Sat.Feb 18, 2023 - Fri.Feb 24, 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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Patients With Diabetes Taking Pioglitazone Less Likely to Develop Dementia

Drug Topics

Not only were people with newly diagnosed type 2 diabetes less likely to develop dementia if they took pioglitazone, but the benefit was stronger among patients with a history of ischemic heart disease or stroke.

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Medicare for all … of East Palestine?

STAT

WASHINGTON — Nearly three weeks after a train derailed in East Palestine, Ohio, spewing toxic chemicals into the air, water and soil, Biden officials are racing to find answers on how the disaster happened. But it’s also unclear what happens next for thousands of Ohioans who could now be sick — and who covers their care. Ohio lawmakers from both parties have already demanded that Biden health officials step up their response and ensure health care through an obscure provisio

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First successful CAR-T treatment for muscle inflammation

European Pharmaceutical Review

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

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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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What they are saying: Nonprofit hospitals are gaming the system at the expense of patients

PhRMA

There have been some alarming stories uncovered by the media on ways nonprofit hospitals — many of which participate in the 340B drug pricing program — are taking advantage of the system and their tax-exempt status to boost their bottom lines, at the expense of patients.

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Recommendations Differ Between WHO and CDC for HPV Vaccine Schedules

Drug Topics

The World Health Organization (WHO) and the CDC recommend different doses when it comes to vaccine protection against the human papillomavirus (HPV).

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More Trending

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

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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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Amoxicillin Shortage Impacting Nearly 75% of Pharmacists Nationwide

Drug Topics

Pharmacists generally agree that domestic production of the commonly used antibiotic could prevent more shortages from happening in the future

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Opinion: Fixing U.S. public health will require a health-systems revolution — and for physicians to take a backseat

STAT

A classic warning in public health goes like this: “A society that spends so much on health care that it cannot or will not spend adequately on other health enhancing activities may actually be reducing the health of its population.” No nation is as guilty of this practice as the United States, with its extremely high health expenditures alongside abysmal population-level health outcomes.

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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Stopping pharmacy benefit managers from “gaming the system”

PhRMA

People around the country say they are paying too much for their prescription medicines. State policymakers could help address this problem now. Doing so starts with stopping pharmacy benefit managers (PBMs) from taking advantage of the health system and patients.

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Kindergarten Vaccination Rates Falling, Creates Opportunity to Offer Catch-Up Vaccine Schedules

Drug Topics

With nearly 250,000 kindergarten age children not receiving their recommended vaccines, pediatric health care providers search for solutions.

Vaccines 187
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Opinion: Needed: a new framework to make sure health companies play fair with patient data

STAT

As a health policy wonk and health economist who has worked in pharmaceutical companies in the United States, Latin America, and Europe, I’ve seen vast volumes of data generated, gathered, aggregated, analyzed, shared, and resold by health care companies and organizations. In my studies with the world’s top medical statistics experts at the University of Oxford’s Centre for Evidence Based Medicine, I’ve also seen how flawed many datasets are, missing critical data pie

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Show 1332: What Everyone Gets Wrong About Weight Loss

The People's Pharmacy

In this week’s episode, find out what everyone gets wrong about weight loss. Why don’t diet and exercise work very well? Do official guidelines and weight loss drugs offer a clearer path to success? Health Consequences of Excess Weight: With nearly three-fourths of American adults either overweight or obese, we can’t ignore the problem any longer. For decades, people have acted as though packing on extra pounds was simply a matter of poor willpower. “Eat less and exercise more” is th

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The one-shot cervical cancer vaccine paradigm

Pharmaceutical Technology

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. The WHO now says that a one-dose schedule for girls ages 9–14 years adequately protects against human papillomavirus (HPV), and more specifically, the HPV 16 and HPV 18 strains. The insights and amendments came following findings from a meeting held by WHO’s independent expert advisory group in April 2022.

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Increase Seen in Eczema, Prevalence Varies by Race and Ethnicity

Drug Topics

Previous surveys suggested care disparities. Investigators compared these outcomes because of a lack of research in this space.

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Amid fentanyl crisis, first-of-its-kind study to evaluate expanded methadone access

STAT

Ever since fentanyl entered the U.S. drug supply, many Americans seeking treatment for opioid addiction have found that only a single medication is effective at easing cravings and withdrawal: methadone. But even though the drug is widely considered to be safe and effective, there’s not much data about how methadone stacks up against its main alternative, buprenorphine.

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Major coalition of health groups aims to combat health misinformation

Fierce Healthcare

Major coalition of health groups aims to combat health misinformation rking Fri, 02/24/2023 - 11:17

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Biohacking is a response to societal problems, but is not the answer

Pharmaceutical Technology

Biohacking is a do-it-yourself biology movement that aims to improve the hacker’s health, appearance, performance, and overall well-being. It covers a broad range of techniques from the less invasive practice of intermittent fasting to drastic and invasive procedures, such as the implanting of microchips or injecting of gene-editing enzymes. As a broader concept, biohacking encourages experimental biotechnology outside the confines of traditional research environments.

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Does a Prior COVID-19 Infection Protect Patients from Reinfection?

Drug Topics

Researchers estimate the protection from COVID-19 reinfection based on the variant and time since a patient's previous infection.

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Tools to predict stroke risk work less well for Black patients, study finds

STAT

Stroke risk prediction tools are meant to guide how doctors approach a potentially deadly condition, using factors like heart disease and high blood pressure to get a handle on which patients might benefit from a particular treatment. For years, doctors have used several different algorithms to try to capture the true risk of stroke, including newer models that use machine learning.

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He Slimed Me: FTC Hits GoodRx Over Unauthorized Use of Consumer Data

The FDA Law Blog

By Jeffrey N. Wasserstein — GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal Trade Commission (FTC) and its partners at DOJ’s Consumer Protection Branch recently file a civil complaint against GoodRx for data privacy breaches.

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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

Vaccines 111
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Moderna Plans to Offer Free COVID-19 Vaccine to Uninsured Patients

Drug Topics

More traditional health care coverage will begin when the U.S. public health emergency response to COVID-19 ends on May 11.

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STAT+: Moderna expands CRISPR gene editing research with ElevateBio partnership

STAT

Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham.

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Costly discharge delays highlight need for more downstream care options, New York group's analysis shows

Fierce Healthcare

Costly discharge delays highlight need for more downstream care options, New York group's analysis shows dmuoio Wed, 02/22/2023 - 12:48

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Patent wars: what’s behind Amgen’s possible win over Sanofi at the US Supreme Court

Pharmaceutical Technology

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. While some courts were previously on Sanofi’s side, it is possible that Amgen’s case could win this time, some legal experts say. However, Sanofi’s side also has significant support, highlighting the dispute’s contentious nature.

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Young Children Benefit from 3 Doses of Pfizer-BioNTech COVID-19 Vaccine

Drug Topics

The vaccine was 73.2% effective in children aged 6 months to 4 years when administered during the Omicron-dominant phase.

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STAT+: Little transparency, lots of waste: NIH funds pediatric research, but many trials results go unpublished

STAT

The National Institutes of Health provided $362 million in grants for clinical trials that enrolled at least 41,000 children over a recent three-year period — but many results were never published, a new analysis found. The results are a worrisome sign of a lack of transparency that can lead to wasted research funding. Specifically, just under two-thirds of the 354 trials studied were registered in advance with ClinicalTrials.gov , the federal database, and just 13% of finished trials wer

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Hospital lobby urges FTC to withdraw or add healthcare exceptions to sweeping noncompete ban

Fierce Healthcare

Hospital lobby urges FTC to withdraw or add healthcare exceptions to sweeping noncompete ban dmuoio Wed, 02/22/2023 - 15:55

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Scotch Porter enters body care space

Drug Store News

New from the brand is the Hydrating Body Wash and Intense Anti-Dry Body Lotion, which will be available in two scents inspired by the brand’s fine fragrance collection.

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Organizations, Pharmacists Urge Flu Vaccine for Patients With Diabetes

Drug Topics

Leading health organizations are urging those with diabetes and other chronic conditions to get the influenza vaccine.

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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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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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Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

Advances with microbiological methods are providing more accurate and sensitive datasets at a faster rate, relating to bacterial identity, numbers, responses to environments and so on. Recent years have seen progress with applying a long-established spectrophotometric phenomenon – Raman spectra – to advance our understanding of bacterial populations, including differentiating between living and dead cells and interpreting phenotypic variations to different environmental stressors.

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