Wed.May 01, 2024

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FDA Approves Second Formulation of Humira Biosimilar Cyltezo

Drug Topics

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.

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As AI proliferates in pharma, regulators look to catch up in clinical trials

PharmaVoice

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

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Expert: Education of Providers, Patients Key to Biosimilar Uptake

Drug Topics

Savings associated with biosimilar uptake are projected to reach $181 billion through 2027.

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Opinion: From sewage to safety: Hospital wastewater surveillance as a beacon for defense against H5N1 bird flu

STAT

Pandemics start slowly — a few cases here, a few there — until suddenly people are sick or dying everywhere. Early detection by monitoring wastewater can help short-circuit that cycle. It’s difficult to tell what is happening right now with highly pathogenic avian influenza A H5N1 (bird flu), which is rapidly spreading among cows and other mammals.

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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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Incentives Drive Provider, Patient Biosimilar Adoption

Drug Topics

One notable incentive includes the launch of biosimilars at both low- and high wholesale acquisition costs.

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Pasteurization inactivates H5N1 bird flu in milk, new FDA and academic studies confirm

STAT

Extensive testing of pasteurized commercially purchased milk and other dairy products from 38 states has found no evidence of live H5N1 bird flu virus, Food and Drug Administration officials said at a press briefing Wednesday. The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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DEA Aims to Reclassify Marijuana as Less Dangerous Drug

Drug Topics

Although the US Drug Enforcement Agency's (DEA) proposed reclassification of marijuana wouldn’t legalize the drug nationwide, it could shake up the current marijuana landscape.

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STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

NEW YORK — By the time Peter Bauman considered deep brain stimulation, he was desperate. Early onset Parkinson’s disease, diagnosed at age 49, had disabled him, ended his bartending career, and led him to consider suicide. He hoped that the treatment, known as DBS, in which an electrode connected to an external battery is inserted into the brain and emits electrical impulses, would ease his Parkinson’s tremors.

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Biosimilars Poised to Save Billions in Health Care Spending

Drug Topics

Pharmacists can help financial decision makers understand the value of biosimilar therapies.

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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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After private equity firms gobbled up wheelchair makers, users pay the price in long repair times

STAT

When Maureen Amirault purchased her first electric wheelchair in 2020, she had been living with muscular dystrophy for decades. Braces and a cane helped, but walking became too arduous, so she got a chair through a company called Numotion. The first few months were great. The headrest fell off, but Numotion fixed it in a matter of days.

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UnitedHealth CEO Testifies Before Congress on Change Healthcare Cyberattack

Drug Topics

In a testimony to the Senate Finance Committee, Andrew Witty discussed what led to the February Change Healthcare cyberattack and the organization’s response.

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Opinion: Colorectal cancer is increasing among young people. It’s time to boost research on it

STAT

I am not writing here to talk about my husband, Chadwick Boseman, who died far too young from colorectal cancer. I am not here to give any glimpses into our obviously private life and his obviously private battle with this cancer, which is affecting far more young lives than it should. The legacy he created is not about cancer and I hope you don’t remember him that way.

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FDA Approves Fidanacogene Elaparvovec-dzkt as One-Time Gene Therapy for Adults With Hemophilia B

Pharmacy Times

The 1-time treatment may be a better alternative for patients who don’t want to undergo frequent doses of standard of care intravenous factor IX infusions.

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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+: Lawmakers grill UnitedHealth CEO on Change cyberattack: ‘Your company let the country down’

STAT

On Wednesday, UnitedHealth CEO Andrew Witty appeared before Congress to answer for what lawmakers called a “single attack [that] kicked off a cascading series of crises that are unmasking some deep vulnerabilities in the core of our health care system”: the February Change Healthcare cyberattack that is still disrupting payment processing across the country.

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'Too big to fail': Consolidation concerns loom over hearing on Change Healthcare cyberattack

Fierce Healthcare

The scale of UnitedHealth Group's sprawling empire was under the microscope on Wednesday as CEO Andrew Witty testified before a key Senate panel about the cyberattack on Change Healthcare that's ha | The scale of UnitedHealth Group's sprawling empire was under the microscope on Wednesday as CEO Andrew Witty testified before a key Senate panel about the cyberattack on Change Healthcare that's had ripple effects across healthcare.

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STAT+: Moderna ends collaboration with CRISPR company Metagenomi, parts ways with gene editing chief

STAT

Three years ago, Moderna, flush with cash from Covid vaccine sales, announced it would start investing in the burgeoning field of gene editing. It created a new division called Moderna Genomics and struck a collaboration with Metagenomi, a University of California-Berkeley spinout that specializes in developing new gene-editing enzymes. “This will be a completely new approach for Moderna and a dramatic expansion of our modality strategy,” Moderna president Stephen Hogue told invest

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Hospitals' patient experience, preventable infection improving after pandemic struggles, Leapfrog finds

Fierce Healthcare

The latest batch of Hospital Safety Grades from independent watchdog The Leapfrog Group suggest that patients’ care experiences, which deteriorated during and since the pandemic, may finally be tur | New data from the watchdog reflecting CMS-reported patient safety measures show that hospitals are, on average, working their way back from patient experience and hospital-acquired infection scores that plummeted during the COVID-19 pandemic.

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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+: DEA reverses a policy to avert morphine shortages

STAT

WASHINGTON  — The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. The DEA dictates the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, such as morphine and other injectable opioids that hospitals regularly use.

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New collective of women's health companies aims to scale access to specialty care

Fierce Healthcare

A newly formed group of women’s health companies aims to tackle gaps in care, with a focus on improving outcomes while reducing costs. | A newly formed group of women’s health companies aims to tackle gaps in care, with a focus on improving outcomes while reducing costs.

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STAT+: To regrow blood vessels after heart attack, a little transplant of mitochondria goes a long way in mice

STAT

Blood vessels in the legs or heart sustain considerable damage when they are narrowed by poor circulation from diabetes or blocked in a heart attack. To repair them, researchers have tried using grafts from other blood vessels or giving growth factors to stimulate new tissue, but those solutions often fall short. Scientists from Boston Children’s Hospital report Wednesday in Nature that they managed to boost blood vessel growth by enlisting mitochondria, organelles that power the cell, to

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Prevention revolution: How digital tools can help us get ahead of health problems

pharmaphorum

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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Investment Trends in Women's Health Are Driving Growth in Health Care Innovation

Pharmacy Times

Venture capital investments in women's health are growing, with innovation looking beyond traditional avenues.

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U.S. maternal mortality rate dips, but will the trend continue?

STAT

After years on the rise, the U.S. maternal mortality rate decreased in 2022, new government data show. But maternal health experts warn there’s no reason to celebrate: The dip is a course correction following the Covid-19 pandemic, and mothers in the United States continue to die at dramatically higher rates than mothers in other high-income countries.

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The Evolution of Pharmacy From Dispensing to Site of Care

Pharmacy Times

The COVID-19 pandemic spring boarded the evolution of pharmacies toward establishing their position as sites of care.

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STAT+: CVS went hard after Medicare Advantage patients, now it’s retreating

STAT

CVS Health got walloped at the outset of 2024 as older adults in its Medicare plans continue to get a lot more medical care than the company expected. CVS’ operating income fell by 34% — roughly $1.2 billion — in the first quarter compared with the prior-year period, according to results released Tuesday. The company, which absorbed the health insurer Aetna in 2018, marketed its Medicare Advantage plans aggressively last year and expanded its geographic reach more than any i

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HHS modernizes disability rights rule, stresses importance of enforcement

Fierce Healthcare

The Office for Civil Rights (OCR) announced an update to Section 504 of the Rehabilitation Act of 1973 Tuesday, fortifying support for Americans with disabilities. | HHS finalized a proposed rule from September, granting greater protections to individuals with disabilities. Secretary Xavier Becerra says the department is willing to help providers meet new standards.

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Opinion: Unnecessary insurance claim denials compromise patient care and provider bottom lines

STAT

Health care providers are in an acute financial situation. Record-high wages required to attract and retain talent coupled with price inflation not seen since the early 1980s are driving higher costs, while reimbursement and federal policies limit providers’ ability to cover expenses. Adding to this budgetary stranglehold are payment delays and insurance claim denials by payers, which compromise patients’ access to health care and providers’ financial viability.

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Weight loss treatments bring in billions but capacity remains an issue

pharmaphorum

Explore the challenges in weight loss treatments despite the billions spent on clinical trials for weight loss drugs. Discover why capacity remains a critical issue in the industry.

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STAT+: Experimental gene therapy seems to alleviate skeletal defects tied to rare inherited disease, study shows

STAT

LONDON — In 2021, a team of Italian researchers reported that an experimental gene therapy they had developed seemed to be correcting the metabolic issues at the core of a rare genetic disease that left children unable to break down sugar molecules. There remained an open question, however, about whether the therapy could address a particularly debilitating manifestation of the disease, the severe skeletal deformities it caused.

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FTC steps up campaign on junk patents with warning letters

pharmaphorum

FTC sends more warnings to pharma companies over 'junk' patents to protect drugs from generic competition, including Novo Nordisk's Ozempic.

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CVS lowers 2024 guidance as it misses on profit, revenue in Q1

Fierce Healthcare

CVS Health is lowering its guidance for the year after a first-quarter miss on both profit and revenue. | The company posted $1.1 billion in profit for the quarter as well as $88.4 billion in revenue. Both fell short of Wall Street analysts' expectations, according to Zacks Investment Research.

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Biotts claims a first with insulin delivery across skin

pharmaphorum

Polish drug delivery company Biotts says it has demonstrated delivery of insulin across the skin for the first time without the use of an injection system.

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