Tue.Mar 26, 2024

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Addressing The Need for Better Access to CGM in Low-Income Areas

Drug Topics

In a poster presented at the 2024 American Pharmacists Association Annual Meeting and Exposition, researchers addressed continuous glucose monitoring and its potential role in indigent communities.

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STAT+: Some nonprofit hospitals spend less on charity care than they receive in tax breaks, new analysis shows

STAT

A new study of hospitals’ charity care spending suggests nonprofit hospitals really aren’t that different from their for-profit counterparts. One major benefit of being a nonprofit hospital is receiving tax exemptions on property taxes, income taxes, and sales taxes. Experts told STAT that implies a “social contract” with taxpayers, where these hospitals will help take care of the most vulnerable.

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Examining Pharmacists Role in the Current Vaccine Landscape

Drug Topics

Posters presented at the APhA 2024 Annual Meeting and Exposition discussed pharmacist barriers in pediatric immunizations, a novel meningococcal vaccine, and the need for inpatient reviews of vaccination history.

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STAT+: Steward Health Care has deal to sell doctor network to UnitedHealth

STAT

Troubled hospital operator Steward Health Care, grappling with a financial crisis that’s engulfed its eight Massachusetts hospitals, has moved to shore up its finances by striking a deal to sell its nationwide physician network to insurance giant UnitedHealth’s Optum Care unit. The proposed sale of the doctors group, called Stewardship Health, is part of Steward’s plan to bolster its national system of 33 hospitals after the Dallas-based company last year fell behind in payi

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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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DefenCath Approved to Reduce Incidence of Catheter-Related Bloodstream Infections in Adults

Drug Topics

This new drug utilizes the bactericidal properties of taurolidine and the bloodthinning effects of heparin to maintain catheter patency.

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FDA Approves Cobas Malaria to Help Reduce Risks Infections From Transfused Blood Products

Pharmacy Times

The test scans whole blood samples from individual human donors for the 5 parasite species that can cause malaria in humans and detects Plasmodium RNA and DNA.

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How Amazon Pharmacy is using AI to deliver medications faster as it expands same-day delivery

Fierce Healthcare

Amazon Pharmacy expanded its same-day medication delivery service to New York City and Los Angeles, with plans to add a dozen more U.S. | Amazon Pharmacy expanded its same-day medication delivery service to New York City and Los Angeles, with plans to add a dozen more U.S. cities by the end of the year, the company announced Tuesday.

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STAT+: Amgen sues Colorado over its prescription drug affordability board

STAT

Amgen has filed a lawsuit accusing a Colorado state board of violating the U.S. Constitution over a plan to pursue a first-in-the-nation move to cap the cost of a pricey prescription medicine. In its lawsuit , the company argued the mandate for the state prescription drug affordability board is unconstitutional because its actions will conflict with federal law, violate basic requirements of due process, and seek to regulate business outside of Colorado.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

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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+: Viking Therapeutics to move its oral obesity drug into Phase 2 study after early success

STAT

Viking Therapeutics said Tuesday that its closely watched oral obesity drug had succeeded in an early-stage trial and that it planned to advance the medicine into the next phase of development.   The top-line results released Tuesday were only from a Phase 1 study, which primarily focuses on a drug’s safety. But Viking said that in the study, its medicine led to a roughly 3.3% placebo-adjusted average weight loss after four weeks and that it showed no safety issues.

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Insurers are booming as ACA debate rages. What does the future hold?

Fierce Healthcare

The Affordable Care Act (ACA) is still a very big deal. | Love it or hate it, the Affordable Care Act's enrollment numbers have exceeded 21 million as some companies double down on ICHRA.

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Opinion: Eliminate the waiting period for sterilization covered by Medicaid

STAT

It’s time to acknowledge when a law intended to right an egregious wrong has become harmful — and change it. That’s the case for a law that requires people covered by Medicaid to wait at least 30 days after signing a consent to sterilization form to actually undergo the procedure. But there’s no waiting period for people covered by private insurance.

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Aduhelm and an expensive failure to launch

pharmaphorum

Aduhelm (aducanumab) and Leqembi are examples of controversial drugs that faced challenges with FDA approval. Learn more about the expensive failure to launch of these medications.

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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+: FDA is still struggling to inspect clinical research sites, watchdog finds

STAT

The U.S. Food and Drug Administration’s oversight of clinical research in hospitals and clinics has fallen considerably in recent years, due to disruptions caused by the Covid pandemic and challenges finding and keeping investigators, according to a new report by the U.S. Government Accountability Office. In 2022, the health regulator inspected 537 hospitals and clinics that were conducting studies of medicines for which drug manufacturers were seeking approvals.

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FDA Grants Orphan Drug Designation to Felzartamab for Kidney Transplant Recipients

Pharmacy Times

Previously, felzartamab received orphan drug designation and breakthrough therapy designation for the treatment of primary membranous nephropathy.

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STAT+: Merck drug for rare, deadly lung condition appears set for approval in U.S.

STAT

The Food and Drug Administration is expected to approve Merck’s drug to treat a rare lung disorder called pulmonary arterial hypertension on Tuesday, making available a novel treatment for a deadly condition that’s long been challenging to treat. In a large trial published last year, the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting the risk that their condition would worsen, that they would die, and th

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Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

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Female leadership and lessening disease burden

pharmaphorum

As Women’s History Month comes to its final week, today’s podcast sees web editor Nicole Raleigh in conversation with Debra Weiss, COO of the Bill & Melinda Gates Medical Research Institute (Gates MRI), discussing her role as a female leader in the leader and the non-profit organisation’s work in developing novel biomedical interventions and lessening the burden of disease in LMICs.

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The sleep-testosterone link

The Checkup by Singlecare

Testosterone replacement therapy (TRT) is a buzzing topic in men’s health. If you have low testosterone levels—also known as hypogonadism—TRT may balance your hormones and improve your overall well-being. But experts say TRT does not come without risks. First-line treatment of low testosterone should always be lifestyle modifications. Changes like consuming a healthy diet, getting regular exercise, practicing stress-reduction techniques, and logging sufficient sleep can raise testosterone levels

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Industry Voices—Healthcare is changing. Hospital staffing must, too

Fierce Healthcare

Walk the floors of a busy hospital today and you’ll see signs of a healthcare workforce in crisis. It really doesn’t matter which hospital, or where. The signs are the same across the country. | Nurses have been pushed to the limit. Their dedication and resolve is tested every day against the stark reality of an overburdened system. It’s a persistent and pervasive crisis, and the healthcare system has so far failed to adequately address it.

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Amgen, facing potential Enbrel price cap in Colorado, takes state's new drug affordability board to court

Fierce Pharma

Amgen’s arthritis blockbuster Enbrel already owns an undesirable spot on the list o | The state's new Prescription Drug Affordability Review Board voted to subject the blockbuster arthritis med to an upper price limit, which Amgen calls a violation of the company's constitutional rights.

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Ex-BioMarin CEO Bienaimé re-emerges at Owkin

pharmaphorum

Just four months after ending an 18-year stint as chief executive of BioMarin, Jean-Jacques Bienaimé has been named chairman of Owkin, a specialist in applying artificial intelligence to the discovery and development of drugs and diagnostics. Owkin said Bienaimé will help to grow the company, including taking it through its next fundraising round and expanding its drug discovery, drug development and diagnostics capabilities.

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HHS releases newest list of inflation-capped Part B drugs

Fierce Healthcare

It's Groundhog Day for Medicare Part B drug manufacturers. | Now a quarterly tradition, HHS revealed its latest list of 41 drugs to be capped by inflation.

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Nuvation Bio nears commercial stage with AnHeart buy

pharmaphorum

Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib

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STAT+: Roche subsidiary Foundation Medicine opens new headquarters in Boston

STAT

Contemporary paintings by artists who have overcome homelessness or disabilities greet visitors in the lobby. Upstairs in the cafeteria, employees order lunches served by local restaurants, including barbecued pulled pork sandwiches from Pennypacker’s. On the top floor, workers can savor a panoramic view of the Seaport District and downtown Boston.

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Reuters Pharma USA 2024 - Day 1

pharmaphorum

Get live coverage of the latest updates and developments from Day 1 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

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STAT+: European antitrust regulators probe Zoetis over pain drug for dogs

STAT

The European Commission has opened a formal antitrust investigation to determine whether Zoetis, one of the largest purveyors of medicines for dogs and cats, breached European Union competition rules by preventing the launch of a competing novel medicine that is used to treat chronic pain in canines. The company sells the first and only monoclonal antibody, called Librela, that is available to treat pain stemming from osteoarthritis suffered by dogs.

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MSD leaps on FDA approval of PAH drug sotatercept

pharmaphorum

MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms

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Are Adults With Diabetes Who Switch to High-Deductible Health Plans at Greater Risk for Complications?

Pharmaceutical Commerce

A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.

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At second ask, FDA clears AZ’s Ultomiris for NMOSD

pharmaphorum

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier application was turned down with a request for changes to the risk evaluation and mitigation strategy (REMS) for the drug.

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Bluebird's Lyfgenia launch gains traction but shares tumble with report of accounting errors

Fierce Pharma

Bluebird bio reported progress of its launch of three gene therapies and said it will have to refile financial statements because of accounting errors

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Merck’s next big thing is (probably) on the way

STAT

New biotech newsletter launching this Thursday.  Don’t miss out. Hello, everyone. Damian here with a look at a pivotal FDA approval, good news for a small biotech company, and why not all buyouts are worth writing home about.

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Ascension divesting 3 Michigan hospitals to MyMichigan Health

Fierce Healthcare

Ascension has a definitive agreement in place to offload three Northern Michigan hospitals and other facilities to MyMichigan Health. | The large Catholic nonprofit system's selloff, set to close in the summer, follows last year's deal to hand management of eight other Michigan hospitals to Henry Ford Health under a joint venture arrangement.