Wed.Sep 06, 2023

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How a conservative, gun-toting doctor defended abortion access in Appalachia

STAT

BRISTOL, Va. — When Wes Adams’ youngest son was little, he’d sometimes toddle over to the TV, pop in a cassette, and watch himself being born. It was a home video, filmed by his older brother. There was his mother, her belly anesthetized but her head very much awake, asking the doctors to keep the incision small, please. There was his dad’s medical partner, making the cut for the C-section.

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FDA Issues Tentative Approval to Abacavir/Dolutegravir/Lamivudine Combo to Treat HIV in Pediatric Patients

Pharmacy Times

The fixed-dose abacavir/dolutegravir/lamivudine combination is indicated for the once-daily treatment of children weighing at least 6 kg to <25 kg with HIV-1 infection.

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STAT+: South Africa was forced into ‘one-sided’ deals with Covid-19 vaccine suppliers, contracts reveal

STAT

South Africa was “bullied” into signing one-sided contracts with Covid-19 vaccine suppliers that forced the government to pay more than the European Union but offered little protection against delivery failures, according to an advocacy group. For instance, Johnson & Johnson charged South Africa $10 a dose, 15% more than the company charged the European Union, while the government was required to pay a non-refundable down payment of $27.5 million.

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MorningRX: September 6, 2023

Drug Topics

The CDC issues an alert for increased RSV activity, a survey finds men's habits don't stack up to their perceptions on their health, and the WHO announces an air pollution training course for health care workers.

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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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STAT+: Covid hospitalizations on the rise, Humana says

STAT

More older adults have been hospitalized for Covid-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana. Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.

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More than half of Americans are unfamiliar with chronic kidney disease, survey finds

Fierce Healthcare

Chronic kidney disease (CKD) is a major blind spot for many Americans, a new survey suggests. | Though many respondents used the internet for medical information and had a regular doctor and blood work done once or twice a year, 58% of respondents were unfamiliar with the illness.

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More Trending

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YouTube expanding health videos to more diverse audiences with new content creator, AI dubbing programs

Fierce Healthcare

YouTube announced two programs Thursday that the Google-owned video platform said will give healthcare content creators new opportunities to educate diverse audiences. | The two new initiatives leverage cultural representation and targeted messaging to reach audiences impacted by health inequity, Google's Garth Graham, M.D., said.

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Phase 3 Trial Results Show Tisotumab-Vedotin Improved OS in Adult Patients With Recurrent or Metastatic Cervical Cancer

Pharmacy Times

In addition to overall survival, main efficacy outcomes, such as progression-free survival, objective response rate, and time to response, were compared to chemotherapy alone.

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With affirmative action off the table, medical schools plan new diversity tactics

STAT

“Lots of scrambling on the ground.” That’s how Consuelo Wilkins, the senior associate dean for health equity and inclusive excellence at Vanderbilt University Medical Center, describes medical schools’ current efforts to maintain diversity in the wake of the U.S. Supreme Court’s decision to strike down affirmative action based on race.

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Study: Blood Cancer Treatment Found to Kill Latent HIV-Infected Cells, Possible New Treatment

Pharmacy Times

Although antiretroviral therapies are the standard of care treatment for those with HIV, the drugs cannot target latent infections; however, venetoclax, a blood cancer treatment, shows promise.

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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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Robert Winn: Without ‘high-touch’ strategies, cancer’s breakthroughs will increase disparities

STAT

Looking at the dizzying progress in cancer medicine over the last couple of decades, it’s easy to imagine that advances in synthetic biology or immunology will soon help cure or prevent more cancers. But without a strategy to connect “these miracles” to all communities, only some will benefit and others will be left behind, said Robert Winn, the director of the Massey Cancer Center at Virginia Commonwealth University.

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Clinical Overview: Opill as First OTC Contraception in United States

Pharmacy Times

Norgestrel (Opill) for pregnancy prevention will be accessible at various retail locations, including drug stores, convenience stores, grocery stores, and online platforms.

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Opinion: What does ‘bona fide competition’ actually mean in the biologics market?

STAT

On Aug. 29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026. The Inflation Reduction Act (IRA), passed in August 2022, gives Medicare pricing power over therapies that both cost Medicare lots of money and have by 2026 enjoyed market exclusivity for a certain number of years — nine for small-molecule drugs and 13 for biologics.

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Unite Us, tech company focused on social determinants of health, lays off employees amid profitability struggles

Fierce Healthcare

Unite Us, tech company focused on social determinants of health, lays off employees amid profitability struggles agliadkovskaya Wed, 09/06/2023 - 14:25

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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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J&J's patient assistance program suffers data breach, IBM says

Fierce Pharma

IBM disclosed "unauthorized access" to J&J’s Janssen CarePath patient assistance program, which helped over 1 million U.S. patients last year.

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STAT+: Cancer care appears brighter as off-the-shelf CAR-T advances

STAT

If you ask biopharma leaders what’s ahead for CAR-T cancer therapy, they say the future is bright. And that future will also look markedly different than it does today, three of them said at the STAT 2023 Future Summit on Wednesday. Now in its second decade, the cell therapy — which attacks cancer by extracting white blood cells from a patient, genetically modifying them, and then re-infusing them to fight the cancer — has made remarkable strides.

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Hospitals push FTC to withdraw 'largely unnecessary' updates to pre-merger regulatory filings

Fierce Healthcare

The American Hospital Association (AHA) is among those pushing back against the Federal Trade Commission’s (FTC's) plans to update pre-merger notification requirements, calling the proposal “a subs | "There is no need to subject hospitals to burdensome rules aimed at other sectors of the economy,” the AHA wrote of amendments to the Hart-Scott-Rodino Form proposed in June.

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Results of a 10-year Follow-Up of Gardasil Vaccine Show Peak Antibodies At Month 7

Pharmacy Times

Cases of certain HPV-related high-grade disease were not found in the 10-year follow up for girls and boys who received 3 doses of the Gardasil 9 injection.

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Astellas withdraws IRA lawsuit after avoiding CMS' price negotiations list

Fierce Pharma

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). | Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act. But now that the Centers for Medicare & Medicaid Services has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation.

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Research Seeks to Aid Management of Type 2 Diabetes Through Dietary Education

Pharmacy Times

An upcoming large-scale clinical trial of the Glucose Everyday Matters program will evaluate its safety and efficacy in managing type 2 diabetes.

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Before key Tagrisso showdown, J&J notches Rybrevant trial win in large lung cancer area

Fierce Pharma

Johnson & Johnson’s Rybrevant is currently approved for a tiny non-small cell lung cancer (NSCLC) niche. | Johnson & Johnson’s Rybrevant is currently approved for a tiny non-small cell lung cancer niche. A late-stage study could move the drug to a larger disease area where AstraZeneca’s blockbuster Tagrisso plays, but the most important readout still lies ahead.

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Huge decline in spending on Medicare begs the question: Why?

Fierce Healthcare

Research shows that Medicare spending has leveled off for the past decade, morphing from something that experts worried might break the federal budget to an unexpected bright spot. | Medicare had once been seen as something that would one day break the budget. However, Medicare spending in the last decade slowed greatly. But why?

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AstraZeneca hit with FDA rejection for Ultomiris in rare autoimmune disorder

Fierce Pharma

AstraZeneca’s Ultomiris expansion plan has hit a snag in the U.S. | The FDA handed the company a complete response letter for its Ultomiris application in neuromyelitis optica spectrum disorder, a rare autoimmune disease affecting the central nervous system.

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Telehealth Medication Abortion Services Effective for Diverse Patient Populations

Drug Topics

Many women seek out abortion medications, but this process has seen increased barriers as options become restricted by federal and state regulations.

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After manufacturing setback at FDA, Ascendis strikes $150M royalty deal on its first commercial drug

Fierce Pharma

Royalty Pharma, a company known for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa. | Ascendis hopes to bring its second TransCon product to the market and overcome manufacturing issues. Meanwhile, the company's Skytrofa is going up against a new competitor in Pfizer and OPKO Health's Ngenla.

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Lactation coverage advocates say ACA mandate is still not enforced

Fierce Healthcare

When the Affordable Care Act (ACA) was passed in 2010, the legislation set forth requirements for insurers to cover lactation services for mothers, a stark contrast from expecting families to pay o | The Affordable Care Act says insurance companies must front the cost for lactation care. Many are still not doing so, forcing other providers to step up.

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Novartis cuts top commercial title, replaces departing exec Marie-France Tschudin with AbbVie vet Patrick Horber

Fierce Pharma

Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial offic | Just as Novartis’ C-suite appeared to have stabilized amid a major overhaul of the company, the Swiss pharma is losing its international markets leader and getting rid of its chief commercial officer title.

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Genuine Health Group brings on former UHC executive as it charts future growth

Fierce Healthcare

Former UnitedHealthcare executive Roger Rodriguez said that during his tenure with the insurance giant, he endeavored to view payer issues through a provider lens. | Former UnitedHealthcare executive Roger Rodriguez said that during his tenure with the insurance giant, he endeavored to view payer issues through a provider lens.

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Moderna’s Updated COVID-19 Vaccine Effective Against BA.2.86 Variant

Drug Topics

Previous clinical data has shown that the vaccine also generates a strong response to the EG.5 and FL.1.5.1 variants.

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C&S, SoftBank reportedly close to deal to purchase stores from Kroger, Albertsons

Drug Store News

C&S could announce the deal to acquire most or all of the stores that Albertsons and Kroger are divesting for antitrust reasons as soon as this week, per a Bloomberg report.

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STAT+: Pharmalittle: Novartis is losing its chief commercial officer; vaccine experts urge more inclusivity in clinical trials

STAT

Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation (which happens to be coconut rum today). But this is to be expected at this time of year, yes? In any event, there is work to be done, so as always, we have assembled a few items of interest for you.

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8 ways to stop a runny nose

The Checkup by Singlecare

A runny nose isn’t usually serious, but that doesn’t mean it isn’t bothersome or uncomfortable. A runny nose can cause congestion , make breathing more difficult, interrupt sleep, and may be accompanied by other annoying symptoms like coughing and sneezing. If you’re dealing with these issues, you probably want some relief. Many simple remedies for runny noses include at-home treatments like hot compresses, steam treatments, and over-the-counter medications like antihistamines and decongestant

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Sally Hansen celebrates latest ‘Trolls’ movie with limited collection

Drug Store News

The limited-edition Sally Hansen Insta-Dri x Trolls collection features eight new pearl and creme finish shades that reflect the energy of the Trolls universe, the company said.

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How Rapid Whole Genome Sequencing Can Change the Rare Disease Game for Every Newborn

Fierce Healthcare

If there’s one thing we know about rare diseases, it’s that their prevalence is not so rare. | The rare disease journey can be long and difficult. rWGS could offer newborns a greater chance of successful diagnosis and intervention at birth.

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