Wed.Aug 16, 2023

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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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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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Adjusting Pharmacy Education In The Era of AI

Drug Topics

As AI becomes more prevalent, how must the pharmacy world change how it learns?

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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Cigna rolls out new digital dental screening tool to 16.5M members

Fierce Healthcare

Cigna has launched a new tool that will allow its members to use their smartphones to check for dental health issues including gum disease and cavities. | Cigna has launched a new tool that will allow its members to use their smartphones to check for dental health issues including gum disease and cavities.

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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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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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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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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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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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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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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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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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Leprosy potentially endemic in Central Florida

Pharmaceutical Technology

The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.

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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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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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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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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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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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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+: A new mom’s illness led to the first diagnosis of a rare condition after childbirth

STAT

Figuring out the right medical diagnosis for patients can be a tricky process. The recent case of a woman who became sick with a life-threatening disease shortly after giving birth shows how many factors had to align to offer clinicians new insights into a rare complication that had never before been documented. A letter published Wednesday in the New England Journal of Medicine highlights the circumstances of the unusual case that occurred at University of Colorado Hospital.

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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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STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results

STAT

For only the fifth time, the U.S. Food and Drug Administration recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. And transparency advocates say this is the latest proof that the agency needs to step up enforcement. In a July 19 letter , the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov.

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Taro intros 2 new OTCs for children

Drug Store News

Taro is debuting FeverAll Children’s Liquid Oral Acetaminophen and bébé Bottoms Diaper Rash Crème Spray.

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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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STAT+: Pharmalittle: Chinese drugmakers develop copycat weight loss drugs; SEC eyes supplier of research monkeys

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is butter pecan, a household favorite — and get started. Meanwhile, do keep us in mind if you hear anything interesting.

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FDA will not meet ahead of bluebird bio’s sickle cell disease gene therapy PDUFA date

Pharmaceutical Technology

Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.

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Submit your essay to First Opinion

STAT

First Opinion , STAT’s platform for opinion and perspective essays, welcomes submissions about the biopharma industry, medical science and health care, and other topics related to the life sciences writ large.

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Robotics: Transforming cell and gene therapy manufacturing

Pharmaceutical Technology

Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.

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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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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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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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Gilead taps Tentarix for cancer, inflammation projects

pharmaphorum

Gilead taps Tentarix for cancer, inflammation projects Phil.

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Aldi to acquire Winn-Dixie and Harveys Supermarket

Drug Store News

The acquisition will add approximately 400 Winn-Dixie and Harveys Supermarket locations across Alabama, Florida, Georgia, Louisiana and Mississippi.

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