Wed.May 10, 2023

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Insulin: Key Facts on Access & Affordability

PhRMA

Today, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) will examine the cost of insulin and how to make this lifesaving medicine more affordable for patients. The nation’s largest pharmacy benefit managers (PBMs) are expected to testify. These are the middlemen that insurance companies use to determine what’s covered and what patients pay out of pocket at the pharmacy.

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Impact of the Specialty Pharmacy Care Model on Patient Outcomes

Pharmacy Times

The extra surveillance by a specialty pharmacy teams allows for faster initiation of therapy, earlier recognition of adverse effects, and promotes patient safety.

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Trending Sources

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“I don’t see this as an end to the pandemic”: Ashish Jha on the end of Covid public health emergency

STAT

On the eve of the expiration date for the federally declared coronavirus public health emergency , White House Covid-19 Response Coordinator Ashish Jha warned that the pandemic is far from over. “I don’t see this as an end to the pandemic or fighting Covid,” Jha said at a STAT event in Boston on Wednesday. “I see this as a transition out of this emergency phase into a very different phase.

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Overcoming Workplace Challenges, Providing Personalized Health Care With Generative AI

Pharmacy Times

Commonly, essential yet routine and time-consuming tasks, such as answering phone calls, scheduling appointments, or other administrative work, prevent health care workers from focusing on more value-added and enjoyable job functions.

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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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Why Is There Such A Large Disparity In Who Meets Critera For Hepatitis B Treatment?

Drug Topics

Findings reported in JAMA Network Open don’t find racial disparities among those who meet the treatment criteria. But Black individuals were less likely than Asian or White individuals to be among those meet the criteria.

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FDA Panel Votes Unanimously in Favor of First OTC Birth Control Medication

Pharmacy Times

An FDA committee voted 17-0 to make the once-daily birth control medication Opill available OTC after deciding the benefits outweigh any potential harms.

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Understanding the Impact Nitrosamine Impurities Can Have in the Work of Pharmacy Professionals

Pharmacy Times

Naiffer Romero, MSc, MPH, discusses his work at U.S. Pharmacopeia to regulate nitrosamine impurities and ensure medication quality.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. A jury in the Delaware District Court gave a favourable verdict to the Foster City, California-headquartered company, concluding that Gilead did not infringe any of the US government’s patents.

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Human ‘pangenome’ published, with goal of making genomics more useful for diverse populations

STAT

An international team of scientists has assembled the first human “pangenome” — an attempt to make a more representative reference genome, one that captures almost all the genetic variability residing in the DNA of humans around the globe. The technological achievement, published Wednesday in Nature , is the result of years of work by more than 100 researchers behind The Human Pangenome Project , a $30 million effort launched in 2019 and funded by the U.S.

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Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients. SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli)

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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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Opinion: The tragedy of the Golden Gate Bridge’s $400 million anti-suicide net

STAT

Each year about 30 people make the gut-wrenching decision to leap off the Golden Gate bridge to their deaths. To address this tragedy, a Suicide Deterrent Net is being constructed — a planned $142 million project that, after years of delays, may end up costing more than $400 million, according to contractors embroiled in a lawsuit. The stainless steel barrier will undoubtedly catch people before they hit the frigid San Francisco Bay.

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Roflumilast Foam 0.3% Evaluated for Seborrheic Dermatitis in Adults

Drug Topics

Roflumilast foam can help address the unmet need for an effective, cosmetically tolerable treatment for seborrheic dermatitis.

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STAT+: In small study, weight loss drug boosts immune cells that help fight cancer

STAT

Drugs like Ozempic and Wegovy have become immensely popular for their ability to help people with obesity lose weight. A new small study suggests they may also be useful in fighting cancer. Prior research has shown that people with obesity have deficiencies in their “natural killer” cells, or NK cells — immune cells that help in combating cancer.

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PBM, pharma play blame game over drug pricing at hearing

Fierce Healthcare

PBM, pharma play blame game over drug pricing at hearing pminemyer Wed, 05/10/2023 - 16:10

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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 reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show

STAT

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday. The FDA documents, released ahead of an advisory committee hearing Friday, found that Sarepta’s clinical studies “conducted to date do not provide unambiguous evidence” that the therapy, known as SRP-9001, is “li

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Algorithm used to cut ER overutilization for kids penalizes Black, Hispanic patients: study

Fierce Healthcare

Algorithm used to cut ER overutilization for kids penalizes Black, Hispanic patients: study fdiamond Wed, 05/10/2023 - 13:18

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STAT+: Insulin makers, PBMs echo old finger-pointing in Senate hearing

STAT

A Senate hearing on high insulin costs billed as a blockbuster showdown with drugmakers and middlemen turned out to be a familiar case of political theater that appeared to satisfy no one. The nation’s three biggest insulin makers, Eli Lilly, Novo Nordisk, and Sanofi, and the trio of middlemen known as pharmacy benefit managers, Express Scripts, OptumRx and CVS Health, testified Wednesday in a three-hour hearing before the Senate Health, Education, Labor, and Pensions Committee.

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5 signs your antidepressant dose is too high

The Checkup by Singlecare

Antidepressants are medications commonly used to relieve symptoms of depression or anxiety. They are only available with a prescription, so a patient’s healthcare provider decides the dosage. Still, sometimes finding the right dose takes time. Everyone’s body chemistry is unique, and many antidepressants can take weeks or months to reach full effectiveness.

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Opinion: Three misconceptions about the accelerated drug approval pathway

STAT

On Friday, the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee will meet to discuss the Biologics License Application for Sarepta Therapeutics’ gene therapy delandistrogene moxeparvovec for the treatment of Duchenne muscular dystrophy. The late decision by the FDA to reverse course and hold an advisory committee to get expert input into the drug’s review occurred after concerns were apparently raised that the FDA was leaning toward rejec

FDA 101
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Standing out using social media

Drug Store News

A strategic social media campaign can be a conduit for building a customer base for a brand at a fraction of the investment associated with a more traditional marketing approach.

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Black patients far less likely to receive key opioid addiction medication, study finds

STAT

Black people are far less likely than other Americans to receive buprenorphine , a key medication for treating opioid use disorder, according to a new study. White patients in need of addiction care were prescribed buprenorphine at more than twice the rate of Black patients in the six months preceding an addiction-related health emergency, according to the analysis.

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Optimized for Growth? Revenue Management in Pharma

PharmExec

According to the latest State of Revenue survey of c-suite executives, pharma manufacturers are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

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STAT+: Skin patch for toddlers with peanut allergy shows promising results in late-stage trial

STAT

Parents of kids who have peanut allergies have to practice constant vigilance, whether that means carefully skimming the ingredients on food packaging or warning teachers about the dangers of unexpected treats at school. A new study in the New England Journal of Medicine presents a simple treatment option for peanut allergies in kids from 1 to 3 years of age: a skin patch.

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Eli Lilly damages tripled to $184M in Medicaid rebate fraud case

Fierce Pharma

Eli Lilly damages tripled to $184M in Medicaid rebate fraud case fkansteiner Wed, 05/10/2023 - 10:25

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STAT+: Brigham creates institute focused on immunology with record $100 million gift

STAT

Brigham and Women’s Hospital will launch a new institute focused on immunology and inflammation, thanks to a $100 million gift, the largest in the hospital’s history. The donation, from Gene Lay, founder and CEO of San Diego-based company BioLegend, will establish the Gene Lay Institute of Immunology and Inflammation. The institute will be led by Brigham immunologist and principal investigator Vijay Kuchroo, who will lead teams dedicated to studying chronic inflammation and discove

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Tralokinumab Efficacy, Tolerability in Adolescents With AD Evaluated

Drug Topics

There are only a few long-term treatments currently available for adolescents with moderate to severe AD.

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STAT+: Pharmalittle: Gilead wins lawsuit against HHS over HIV pill patents; most Americans say abortion pill should remain on the market

STAT

Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. And while you indulge, you can peruse some of the tidbits we have assembled to help you start the day.

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Envision Healthcare likely to file for Chapter 11 bankruptcy: WSJ

Fierce Healthcare

Envision Healthcare likely to file for Chapter 11 bankruptcy: WSJ pminemyer Wed, 05/10/2023 - 12:54

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Ask STAT: What do you want to know about ChatGPT in medicine?

STAT

From medical note-taking to analyzing X-rays and mammograms , new artificial intelligence tools are swiftly gaining traction in the world of science and medicine. STAT is reporting on the use of generative AI — content-creating technology that includes models like ChatGPT and its rivals  — in health care and scientific research. We want to hear your questions about how the technology works, its potential in science and medicine, and the risks that it carries.

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Nurses Know that Home Remedies Knock Out Nasty Nail Fungus

The People's Pharmacy

Many people are reluctant to visit a dermatologist or podiatrist because of nail fungus. There is the embarrassment factor. Nail fungus looks kind of gross. Nasty nail fungus infections just don’t seem like that big a deal, but the longer they persist, the worse they get. When a condition is not worrisome, we are OK with home remedies. To be on the safe side, people with diabetes and those with psoriasis should have their discolored or deformed nails checked by a doctor.

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Opinion: Listen: The coercion built into medical privacy consent forms

STAT

Alex Rosenblat is particularly careful when it comes to her digital privacy. She requests to fill out paper forms instead of digital ones; she documents and tracks what she signs. But even her diligence can’t always save her. Rosenblat recently spent months retracing her digital steps after Phreesia, a company that collects demographic information, claimed to have her authorization to share her data — authorization she knew she hadn’t consented to.

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Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

Fierce Pharma

Sandoz taps Evotec in long-term biosimilar development and manufacturing deal fkansteiner Wed, 05/10/2023 - 08:39

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Sandoz to boost biosimilar development with manufacturing expansion

European Pharmaceutical Review

Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The company intends to grow its Biopharma Technical Development (BioTD) capabilities and transform the lab building into a state-of-the-art biotech lab by the last quarter of 2023. The financing is intended to bring together these highly advanced laboratories and analytical expertise at one site.

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A New Era for Market Access: Organizing the Function’s Broader Strategic Role

PharmExec

BCG’s 2022 benchmark study uncovers new competencies needed for pharma access leaders in enterprise-wide business strategy, where thoughtfully designed approaches and goals focused on shared priority and responsibility are increasingly important.

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