Thu.Mar 09, 2023

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FDA Sets Target Date To Expand Dwarfism Care Voxzogo To Younger Children

Drug Topics

Voxzogo is already available for patients over 5 years with a genetic cause of dwarfism. The PDUFA date is set for Oct. 21, 2023, and will potentially expand the drug to children 5 and under.

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Janssen neuroscience leader takes on rare diseases one small ‘eureka’ at a time

PharmaVoice

Fueled by a fascination with the scientific process, Sindhu Ramchandren is exploring how a new drug could treat patients with a range of rare diseases.

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The Case for Best-in-Class Inventory Automation and 3 Ways to Achieve It

Drug Topics

Don't let insufficient inventory management hinder the success of your pharmacy. "Getting by" only leads to missed opportunities, lost revenue, and frustration for both staff and patients. Download our white paper to learn how you can work smarter and save time without overhauling your existing systems.

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Pfizer CEO Albert Bourla maxed out campaign contributions to Dr. Oz ahead of midterm elections

STAT

WASHINGTON — Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records. Oz is well-known for spreading medical misinformation , including touting astrology as a legitimate medical tool and the myth that apple juice contains unsafe levels of arsenic — a surprising political ally for Bourla, who runs one of the largest pharmaceutica

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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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Supplemental BLA Accepted For Melanoma Treatment

Drug Topics

The FDA agreed to review a supplemental Biologics License Application for Opdivo to treat stage 2B or C, fully resected melanoma.

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STAT+: ‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. “Anne” is sitting in a small, wood-paneled consultation room, at the Mayo Clinic in Rochester, Minn., about to embark on yet another weight loss journey.

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While many leverage precision medicine, Faeth is banking on precision nutrition to tackle cancer

PharmaVoice

The San Francisco-based biotech is pairing metabolically-engineered diets with existing therapies to starve and kill tumors.

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What Biden's proposed budget means for Medicare Advantage

Fierce Healthcare

What Biden's proposed budget means for Medicare Advantage rking Thu, 03/09/2023 - 16:16

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Wegmans enhances in-store capabilities for shoppers with sensory disabilities

Drug Store News

The retailer introduced enhanced in-store pharmacy auxiliary aids and accessibility options for customers with sensory disabilities.

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Biden administration requests $20 billion cash infusion to bolster public health

STAT

WASHINGTON — The Biden administration is calling for a big boost for public health funding across the federal health department, but left out specific funding for Covid-19 activities. In its budget request to Congress on Thursday, the White House asked for $20 billion over five years to support pandemic preparedness efforts at the Administration for Strategic Preparedness and Response, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Adminis

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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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Cantu Beauty, celebrity stylist Angela Stevens debut Protective Styles lines

Drug Store News

The new collection features products that nourish and protect wigs, braids, weaves and locs while promoting healthy hair growth, the company said.

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Capital Rx CEO: PBM industry needs to be repaired, not ditched

Fierce Healthcare

Capital Rx CEO: PBM industry needs to be repaired, not ditched fdiamond Thu, 03/09/2023 - 16:35

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Could default eligibility improve clinical trial enrolment?

European Pharmaceutical Review

A new approach developed at the Medical University of South Carolina (MUSC) aiming to improve clinical trial eligibility has shown positive results. The South Carolina Clinical & Translational Research (SCTR) Institute’s patient outreach recruitment (POR) team and partners made potential patients eligible by default. This enabled them to learn of clinical trials in which they could participate.

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Prior authorization reform vital to combat nationwide clinician burnout crisis, US surgeon general says

Fierce Healthcare

Prior authorization reform vital to combat nationwide clinician burnout crisis, US surgeon general says dmuoio Thu, 03/09/2023 - 15:03

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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+: Insulin for $20 a vial? Sanders pushes bill for price caps on the diabetes treatment

STAT

Now that Eli Lilly is cutting prices on some of its insulin products, Sen. Bernie Sanders (I-Vt.) is seeking to build on that momentum. This week, he introduced a bill that would place a $20 cap on all insulin, a move designed to drastically lower costs for millions of Americans. The legislation — dubbed the Insulin for All Act — would prohibit all insulin manufacturers from charging more than $20 per vial.

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DC Health Link hack exposed health data on legislators: media reports

Fierce Healthcare

DC Health Link hack exposed health data on legislators: media reports pminemyer Thu, 03/09/2023 - 11:07

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STAT+: Biden makes drug pricing a central part of his deficit reduction plans

STAT

WASHINGTON — President Biden made lowering drug prices a key part of his budget with proposals to expand Medicare drug price negotiation, squeeze more rebates out of drug companies, and lower the cost of insulin for everyone with insurance. The request made Thursday also details a $7.2 billion ask for the Food and Drug Administration, which includes funding specifically set aside for improving the oversight of food manufacturing, regulating cosmetics, and making the medical device supply

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Georgia lawmakers, NAACP ask HHS, IRS to investigate Wellstar's Atlanta hospital closure

Fierce Healthcare

Georgia lawmakers, NAACP ask HHS, IRS to investigate Wellstar's Atlanta hospital closure dmuoio Thu, 03/09/2023 - 16:35

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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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Watch: The troubled history of BMI, the body mass index

STAT

The body mass index, or BMI, is the formula that’s used most often to diagnose overweight and obesity. But unlike other common diagnoses, there is a certain stigma applied to people with a high body mass index, or BMI, which can affect how they are perceived by peers, providers, and society at large. Despite the ubiquity of the BMI in medicine, many argue that it is a flawed tool, with a strange history.

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Flowly, VR-enabled app to manage chronic pain and stress, rolls out program for providers

Fierce Healthcare

Flowly, VR-enabled app to manage chronic pain and stress, rolls out program for providers agliadkovskaya Thu, 03/09/2023 - 18:16

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STAT+: Mice with two fathers and base-edited baby monkeys highlight potential — and limitations — of hereditable gene editing

STAT

LONDON — Scientists at this year’s genome editing summit spent Tuesday showing the world just how far CRISPR -based medicines for treating human diseases have come in a decade. But Wednesday was an exhibition in how far the same technology has to go before it might be safely used to alter the genetic afflictions people may pass on to future generations.

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Former fintech engineers launch startup that aims to tackle insurance verification for virtual care

Fierce Healthcare

Former fintech engineers launch startup that aims to tackle insurance verification for virtual care hlandi Thu, 03/09/2023 - 09:47

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U.S. requires new info on breast density with all mammograms

STAT

WASHINGTON — All U.S. women getting mammograms will soon receive information about their breast density , which can sometimes make cancer harder to spot. The new requirements, finalized Thursday by the  Food and Drug Administration , are aimed at standardizing the information given to millions of women following scans to detect breast cancer.

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Handling HPAPIs safely – what does it take?

European Pharmaceutical Review

Highly potent active pharmaceutical ingredients (HPAPIs) are used in formulations for high potent drugs, owing to their ability to target precise disease cells including cancer cells. 1 These substances “are pharmacologically and biologically active at low doses,” Dr Kishore Hotha, Global Head of Analytical Research & Development at Veranova, explained.

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STAT+: An unlikely new 340B alliance emerges between PhRMA and community health centers

STAT

WASHINGTON — An unusual new alliance of the brand-drug lobby PhRMA and community health centers is forming to push reforms in the 340B drug discount program, the groups announced Thursday. The groups argue that the federal drug discount program has expanded beyond its original mission to help low-income and other vulnerable populations, and instead is benefiting large, well-resourced hospitals.

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NICE approves semaglutide for weight loss

Hospital Pharmacy Europe

NICE has recommended use of semaglutide with a reduced-calorie diet and increased physical activity as a therapeutic option for weight loss In a technology appraisal guidance, the UK’s NICE has recommended the use of semaglutide as part of a weight loss management strategy. Obesity is a global health problem and the World Obesity Atlas 2023 report has estimated based on current trends, that overweight and obesity will affect over 4 billion people by 2035, reflecting an increase from 38% of

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Listen: Robert Califf on how drugs get approved, plus the nascent revolution in obesity

STAT

What keeps the FDA commissioner up at night? How will Ozempic change the world? And what’s behind WeightWatchers’ pivot? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. FDA Commissioner Robert Califf joins to discuss his first year on the job, the future of drug approvals, and how Duke basketball will do without Coach K.

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Higher particulate matter exposure increases infant all-cause and respiratory infection-related ED visits

Hospital Pharmacy Europe

Greater particulate matter exposure during the first year of life is linked to higher all-cause and respiratory -related visits to the ED Researchers from from San Diego, La Jolla in the US, have shown that an increased exposure to particulate matter 2.5 μm or less in diameter (PM2.5), increases the risk for all-cause and respiratory infection-related visits to an emergency department among infants during their first year of life.

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Opinion: Use warranties, not outcomes-based agreements, to make payers whole when a gene therapy fails

STAT

A decade ago, I had pegged gene and cell therapies as the next frontier. As an investment banker, I was sure they would someday change how patients were treated. But a question from a biotech CEO started me thinking about not only how to pay for them, but how to offer guarantees for these therapies to payers who rightfully wanted reassurances that they were paying for something that works for their beneficiaries.

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Here are the top health items in Biden's new fiscal 2024 proposed budget

Fierce Healthcare

Here are the top health items in Biden's new fiscal 2024 proposed budget rking Thu, 03/09/2023 - 12:39

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Oral PCSK9 inhibitor MK-0616 significantly lowers LDL cholesterol

Hospital Pharmacy Europe

MK-0616 is an oral PCSK9 inhibitor and in a Phase II trial significantly lowered LDL cholesterol in patients with hypercholesterolaemia Drug manufacturer Merck, has reported in a press release that their investigational, oral and once daily, PCSK9 inhibitor, MK-0616, produced significant reductions in LDL cholesterol in adult patients with hypercholesterolaemia.

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Cardinal Health’s Outcomes, Signify Health to offer in-home medication therapy management

Drug Store News

The collaboration will initially focus on addressing interventions recommended for Medicare Advantage members of joint clients, but it may expand into additional services.

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Industry Voices—Let's be transparent about hospital price transparency

Fierce Healthcare

Industry Voices—Let's be transparent about hospital price transparency pminemyer Thu, 03/09/2023 - 11:28