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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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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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Fungi find their way into cancer tumors, but what they’re doing there is a mystery

STAT

For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.

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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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More Trending

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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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Tertiary Lymphoid Structure May Improve Immunity for Patients With Ovarian Cancer

Pharmacy Times

A researcher discusses how developing tertiary lymphoid structures may reach a greater maturity level within the tumor microenvironment.

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Sarepta files Duchenne muscular dystrophy gene therapy with FDA

pharmaphorum

Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle of 2023. Roche-partnered SRP-9001 (delandistrogene moxeparvovec) has been submitted for approval to treat ambulatory (walking) patients with DMD, a genetic disorder characterised by progressive muscle degeneration due to alterations in a protein called dystrophin that helps keep muscle cells intact.

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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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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+: 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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A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases

The FDA Law Blog

By Frank J. Sasinowski & James E. Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare conditions where there is a serious and/or life-threatening unmet medical need, as is very often the case.

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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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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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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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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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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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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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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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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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Enabling multi-dimensional biotherapeutic analysis

European Pharmaceutical Review

Researchers have developed an open and flexible liquid chromatography-native ion mobility mass spectrometry method to separate and analyse native protein/protein complexes and monoclonal antibodies (mAbs). In doing so they proved that coupling a simple binary pump with an external isocratic flow pump could transform any binary liquid chromatography (LC) system into a simple multi-dimensional analytical tool.

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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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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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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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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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Notable products from NACDS Total Store Expo: Part 2

Drug Store News

DSN spent two days walking the hall and these are among some of the cool products we found.

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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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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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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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GSK picks up antibiotic in $66m deal

Outsourcing Pharma

GSK pays for the exclusive license of Speroâs late-stage antibiotic to potentially treat complicated urinary tract infections.

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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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Omidubicel Shows Clinical Benefit at 3 Years for Individuals With Hematologic Malignancies

Pharmacy Times

The functional and physical well-being and other scores from the survey are more favorable for those who were treated with the therapy, investigators say.

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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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FDA Approves Chloroprocaine Hydrochloride Ophthalmic Gel for Ocular Surface Anesthesia

Pharmacy Times

Iheezo is a sterile, single use ophthalmic gel preparation.

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Benefits of Medical Marijuana for Epilepsy

BuzzRx

Medical marijuana (cannabis) has been studied to treat several neuropsychiatric disorders and health conditions, such as Alzheimer’s disease , multiple sclerosis , HIV/AIDS , Crohn’s disease, glaucoma, and epileptic seizures. In June 2018, the U.S. Food and Drug Administration approved Epidiolex , the first plant-based CBD (cannabidiol) formulation for the treatment of two rare forms of childhood-onset epilepsy: Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

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