Fri.Apr 14, 2023

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CMS guidance on IRA price setting process doubles down on bad policy

PhRMA

As part of the implementation of the Inflation Reduction Act (IRA), the Centers for Medicare & Medicaid Services (CMS) issued draft guidance on the process for setting the price of medicines. The process is in no way a “negotiation,” and CMS chose to go beyond what was outlined in the statute, taking the most extreme stance to sweep in as many medicines as possible and be as punitive as possible.

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Hundreds Of Pharma Executives Sign Open Letter Condemning Mifepristone Ruling

Drug Topics

Over 400 pharmaceutical employees and executives signed an open letter in a show of solidarity with the FDA, but some say that big pharma’s actions helped lead to this moment in the first place.

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Study Shows Psilocybin Therapy Improves Major Depressive Disorder in Patients With Cancer

Pharmacy Times

Based on the study results, investigators concluded that there is justification for a randomized clinical trial.

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Case Study: Treating Infants for Cannabis Exposure

Drug Topics

As more and more states legalize recreational marijuana, caregivers need to be vigilant about keeping products out of the reach of children.

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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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In counties with more Black doctors, Black people live longer, ‘astonishing’ study finds

STAT

Black people in counties with more Black primary care physicians live longer, according to a new national analysis that provides the strongest evidence yet that increasing the diversity of the medical workforce may be key to ending deeply entrenched racial health disparities. The study , published Friday in JAMA Network Open, is the first to link a higher prevalence of Black doctors to longer life expectancy and lower mortality in Black populations.

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Breaking: HHS Extends PREP Act Authority for Pharmacists, Pharmacy Technicians

Drug Topics

HHS Secretary Xavier Becerra will release an amendment to the declaration in the coming weeks.

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AAP Members Celebrate Their Independent Pharmacy Stories

Drug Topics

Four independent pharmacists shared their journeys to become pharmacy owners.

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The Biden administration will hang on to some Covid pandemic emergency powers

STAT

WASHINGTON — Even though the Biden administration is ending its highest-profile Covid-19 emergency declaration next month, it’s still going to hold on to some pandemic-era powers. The Department of Health and Human Services gave governors a heads-up on Friday that it is planning to keep pharmacists’ ability to administer Covid-19 and flu vaccines past the end of the public health emergency.

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A Return to Normalcy

Drug Topics

Despite a massive COVID-19 vaccination campaign, many still fear a return to normal.

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Psychedelic-assisted Therapy Is More Analogous to Oncology Care Than Traditional Mental Health Care

Pharmacy Times

The Aquilino Cancer Center established the Bill Richards Center for Healing inside the same building, so patients with cancer can receive psychedelic-assisted therapy in the same location as their cancer care.

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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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Oncology Pharmacists Are Crucial in Skin Cancer Management

Drug Topics

From explaining how medications work and should be taken to reviewing potential adverse effects and financial details, pharmacists are crucial resources for patients undergoing treatment for skin cancer.

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FDA declines Eli Lilly’s bowel disease drug over manufacturing issues

Pharmafile

Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine. Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon.

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News Roundup: April 10 - April 14

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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Ghana becomes first country to approve Oxford’s malaria vaccine

Pharmaceutical Technology

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

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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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Google, Microsoft and startups test out generative AI in healthcare

Fierce Healthcare

Google, Microsoft and startups test out generative AI in healthcare hlandi Fri, 04/14/2023 - 08:04

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Overcoming Our Blind Spots: Pharmacists Can Help Address Human Trafficking

Pharmacy Times

Being observant and knowing how to ask screening questions are critical to identifying red flags.

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TORL BioTherapeutics raises funds to develop new oncology therapies

Pharmaceutical Technology

Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients. Led by Goldman Sachs Asset Management, the financing round has also seen participation from Deep Track Capital, Moore Strategic Ventures, Cowen Healthcare Investments, Bristol Myer

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Cleveland Clinic Study: Long COVID Shows Link to Sleep Disturbances

Pharmacy Times

41% of patients report moderate-to-severe issues, with Black individuals 3 times more likely to develop these difficulties.

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Ginkgo Bioworks partners with WARF for new GD2 CAR T-cell therapies

Pharmaceutical Technology

Ginkgo Bioworks (Ginkgo) and the Wisconsin Alumni Research Foundation (WARF) have collaborated to discover next-generation GD2 CAR T-cell therapies to treat solid tumours. WARF is the patenting and licensing organisation for the University of Wisconsin–Madison in the US. Ginkgo will partner with researchers from Wisconsin-Madison to discover new and improved GD2 CAR designs with improved persistence, fitness and proliferation.

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Walgreens hosts ‘Reimagining Local Healthcare’ event

Drug Store News

Following Walgreens' recent acquisitions of CareCentrix and Shields Health Solutions, leaders from the companies discussed how they are working to change the patient experience.

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About 800,000 nurses planning to leave the profession by 2027, data show

Fierce Healthcare

About 800,000 nurses planning to leave the profession by 2027, data show dmuoio Fri, 04/14/2023 - 14:25

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What Pharmacists Need to Know About Point-of-Care Testing for STIs

Drug Topics

Pharmacists need a depth and breadth of knowledge to get the most out of point-of-care testing for sexually transmitted infections.

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Fitch Ratings says Medicaid disenrollment will pinch revenue for not-for-profit hospitals

Fierce Healthcare

Fitch Ratings says Medicaid disenrollment will pinch revenue for not-for-profit hospitals fdiamond Fri, 04/14/2023 - 14:26

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Navigating delivery challenges of nucleic acid therapeutics

European Pharmaceutical Review

The current progress, challenges and opportunities for achieving stable formulations of nucleic acid (NA) therapeutics with novel drug delivery systems (DDSs) has been discussed in a paper published in Pharmaceutics. Over the past decade, the impact of nucleic acid (NA)-based biopharmaceuticals has been facilitated by breakthroughs associated with high-end manufacturing and pharmaceutical drug delivery.

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Opinion: I’m a biopharma supply chain specialist — and even I can’t find the Adderall I’m prescribed

STAT

For 10 years, I have depended on Adderall to help me function. But in February, for the first time, the pharmacy down the street was unable to fill my prescription. In fact, 19 pharmacies in a row told me that they were out of stock. Thankfully, the 20th was able to fill it — though it meant a 50-minute drive. The quest to find my daily medication left me struggling to function and feeling utterly helpless.

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Does Adderall make you lose weight

The Checkup by Singlecare

Losing weight is a marathon, not a sprint—a long and arduous marathon, sometimes, depending on how much weight you want to lose, and many people look for medications to aid in the process. Take stimulant medications for conditions like attention-deficit/hyperactivity disorder (ADHD) or narcolepsy, for example. Since weight loss is often noted as a possible side effect, some people try to use stimulants like Adderall (amphetamine/dextroamphetamine) to reach their weight loss goals.

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Supreme Court pauses new limits on abortion pill, pending further review next week

STAT

Access to the abortion pill mifepristone will remain unchanged until next Wednesday, after a U.S. Supreme Court justice on Friday issued a stay on last week’s ruling from a conservative Texas judge banning the medicine. Supreme Court Justice Samuel Alito issued an administrative stay preserving access to mifepristone, which has been approved by the Food and Drug Administration since 2000, until 11:59 p.m.

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FDA grants rare paediatric drug status for IPS HEART’s stem cell drugs

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. GIVI-MPC is intended to create new skeletal muscle with 100% full-length dystrophin, while ISX9-CPC is designed to create new functional cardiac muscle for indicated patients.

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Bimekizumab provides clinical benefit in patients with moderate to severe hidradenitis suppurativa

Hospital Pharmacy Europe

Bimekizumab has been shown to be an effective treatment for hidradenitis suppurativa according to the findings of two phase 3 trials In a press release from the manufacturer, UCB , two phase 3 trials showed that bimekizumab provides a clinically meaningful benefit to patients with hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic inflammatory disorder affecting intertriginous areas of skin. and affects around 1% of the population.

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Twist rolls out TCR and CAR libraries for cell therapies development

Pharmaceutical Technology

Twist Bioscience has introduced Twist T-cell receptor (TCR) and Twist chimeric antigen receptor (CAR) libraries to facilitate the development of cell therapies. Researchers will now be able to speed up the creation of tailor-made libraries that can help in identifying and developing new cell therapies. Both libraries feature up to 10,000 gene fragment combinations, and allow the high-throughput screening and characterisation of new and known sequence variants to develop therapeutic solutions.

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Navigating Generational Differences in HCP Marketing

PharmExec

By tailoring messages, leveraging digital channels, creating personalized experiences, and fostering relationships, healthcare marketers can connect with HCPs across generations and build lasting partnerships.

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Tiziana Life Sciences plans to assess intranasal foralumab for long Covid

Pharmaceutical Technology

Biotechnology company Tiziana Life Sciences has revealed plans to assess intranasal foralumab as a potential treatment for long Covid. Long Covid is a health condition characterised by the continuation or development of new symptoms three months after an initial SARS-CoV-2 infection. The work is supported by the role of foralumab in dampening activated microglia cells, said to be an important component of the pathogenesis of this disease.

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Help Specialty Pharmacy Patients Access Out-of-Stock Drugs

Pharmacy Times

Establish procedures, including training employees, to address shortages, back-order situations.

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Oral Treatment Approved for Anemia Caused by CKD

Drug Topics

Daprodustat increases erythropoietin production, leading to an increase in the production of red blood cells.

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