Tue.Jan 30, 2024

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Dexcom Submits New CGM For Non-Insulin Type 2 Diabetes for FDA Clearance

Drug Topics

Although continous glucose monitors (CGMs) have often been tailored to patients with type 1 diabetes, data elicited by these technologies add value to the management of type 2 diabetes by offering insights into patients’ unique responses to food, activity, medications, and more.

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Behavioral Psychotherapy, Antidepressants Yield Minimal Differences in Depression Treatment Coinciding With Heart Failure

Pharmacy Times

Investigators determined the effectiveness of behavioral activation psychotherapy versus antidepressant medication management for inpatients with heart failure and depression.

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Short Animated Videos on Social Media May Help Increase Knowledge of Vaccines

Drug Topics

Findings from a recent study showed that participants who watched a video discussing COVID-19 vaccination had significantly higher knowledge scores compared to those who did not watch it.

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STAT+: Can Wegovy treat depression as well as obesity? New research looks to GLP-1 drugs for mental illnesses

STAT

Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder. Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious.

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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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Insurer survey: No Surprises Act shielded patients from 10M surprise bills

Fierce Healthcare

Patients were protected from more than 10 million surprise medical bills thanks to reforms in the No Surprises Act, according to a new survey. | Patients were protected from more than 10 million surprise medical bills thanks to reforms in the No Surprises Act, according to a new survey.

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Opinion: The emergency room is where the United States’ social problems come home to roost

STAT

From “ Legacy ” by Uché Blackstock, M.D., published by Viking, an imprint of Penguin Publishing Group, a division of Penguin Random House, LLC. Copyright © 2024 by Uché Blackstock, M.D. In the U.S., access to health care has long depended on insurance and a person’s ability to pay, with patients of color making up a disproportionate number of the under- or uninsured, as I have seen firsthand.

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More Trending

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STAT+: Ultima Genomics launching high-end DNA sequencers that can read genome for $100

STAT

Ultima Genomics, an upstart some observers have called a “ dark horse ” in the world of DNA sequencing, will soon launch a line of high-power instruments that can read a human genome for as little as $100, the company’s leadership told STAT. The sequencer, dubbed the UG 100, is a $1.5 million machine that can read up to 20,000 human genomes a year.

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Cell-Based Flu Vaccine May Be More Cost-Effective, Beneficial Among Children

Drug Topics

A new study found that switching from a primary national plan of egg-based vaccines to cell-based vaccines for the flu would significantly reduce the impact of the seasonal virus at a lesser production and distribution cost.

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The U.S. hasn’t seen syphilis numbers this high since 1950. Other STD rates are down or flat

STAT

NEW YORK — The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults. But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.

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Amid strategic pivot, 2seventy bio plots comeback for BMS-partnered CAR-T Abecma

Fierce Pharma

2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. | 2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. Now, the company is splitting in two once again, passing its R&D programs to Regeneron and going all-in on its Bristol Myers Squibb-partnered CAR-T Abecma.

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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+: CMS will use outcomes-based agreements in bid to help Medicaid pay for sickle cell gene therapies

STAT

In response to concerns over multimillion-dollar price tags for new gene therapies for sickle cell disease, the U.S. government on Tuesday announced a long-awaited “access model” designed to blunt the cost that state Medicaid programs would pay for these curative treatments. Two therapies recently approved by health regulators cost $2.2 million and $3.1 million, respectively, and have raised alarms over the ability of financially strapped state Medicaid programs to absorb the expen

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Systemic Treatment Plus Embolization Reduces Risk of Death in Patients With Hepatocellular Carcinoma

Pharmacy Times

Compared to embolization alone, the systemic treatment combination nearly doubled progression-free survival among patients with unresectable liver cancer.

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STAT+: Vertex pain drug results met with measured optimism — and questions — by observers and experts

STAT

Late-stage trial results for a pain medication developed by Vertex Pharmaceuticals reinforced experts’ sense that the drug was both safe and offered modest pain relief. But the findings also prompted fresh debate on Tuesday about how widely used the therapy would be should it win regulatory approval. The company reported that its small molecule drug, VX-548, outperformed placebo in a pair of pain relief trials that recruited patients who had gotten an abdominoplasty (tummy tuck) or bunion

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CMS: Cell and gene therapy model to focus first on sickle cell treatments

Fierce Healthcare

Expect sickle cell disease to be the primary focus of the new Cell and Gene Therapy Access Model, the Centers for Medicare & Medicaid Services said Tuesday. | CMS gave an update to its Cell and Gene Therapy Access Model announced in February, opting to focus first on sickle cell disease.

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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+: Vertex’s closely-watched pain relief drug succeeds in late-stage trials — with a catch

STAT

A pain relief drug developed by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field. In a pair of randomized, placebo-controlled Phase 3 trials for patients with pain after a tummy tuck or bunion surgery, the drug showed statistically significant pain reduction compared to placebo,

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Digital prescriptions added to NHS App

pharmaphorum

From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.

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STAT+: Sophisticated phishing and deepfakes: How generative AI brings new threats for hospitals

STAT

The ubiquity of AI tools like ChatGPT could be a boon to hospitals eager for diagnostic aids or administrative assistants that can flag crucial medical details and ease the burden of repetitive tasks. But security experts say they can just as easily be harnessed by malicious hackers to exploit an industry known for outdated cyber protections. Health leaders tell STAT they’re assessing risks, recruiting cybersecurity teams and updating training materials to warn staff about increasingly so

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FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

Pharmafile

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, which allows them to initiate a phase 1 trial of GC012F in the US for the early-line treatment of multiple myeloma (ELMM). GC012F is “an autologous CAR T therapeutic candidate dual-targeting B cell maturation antigen […] The post FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment appeared first on Pha

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STAT+: Cour Pharmaceuticals, a biotech taking aim at autoimmune diseases, raises $105 million

STAT

John Puisis was dubious when he first heard about the autoimmune science being developed by a coalition of scientists from Northwestern University and the University of Sydney. The group was developing a sort of Trojan horse that it hoped could be used to treat autoimmune diseases. They had developed polymer nanoparticles that could mimic dying cells, which the immune system won’t attack, but will naturally pull from the bloodstream and throw into the body’s waste collection and re

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Neoadjuvant Nivolumab May Boost Survival Outcomes in Patients With Renal Cell Carcinoma

Pharmacy Times

The immune checkpoint inhibitor increased inflammation within the tumor, which may be linked to better response to nivolumab treatment.

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The future of pharmacovigilance – beginning the shift to AI-driven processes

pharmaphorum

Explore the future of pharmacovigilance as we begin to shift towards AI-driven processes. Learn about the advancements in AI models, the role of GenAI, and how experts are leveraging these technologies to improve drug safety and monitoring.

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ICER would contribute to Medicare price negotiations under one condition, new president says

Fierce Pharma

With the Inflation Reduction Act's Medicare price negotiations moving ahead (PDF) rapidly, one party n | The price-negotiation component of the Inflation Reduction Act appears right up ICER’s alley. But the watchdog’s new president says there’s a condition that needs to be met for the organization to regularly contribute to the process.

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Getting down to the nitty gritty of actively creating healthier societies

pharmaphorum

In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Stuart Cooper, CEO of Adelphi Group, about Anthropy – a yearly event that aims to spark innovation and foster fresh thinking among diverse leaders – and about creating healthier societies, about biopharma’s role in that, including implementation of preventative methods in ameliorating global health.

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Researchers Suggest New Theory on the Development of Type 1 Diabetes

Pharmacy Times

Defective RNA editing in cells in the pancreas may spur the body to initiate an inflammatory attack against its own cells.

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Can stress cause hives or a rash?

The Checkup by Singlecare

Not many skin conditions have a place in pop culture, but stress rash was actually a plot point in the 1998 Farrelly brothers’ comedy There’s Something About Mary. Chris Elliot, who has been itching intermittently throughout the film, is revealed to be Cameron Diaz’s longtime stalker when he appears with his face and head covered in large red welts.

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FDA rejects Defender Pharma's motion sickness nasal gel candidate

Fierce Pharma

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. | A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion.

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VBC enabler Valendo Health launches for endocrinologists to provide 'across the board' diabetes care

Fierce Healthcare

A new value-based care enabler focused on endocrinology has launched with a mission to shape the future of diabetes care. | Valendo Health uses a phased approach to offer expertise, technology and data-rich tools to help independent physicians enhance clinical capacity, streamline operations and transition to value-based care.

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After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

Fierce Pharma

After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?

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STAT+: Pharmalittle: We’re reading about a Vertex pain pill, an abortion pill hearing, and more

STAT

Top of the morning to you. And a fine one it is. Despite gray skies, the temperature is gradually rising and a large family of deer is parading alongside the Pharmalot campus, which our official mascots find quite provocative. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own busy agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is cinnamon sticky bun — and attack the fast-growing to-do list.

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Sandoz’s Keren Haruvi named chair of AAM’s board of directors

Drug Store News

AAM also elected Bob Hoffman, chief commercial officer of U.S. generics for Lupin, as vice chair of the board and Jeff Burd, president and CEO of North America of Ajanta Pharma USA, as treasurer.

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Payer Roundup–Molina Healthcare strengthens partnership with BeMe Health; North Carolina health plan limits GLP-1 coverage

Fierce Healthcare

Payer Roundup–Molina Healthcare strengthens partnership with BeMe Health; North Carolina health plan limits GLP-1 coverage ntong Tue, 01/30/2024 - 16:37

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US bill paints some Chinese biotechs as security threats

pharmaphorum

Legislation filed in the US is seeking to block Chinese biotech companies from federal contracts on the grounds they are a national security concern

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Pharmacists Can Help Children and Adolescents Manage Migraines

Pharmacy Times

Be of value to patients and caregivers in forming a care plan for this challenging condition

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REX Awards 2024: Natural Products

Drug Store News

Drug Store News’ REX Awards—Natural Products recognizes those manufacturers who have made a difference in their respective industries.

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