Sat.Feb 10, 2024 - Fri.Feb 16, 2024

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How Will the Extinction of B/Yamagata Impact Global Flu Vaccination Strategies?

Drug Topics

Drug Topics talked with Gregg Sylvester, MD, chief health officer and vice president of medical affairs at CSL Seqirus, about what can we learn from this unique situation to improve future vaccine development and distribution.

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Biosimilars: Are They Delivering the Cost Savings Promised?

Pharmacy Times

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

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Transforming drug development with AI

pharmaphorum

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

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STAT+: In ‘major milestone,’ FDA approves first cell therapy for solid tumors

STAT

Nearly four decades after its first conception, the first TIL therapy, an immunotherapy that harvests cancer-fighting immune cells from the patient’s own body, received accelerated approval from the Food and Drug Administration for advanced melanoma. The therapy, called Amtagvi or lifileucel from Iovance, is the first cell therapy approved for a solid tumor.

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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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Fragmented Policy, Insurance Landscape Challenges Newly Approved Vaccines

Drug Topics

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.

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FDA Accepts New Drug Application for MDMA-Assisted Therapy for PTSD

Pharmacy Times

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

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Opinion: Independent doctors like me are becoming an endangered species

STAT

More than 100,000 doctors have  left private practice  and become employees of hospitals and other corporate entities since 2019. Today, nearly  three in four physicians  are employees of larger health care entities or other corporations — a record high. As an independent physician, I know exactly why so many are making that choice.

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Patients With Type 1 Diabetes Not Achieving Glycemic Targets Despite Use of New Technology

Drug Topics

Many patients with the condition continue to experience severe hypoglycemic events even with the use of continuous glucose monitors and other disease management tools.

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FDA Approves Omalizumab to Reduce Food-Based Allergic Reactions in Adult and Pediatric Patients

Pharmacy Times

This marks omalizumab’s fourth FDA-approved indication for allergic and inflammatory conditions, such as severe persistent allergic asthma, with its initial approval being in 2003.

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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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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’s internal playbook opens a rare window into influence in Washington

STAT

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government. It’s well documented that Juul spent significant sums on registered lobbyists and political donations back in 2018 and 2019, when the head of the Food and Drug Administration declare

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'New set of digital table stakes': Most executives see tech as worthy investment, EY survey finds

Fierce Healthcare

Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals. | Nearly all healthcare executives believe technology is worth the cost, even though they have yet to see a financial return from it, according to a new survey from EY. Most believe in its power to reduce costs and boost provider credibility.

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Pharmacy Focus: Policy Editions - February 2024 Rx Roundup

Pharmacy Times

The meeting provided a brief overview of California's new Stop Dangerous Pharmacies Act, the benefits of e-prescribing for improving patient safety and outcomes, and New Jersey's pilot program for anonymous dispensing of opioid antidotes from pharmacies.

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain 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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STAT+: For unlucky mountaineers, tundra explorers and the unhoused, a new drug could avert the ravages of frostbite

STAT

Two days after his right hand froze, Hart Bezner realized for the first time that he might lose it.  The retired physics professor was sitting in an emergency room in Whitehorse, the capital of Canada’s Yukon territory, where two doctors and a pharmacist were taking an unusual amount of interest in the appendage and the pink blisters that now covered it.

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CMS: Providers may now text patient info, orders to care teams

Fierce Healthcare

Providers working in hospitals and critical access hospitals may now text patient information and patient orders among care team members without landing on the wrong side of Medicare’s Conditions o | Texting patient info has been against Medicare's Conditions of Participations for over half a decade, due to concerns of insecure texting platforms.

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AI Algorithm Demonstrates Ability to Predict the Efficacy of Sertraline in Patients With Depression

Pharmacy Times

Despite the tool’s ability to predict efficacy of sertraline in patients with major depressive disorder, the investigators note that future research will seek to improve the algorithm.

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'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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Ebola vaccine cuts fatality even in people who were infected before the jab, new study shows

STAT

A new study has shown that people vaccinated against Ebola who still developed the disease had a substantially lower risk of dying than people who were not vaccinated, even if they received the vaccine when they were already infected with the virus. It confirms just how major an advancement the Ebola vaccine remains; the study is the first to show that in addition to preventing infections, the vaccine can save some people who are already sick with the often fatal disease.

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Kaiser Permanente reports $4.1B profit, exceeds $100B operating revenues in 2023

Fierce Healthcare

Kaiser Permanente wrapped up its fiscal year with $329 million of operating income (0.3% operating income), net income of $4.1 billion and more than $100 billion in both operating revenues and expe | The California-based nonprofit noted cost pressures, labor challenges and membership declines but still logged a 0.3% operating income in the wake of 2022's losses.

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Study Shows 40% of Participants Sustain Cognitive Improvement After Surgery-Induced Weight Loss

Pharmacy Times

Sustained cognitive improvement is likely a result of lower inflammation, remission of comorbidities, higher physical activity, and better mood.

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Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'

Fierce Pharma

While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.

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Smoking impairs immune response, even after quitting, new study says

STAT

Public health messages have told us for decades that if you smoke, you should quit. And if you don’t smoke, don’t start. But a new study suggests smoking may be even worse than we thought. The study , published Wednesday in Nature, underscores the importance of never lighting up that first cigarette, based on its conclusion that smoking has much longer harmful effects on immune responses than previously understood.

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'A giant unknown': What the alleged $2B Medicare catheter fraud scheme means for ACOs

Fierce Healthcare

Seven durable medical equipment companies cost the Medicare system $2 billion in payments, the National Association of ACOs (NAACOS) told the federal government in recent months. | ACOs could face lasting financial difficulties because of a recent, alleged $2 billion Medicare catheter fraud scheme. Experts worry this could be just the beginning.

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FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis

Pharmacy Times

The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.

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Novartis, zeroing in on innovative meds, launches strategic review of India outfit

Fierce Pharma

A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines. | A Novartis subsidiary handling old products in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.

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STAT+: A flurry of research misconduct cases has universities scrambling to protect themselves

STAT

There was a time when an allegation of data mishandling, scientific misconduct, or just a technical error felt like a crisis to Barrett Rollins, an oncologist and research integrity officer at Dana-Farber Cancer Institute. Now, it’s a Tuesday. The renowned cancer treatment and research center is in the midst of a lengthy review of possible discrepancies involving around 60 papers co-authored by four of its top researchers over a period of over 15 years, including CEO Laurie Glimcher and C

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Hospital violence isn't confined to EDs, often rising during COVID-19 surges, full moons, data show

Fierce Healthcare

Most alarms triggered by hospital staff’s wearable safety alert systems occurred outside of the emergency department and more often during weekdays, non-holidays, surges of COVID-19 and even during | Aggregate data from 200,000 workers' wearable duress systems suggest emerging or active violent incidents occur "throughout every part of the hospital," and are more frequent during weekdays, COVID-19 surges and full moons.

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Seeing Through the Fog of ‘Pharmageddon’

Pharmacy Times

Pharmacists are uniquely positioned to play a frontline role in advancing health equity. This will require, however, that we build the pipeline of future pharmacists and preserve vital community touchpoints.

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Women’s health is a priority not a charity

pharmaphorum

Investing in women's health research and funding is not a charity, but a priority. Discover the importance of allocating resources and supporting initiatives that promote women's health and well-being.

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Stem cell study offers clue to South Asians’ increased risk of cardiovascular disease

STAT

A growing body of data show that South Asians are at greater risk of developing heart disease than white people, and they tend to get complications at younger ages, but it’s not been fully clear what explains this disparity. A new study suggests one potential reason is that South Asians have a decreased ability to repair blood vessels that get injured from cardiovascular problems.

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Redesign Health reduces workforce as it slows down pace of new company launches in 2024

Fierce Healthcare

Redesign Health, a healthcare startup creator, is reducing its workforce, cutting 77 staff positions, as it slows the pace of new company launches this year, Fierce Healthcare has learned. | Redesign Health, a healthcare startup creator, is reducing its workforce, cutting 77 staff positions, as it slows the pace of new company launches this year, Fierce Healthcare has learned.

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FDA Accepts Priority Review Application for RSV Vaccine to Prevent Illness in Adults

Pharmacy Times

The updated indication for the respiratory syncytial virus vaccine is for adults aged 50 to 59 with underlying conditions who are at an increased risk of contracting the virus.

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J&J consumer health spinoff Kenvue telegraphs 100-plus layoffs in California, New Jersey

Fierce Pharma

While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.

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