Thu.Jan 26, 2023

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New Report: More than 160 medicines in development for mental illness

PhRMA

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together.

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For the First Time Medicaid Net Drug Spending Hits Double-Digits

Drug Topics

Spending on specialty drugs fueled a 11% increase in Medicaid drug spending from 2020 to 2021, says Magellan's seventh annual Medicaid Pharmacy Trend Report.

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A new dawn of the genomic age: five areas set to be transformed in 2023

pharmaphorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

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Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines

STAT

Fasten your seat belts, folks. We’re about to hit some turbulence. If you’re reading this, you’re interested in the discussion on the future of Covid-19 vaccination that’s going to take place today in a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. We at STAT can’t predict the outcome, but we know enough to expect that this meeting will feature some heated debate.

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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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The Case for Best-in-Class Purchasing Automation and Five Ways to Achieve It

Drug Topics

“Purchasing automation” may sound like just using electronic systems to buy products. But best-in-class purchasing automation is critical to your pharmacy’s success. Our white paper shows you how harnessing advanced technology to enhance your process and optimize purchasing services can give you an integrated, accurate, and efficient solution for all aspects of your purchasing.

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First CAR T-cell therapy recommended on NHS

European Pharmaceutical Review

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

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After nearly 4 years of deliberation, FDA punts on how to regulate CBD

STAT

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons

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ABPI code updated with first social media guidance

pharmaphorum

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical In

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Opinion: A dangerous loophole for drug ads needs to be closed

STAT

A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.

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Dark & Lovely appoints actress Meagan Good as brand ambassador

Drug Store News

Actress Meagan Good will serve as the face of the Fade Resist collection and full product range, as well as spread awareness about the company’s Building Beautiful Futures initiative.

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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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Watch: How do the new obesity drugs work?

STAT

Drugs like Wegovy and Ozempic are rapidly growing in popularity as weight-loss treatments. These medications contain semaglutide, a drug originally formulated to help people with diabetes control their blood sugar but also has shown to have a significant effect on appetite and is now also used for obesity. This video explains exactly how these drugs work in the body.

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Health Canada accepts Veru’s Covid-19 therapy NDS-CV for review

Pharmaceutical Technology

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.

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STAT+: The unexpected alliance lobbying for Medicare to pay for new obesity drugs

STAT

WASHINGTON — It’s not every day that the pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to achieve the same policy goal. But an effort to expand Medicare coverage for obesity drugs has managed to unite them all, and many more groups across the health care industry, too.

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Critical Balance of Profit and Cash Flow for Pharmacy Owners

DiversifyRx

Your pharmacy needs a balance of both cash flow and profits to thrive. Winter Is Coming This is even more critical now with the upcoming changes to DIR fees in 2024. These changes will strangulate cash flow for pharmacies for the first several months of 2024. I have been calling this the 2024 DIR Fee Apocalypse. No, I don’t think I am fearmongering.

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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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FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy

STAT

The evolution of the coronavirus has knocked out another treatment. The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.

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Reforms needed to make voluminous insurer price data usable: report

Fierce Healthcare

Reforms needed to make voluminous insurer price data usable: report rking Thu, 01/26/2023 - 14:54

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STAT+: ChatGPT in health care: 5 burning questions about the buzzy new tool

STAT

If the buzz is to be believed, ChatGPT seems poised to upend everything from high school essays and news articles to computer coding and scientific research. The program has generated huge interest for its ability to write nearly anything it’s asked to write and to answer questions. Microsoft has announced a “multiyear, multibillion dollar” investment — rumored to be as high as $10 billion   — into its maker, the artificial intelligence company OpenAI.

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Roche, Boehringer tap biosensor firms for patient studies

pharmaphorum

Roche and Boehringer Ingelheim have both formed partnerships with tech companies this week to develop and deploy wearable biosensor technology for use in clinical trials and patient monitoring. Roche’s alliance with France’s Sysnav Healthcare is in the area of movement disorders, and will build on the tech company’s wearable magneto-inertial sensor device for 3D movement tracking, which has already been accepted as a digital endpoint for use in Duchenne muscular dystrophy (DMD)

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STAT+: Warren urges the FTC to scrutinize two pharma mergers over “anti-competitive” practices

STAT

In her latest bid to address prescription drug prices, U.S. Sen. Elizabeth Warren (D-Mass.) is urging the U.S. Federal Trade Commission to “closely scrutinize” two pending pharmaceutical company mergers over concerns that “rampant consolidation” will drive up costs for consumers. One deal involves Amgen, which plans to pay $28.7 billion to acquire Horizon Therapeutics, a company that markets treatments for autoimmune disorders and recently generated takeover interest

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ebook: Extractables and leachables: a guide to analytical methods

European Pharmaceutical Review

Typical extractables and leachables (E/L) studies aim to identify, quantify and ultimately minimise any impurities that can migrate from packaging into a final product or drug. Gas or liquid chromatography-mass spectrometry (LC/MS) or (GC/MS) have been widely used in extractables studies however, there are several challenges associated with E&L analyses including: Detection and quantification of unknowns Sensitivity and detection at trace levels Reducing uncertainty factors Increasing s

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Opinion: Physicians need — and should take — paternity leave

STAT

When my daughter was born, I was just a year out of fellowship training, working hard within my hospital’s medical hierarchy. Fearful of burdening my colleagues with extra work, I did not use the Family and Medical Leave Act (FMLA), a national law requiring employers to provide job-protected, unpaid leave for personal reasons. Instead, I took three weeks of unpaid vacation time masquerading as my paternity leave.

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Private equity owns at least 130 rural hospitals, and other revelations in a sweeping new report on PE in rural healthcare

Fierce Healthcare

Private equity owns at least 130 rural hospitals, and other revelations in a sweeping new report on PE in rural healthcare agliadkovskaya Thu, 01/26/2023 - 09:45

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STAT+: Pharmalittle: Strange bedfellows lobby for Medicare coverage of obesity drugs; FDA working with WHO to probe cough syrups

STAT

Hello, everyone, and how are you this morning? We are doing just fine, thank you, as we muddle along, trying to organize our to-do list and set our priorities. There is an intensity to such mundane tasks, though, that calls for a cup of stimulation. So as we fire up the coffee kettle today, we are reaching for Vermont maple walnut. As always, you are invited to join us.

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CMS approves waiver to enable California to offer Medicaid coverage to incarcerated individuals

Fierce Healthcare

CMS approves waiver to enable California to offer Medicaid coverage to incarcerated individuals rking Thu, 01/26/2023 - 16:16

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HHS’ Becerra on enrolling in Medicare, annual Covid vaccines, and seniors’ mental health

STAT

WASHINGTON — The hottest birthday spot in town: A Hispanic senior center in northwest D.C. That’s where Health and Human Services Secretary Xavier Becerra heralded his 65th birthday Thursday morning, with songs sung by the center’s choir, speeches about Covid-19 vaccines, and a giant replica of a Medicare card to signify his new eligibility for the federal program he oversees.

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Sam’s Club outlines store expansion plans

Drug Store News

Sam’s Club is planning to open more than 30 new clubs across the United States over the next several years, with the first new location slated for 2024.

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ChatGPT in health care, pharma’s latest digital health deal, and long-awaited diabetes tech

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Sam’s Club outlines store expansion plans

Drug Store News

Sam’s Club is planning to open over 30 new clubs across the United States over the next several years, with the first new club slated to open in 2024.

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Listen: George Scangos’ retirement, annual Covid vaccines, an Alzheimer’s drug rejection

STAT

Who needs an annual Covid jab? Why did the FDA reject an Alzheimer’s treatment? And what’s in store for one of biotech’s most highly respected executives now that he’s stepping back from his CEO role? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. George Scangos, the CEO of Vir Biotechnology, joins us to discuss his retirement and offer some perspective and lessons from a remarkable, 40-year career in biotech.

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Children See Higher Rates of Early Influenza Than Adults

Drug Topics

In a report from the Centers for Disease Control and Prevention, it was shown that symptoms and hospitalizations associated with influenza this season are higher among children than adults.

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Urovant Sciences, Holly Robinson Peete raise awareness for overactive bladders

Drug Store News

Urovant Sciences and Holly Robinson Peete are bringing awareness to overactive bladder symptoms and management options as part of a new campaign.

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.

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US moves to simplify Covid vaccines into yearly dose to target variants

The Guardian - Pharmaceutical Industry

The FDA asked its scientific advisers on Thursday to help chalk out plan to move to a flu shot-like schedule for coronavirus The US is poised to make Covid-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus. The Food and Drug Administration asked its scientific advisers on Thursday to help lay the groundwork for switching to once-a-year boosters for most Americans – and how and w

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How Amazon's latest pharmacy move lays the groundwork for longer-term play

Fierce Healthcare

How Amazon's latest pharmacy move lays the groundwork for longer-term play hlandi Thu, 01/26/2023 - 06:16

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