Wed.Aug 16, 2023

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Chikungunya Vaccine for Adolescents Shows Positive Topline Results in Phase 3 Trial

Drug Topics

PXVX0317 has received Fast Track and Breakthrough Therapy designation from the FDA.

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Study Indicates Take-at-Home, Oral Ketamine is an Effective Option for Treatment-Resistant Depression

Pharmacy Times

The daily oral formulation of ketamine, KET01, has the potential to greatly improve the standard treatment practices for treatment-resistant depression, according to investigators.

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MorningRX: August 16, 2023

Drug Topics

National organizations call for Improvements to youth mental health care, Wednesday marks 1 year since passing of Inflation Reduction Act, and a new study finds link between fracking and lymphoma.

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Potential Associations Found Between Microbiome, Early Cognitive Development in Infants

Pharmacy Times

Key study finding shows associations between the beat frequency in the rhythmic stimulus in the frontal left sites of infant brains and pathways related to brain modulation and nucleotide levels.

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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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Recess’ relaxation beverages hit retailer shelves

Drug Store News

The company announced that its products have recently launched into 5,000 new locations across several retailers, including Target, Albertsons, CVS, H-E-B, Sprouts and Winn-Dixie.

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From Science Fiction to Reality: How AI is Reshaping Pharmacy Workflow

Pharmacy Times

Pharmacies brace for a double wave of DIR fees while paddling against profit struggles. Enter Pharmacy AI: a transformative vehicle to navigate stormy waters, enhance efficiency, and prioritize patient care.

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FDA Approves Hepzato Kit for Liver-Directed Treatment of Metastatic Uveal Melanoma

Pharmacy Times

Melphalan/hepatic delivery system (Hepzato Kit; Delcath Systems Inc) is currently the only liver-directed therapy approved by the FDA for the treatment of netastatic uveal melanoma and percutaneous hepatic perfusion.

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Opinion: The CDC faces $1.5 billion in budget cuts. Layoffs will almost certainly follow

STAT

The nation’s health faces a dual threat — one anticipated, the other, self-inflicted. Covid-19 has not gone away; the Centers for Disease Control and Prevention reports that infections are showing signs of a late summer wave. The new strain, EG.5 , spreads easily and is more resistant to neutralizing antibodies but does not, to date, seem to be more virulent.

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NUDGE-FLU Trial Analysis

Pharmacy Times

Chad Worz, PharmD, BCGP, FASCP, and the panel review the NUDGE-FLU Trial and discuss the study design, outcomes, and how similar nudges can be incorporated into practice.

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Here are 22 health systems billing patients for certain EHR and text messages

Fierce Healthcare

Online messages have become a linchpin of many patients’ relationships with their doctors. | An influx of patient portal messages during recent years are taking a toll on clinicians. As a result, at least 22 systems across the country have added a price tag to the subset of missives demanding the most time and expertise.

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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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Case Study: Intravenous Immunoglobulin Can Treat Myelin Oligodendrocyte Glycoprotein Antibody-Associated Optic Neuritis in Pediatric Population

Pharmacy Times

Intravenous immunoglobulin was found to be the most effective immunotherapy in preventing relapses after treatment with steroids in pediatric patients.

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STAT+: With an age cutoff for a new gene therapy, families and doctors scramble to treat kids before their 6th birthday

STAT

In mid-July, Kristen Secrist hopped on a call with her 5-year-old son’s doctor, who had urgent news: The first gene therapy had been approved for Duchenne muscular dystrophy. Her son, Hiram, would be a perfect candidate — if, she added, they could get him dosed in time. The treatment was approved only for 4- and 5-year-olds. Hiram turned 6 in three weeks.

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Social Determinants Associated With Low Immunization

Pharmacy Times

Experts discuss the social determinants that can affect the rates of flu immunizations and strategies to boost immunization rates.

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Why drug shortages are having an outsize impact on ovarian cancer patients

STAT

Sarah Evans considers herself a lucky ovarian cancer patient, though she is dealing with the second recurrence of the disease since she was first diagnosed in February 2018. She is grateful that, even by her third round of chemo in March of this year, her cancer was still responding to carboplatin treatment — the most common first line of treatment for ovarian cancer, and one Evans tolerates without unbearable side effects.

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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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HIV Experts Discuss Conditions, Functionalities for Patient Use of COMTRAC-HIV App

Pharmacy Times

Topics discussed include care workflow, app functionalities, problems and disadvantages, and benefits for HIV experts.

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National Quality Forum joining accrediting giant Joint Commission as 'affiliate member'

Fierce Healthcare

National Quality Forum is joining the Joint Commission in a merger deal that the groups say will allow both to refine quality and outcome measures they develop for the industry. | The combination will help bolster Joint Commission’s standard development processes, expand the National Quality Forum's platform and refine both groups' quality measures, leaders said in the announcement.

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CSL gets top-line boost thanks to a post-pandemic boom in plasma collections

Fierce Pharma

With plasma collection as its stock-in-trade, the struggles of | With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a surge in post-pandemic collections—and an $11.7B acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech. With plasma collections up 31% and to a record level for the company, CSL reported revenue of $13.3 billion for fiscal year 2023.

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Bright, Friday could cost other payers $1B in risk adjustment payments, expert says

Fierce Healthcare

The collapse of insurtechs Bright Health and Friday Health Plans might mean that legacy health insurers in states where Bright and Friday operated will not receive over $1 billion worth of expected | Florida Blue, HCSC, Medica, Centene and Molina Healthcare might also suffer because of the financial troubles experienced by Bright Health and Friday Health Plans by not receiving risk-adjustment payments, an expert said.

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Appeals court upholds limits to abortion pill

STAT

A federal appeals court on Wednesday ruled to restrict access to the abortion pill mifepristone but not remove it from the market entirely, partially upholding a lower court’s decision. The decision from the three-judge panel of the 5th U.S. Circuit Court of Appeals would effectively block mail-order prescriptions of the pill. However, access will remain unchanged for now, as the Supreme Court issued an emergency order this spring to preserve the status quo while the case goes through the

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Drug pricing concerns cross party lines to become 'core value' for voters, pollsters say

Fierce Pharma

Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines. | Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found. Two pollsters presented results from their recent survey on Tuesday.

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How long does mono last? Duration and stages of mono

The Checkup by Singlecare

What is mono? | Duration | Stages | Do I need to isolate? | Treatment Infectious mononucleosis, often referred to as “mono,” is a viral illness caused by the Epstein-Barr virus. This common infection primarily affects adolescents and young adults, with symptoms including fever, sore throat, swollen glands, and fatigue. Mono is commonly known as the “kissing disease,” as it is often transmitted through saliva.

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Inside Beauty: Inverness’ ear piercing available at Ulta Beauty salons

Drug Store News

Michael Schwartz, CEO of Inverness, takes viewers into a step-by-step technique of its ear piercing process and discusses how the company’s partnership with Ulta Beauty came to life.

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Less than half of members are satisfied with their health plan: survey

Fierce Healthcare

Insurers still have plenty of work to do when it comes to improving member satisfaction, according to a new survey. | Insurers still have plenty of work to do when it comes to improving member satisfaction, according to a new survey.

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J&J, Legend's myeloma CAR-T Carvykti not slowing down in the face of new bispecific: Legend exec

Fierce Pharma

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. | Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option.

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Applications open for Physicians Foundation grant, fellowship focused on SDOH innovation

Fierce Healthcare

The Physicians Foundation has opened applications for a grant award and fellowship program aimed at helping drive awareness and best practices around the social determinants of health (SDOH). | The grant award and fellowship program are aimed at helping drive awareness and best practices around the social determinants of health. They are open to medical associations and doctors, respectively.

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Key drivers for future pandemic preparedness in pharmacy outlined by FIP

Hospital Pharmacy Europe

The key areas of development deemed necessary in pharmacy to prepare for future pandemics have been identified and outlined in a new report by the International Pharmaceutical Federation (FIP). Bringing together the experiences of the Covid-19 pandemic from 10 countries across the world, including 11 case studies, FIP sought to derive key lessons, recommendations and considerations for future pandemic preparedness, response and recovery.

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Teva's trial in high-stakes kickbacks case delayed as company pursues rare pretrial appeal

Fierce Pharma

For three years, Teva has been defending against claims from the | The trial was previously set to begin in September but is now on hold as the company appeals a key ruling from July.

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How much is Wegovy without insurance?

The Checkup by Singlecare

Is Wegovy covered by insurance? | How much does Wegovy cost without insurance? | How to get Wegovy without insurance Wegovy is a brand-name prescription drug used along with a reduced-calorie diet and physical activity for chronic weight management. Healthcare providers prescribe the drug only for people with a body mass index over 30 or who have risk factors for heart disease such as high blood pressure or high cholesterol and a BMI of 27 or greater.

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Walgreens’ Kevin Ban shares research findings, testing plans ahead of respiratory virus season

Drug Store News

Walgreens’ executive vice president and global chief medical officer, Kevin Ban, shared consumer research findings as well as pharmacy offerings ahead of the fall and winter respiratory season.

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STAT+: FDA approves first treatment for ultra-rare bone disease

STAT

U.S. regulators on Wednesday approved the first treatment for an ultra-rare disease that causes people to grow bone where it otherwise shouldn’t be, extending an option to patients who have been advocating for access to the medicine. The treatment, an oral medication that will be marketed as Sohonos, faced some questions about the quality of its data, and was rejected earlier this year by European regulators.

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GMP Update: CDER Official Explains, Advises, and Predicts

The FDA Law Blog

By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of

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The latest recall of Philips ventilators reveals one death, two injuries

STAT

In March, Philips recalled more than 73,000 ventilators that absorbed dust and dirt into breathing tubes. This week, the Food and Drug Administration reported that the issue has been associated with at least one death and two injuries. The recall impacts Philips’ Trilogy Evo ventilators, which are used primarily in hospital settings to support breathing for pediatric and adult patients.

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Sandoz to file for approval of aflibercept biosimilar

European Pharmaceutical Review

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar a

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Abridge inks Epic partnership, Emory Healthcare tie-up for its generative AI tech

Fierce Healthcare

As the generative artificial intelligence race in healthcare continues with big tech companies jumping into the space, startup Abridge nabbed several notable partnerships to expand the use of its g | As the generative artificial intelligence race in healthcare continues with big tech companies jumping into the space, startup Abridge nabbed several notable partnerships to expand the use of its gen-AI-powered medical note-taking service.

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