Fri.Sep 30, 2022

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New Report: Nearly 800 medicines in development to treat chronic condition

PhRMA

Chronic conditions impose a substantial health and economic burden that affects millions of patients, families and communities across the United States each day. While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity.

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FDA Approves Dupilumab for Adult Patients With Prurigo Nodularis

Pharmacy Times

Dupilumab is the first and only medicine approved specifically for the treatment of prurigo nodularis in the United States.

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Opinion: Maternal-fetal surgery is not an alternative to abortion care

STAT

Every day, pregnant people across the United States get the news that the futures they imagined for their babies are at risk due to a fetal condition. It may be something relatively minor, like a small benign growth on a lung, or something major, like a life-threatening heart or developmental problem. Some of these problems can be mediated by maternal-fetal surgery.

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Improved Glycemic Control, Time in Target Range Found with iLet Bionic Pancreas

Drug Topics

The iLet Bionic Pancreas was associated with improved glycemic control and time in target glucose range compared to standard care in a cohort of people with type 1 diabetes aged 6-79 years of age.

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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 Empowered Yet Again

Pharmacy Times

FDA revises emergency use authorization to grant prescribing authority for Pfizer’s Paxlovid antiviral treatment for COVID-19.

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Lecanemab Hopes to Succeed Where Aduhelm Failed

Drug Topics

The announcement of positive phase 3 results for the investigational Alzheimer’s disease drug comes against a backdrop of Aduhelm flaming out. Both drugs are predicated on the theory that Alzheimer’s is caused by beta-amyloid deposits.

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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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Who will get the call from Stockholm? It’s time for STAT’s 2022 Nobel Prize predictions

STAT

We live in a time where the rate of medical and superlative scientific advances is accelerating — by more than 1,300% since 1985, according to one recent estimate. With so many “unprecedented,” “transformative” breakthroughs happening, forecasting which one will be awarded top research honors isn’t getting any easier.

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Walmart opens 1st of 4 next-generation fulfillment centers in Joliet, Ill.

Drug Store News

​​​​​​​The new high-tech facility will begin operations ahead of the holiday season, bringing next-day or two-day shipping to customers across Illinois, Indiana and Wisconsin.

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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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FDA approves ALS drug from Amylyx, giving patients a much-needed treatment option

STAT

The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease. The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

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NACDS urges action to curb prescription drug misuse, abuse

Drug Store News

Comments to the Centers for Medicare & Medicaid Services call for enforcement of electronic prescribing of controlled substances requirements no later than Jan. 1, 2023.

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Juul exec slams FDA over its approach to regulating vaping

STAT

WASHINGTON — A Juul executive fiercely criticized the Food and Drug Administration’s approach toward regulating vaping companies during a tobacco industry conference Thursday. Joe Murillo, the company’s chief regulatory officer, came armed with a number of criticisms of the agency, including its alleged inability to withstand political pressure.

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Walmart opens first of four next-generation fulfillment centers in Joliet, Ill.

Drug Store News

​​​​​​​The new high-tech facility will begin operations ahead of the holiday season, bringing next- or two-day shipping to customers across Illinois, Indiana and Wisconsin.

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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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STAT+: The biotech scorecard for the fourth quarter: 14 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter: Arrowhead Pharmaceuticals and partner Takeda Pharmaceuticals are nearing the completion of a mid-stage, placebo-controlled clinical trial of an RNA-based drug called fazirsiran in patients with alpha-1 antitrypsin deficiency, or AATD, an inherited disease that causes severe liver and lung damage.

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Scent Beauty, Cher intro Decades fragrance collection

Drug Store News

Decades features four scents that capture an aura of a particular decade and come in packaging designs inspired by the singer’s singular fashions, the company said.

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Health Innovators – Dr. Houda Hachad

pharmaphorum

Dr. Houda Hachad is vice president of clinical operations at AccessDx Laboratory, where she focuses on expanding the use of pharmacogenomic testing, a major piece of the puzzle for precision medicine. Genetic testing has become vastly more accessible in the last 20 years and has opened all kinds of doors in medicine, from pharmacogenetics and better understanding drug interactions and adverse events to tremendous advances in oncology: understanding the underlying genetics of cancer cells has all

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Evaluating Severe COVID-19 Incidence After Initial, Booster Vaccination

Drug Topics

Data from periods of Delta and Omicron variant predominance were evaluated in a retrospective cohort study.

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STAT+: With rivals on its heels, Illumina launches a new line of high-end DNA sequencers

STAT

SAN DIEGO — After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply. The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced.

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Monkeypox and Your Pharmacy

DiversifyRx

While cases of monkeypox are currently on the decline, it is still vital to keep up to date on information. We have fielded several questions from pharmacy owners asking how they can support their patients to combat monkeypox. Let’s dive into monkeypox and your pharmacy and what you can do to help your community. Dr. Tara Newton, PharmD. We partnered with the fantastic Dr.

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STAT+: Health app companies wrestle with how to design studies to prove treatments work

STAT

For companies that have spent years developing interactive technologies to help treat disease, the tricky question inevitably comes: How far are you willing to go to prove it works? Some test their products, sometimes called digital therapeutics, in the most rigorous, and expensive, way. They run a randomized trial with a sham control that mimics everything about a product, except the piece that’s supposed to have therapeutic effect.

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Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

pharmaphorum

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017.

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Opinion: How the Inflation Reduction Act can help decarbonize the health care industry

STAT

The climate crisis — the greatest threat to human health in history — is often framed “in ways that pay little attention to its health dimensions,” as the authors of The Lancet’s annual “Countdown: Tracking Progress on Health and Climate Change” report were forced to remind us. This tragic reality was on display in Health Affairs , JAMA , Kaiser Health News , and The Lancet itself, among others, when they limited their reporting on the recently pa

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Low-Priced Oncology Disruptors: The Cuckoo in the PD-1/PD-L1 Nest or the Runt of the Clutch?

pharmaphorum

Part I. Novel oncologic drugs continue to command premium pricing, driven by a combination of unmet needs, and delivering often-iterative, sometimes-significant improvements in survival or maintenance of a progression-free state. The stable of PD-1/PD-L1 checkpoint inhibitors, led by Keytruda (pembrolizumab), represents the current generation of high value, high price drugs to tackle a variety of cancers in mono- or combination therapy.

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Strategic moves to drive results this holiday season

Drug Store News

In his latest column, David Orgel illustrates how relying on proven retail strategies help retailers succeed in the fourth quarter.

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FDA moves on AI tools, bionic pancreas research, & equity in digital therapeutics

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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September Month in Review: Top Stories on Drug Topics®

Drug Topics

Take a look back at our most popular news from September 2022.

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STAT+: Pharmalittle: Medicare plans sizable infrastructure for negotiating drug prices; Alzheimer’s data also boost Roche and Lilly

STAT

Rise and shine, everyone, another busy day is on the way. We can tell by the volume of traffic outside our window and the volume of e-mail arriving. But today is especially busy because it is National Cup of Stimulation Day. Of course, we are celebrating by firing up the coffee kettle in order to indulge. And you are invited to join us. Our choice today, by the way, is butter pecan, which Mrs.

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NCI Acting Director: Equitable Precision Medicine Requires Concerted Implementation Efforts

Pharmacy Times

Despite significant advances in cancer treatment, molecular sequencing and enrollment of Black patients in clinical trials are still less than that of White and Asian patients.

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Listen: A surprise success in Alzheimer’s and how FDA history seeded modern controversy

STAT

Does the latest Alzheimer’s disease drug actually work? When does the FDA call in security? And who’s going to be CEO of Biogen? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Lecanemab, a new Alzheimer’s treatment from partners Biogen and Eisai, succeeded in a pivotal clinical trial, and we explain the surprising development and its sweeping implications.

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Drug Therapy Combinations Could Reduce Hospitalization Among Heart Failure Patients with Higher Ejection Fraction

Pharmacy Times

The incremental use of drug combinations could prevent hospitalizations from heart failure among those who have higher ejection fraction, a subgroup that struggles with insufficient data on treatments.

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Meijer to offer discounts on produce for SNAP customers

Drug Store News

Mejer has received a USDA waiver to provide SNAP customers incentives for purchasing healthy foods.

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Pharmacy Focus: Public Health Matters- Properly Treating Youth, Sexual and Gender Minority Populations

Pharmacy Times

Confidential care is a topic that is not discussed as frequently in healthcare, although it is extremely important for adolescents and different vulnerable communities.

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O Positiv caters to women’s health needs with capsules

Drug Store News

O Positiv’s new product launches include Vaginal Probiotic and Urinary Tract vitamin capsules.

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