Mon.Jan 09, 2023

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Pilot Program From Custom Health, L.A. Care, Tackles Medication Adherence

Drug Topics

Custom is one of the growing number of companies focusing on adherence. It changed its name from Pack4U last year.

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Hybrid Immunization Can Provide 90% Protection Against Omicron BA.5 Variant

Pharmacy Times

Relative risk calculations show that vaccinated individuals infected with the first Omicron subvariants of COVID-19 could have protection that lasts nearly 3 seasons.

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Trending Sources

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Is It Easy Being Green?

Drug Topics

Pharmacists can make simple changes that add up to big environmental impacts.

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Pain Management in Patients With Opioid Use Disorders

Pharmacy Times

The chronic and excessive use of opioids has been associated with a wide range of psychosocial effects on the patient.

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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 Terlipressin for the Management of HRS-1

Drug Topics

Approval followed resubmission of data from the phase 3 CONFIRM trial to the agency.

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STAT+: FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises”

STAT

SAN FRANCISCO –  U.S. Food and Drug Administration commissioner Robert Califf doesn’t disagree with the basic findings of a congressional investigation into the agency’s role in the controversial approval of Aduhelm, Biogen’s first Alzheimer’s drug. He just wishes the report’s tone had been different. “There were no surprises in the report,” Califf told STAT’s Matt Herper during a Monday night event hosted by STAT during the J.P

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STAT+: Medicare Advantage-focused Oak Street, Agilon Health chart out growth at J.P. Morgan

STAT

Senior-focused primary care providers Oak Street Health and Agilon Health used their stage time at the J.P. Morgan Healthcare Conference in San Francisco on Monday to talk up their ambitious growth plans in the coming year. Both Oak Street and Agilon’s business models are centered around the Medicare Advantage program, the private form of Medicare for people over 65.

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CVS, Cigna back kidney care coordination, tech startup Monogram Health's latest $375M raise

Fierce Healthcare

CVS, Cigna back kidney care coordination, tech startup Monogram Health's latest $375M raise. dmuoio. Mon, 01/09/2023 - 12:24.

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Free access to Zolgensma curbed, says Novartis

pharmaphorum

Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

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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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JP Morgan 2023 – Day 1

pharmaphorum

We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. Check below for updates throughout the day.

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India’s lax oversight of pharmaceutical manufacturing imperils health around the world

STAT

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases. In the summer of 2022, at least 70 children in Gambia died from kidney failure after using cough medicine made by India-based Maiden Pharmaceuticals that contained ethylen

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Generous Parental Leave Protects Against Poorer Mental Health, Study Results Show

Pharmacy Times

Mothers, in particular, benefit when they are given longer leaves and policies that offer incentives or wage replacement, analysis indicates.

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JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023

Fierce Pharma

JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023. kdunleavy. Mon, 01/09/2023 - 10:34.

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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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Disparity Among Black, White Adults With Uncontrolled Blood Pressure

Pharmacy Times

Black patients aged 18 to 49 years showed a greater association with uncontrolled blood pressure while on an antihypertensive medication.

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STAT+: Moderna plans to follow in Pfizer’s footsteps, charge up to $130 for Covid-19 vaccine in U.S.

STAT

Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts. The timing was not disclosed, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 s

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These socioeconomic factors may be indicators of long COVID risk, study says

Fierce Healthcare

These socioeconomic factors may be indicators of long COVID risk, study says. fdiamond. Mon, 01/09/2023 - 16:48.

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‘I want people to see us’: A writer gives voice to long Covid and mothering from bed

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. Kristin Houlihan, 38, got sick in March 2020 with a virus she assumes was Covid. She wasn’t sick, in a flu-like sense, for long. But then, some symptoms never went away: night sweats, extreme temperature swings after meals.

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Sally Hansen enters press-on nail category

Drug Store News

Sally Hansen’s Salon Effects Perfect Manicure collection consists of ready-to-wear press-on nails that come in a variety of nail lengths, shapes, colors and designs.

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STAT+: Mental health data complicate the question of whether telehealth drives up costs

STAT

The surge in telehealth during the pandemic promised to shed light on a crucial question: Does the convenience of telehealth drive up costs when patients make more appointments than they would in-person? The answer stands to shape investments in — and oversight of — the fast-growing field. But three years in, the mountain of telehealth claims data has created a fresh set of questions, and left regulators, insurers, researchers, and health systems with a newfound recognition that vi

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Novartis to pay $245M to end antitrust litigation over generic Exforge

Drug Store News

Novartis AG agreed to pay $245 million to end antitrust litigation accusing the company of trying to delay the launch of generic versions of the drug Exforge in the United States.

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STAT+: Study finds heavier reliance on nurse practitioners, physician assistants after private equity takeovers

STAT

A new study suggests physician practices acquired by private equity rely more heavily on advanced practice providers like nurse practitioners and physician assistants and experience higher churn compared with their non-private equity owned peers. The researchers used clinician-level and practice acquisition data to study changes in the makeup of clinician workforces at private equity-acquired versus non-private equity-acquired dermatology, ophthalmology, and gastroenterology practices between 20

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11 ways to relieve insomnia from quitting smoking

The Checkup by Singlecare

If you’re considering quitting smoking, or have recently given it up, congratulations! No matter how long you’ve been smoking, quitting is one of the best things you can do for your health. But for all its benefits—and there are many !—it’s not an easy road. You can expect withdrawal symptoms to peak at three days after stopping (and to subside within a month).

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Pediatricians recommend weight-loss drugs and surgery for children with obesity

STAT

Children struggling with obesity should be evaluated and treated early and aggressively, including with medications for kids as young as 12 and surgery for those as young as 13, according to new guidelines released Monday. The longstanding practice of “watchful waiting,” or delaying treatment to see whether children and teens outgrow or overcome obesity on their own only worsens the problem that affects more than 14.4 million young people in the U.S.

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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinical trials.

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Opinion: Four types of bias in medical AI are running under the FDA’s radar

STAT

Although artificial intelligence is entering health care with great promise, clinical AI tools are prone to bias and real-world underperformance from inception to deployment, including the stages of dataset acquisition, labeling or annotating, algorithm training, and validation. These biases can reinforce existing disparities in diagnosis and treatment.

Labelling 101
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Upgrading Omnichannel Coordination to Improve Customer Centricity

PharmExec

"The customer is always right" — a commitment to omnichannel marketing is a commitment to serving the customer. David Laros of Beghou Consulting offers up this tersely written playbook on the topic.

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Telehealth abortion providers eye new options for patients under loosened FDA rules

STAT

In the past year, there’s been a significant surge in interest in medication abortion via telehealth, after the Supreme Court overturned Roe v. Wade and the Food and Drug Administration made it possible for patients to get a prescription online and have the drug delivered to their front doors. Now, telemedicine patients will have more pathways to care.

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Does Medicare cover Freestyle Libre?

The Checkup by Singlecare

Living with diabetes can be manageable, but that doesn’t mean it’s always easy when living with the condition. One less than stellar requirement of managing your diabetes is the daily finger pricks needed to monitor your blood sugar levels. But what if there was a way to track your blood sugar accurately without the constant needle sticks? What is FreeStyle Libre ?

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STAT+: Regeneron’s Eylea sales dip, as competition looms

STAT

SAN FRANCISCO — Regeneron said Monday that it collected $1.5 billion in revenues from its blockbuster eye degeneration drug Eylea in the fourth quarter — a substantial sum for many companies but a possible poor omen for the New York-based biotech. The figures, released ahead of Regeneron’s JPM presentation on Monday, were substantially below analyst projections.

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Alzheimer’s drug Leqembi to launch at discount to Aduhelm

pharmaphorum

Eisai and Biogen’s Alzheimer’s therapy Leqembi will be priced at $26,500 per year – a little less than misfired predecessor Aduhelm – after getting conditional authorisation for the drug from the FDA on Friday. The US regulator has granted accelerated approval to anti-amyloid therapy Leqembi (lecanemab) with a fairly broad label to treat patients in the mild cognitive impairment or mild dementia stage of disease who have confirmed presence of amyloid pathology.

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STAT+: New Biogen CEO: New drug launches, more cost cuts, but no ‘radical left turns’ needed

STAT

SAN FRANCISCO — In some of his first extended comments since taking over as Biogen’s CEO, Chris Viehbacher described the commercial launches this year of an Alzheimer’s treatment and a new medicine for depression as “breakthrough” products will help the company return to sustainable growth. But Viehbacher also acknowledged he has about six months of internal work ahead of him to fix the company’s cost structure.

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Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. is to acquire the 2015-established Amryt Pharma Plc. in an all-cash transaction at $14.50 per American Depositary Share (ADS). Each ADS represents five Amryt ordinary shares. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 billion, with upfront consideration of $1.25 billion representing a 107%

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South Dakota plans major ramp-up of hepatitis C treatment in prison

STAT

WASHINGTON — The head of South Dakota prisons is pledging to dramatically overhaul how the system treats hepatitis C in the coming year. South Dakota’s new hepatitis C policy for incarcerated people, which is not yet final or public, will treat all people with hepatitis C for the virus, regardless of the stage of their infection, Corrections Secretary Kellie Wasko told STAT in an interview Monday.

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