Wed.Nov 29, 2023

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Walking at Faster Speeds Could Significantly Reduce Type 2 Diabetes Risk

Drug Topics

A new systematic review and meta-analysis found that the risk of type 2 diabetes decreased significantly at walking speeds of 4 km/h or above.

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Learning Clinical Microbiology Using Podcasting: The Let’s Talk Micro Podcast

IDStewardship

In this article the host of the Let’s Talk Micro Podcast (Luis Plaza Rios) is interviewed about his experience and learning clinical microbiology using podcasting via the Let’s Talk Micro podcast. Interviewee: Luis Plaza Interviewer: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 1 December 2023 Podcasting has emerged as an incredible way to reach a global audience and discuss scientific information.

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FDA: Roflumilast Cream sNDA Accepted for Atopic Dermatitis

Drug Topics

The treatment from Arcutis Biotherapeutics has a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2024.

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

PharmaVoice

U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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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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2022-2023 Influenza Season Classified as High Severity by CDC

Drug Topics

This season marks the fourth to be classified as high severity since the 2009 influenza A(H1N1) pandemic.

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STAT+: Colon cancer prevention paradox: Higher-risk patients pay more for colonoscopy

STAT

Ashley Conway-Anderson was prepared for a lot of things when it came to her first colonoscopy. She sought out tips to make the daylong prep more bearable. She braced herself mentally for what the doctors would find; her mother, after all, was just a couple years out of recovery from colorectal cancer. When she awoke from the procedure, she said, things seemed relatively fine.

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With latest tranche, U.K. Biobank has genome sequences from 500,000 people available for research

STAT

LONDON — Data from half a million people’s whole genome sequences are now available to researchers worldwide, as the U.K. Biobank on Thursday debuted the latest addition to what it aims to be the world’s most comprehensive health data resource. The Biobank has been building its collection over 20 years, with 500,000 volunteers recruited to provide survey responses about their health, medical records, tests of molecular markers, and imaging scans.

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Role of Specialty Pharmacies in Hemophilia Care: A Collaborative Approach

Pharmacy Times

Lisa Schrade, PharmD, and Robert Sidonio Jr, MD, MSc, explore the integral partnership between specialty pharmacists and hematologists in managing patients with hemophilia.

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Opinion: Neuroscience has to grapple with a long legacy of racism if it wants to move into the future

STAT

Many parts of neuroscience research have a race problem. Black people are often excluded from studies due to the texture of their hair , receive erroneous and inaccurate readings due to the melanin content of their skin , and are severely underrepresented in neuroimaging datasets. Now neurotechnology is undergoing a moment of tremendous change, as Elon Musk’s Neuralink has obtained independent review board approval to conduct its first human trials for the R1 robot and N1 brain implant.

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Case study: The pinnacle of person-centred care in hospital pharmacy

Hospital Pharmacy Europe

In November 2022, London North West University Healthcare NHS Trust embarked on a person-centred care pilot that has changed the face of their pharmacy practice for the better. Helena Beer speaks to four of the key players about how they went about the ground-breaking project, the impact it’s having on patients, staff and the wider healthcare community, and their top tips for success.

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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+: UnitedHealth Group now employs or is affiliated with 10% of all physicians in the U.S.

STAT

UnitedHealth Group has about 90,000 employed or affiliated doctors, approximately 10% of all physicians in the U.S. The number — disclosed Wednesday at the company’s investor day by Amar Desai, the CEO of UnitedHealth’s Optum Health division — means the company acquired or hired 20,000 doctors in the past year alone. The rapid growth of UnitedHealth’s physician base underscores how the company, which already is the country’s largest private health insure

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Octave Bioscience is navigating the Parkinson’s labyrinth with Michael J. Fox’s help

PharmaVoice

A grant from the notorious Parkinson’s foundation has sped up Octave’s timeline to further advance biomarker development in the field.

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STAT+: Cigna, Humana in talks to merge into health insurance giant, per report

STAT

Cigna and Humana are in discussions to merge, a potential move that would create a health insurance and prescription drug benefits titan with approximately $300 billion of annual revenue. A proposed transaction would almost certainly prompt a close review from antitrust enforcers at the Department of Justice and the Federal Trade Commission. A merged Cigna-Humana would further consolidate the market for pharmacy benefit managers.

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Melanoma LIMS, Algorithmic-Based Classification Achieves Specificity, Precision in Skin Cancer Diagnosis

Pharmacy Times

The study authors are encouraged by the findings, noting that LIMS with algorithmic-based classification can aid in early and accurate diagnosis of skin cancer, improving patient prognosis.

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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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WSJ: Cigna, Humana exploring insurance mega-merger

Fierce Healthcare

A health insurance megamerger is reportedly brewing. | The Wall Street Journal, citing people familiar with the matter, reported on Wednesday that payer giants Cigna and Humana are exploring a combination that could shake up the power dynamics of the industry.

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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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Amgen expands pact with Amazon to usher drug manufacturing into the AI era

Fierce Pharma

Seeking to identify ways to improve the discovery and production of medicines, Amgen is expanding its partnership with tech giant Amazon. | Amgen is growing its decade-old collaboration with Amazon Web Services—a widely used cloud platform—to create generative artificial intelligence that the companies aim to use to increase the manufacturing throughput of pharmaceuticals.

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STAT+: FDA chief scientist to replace Woodcock

STAT

WASHINGTON — The Food and Drug Administration’s chief scientist will replace retiring Janet Woodcock as principal deputy commissioner of the agency next year, the FDA commissioner announced Wednesday. Namandjé N. Bumpus was named chief scientist in June of last year. The chief scientist works closely with the FDA’s product centers, and Bumpus played a big role in the expansion of the agency’s regulation of cosmetics.

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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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Gene Therapy in Hemophilia A: Safety, Efficacy, and the Changing Landscape

Pharmacy Times

Atta Chowdhry, RPh, and Robert Sidonio Jr, MD, MSc, discuss the safety and efficacy of gene therapy for hemophilia A, highlighting recent approvals, with insights into adverse effects, immunosuppression, and the evolving treatment landscape.

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STAT+: Blood cancers may arise from CAR-T cells, but experts think only in very rare cases

STAT

The announcement on Tuesday that the Food and Drug Administration was investigating whether CAR-T immunotherapy had itself caused blood cancers initially appeared to be a significant blow to one of the brightest spots in cancer care. But experts quickly cautioned that risk of this complication is probably minuscule compared to the known risk of secondary cancers from other cancer therapies like chemotherapy and radiation.

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ACOs not shown to improve mental health outcomes: study

Fierce Healthcare

Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs. | A new study pours water on the belief that ACOs are well-suited to handle chronic mental health conditions its patients experience.

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FIP report: Pharmacy-based point-of-care testing is expanding worldwide, but challenges remain

Drug Store News

The report highlights obstacles to pharmacy POCT, such as lack of reimbursement, inadequate collaborative practice models, legislative barriers and more.

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Mayo Clinic unveils $5B, 6-year renovation of its flagship Rochester campus

Fierce Healthcare

This week Mayo Clinic pulled back the curtain on a $5 billion, six-year plan to overhaul its flagship campus located in downtown Rochester, Minnesota. | The nonprofit will add five new buildings spanning 2.4 million square feet, two of which will be clinical facilities with designs intended to support continuous, tech-enabled care.

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U.S. life expectancy rose in 2022, but it remains below its pre-pandemic level

STAT

NEW YORK — U.S. life expectancy rose last year — by more than a year — but still isn’t close to what it was before the Covid-19 pandemic. The 2022 rise was mainly due to the waning pandemic, Centers for Disease Control and Prevention researchers  said Wednesday. But even with the large increase, U.S. life expectancy is only back to 77 years, 6 months — about what it was two decades ago.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

The FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.

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Why the Novo Nordisk Foundation is betting big on stem cells

pharmaphorum

Why the Novo Nordisk Foundation is betting big on stem cells Mike.

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Ferring reveals long-term data for cancer gene therapy

European Pharmaceutical Review

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. Adstiladrin is the first FDA-approved intravesical gene therapy to be authorised for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

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Opinion: Listen: What we take for granted after 30 years of Prozac

STAT

When Prozac first entered the psychiatry scene in in the late ’80s, the profession was still Freud’s territory. Many considered taking medication to treat depression a failure. But that was all about to change, as early stewards like psychiatrist Peter Kramer refused to shy away from the new drug’s potential. These days, he says that people take for granted all of the progress that’s been made with antidepressant treatment in the past three decades.

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Cigna reportedly in talks to merge with Humana

Drug Store News

Cigna is reportedly in talks to merge with Humana, per a Wall Street Journal report.

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How long does it take for MiraLAX to work?

The Checkup by Singlecare

If it’s been days since you’ve been able to go, you may visit your pharmacy looking for an over-the-counter (OTC) treatment to help move things along. One common OTC option is MiraLAX , an osmotic laxative used to treat occasional constipation. It works by drawing water into the colon, which softens the stool and makes it easier to pass, while also increasing the colon’s contents to trigger a bowel movement.

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FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy

PharmExec

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

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What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials

pharmaphorum

What the FDA’s groundbreaking guidance really means for psychedelic therapy clinical trials Mike.

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What’s on the Horizon in Pharma Marketing & Innovation: Q&A With Faruk Capan, Chief Innovation Officer at EVERSANA

PharmExec

Capan discusses the industry is embracing new technologies and how these use cases may evolve in the coming year.

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