Wed.Mar 08, 2023

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FDA Accepts Biologics License Application for Proposed Denosumab Biosimilar

Drug Topics

The drug, manufactured by Sandoz, will treat conditions including osteoporosis in postmenopausal women

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

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Trending Sources

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Opinion: How cross-state licensure reform can ease America’s mental health crisis

STAT

Teletherapy has made mental health care more accessible than ever before, making care possible for people who otherwise would never have been able to get it. But the antiquated system of licensure in the United States is creating a huge barrier to realizing the potential for telehealth. I’ve seen the benefits of teletherapy firsthand. As the founder and CEO of Alma, a mental health company that helps independent mental health providers run their private practice and accept insurance, we s

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An Inside Look at Pharma Revenue Management

PharmExec

According to the 2023 State of Revenue Report, pharma companies are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

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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 issues rare comment on approval of Covid and flu home test from company that went bankrupt

STAT

Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems. Now the FDA has released a rare comment clarifying what happened during its authorization process.

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How long does hyoscyamine take to work?

The Checkup by Singlecare

When starting any new medication, a couple of key questions tend to bubble up, notably “Is this going to help me?” and “How long will it take to work?” Consider hyoscyamine , an antispasmodic medication that is often used to treat gastrointestinal (GI) tract disorders. You may know this medication by its brand names, such as Levsin , Anaspaz , Hyosyne , Symax, and Ed-Spaz—in fact, you might have even taken it for a stomach or intestinal problem.

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More Trending

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RangeMe expands premium offerings to UK-focused brands

Drug Store News

The premium subscription will provide brands with opportunities for increased visibility and engagement among the more than 1,000 U.K. buyers on the platform from leading retailers.

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HHS secretary signals support for new restriction on addiction treatment

STAT

WASHINGTON — A federal proposal to impose new restrictions on a key addiction-treatment medication has caused an uproar in certain segments of the medical community. But health secretary Xavier Becerra seems to be on board. The new Drug Enforcement Administration proposal would require that patients receive an in-person examination before obtaining refills of buprenorphine , a key drug used to treat opioid use disorder.

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US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The oncology drug has been approved to treat T-cell Lymphoblastic Lymphoma (T-LBL) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

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‘A different type of fatigue’: One woman’s Parkinson’s diagnosis is a test of flexibility and gratitude

STAT

“Living With” explores the contours of life with chronic illness, from the prelude to diagnosis to new patterns of living, to wrestling with big questions about illness and health. In 2020, Sandra Coplin, now 66, moved her life from her native New York — at the time, an epicenter of Covid’s devastation — to North Haven, Conn., to be close to family.

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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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Giant, customers raise $1.3M to combat hunger

Drug Store News

Customers at Giant, Martin’s and Giant Heirloom Market stores were invited to round up their grocery purchases to the nearest dollar or convert their Choice points into donations to support their local public school districts’ food programs.

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STAT+: Pharmalittle: FDA head wants to get rid of advisory panel votes; premature-birth drug is finally withdrawn

STAT

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is caramel apple, a sweet treat.

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Danaher and University of Pennsylvania partner for cell therapies

Pharmaceutical Technology

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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STAT+: Medicare chief on the new drug price negotiation program’s operations, hiring, and timelines

STAT

WASHINGTON — Medicare officials are still hammering out the technical specifics of how the massive program will start to negotiate drug prices — let alone the substantive ones, Medicare chief Meena Seshamani said at a STAT event Tuesday. “There are operations that need to be stood up both on the [Medicare] side and on the manufacturer side,” she said, describing “monthly technical calls.

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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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Targeting the new ‘Golden Girls’

PharmaVoice

With unprecedented buying power, women over 50 wield a lot of influence — but are still underserved by pharma. Urovant hopes to change that with its potential blockbuster drug.

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Hershey’s, Reese’s go plant-based

Drug Store News

Made with dairy alternatives, the new launches include Hershey’s Plant Based Extra Creamy with Almonds and Sea Salt bars and Reese’s Plant Based Peanut Butter Cups.

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Greater digital biomarklers adoption in clinical studies as Koneksa and SSI Strategy collaborate

Outsourcing Pharma

The two partners will pool capabilities to provide an expanded service to their clients, which will see Koneksa provide its digital biomarkers tools and SSI Strategy its expertise in drug development.

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Patients are likely to avoid preventive care should ACA coverage ruling stand, survey finds

Fierce Healthcare

Patients are likely to avoid preventive care should ACA coverage ruling stand, survey finds pminemyer Wed, 03/08/2023 - 14:10

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Natural allopregnanolone made orally bioavailable

European Pharmaceutical Review

PureTech Health has announced it will advance its oral allopregnanolone candidate LYT-300, for the potential treatment of anxiety and postpartum depression (PPD). A placebo-controlled, Phase IIa, proof-of-concept, social anxiety clinical trial is expected to begin in the first half of 2023. The results are anticipated by the end of 2023. An open-label, Phase IIa, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023.

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SimplePractice launches therapist mentorship matchmaking pilot in California

Fierce Healthcare

SimplePractice launches therapist mentorship matchmaking pilot in California agliadkovskaya Wed, 03/08/2023 - 16:16

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Walmart’s employee education program offering online tech courses

Drug Store News

Walmart is partnering with online learning platform Springboard to bring tailored upskilling and reskilling programs to its Live Better U offerings.

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Oral PCSK9 inhibitor substantially reduces cholesterol, study finds

European Pharmaceutical Review

MK-0616, a daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, reduced low-density lipoprotein (LDL) cholesterol levels by around 60 percent in people with high cholesterol and/or heart disease in a Phase II trial. Developed by Merck & Co. Inc., MK-0616 is one of the first oral PCSK9 inhibitors to be tested in clinical trials.

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Winn-Dixie lowers prices on more than 150 spring essentials

Drug Store News

Through the Down Down program, customers can save more than 15% on average at their neighborhood store, the grocer said.

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WeightWatchers buys Sequence to expand into remote prescribing of hot weight loss drugs

Fierce Healthcare

WeightWatchers buys Sequence to expand into remote prescribing of hot weight loss drugs aburky Wed, 03/08/2023 - 15:23

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Catering to men’s needs in skin care

Drug Store News

With a focus on fragrance and men’s skin care, Slate Brands, says the company’s goal is to bring innovative products to the market.

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FDA Approves Expanded Indication for Adjuvant Abemaciclib in HR+/HER2- Early Breast Cancer

Drug Topics

The expansion was based on 4-year data from the monarchE study.

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Ghost, Cinnabon roll out vegan, whey protein powders

Drug Store News

The companies have partnered to launch two nutritional powders that incorporate the authentic taste of a cinnamon roll.

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Woman of the Week: Lucy Therapeutics’ Amy Ripka

PharmaVoice

How a 32-million-year-old fossil inspired the CEO to unlock the mysteries of mitochondrial dysfunction.

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Walgreens-controlled VillageMD acquires Starling Physicians

Drug Store News

Starling has more than 30 locations in Connecticut, offering primary care and a range of specialties.

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What’s holding back health IT interoperability in 2023? ONC has some thoughts

Fierce Healthcare

What’s holding back health IT interoperability in 2023?

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Select Hy-Vee pharmacy locations in Iowa pilot COVID-19 and flu test-to-treat service

Drug Store News

With one test, patients can get tested for both COVID-19 and flu and receive a prescribed treatment from a pharmacist.

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Elevance Health study links heart problems to long COVID

Fierce Healthcare

Elevance Health study links heart problems to long COVID fdiamond Wed, 03/08/2023 - 09:23

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Degree Deodorant, Ciara partner to launch Unlimited collection

Drug Store News

The collection offers five gender-neutral fragrances in both dry sprays and antiperspirant sticks.

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International Women's Day interview: Addressing the balance of women in medicine, research and clinical trials

Outsourcing Pharma

In the first of a two-part interview with Medableâs chief growth officer, Sanskriti Thakur, we will learn about why she thinks the world of medicine is letting women down, what the future holds and how everyone should be paying more attention.

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