Mon.Mar 13, 2023

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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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Nasal Spray For Migraines Gets FDA Approval

Drug Topics

The spray, called Zavzpret, intends to help individuals who struggle with migraines but can't take oral medication because of nausea or vomiting

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STAT+: Veterans Health Administration will cover the newest Alzheimer’s drug

STAT

In an unexpected move, the Veterans Health Administration decided that it will widely cover a new Alzheimer’s treatment , even as Medicare has decided to wait for additional data about the medicine before taking the same step. The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment.

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9 ways to improve your gut health

The Checkup by Singlecare

If you think your stomach’s only job is to digest food, think again: The human gut plays a major role in your immune system and mental health. Meaning, when your gut is unhappy, there’s a good chance the rest of your body will be, too. An unhealthy gut, or dysbiosis, can cause inflammation in the gut, says physician and registered dietitian Amy Burkhart, MD, of The Celiac MD.

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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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Opinion: The second age of psychedelic therapies for mental health

STAT

Psychedelics like psilocybin and ketamine are being touted as the next generation of treatment for depression, anxiety, and other mental health issues. There’s no question that a next generation is needed. But it’s not like flipping a switch: These therapies involve a novel administration paradigm, acceptance by regulatory bodies, and public appreciation of their unique medicinal value.

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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

The FDA Law Blog

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab

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STAT+: Buyer’s remorse: How a Medicare Advantage business is strangling one of its first funders

STAT

When NaviHealth began building a business around using algorithms to scrutinize the care of older patients a decade ago, one of the country’s largest chains of inpatient rehab and long-term care hospitals was among the first to invest. Select Medical cut a check of about $5 million — a rounding error for a conglomerate that generates more than $6 billion of revenue every year.

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Kroger hires former House Speaker Boehner to push for approval of proposed merger with Albertsons

Drug Store News

Boehner, who is employed by Squire Patton Boggs, a law and lobbying company, will “provide strategic counsel” to Kroger executives and won’t register to lobby, according to a report in The Hill.

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Bempedoic acid reduces major cardiovascular adverse events among statin-intolerant patients

Hospital Pharmacy Europe

Bempedoic acid use among statin intolerant patients led to a significant reduction of adverse cardiovascular outcomes compared to placebo Bempedoic acid (BPA) given to patients at a high risk for cardiovascular disease or who are statin intolerant, led to a significant reduction in the level of major adverse cardiovascular events compared to placebo according to the findings of a large, randomised, double-blind, placebo-controlled trial by an international research group.

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Queen V survey explores women’s feelings about their vagina

Drug Store News

Queen V’s data reveals that over half of women (52%) said their first intimate health issue had a negative impact on their emotional health and well-being and 41% said it made them not want to leave the house.

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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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Common Painpoints to Avoid When Shopping for Pharmacy Software

Digital Pharmacist

Purchasing software can seem like a daunting task for pharmacy owners to tackle on top of all their other day-to-day tasks – but purchasing the right software can automate those tasks and thus free up so much valuable time in the long run. Today we will discuss some pain points to avoid in the process to help you choose wisely the first time and get to the end goal… a more efficient team and happier patients.

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STAT+: Pfizer buys Seagen, maker of targeted cancer drugs, for $43 billion

STAT

Pfizer said Monday it is acquiring Seagen, a maker of targeted cancer drugs, for $43 billion. The deal helps Pfizer, flush with cash but in need of new sources of revenue due to declining sales of Covid treatments, by adding a lineup of cancer drugs called antibody-drug conjugates that work by delivering chemotherapy directly to tumors.

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Sephora, TikTok pioneer Incubator Program for brands, content creators

Drug Store News

The Sephora x TikTok Incubator Program aims to aid participants in learning impactful social content strategies through educational training modules, the companies said.

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Injectable peptide rapidly reduces intracranial pressure

European Pharmaceutical Review

Patients with Idiopathic Intercranial Hypertension (IIH) could be treated with an injectable peptide used for type 2 diabetes, a Phase II trial has found. According to the study results, brain pressure was significantly reduced within two and half hours after an injection of exenatide, a GLP-1 receptor agonist. IIH is a condition that raises pressure in the brain, likely due to a cerebrospinal fluid (CSF) imbalance.

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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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BIC joins forces with Eric Andre, Annie Murphy on EasyRinse razor launch

Drug Store News

The brand is debuting the EasyRinse razor with its “All Shave. No Clog,” campaign starring comedian Eric Andre and actress Annie Murphy.

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With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs'

Fierce Pharma

With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs' kdunleavy Mon, 03/13/2023 - 10:16

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STAT+: Illumina has been ignoring its investors, but it can’t ignore Carl Icahn

STAT

Illumina, the DNA sequencing giant whose stock has fallen 40% in two years, already had problems. Now it has to contend with Carl Icahn. The granddaddy of activist investors announced Monday morning that he’s taken a stake in Illumina and wants three handpicked directors added to the company’s board. The message Illumina’s management should hear is this: Icahn usually gets much of what he wants.

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As hearing health moves onto digital platforms, experts emphasize that hearing aids won't be replaced

Fierce Healthcare

As hearing health moves onto digital platforms, experts emphasize that hearing aids won't be replaced aburky Mon, 03/13/2023 - 17:21

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STAT+: Pharmalittle: Biogen exec who quarterbacked Aduhelm leaves; Pfizer to buy Seagen for $43 billion

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings and deadlines has returned. But you knew this would happen, yes? After all, the world continues to spin no matter how we try to slow it down. So to cope, we are firing up the coffee kettle and brewing cups of stimulation.

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Giant recognizes team members during annual business meeting

Drug Store News

The company granted 15 awards recognizing the recipients’ commitments to the company and their efforts to connect families for a better future.

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STAT+: French pharma Sanofi buys maker of diabetes treatment for $2.9 billion

STAT

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion. The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

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Sandoz to build biologics plant in Slovenia

European Pharmaceutical Review

Sandoz has signed a Memorandum of Understanding (MOU) to build a new biologics production plant in Lendava, Slovenia. The company’s expected $400 million investment is the largest-ever international private-sector investment in the country. The “state-of-the-art” site will enable Sandoz “to meet growing demand for our current and future biosimilars in the mid- to long-term,” noted Glenn Gerecke, Global Head of Sandoz Technical Operations. “Not only does the location has offer c

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STAT+: 102 hours of chaos: How SVB’s collapse rattled the biotech industry

STAT

Paul Rennert was surprisingly energized after deplaning a transatlantic flight in Boston Thursday evening. He had just wrapped up weeks of international travel and investor meetings, and was pleased that even though the biotech industry was in the midst of one of the worst financing environments in years, venture capitalists had seemed receptive to the idea of investing in his startup, Aleta Biotherapeutics.

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ECRI: The growing pediatric mental health crisis is 2023's biggest patient safety challenge

Fierce Healthcare

ECRI: The growing pediatric mental health crisis is 2023's biggest patient safety challenge pminemyer Mon, 03/13/2023 - 16:55

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US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule. It increased the branching of dendrites and synaptic plasticity signals in animal trials.

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Oak Street Health: Medicare Advantage advance notice could divert resources from dual eligibles

Fierce Healthcare

Oak Street Health: Medicare Advantage advance notice could divert resources from dual eligibles rking Mon, 03/13/2023 - 17:07

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Acadia's Daybue wins FDA nod as first treatment for Rett syndrome

Fierce Pharma

Acadia's Daybue wins FDA nod as first treatment for Rett syndrome esagonowsky Mon, 03/13/2023 - 09:28

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SXSW 2023: Tech innovation in the spotlight, but SVB fallout casts a shadow

Fierce Healthcare

SXSW 2023: Tech innovation in the spotlight, but SVB fallout casts a shadow hlandi Mon, 03/13/2023 - 07:34

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So Delicious Dairy Free rolls out no added sugar yogurt alternative

Drug Store News

The new yogurt alternative is available in four flavors—coconut, strawberry, vanilla and blueberry.

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Patients seek appeal in landmark UnitedHealth mental health parity case

Fierce Healthcare

Patients seek appeal in landmark UnitedHealth mental health parity case pminemyer Mon, 03/13/2023 - 15:36

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Sanofi to acquire Provention Bio in $2.9bn deal

Pharmafile

Sanofi has agreed to acquire Provention Bio as part of a $2.9bn deal that aims to improve the company’s portfolio of diabetes medicines, with a new treatment developed by Provention having recently been approved in the US. The companies had an existing agreement for the commercialisation of Provention’s drug, a monocloncal antibody to delay clinical type 1 diabetes, which the new deal builds on.

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Seeking to boost shareholder returns, Novartis readies new $11B buyback round

Fierce Pharma

Seeking to boost shareholder returns, Novartis readies new $11B buyback round aliu Mon, 03/13/2023 - 11:07

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Babson aims to shed Theranos curse with new blood testing tech

PharmaVoice

Babson Diagnostics is trying to create a less invasive blood testing technology — can it gain trust in the post-Theranos era?

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Advancing ‘Smart Pharma’ Capabilities in 2023 and Beyond

Pharmaceutical Commerce

Q&A explores new opportunities to strengthen supply chain resilience—and build on the lessons learned.

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