Thu.Feb 23, 2023

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Holding pharmacy benefit managers accountable

PhRMA

State legislative sessions across the country are in full swing, and many state officials have made lowering the cost of medicine for patients a top priority. If policymakers are serious about addressing high out-of-pocket costs for patients, they should start by taking steps to finally hold pharmacy benefit managers (PBMs) accountable.

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Most Consumer Health Care Decisions Being Affected by Inflation

Drug Topics

As inflation rises, consumers are beginning to lose confidence in their ability to cover health care expenses.

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PhRMA submits comments to USPTO highlighting important role of patent system in medicine development

PhRMA

PhRMA responded to the U.S. Patent and Trademark Office’s (USPTO) request for comments regarding USPTO initiatives to ensure the robustness and reliability of patent rights.

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Interactive Risk Ratio Simulation Abates Vaccine Hesitancy

Drug Topics

Vaccine-hesitant adults were more likely to show positive change in opinion after being presented with an interactive risk ratio simulation according to a new study.

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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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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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Exposure to Air Pollution Connected to Bone Damage Among Postmenopausal Women

Drug Topics

A strong association between air pollution exposure and bone mineral loss in postmenopausal women was identified by investigators.

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More Trending

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Mother-to-Child Transmission of Hepatitis B Eliminated in England

Drug Topics

England met the new target of the World Health Organization by eliminating the transmission of hepatitis B from mother to child.

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Google, Microsoft execs share how racial bias can hinder expansion of health AI

Fierce Healthcare

Google, Microsoft execs share how racial bias can hinder expansion of health AI rking Thu, 02/23/2023 - 12:36

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STAT+: More physicians are calling for fallopian tube removal to prevent ovarian cancer

STAT

Ovarian cancer has long been one of the deadliest cancers to strike women. No tests are available to detect it early, so most patients are diagnosed in later stages, when the cancer is more likely to have spread. Fewer than half of women survive 5 years past their diagnosis, and 80 percent have no known risk factors. Now, a growing chorus of physicians is recommending a procedure that can significantly reduce the chances of developing ovarian cancer.

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FDA approves Syfovre for geographic atrophy in advanced age-related macular degeneration

Hospital Pharmacy Europe

Syfovre (pegcetacoplan) has become the first approved treatment for geographic atrophy secondary to age-related macular degeneration In a press release from the manufacturer Apellis Pharmaceuticals, syfovre (pegcetacoplan), is the first FDA approved therapy for geographic atrophy secondary to age-related macular degeneration which is a leading cause of blindness.

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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: ‘They don’t need your permission.’ When childbirth feels like rape

STAT

The shouting began soon after my son was born. “We’ve got an inversion!” the doctor yelled to his team. Moments earlier, a nurse had pressed my newborn son against my chest. I bent to kiss his dark curls through my surgical mask, then he and my husband were escorted out of the operating room.

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Significant 5-year overall survival following neoadjuvant nivolumab in lung cancer

Hospital Pharmacy Europe

A significant 5-year overall survival rate has been found following neoadjuvant nivolumab therapy in resectable non-small cell lung cancer According to a global 2018 study, lung cancer was the most commonly diagnosed cancer (11.6% of all cases) as well as the leading cause of cancer deaths. The most common form of lung cancer is non-small cell lung cancer (NSCLC), accounting for around 80 to 85% of all cancers.

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STAT+: With so little regulation, it’s easy to buy chemically altered ‘weed’ like THC-O and HHC, even where marijuana is illegal

STAT

TOPEKA, Kan. – When I inquired about cannabis products at a vape shop on the west side of Kansas’ capital city, the employee asked me one question: “Do you have pain, or are you trying to get f—- up?” There were plenty of options for the latter — especially for someone with a sweet tooth. For the chocoholic: “Trips Ahoy” cookies, THC “Snickers,” and “Cookies ‘n’ Cream” flavored chocolate bars.

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CVS Health investing $11M in affordable housing for Detroit

Drug Store News

The affordable project in Brush Park will feature 53 units, with many as low as 30% AMI or below.

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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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Opinion: The Supreme Court doesn’t belong in your medicine cabinet

STAT

The silence from corporate America amid new attacks on women’s reproductive health care has been deafening. As the federal courts consider whether to override the FDA’s judgment on first-trimester abortion pills, it’s time for health care leaders to speak out about the repercussions of taking away medical sovereignty from 40 million women.

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AAM’s Biosimilars Council responds to adalimumab biosimilars report

Drug Store News

The new report from Matrix Global Advisors illustrates the complexities of the burgeoning adalimumab biosimilar market, the Biosimilars Council said.

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American Cancer Society warns about potential impact of missed screenings during Covid

STAT

When the Covid-19 pandemic brought ordinary life to a halt in 2020, routine cancer screenings fell off many people’s list of priorities. Screenings for cervical, breast, and prostate cancer all dropped in the first year of the Covid-19 pandemic, according to a new analysis from the American Cancer Society. Over the course of 2021, screening levels recovered — but the report’s authors say there’s still reason to be concerned about the impact of missed cancer screenings

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Dollar General releases preliminary Q4, fiscal year 2022 results

Drug Store News

Despite continued market share gains in sales of both consumable and non-consumable products, same-store sales for the fourth quarter increased by 5.7%.

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STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

STAT

Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance. In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support (CDS) tools as devices — which regulators say has always been their plan and within their purview.

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Simplified HIV treatment options effective in major trial

European Pharmaceutical Review

Two newer simplified treatment options are at least as effective as standard of care in achieving viral suppression, according to results from a world-first international study into second-line human immunodeficiency virus (HIV) therapy. “This finding of non-inferiority has significant implications for the management of HIV globally,” commented Professor Matthew Law from the Kirby Institute.

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AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

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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DaVita's kidney care charity connections trigger another investigation

Fierce Healthcare

DaVita's kidney care charity connections trigger another investigation dmuoio Thu, 02/23/2023 - 16:23

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STAT+: DaVita faces another probe over ties to kidney care charity

STAT

The Office of the Attorney General for the District of Columbia is investigating DaVita, one of the largest dialysis providers in the country, and its ties to the nonprofit American Kidney Fund. DaVita disclosed the new “civil investigative demand” in its latest annual financial filing to investors. The D.C. attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insure

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UPC opt-out – a strategic balancing act for pharma

European Pharmaceutical Review

The UPC will have exclusive jurisdiction for disputes concerning new unitary patents (UPs). After the end of the seven-year transitional period, 1 this will include classic European patents (EPs) and supplementary protection certificates based on the EP that have not been opted out. 2 During the transitional period – which may be extended to 14 years – there will be shared jurisdiction between national courts and the UPC for litigation of classic EPs, unless an opt‑out is filed, in which case on

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STAT+: Canadian drug price board member resigns over government failure ‘to support real change’

STAT

A member of a Canadian agency that has been working to rein in prices for prescription medicines has resigned and accused the government of failing to follow through on its commitment while acquiescing to pharmaceutical industry objections. In a blistering letter , Matthew Herder stepped down from the Patented Medicine Prices Review Board in response to ongoing delays in implementing new regulations designed to update a decades-old framework for challenging prices set by drug companies.

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BJ’s Wholesale Club opens 6th location in Georgia

Drug Store News

The new store in McDonough marks the retailer’s 6th location in the state of Georgia and brings the retailer's number of clubs to 237.

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STAT+: Its founder hopes to reverse aging, but first Tally Health wants to test how fast your biological clock ticks

STAT

To be a student in David Sinclair’s Harvard University lab is to be a time traveler. The genetics professor has dedicated his career to understanding the processes that define getting older, and more recently, how to use that understanding to turn back a cell’s inner clock. Last month, a team of biologists led by Sinclair’s lab published a new model to explain how aging works — and might be reversed — based on the results of their 13-year study of mice.

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Humana to shed employer group commercial business

Fierce Healthcare

Humana to shed employer group commercial business pminemyer Thu, 02/23/2023 - 11:23

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Ph. Eur. rabbit pyrogen test replacement texts ready for public consultation

European Pharmaceutical Review

The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (One new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1. Replacing the rabbit pyrogen test The texts covering topics such as vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers, have now been revised to replace the RPT with an in vitro alternative, the monocyte activation tes

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CMS says it needs to see more data before rethinking Alzheimer's drug coverage

Fierce Healthcare

CMS says it needs to see more data before rethinking Alzheimer's drug coverage pminemyer Thu, 02/23/2023 - 15:17

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Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio

Fierce Pharma

Sanofi, poised to rival Roche in hemophilia, nabs FDA approval for Altuviiio zbecker Thu, 02/23/2023 - 15:45

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Artificial Intelligence innovation: Leading companies in in-silico drug discovery

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Artificial Intelligence in Pharmaceuticals: In-silico

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Listen: Vertex vs. insurers, Moderna’s future, & biotech’s long winter

STAT

What makes a drug quintuple in cost? How do you follow inventing a Covid-19 vaccine? And what did we learn from biotech’s unicorn era? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT’s Ed Silverman joins us to explain how an escalating fight between Vertex Pharmaceuticals and insurance companies has left patients and families caught in the middle.

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VisualDx's diagnostic support tool to be available to all AMWA members

Fierce Healthcare

VisualDx's diagnostic support tool to be available to all AMWA members agliadkovskaya Thu, 02/23/2023 - 16:25

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