April, 2024

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Hospitals no longer required to report COVID-19 data to CDC

Fierce Healthcare

Hospitals are off the hook for data reporting requirements that have been in place since the early COVID-19 pandemic. | Hospitals were required to share COVID-19 admissions, ICU capacity and other related data on a daily basis during the height of the COVID-19 pandemic, then the reporting frequency shifted. The CDC said it still encourages hospitals to report their data on a "voluntary" basis and will soon begin displaying those data online.

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Comparison Of Rebyota Versus Vowst: A Study Table To Help You Compare Fecal Microbiota Therapies

IDStewardship

In this article a comparison of Rebyota versus Vowst is provided, to help learners differentiate these two fecal microbiota therapies. Authored by: Natalie Boyer, Pharm.D. Candidate 2025 Mentored by: Christina G. O’Connor, Pharm.D., PharmD, BCPS, BCIDP, AAHIV-M Disclaimer : This text and table is intended for use as a study tool to assist people learning pharmacotherapy of recurrent Clostridioides difficile infections (rCDI).

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Myeloma Expert: Earlier Use of Bispecifics Can Improve Patient Outcomes

Drug Topics

As the potential grows to use emerging bispecifics in earlier lines of myeloma therapy, so does the potential to induce better patient outcomes, said Kirollos Hanna, PharmD.

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FDA Grants Breakthrough Device Designation to Assay Supporting Earlier Diagnosis of Alzheimer Disease

Pharmacy Times

If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.

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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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What we’re starting to learn about H5N1 in cows, and the risk to people

STAT

The H5N1 bird flu virus has been around for decades, and the damage it wreaks on chickens and other poultry is well documented. But the recent discovery that the virus has jumped into dairy cattle — whose udders seem to be where the virus either infects or migrates to — has dumbfounded scientists and agricultural authorities. Questions for which there are pretty clear answers when it comes to birds are suddenly unsettled science in cows.

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Cost of developing new drugs may be far lower than industry claims, trial reveals

The Guardian - Pharmaceutical Industry

Exclusive: MSF calls for transparency after its bill for a trial of TB treatment came to a fraction of the billions claimed by pharmaceutical companies Doctors have for the first time released details of their spending on a major clinical trial, demonstrating that the true cost of developing a medicine may be far less than the billions of dollars claimed by the pharmaceutical industry.

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Buyer Beware: Red Yeast Rice Supplements Linked to Deaths, Hospitalizations

Drug Topics

Japan’s health ministry has issued a warning to consumers regarding red yeast rice dietary supplements containing a red species of mold after 5 people died and more were hospitalized after consumption.

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Optical Sensor Shows Promise in Non-Invasive Continuous Glucose Monitoring

Pharmacy Times

Optical glucose sensing techniques have been reported, but they require complex optical instrumentations found in laboratories, so feasibility for patient use has been challenging.

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There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows

STAT

Scientists who know about the types of pathogens — E. coli and Salmonella among them — that can be transmitted in raw milk generally think drinking unpasteurized milk is a bad idea. But right now, they believe, the danger associated with raw milk may have gone to a whole new level. “If I were in charge, for the moment I would forbid the selling of raw milk,” said Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam,

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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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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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Epic plans to launch AI validation software for healthcare organizations to test, monitor models

Fierce Healthcare

As artificial intelligence rapidly advances in healthcare, the industry is grappling with how to evaluate AI models for accuracy and performance and monitor the technology for any downstream advers | The healthcare industry is grappling with how to evaluate AI models for accuracy and performance and monitor the technology for any downstream adverse outcomes.

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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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Virginia Governor Vetoes Bill for Lower Prescription Drug Costs

Drug Topics

Governor Glenn Youngkin vetoed bills HB570 and SB274 that would have allowed the state to establish its first Prescription Drug Affordability Board.

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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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Pharmacists Facilitate Harm Reduction for Patients With Anxiety Using Cannabis

Pharmacy Times

Data for generalized anxiety disorders and cannabis use is scarce, but pharmacists can help educate patients on potential benefits and risks of cannabis usage.

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Opinion: Medical students lose in the research arms race for residency slots

STAT

“Going to medical Spanish class really isn’t worth my time. I’d rather use the time to do research,” one of my classmates told me during the first week of my first year of medical school. Such a comment was my introduction to the publish-or-perish environment that is increasingly pervasive amongst medical students. Before then, I had known publish-or-perish as something for those seeking tenure at universities.

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Medicare Advantage rate cut remains as feds keep up pressure

Fierce Healthcare

Insurers will feel resentful Monday as the feds opted to not reverse its decision to decrease Medicare Advantage benchmark payments by 0.16%, the Centers for Medicare and Medicaid announced. | CMS is not deviating from its January proposal to modestly rein in Medicare Advantage. Benchmark payments will still decrease 0.16% but the feds expect it will still pay up to $600 billion in payments to plans in 2025.

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Spotlight on kidney disease: Driving change for patients

pharmaphorum

Explore the latest advancements and initiatives in kidney disease research, driving change for patients with kidney conditions. Learn more about the current research landscape and potential breakthroughs in treatment from Kidney Research UK.

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GAO Releases Report on States’ Regulation of PBMs

Drug Topics

Representatives from the US Government Accountability Office (GAO) interviewed regulators from 5 states on pharmacy benefit manager laws.

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Recreational Cannabis Legalization Associated with Decreases in Alcohol, E-Cigarette Use

Pharmacy Times

Retail sales were associated with lower e-cigarette use, although recreational legalization also increased the frequency of cannabis use among adolescents.

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Early tests of H5N1 prevalence in milk suggest U.S. bird flu outbreak in cows is widespread

STAT

Andrew Bowman, a veterinary epidemiologist at Ohio State University, had a hunch. He had been struck by the huge amounts of H5N1 virus he’d seen in milk from cows infected with the bird flu and thought that at least some virus was getting off of farms and going downstream — onto store shelves. He knew the Food and Drug Administration was working on its own national survey of the milk supply.

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Number of ongoing US drug shortages reaches new high, pharmacist group says

Fierce Pharma

As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. | The American Society of Health-System Pharmacists has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

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Google, Bayer team up to develop new AI products for radiologists

Fierce Healthcare

Healthcare company Bayer has tapped Google for its cloud and artificial intelligence capabilities to build new tech products to assist radiologists. | Bayer wants to pair its radiology, healthcare regulator and clinical data handling expertise with Google's tech muscle and ongoing work in generative AI to speed up innovation in media imaging.

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12 Questions with Dr Jay Shah

pharmaphorum

Get to know Dr Jay Shah, a prominent figure in the field of cardiovascular medicine, as he answers 12 intriguing questions about his role as Chief Medical Officer at Aktiia and his insights into the field.

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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis

Pharmacy Times

The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.

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With younger women getting breast cancer, national panel lowers mammogram screening age to 40

STAT

A national advisory panel significantly lowered the age recommendations for screening mammography on Tuesday, saying that all women should start breast cancer screening at age 40, rather than 50, and continue every other year until age 74. The previous recommendations from the panel, the United States Preventive Services Task Force, suggested that women make an individual choice on getting mammography from ages 40 to 49.

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FTC targets Novo's Ozempic, others in crackdown on 300-plus 'junk' patent listings in FDA database

Fierce Pharma

The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | The U.S. FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book. After an initial round of challenge launched in November against more than 100 patents, the FTC is back targeting another 300-plus patent listings by eight pharma firms.

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Massachusetts lawmakers tell FTC, DOJ to take hard stance on Optum-Steward deal

Fierce Healthcare

All 11 of Massachusetts’ federal legislators are calling on regulators to keep a short leash on UnitedHealth Group’s proposed acquisition of Steward Health Care’s physician group, even if that mean | The financial jeopardy of Steward's remaining hospitals can't override the long-term cost and quality harms that would likely follow UnitedHealth Group's acquisition of yet another large physician practice, wrote all 11 of the state's federal legislators in a recent letter to reg

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Embracing new delivery models in the UK

pharmaphorum

Learn about the exciting developments in healthcare delivery in the UK, including the IDX2 trial, NHS initiatives, NIHR research, and the Digital Delivery Team. Explore how these new delivery models are revolutionising healthcare.

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FDA Approves Pfizer’s Gene Therapy for Adults with Hemophilia B

BioPharm

Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.

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Study Finds Relationship Between Uncontrolled Severe Asthma, Exacerbations and Health Care Resource Use

Pharmacy Times

The findings emphasize a need for guideline-based care delivery for patients with severe asthma, particularly for patients who are facing social disparities within health care.

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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