Thu.Jul 27, 2023

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Twice-Yearly Subcutaneous Lenacapavir Injection for HIV Provides Favorable Quality-of-Life Outcomes

Pharmacy Times

Further analysis shows that 300 mg lenacapvir tablets plus an optimized background regimen can effectively reconcile a missed dose of lenacapavir injection in patients with HIV.

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Improved Cancer Screening Methods Needed for Patients with Barrett’s Esophagus

Drug Topics

A new study found that 25%-46% of esophageal adenocarcinomas in patients with newly diagnosed Barrett’s esophagus were categorized as post-endoscopy esophageal adenocarcinoma.

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Patients With Cancer Currently Have Lowest Risk of Severe COVID-19 Outcomes Since Start of the Pandemic

Pharmacy Times

Rates of hospitalizations and mortality from COVID-19 were more than 4 times lower in 2022 compared to 2021, as the virus become less severe with new mutations, a recent study found.

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Laser Treatments Are Often Not Covered By Insurance, Survey Finds

Drug Topics

The National Rosacea Society found that a lack of health insurance or the high cost of a copay caused 52% of respondents to avoid obtaining medical care for their rosacea.

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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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Phase 3 Trial Underway for Novel Pembrolizumab Combination for Treatment of High-Risk Melanoma

Pharmacy Times

Pembrolizumab is already indicated to treat patients with unresectable or metastatic melanoma, along with stage 2B-3 melanoma after resection in adults and pediatric patients.

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Daily Bouts of Intense Physical Activity Associated with Reduced Cancer Risk

Drug Topics

A minimum dose of 3.4 to 3.6 minutes of vigorous intermittent lifestyle physical activity per day was associated with a 17% to 18% reduction in total incident cancer risk.

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More Trending

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RSV-Related Hospitalization Rates Higher Among American Indian and Alaska Native Children

Drug Topics

Investigators said that RSV-prevention products and socioeconomic determinants of health for AI/AN children are “urgently needed.

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Establishing Healthy Sleep Routines Earlier Impacts Mother-Infant Quality, Duration of Sleep

Pharmacy Times

A study shows the first 2 years of life are a vital time to establish healthy sleep routines in infant children.

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How providers are navigating Florida's new law restricting access to gender-affirming care

Fierce Healthcare

Last month, the American Medical Association (AMA) passed a resolution to protect access to gender-affirming care, committing to opposing criminal and legal penalties against patients, their famili | Approved by Gov. Ron DeSantis, the law imposes restrictions on adult access to gender-affirming care. Some providers have been forced to stop serving new or existing patients in some capacity.

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Study Indicates Increased Risks of Fatal Heart Attack Due to Combination of Heat Waves, High Fine Particulate Pollution Days

Pharmacy Times

The risk could double if the conditions are met, with deaths more common in women and those aged 80 and older.

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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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Ending health disparities requires full federal government, National Academies panel says

STAT

To narrow the nation’s deeply entrenched health disparities, a permanent entity with regulatory powers should be created by the president to oversee health equity efforts across the entire federal government, says a report issued Thursday by the National Academies of Science, Engineering, and Medicine. In its many recommendations, the committee that wrote the report called for Congress to create a scorecard to assess how new federal legislation might affect health equity; urged all federa

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Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

Fierce Pharma

To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023.

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Cases of alpha-gal syndrome caused by tick bites on the rise, CDC reports

STAT

For many Americans, the warmer spring and summer months bring backyard barbecues and scenic hikes — along with a chorus of cicadas, mosquitoes galore, and hypervigilant self-checks for ticks. Often, insect bites only cause mild discomfort but new reports from the Centers for Disease Control and Prevention warn that a food allergy caused by ticks is on the rise in the U.S.

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Eli Lilly's tirzepatide aces 2 more late-stage obesity trials as FDA decision nears

Fierce Pharma

Eli Lilly continues to bolster the case for its dual GIP/GLP-1 agonist tirzepatide as a powerful weight loss agent. | Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday.

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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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Mitch McConnell’s abrupt episode has an important public health takeaway

STAT

The handling of Senate Minority Leader Mitch McConnell’s abrupt medical issue this week is raising concerns among medical experts that the event sent a potentially dangerous public-health message — that when someone experiences an episode with symptoms like McConnell’s, they can simply return to work as though nothing had happened.

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AWS rolls out generative AI service for healthcare documentation software

Fierce Healthcare

Amazon Web Services announced Wednesday a new AI-powered service for healthcare software providers that will help clinicians with paperwork. | AWS HealthScribe uses generative AI and speech recognition to help doctors transcribe and analyze their conversations with patients and drafts clinical notes.

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Opinion: Why new guidelines recommending screening at 40 can’t end the mammography wars

STAT

New breast cancer screening guidelines from the United States Preventive Services Task Force give the impression that the decades-long debate over when women should start getting mammograms is settled. The agency now recommends beginning at age 40 , reversing the age-50 guideline that had been in place since 2009. This change aligns it with other expert organizations such as the American College of Radiology (though the two still differ on whether women should get mammograms annually or every tw

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Fierce Pharma Asia—Daiichi's leukemia nod; Astellas' protein degrader pact; Takeda's neuroscience setback

Fierce Pharma

Daiichi Sankyo's FLT3 inhibitor overcame FDA rejection to win an approval. Astellas signed another protein degrader deal, this time with PeptiDream. | Daiichi Sankyo's FLT3 inhibitor has overcome an FDA rejection to win an approval. Astellas signed another protein degrader deal. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder.

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STAT+: How the first over-the-counter birth control pill in the U.S. got its ‘unapologetic’ design

STAT

It’s not every day that a marketing team is tasked with designing the branding and packaging of the first over-the-counter birth control pill to be sold in the U.S. This was the challenge, and the opportunity, faced by the team behind Opill, the landmark pill from drugmaker Perrigo that received approval from the Food and Drug Administration earlier this month.

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Is Dramamine pregnancy-safe?

The Checkup by Singlecare

When you’re pregnant, you already have to deal with morning sickness, swollen feet, and hormonal changes—but you’re also more likely to get motion sickness. It doesn’t seem fair, does it? Fortunately, the drug Dramamine, which relieves motion sickness, can also help with morning sickness during early pregnancy —and is considered safe for pregnancy. Here’s what you should know about taking Dramamine while pregnant.

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Biden announces an advanced cancer research initiative as part of the bipartisan ‘moonshot’ effort

STAT

WASHINGTON — President Biden’s administration on Thursday announced the first cancer-focused initiative under its advanced health research agency, aiming to help doctors more easily distinguish between cancerous cells  and healthy tissue during surgery and improve outcomes for patients. The administration’s Advanced Research Projects Agency for Health, or ARPA-H , is launching a Precision Surgical Interventions program, seeking ideas from the public and private sectors

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Merck, insurers advance fight over cyberattack-related coverage to New Jersey Supreme Court

Fierce Pharma

That didn't take long. About a month and a half after Merck & Co. scored a legal win in the insurance case tied to the 2017 "NotPetya" cyberattack, the case is in appeals—again. | That didn't take long. About a month and a half after Merck & Co. scored a legal win in the insurance case tied to the 2017 "NotPetya" cyberattack, the case is in appeals—again.

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STAT+: VC firm starts a new synthetic biology incubator, headed by a former Broad Institute scientist

STAT

Venture capital firm RA Capital is starting a new incubator, setting the stage for the firm to create new startups over the next several years that hone in on synthetic biology, a long-gestating field that insiders say is getting renewed interest. The Boston-based VC’s incubator is called RASyn, and will be led by Robert Nicol, according to people familiar with the firm’s plans.

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Lapses at Catalent plant filling Novo's Wegovy forced 2 prior shutdowns: report

Fierce Pharma

Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, a | Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, according to a new Reuters report, which cites FDA documents stemming from a series of inspections.

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STAT+: A conflict of interest behind the warning on Apellis’ eye drug? The optics are not good

STAT

The eye disease physician in charge of a committee that flagged a rare but severe side effect involving a newly approved drug from Apellis Pharmaceuticals has financial ties to a competing drugmaker. The conflict raises questions about his supervision of an emerging safety issue for patients and its impact on the financial health of Apellis. Peter Kaiser, a retinal disease expert who runs the Cole Eye Institute at the Cleveland Clinic, failed to report consulting fees and stock ownership in Iver

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5 Strategies to Strengthen Relationships with HCPs

Pharma Marketing Network

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. These partnerships not only improve patient outcomes but also foster mutual trust and collaboration. In this blog, we will explore five effective strategies to enhance your relationship-building efforts with HCPs and ultimately achieve better healthcare outcomes.

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STAT+: HCA says smaller share of spending going to labor

STAT

The chief executive of the country’s biggest hospital chain said Thursday that labor costs are now lower as a percent of revenue than they were before the pandemic. “And again, that’s in the face of a very difficult labor market,” HCA Healthcare CEO Sam Hazen noted on the company’s second quarter earnings call. Health care providers and insurers are in the full swing of releasing their second-quarter earnings, and HCA tends to outperform its peers.

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Despite big Q2 declines for Humira and Imbruvica, AbbVie still boosts earnings guidance

Fierce Pharma

As Humira biosimilars enter the U.S. market in a steady stream, AbbVie execs say they're pleased with how the situation is playing out. | As Humira biosimilars continue to swarm the market, AbbVie says the situation is playing out as it had expected—or even slightly better. Still, the company is weathering hefty sales declines.

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Biogen’s sticky situation, Wegovy’s risks, & biotech insider trading

STAT

Why do CEOs talk like that? Do biotech stock tips make good gifts? And what do Anthony Fauci and Stéphane Bancel have in common? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss why Wall Street was less than convinced by Biogen’s attempt to assuage concerns about its credibility.

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Bristol Myers slashes Revlimid sales projection by $1B, now sees overall revenue decline in 2023

Fierce Pharma

Securing FDA approvals last year for three drugs that each have peak sales potential of $4 billion bodes well for the long-term future of Bristol Myers Squibb. | Bristol Myers Squibb is entering a dark stage. In the second quarter, the company's three top-selling drugs—Eliquis, Revlimid and Opdivo—all meaningfully missed analysts’ expectations.

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STAT+: Midwest health systems Fairview and Sanford call off $14 billion merger

STAT

Sanford Health and Fairview Health Services have for the second time scrapped their planned merger , the systems announced Thursday.  The plan to create a $14 billion health system with just shy of 60 hospitals encountered significant resistance from the University of Minnesota, whose main teaching hospital in Minneapolis is part of Fairview. University leaders and state officials alike soured on the idea of the hospital being owned by an out-of-state entity.

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HCA reports $1.2B profit, 7% YoY revenue growth for Q2 2023, adjusts guidance

Fierce Healthcare

Editor's note: This story was updated with executive comments from Thursday morning's earnings call. | Executives said that volumes, revenue payer mix and labor improvements were consistent across nearly all of its service lines and divisions, prompting an upward adjustment to 2023 guidance.

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STAT+: The once-hot market for biotech jobs and lab space has cooled. What now?

STAT

When Crystal Shih Byers left her job at Novartis in 2020, she was excited to make the leap into a smaller startup. Byers had spent almost nine years at Novartis, most recently helping lead a group that worked on gene therapy. But pharmaceutical companies are large and complex, and she craved more immediate impact. “I was looking for a place where I could be in the room,” she says.

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Takeda hypes up dengue vaccine launch progress as Vyvanse generics loom

Fierce Pharma

With generics of the popular ADHD medication Vyvanse circling the gates, Takeda will have to depend on newer launches to grow going forward. | While it’s still early days for Qdenga’s launch, Takeda is “encouraged by the positive momentum” it’s seen in markets where the product is now available, the company’s CEO, Christophe Weber, said on a conference call Thursday.