022 — a period that covers slightly more than one calendar quarter given the drug’s U.S. approval last September.

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Speech disorder diagnoses in children doubled during COVID, Komodo Health finds

Fierce Healthcare

Speech disorder diagnoses in children doubled during COVID, Komodo Health finds agliadkovskaya Tue, 03/14/2023 - 16:11

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A letter from the executive editor: The 2023 STATUS List

STAT

After months of vigorous deliberations, I’m thrilled to announce our 2023 STATUS List — the definitive roster of leaders in health, medicine, and the life sciences whose work over the past year has advanced those fields. There were, of course, many contenders to choose from. For this second annual list, we’ve selected just 46 — an homage to the number of chromosomes in human DNA.

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Nonprofit hospitals’ tax exemptions paid off big once COVID relief began flowing in

Fierce Healthcare

Nonprofit hospitals’ tax exemptions paid off big once COVID relief began flowing in dmuoio Tue, 03/14/2023 - 15:32

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

Parallel import of medicinal products is one of the basic and admissible forms of international trade in the European Union (EU) market, based on the principle of free movement of goods established by the Treaty on the Functioning of the European Union. It is based on the price differentiation of medicinal products between the Member States, which enables parallel importers to purchase medicinal products in EU countries where prices are lower and then resell them in other countries where the pri

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CMS not likely to follow the VA's example and cover Alzheimer's medication lecanemab, say experts

Fierce Healthcare

CMS not likely to follow the VA's example and cover Alzheimer's medication lecanemab, say experts fdiamond Tue, 03/14/2023 - 15:51

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SMC accepts treatment for chronic hepatitis delta virus

European Pharmaceutical Review

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Hepcludex ® (bulevirtide) for chronic hepatitis delta virus (HDV) infection. All eligible patients will now have the option of the only treatment conditionally approved for HDV infection via NHS Scotland. Bulevirtide for chronic hepatitis delta virus Gilead’s bulevirtide aims to slow the progression of chronic hepatitis delta virus infection.

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Surveyed physicians say prior authorization harms patient outcomes, burns healthcare resources

Fierce Healthcare

Surveyed physicians say prior authorization harms patient outcomes, burns healthcare resources dmuoio Tue, 03/14/2023 - 11:55

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Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US

Fierce Pharma

Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US kdunleavy Tue, 03/14/2023 - 10:56

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AbbVie's Humira among 27 drugs subject to Medicare drug price inflation cap rebates

Fierce Healthcare

AbbVie's Humira among 27 drugs subject to Medicare drug price inflation cap rebates rking Tue, 03/14/2023 - 19:50

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GNC goes for 3rd limited-edition Girl Scouts cookie-inspired flavor

Drug Store News

GNC’s AMP Wheybolic and Total Lean products are now available in Toast-Yay, a cinnamon French toast-inspired flavor.

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Google launches Open Health Stack for app developers, unveils new AI partnerships

Fierce Healthcare

Google launches Open Health Stack for app developers, unveils new AI partnerships hlandi Tue, 03/14/2023 - 11:32

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