Wed.Mar 01, 2023

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FDA-USPTO collaboration initiatives should be evidence-based, prioritize innovation

PhRMA

The United States Patent and Trademark Office (USPTO) and the U.S. Food and Drug Administration (FDA) are in the process of considering new collaboration initiatives aimed at biopharmaceutical patents. As outlined in a recent public statement and written comments , PhRMA appreciates the agencies seeking public participation on important innovation policy issues and we strongly support the agencies stated commitment to “ensuring our innovation system strikes the appropriate balance—encouraging me

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CMS Not Willing To Expand Alzheimer's Drug Coverage

Drug Topics

CMS has no plans to change their coverage and approval process, which the Alzheimer's Association believes is standing between patients and treatment.

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Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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DEA Proposes New Telemedicine Regulations

Drug Topics

The DEA is hoping to expand health care accessibility while also safeguarding from incorrectly prescribing medication.

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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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STAT+: CRISPR patent fight redux? A new battle is brewing among biotechs over next-gen gene-editing tools

STAT

Genome editing summits are generally friendly, nerdy affairs, but for a moment at a Lisbon hotel last June, the conversation at the FASEB genome engineering conference grew tense. Tessera Therapeutics chief scientist Michael Holmes had just finished presenting a much-anticipated peek at a technology the company had previously said could “ revolutionize genetic medicine ” and “cure nearly any genetic disease.

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The Cost of Keeping Proper Inventory

Drug Topics

How can technology help pharmacists manage inventory—and the associated costs?

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More Trending

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Pfizer, BioNTech Submit Supplemental BLA for COVID-19 Vaccine as Primary Series

Drug Topics

The supplemental biologics license application seeks approval for the Omicron BA.4/BA.5 bivalent vaccine as both a primary series and a booster dose.

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Target adds drive-up returns to its curbside services

Drug Store News

Target will begin enabling customers to make drive-up product returns at its stores this spring, with plans to offer the service at all of its stores by the end of summer.

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STAT+: Bell Labs for biology: Why Salesforce, Meta, and ByteDance are betting on AI protein design

STAT

It’s an author affiliation that would make even the most seasoned scientist do a double take: New research on artificial intelligence-powered protein design, written by researchers at, of all places, Salesforce. From Meta to TikTok’s parent company ByteDance, nearly every tech company has research programs on large language models, the foundational technology behind text-generating AI tools like ChatGPT.

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How to stop an asthmatic cough

The Checkup by Singlecare

Do you have asthma? If so, you may cough while working up a sweat on the treadmill. Maybe being outdoors among allergens like ragweed and pollen gives you an asthmatic cough. Or maybe your cough is triggered by indoor allergens like pet dander, dust, or mold, chemical irritants such as perfumes and cleaning products, cold air or air pollution. No matter what the cause, it is often uncomfortable and inconvenient.

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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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Eli Lilly cuts prices for some insulin products, but some are wary

STAT

Eli Lilly, one of the largest makers of insulin, said Wednesday it would make dramatic cuts to the prices of several of its older insulin products in an effort to lower costs for consumers whose insulin is not fully paid for by insurance. It also expanded its program to cap out-of-pocket insulin costs at $35 for people who do have health insurance. The moves come amid a public and political uproar over the price of insulin.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

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Covid-19 surveillance added new burdens on essential workers — and gave them little data to protect their health

STAT

At the peak of the pandemic, essential workers faced rampant tech-based surveillance, from overhead infrared thermometers to wearables that tracked their proximity to one another. These technologies forced employees to adjust the way they worked and sometimes made their workplaces less safe. They also didn’t offer workers clear and accurate information that would help them protect their health, according to a new report by the nonprofit Data & Society.

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Coffee intake changes from low to moderate reduces total body fat in metabolic syndrome

Hospital Pharmacy Europe

Coffee intake changes from low to moderate but not to a high lead to significant reduction total body weight loss in metabolic syndrome A change in coffee intake from a low (< 3 cups/month) level to a more moderate (1 – 7 cups/week) consumption in patients with metabolic syndrome, leads to significant reductions in total body fat levels and which may help as part of a weight management strategy according to an analysis by US and Spanish researchers.

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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: HHS’s Environmental Justice Index institutionalizes climate apartheid

STAT

The U.S. Department of Health and Human Services has for decades ignored its responsibility to enforce civil rights laws, as I argued last year in a First Opinion essay. Doing nothing to protect minority populations from inequitable health harms resulting from the health care industry’s greenhouse gas emissions constitutes environmental and institutional racism.

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Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul

Fierce Pharma

Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul fkansteiner Wed, 03/01/2023 - 08:40

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STAT+: Pharmalittle: Eli Lilly cuts prices for some insulin products; congressional committee opens probe into PBMs

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? Besides, consider the alternatives. And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our choice today is Jack Daniel’s (yes, this is a real flavor) — and get started.

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Albertsons launches Sincerely, Food campaign

Drug Store News

The campaign is designed to boost awareness and drive positive perception of the grocer’s strengths in fresh produce, meats and seasonal ingredients and to build a more emotional connection between customers and their local Albertsons Cos.

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STAT+: Medicare Part D plans authorized opioid prescriptions for cancer pain — to people without cancer

STAT

A government watchdog found that Medicare drug plans improperly authorized thousands of prescriptions for certain powerful opioids over a recent four-year period, a failure that cost taxpayers $86 million as the opioid crisis was raging across the U.S. Between July 2015 and December 2019, Medicare Part D plans covered more than 7,500 prescriptions for so-called TIRF opioid painkillers, which contain fentanyl and are administered through the nose or mouth.

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Aspirin use benefits curtailed by statins in those without atherosclerotic disease

Hospital Pharmacy Europe

The myocardial infarction benefits of aspirin use are offset by statin use in patients without atherosclerotic cardiovascular disease Aspirin use to prevent adverse cardiovascular outcomes such as myocardial infarction (MI) in patients without atherosclerotic disease is reduced by concomitant statin use in patients without impacting on the risk of a major bleed according to a meta-analysis by US researchers.

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New purification method could enhance protein drug manufacturing

European Pharmaceutical Review

In a recent study, Massachusetts Institute of Technology (MIT) researchers developed a new purification method to cut the costs of manufacturing protein drugs. The engineers used bioconjugate-functionalised nanoparticles to quickly and inexpensively isolate proteins from a bioreactor. Producing biologics by isolating proteins Biologics like antibodies and other protein-based drugs are produced by living cells such as yeast in large bioreactors.

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Sally Hansen, Peeps once again bring spring vibes to at-home manicures

Drug Store News

The latest Sally Hansen Insta-Dri X Peeps collection comes in seven shades, including a sugar texture for a finish that mimics the feel of sugar-coated Peeps.

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Closing the Vaccination Gap

PioneerRx

In the fight against the pandemic that has taken the lives of over 600,000 Americans, COVID-19 vaccines have offered safety, protection, and a promise to return.

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Bright Health staring down bankruptcy, needs to raise $300M, execs say

Fierce Healthcare

Bright Health staring down bankruptcy, needs to raise $300M, execs say pminemyer Wed, 03/01/2023 - 14:40

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Regeneron, Sanofi's Kevzara becomes first biologic approved for polymyalgia rheumatica

Fierce Pharma

Regeneron, Sanofi's Kevzara becomes first biologic approved for polymyalgia rheumatica zbecker Wed, 03/01/2023 - 10:46

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UK partnership set to revolutionise oligonucleotide manufacture

European Pharmaceutical Review

A new £2.7 million collaboration between the Centre for Process Innovation (CPI), AstraZeneca, Novartis, and The University of Manchester aims to revolutionise oligonucleotide manufacture. The three-year project is planned to translate “…approaches to oligonucleotide synthesis into sustainable manufacturing processes. We are hopeful that this collaboration will… ensure the widest possible access to this emerging class of therapeutics,” shared Sarah Lovelock, Senior Lecturer at Manchester I

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Publix reports gains in Q4, fiscal year earnings

Drug Store News

According to Publix, the additional week in Q4 of 2022 increased sales by 8.1% and comparable-store sales for that quarter increased by 12.4%.

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Computed tomography for in-depth investigation of freeze-dried products

European Pharmaceutical Review

Three-dimensional images using computed tomography (CT) provide a valuable, non‑invasive insight into the inner morphology of freeze-dried products. This technology allows the pore structure to be visualised in a similar way to scanning electron microscopy. It enables the detection and traceability of structural alterations and/or impurities as well as verification of the container closure integrity.

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Ask Your Pharmacist makes its debut

Drug Store News

Ask Your Pharmacist was launched to bring attention and recognition to all of the services pharmacists offer their communities.

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Reata scores first FDA approval in its 21-year history, pushing rare disease drug over finish line

Fierce Pharma

Reata scores first FDA approval in its 21-year history, pushing rare disease drug over finish line kdunleavy Wed, 03/01/2023 - 10:31

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Nestlé’s Natural Bliss launches plant-based oat milk

Drug Store News

Natural Bliss’ plant-based oat milk is made from a blend of oats and fava bean protein and comes in two flavors — original and unsweetened.

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Merck's Keytruda bounces back from pair of trial flops with ?interim win in earlier lung cancer

Fierce Pharma

Merck's Keytruda bounces back from pair of trial flops with ⁠interim win in earlier lung cancer fkansteiner Wed, 03/01/2023 - 10:32

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Precision medicine company Tempus inks 3rd major pharma deal, securing nearly $1B revenue boost

Fierce Healthcare

Precision medicine company Tempus inks 3rd major pharma deal, securing nearly $1B revenue boost hlandi Wed, 03/01/2023 - 11:32

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Giant kicks off free Zoom nutrition classes

Drug Store News

Giant is celebrating National Nutrition Month in March with free, live classes via Zoom for families and chefs of all ages.

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