Mon.Dec 12, 2022

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What’s in a Title?

Drug Topics

When it comes to practicing pharmacy, do titles and degrees actually matter?

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Three things to know about the accelerated approval pathway

PhRMA

If you or a loved one were to receive a diagnosis of a serious or life-threatening disease, you would likely want access to a U.S. Food and Drug Administration (FDA) approved safe and effective medicine as soon as possible. That’s precisely why the accelerated approval pathway was created back in 1992 at the urging of patient advocates. Since then, it has been a lifeline for millions of patients.

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Examining the Impact of the Roe v Wade Decision on Medication Access

Drug Topics

Investigators set out to evaluate how medication access for certain rheumatic conditions has changed since June 2022.

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The pharma giants making the biggest strides with global drug access

PharmaVoice

A recent report ranks the top 20 pharma companies by how well they’re boosting a critical component of health equity.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Technology Tools for Mental Health Screening

Drug Topics

Online portals are accessible via tablet or computer and can streamline the mental health screening process.

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The 2023 PharmaVoice Year in Preview

PharmaVoice

Here’s a look at how industry leaders are navigating the key issues of 2023.

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More Trending

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Spotlight on oncology drug development & its future

PharmaVoice

Learn why an informed, holistic view is needed to succeed in today’s complex and dynamic landscape.

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Dapagliflozin Improves Outcomes in Patients With Chronic Kidney Disease Regardless of Presence of Diabetes

Pharmacy Times

Dapagliflozin (Farxiga) found effective in lowering the risk of hospitalization for patients with chronic kidney disease, with or without a diagnosis of type 2 diabetes, and increased the number of days alive and out of the hospital.

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House and Senate Dems want CMS to drop ACO REACH members due to fraud concerns

Fierce Healthcare

House and Senate Dems want CMS to drop ACO REACH members due to fraud concerns. rking. Mon, 12/12/2022 - 16:08.

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First patient given base-edited CAR T cells

European Pharmaceutical Review

A thirteen-year-old patient with relapsed T-cell acute lymphoblastic leukaemia (T-ALL) has been the first to be treated with base-edited T-cells via CD7 Chimeric Antigen Receptor (CAR)-T cell therapy, which enabled them to achieve remission 28 days later. . A unique clinical trial for T-ALL. The patient enrolled in the ongoing clinical trial ( NCT05397184 ) went on to receive a second bone marrow transplant after the therapy.

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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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Novel Compounds Show Potential for Treating Anxiety Disorders With Fewer Adverse Effects

Pharmacy Times

Lead compounds may lower the risk of abuse and other adverse effects compared with other drugs currently being evaluated for mental health disorders, such as MDMA.

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Revenge of the gaslit patients: Now, as scientists, they’re tackling Ehlers-Danlos syndromes

STAT

Type “Ehlers-Danlos syndromes” into a search engine, and multiple suggestions pop up. Is Ehlers-Danlos an autoimmune disease? Is EDS hereditary? Rare? Then, the algorithm might suggest: Is Ehlers-Danlos syndrome a disease?

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Widespread Implementation of Long-Acting PrEP for HIV May Be Stifled By High Price Tag, Say Researchers

Pharmacy Times

Following the approval of cabotegravir in 2021, governments and donor agencies in low- and middle-income countries are contemplating replacing oral pre-exposure prophylaxis or augmenting the approach with long-acting treatment.

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Is my Software a Medical Device? Use the Digital Health Policy Navigator

The FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device.

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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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Family Supporters Attending Programs Improve Patients’ Management of Diabetes

Pharmacy Times

Relatives who attend low-intensity coaching and monitoring meetings increase individuals’ ability to manage the disease.

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Healthcare companies' default risk steadily rising, with most owned by private equity: Moody's

Fierce Healthcare

Healthcare companies' default risk steadily rising, with most owned by private equity: Moody's. hlandi. Mon, 12/12/2022 - 22:05.

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Proof of Delivery is Key to Maximizing Pharmacy Reimbursement, Defending Audits and Preventing Costly Write-Offs

Pharmacy Times

Five crucial steps pharmacies can take to enhance patient engagement and lower operational costs.

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Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati

Fierce Pharma

Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati. aliu. Mon, 12/12/2022 - 18:14.

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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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ED docs offer better care than nurse practitioners, research finds

Fierce Healthcare

ED docs offer better care than nurse practitioners, research finds. fdiamond. Mon, 12/12/2022 - 16:05.

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STAT+: The Covid-19 test maker that pivoted to being a health insurance company

STAT

Curative rose to prominence during the throes of the pandemic, as people and governments across the country used its Covid-19 tests. But that business is now firmly in the past, and the company has switched to an even more regulated industry: health insurance. Last year, Curative had a cloud hanging over its head. It got into trouble with the Food and Drug Administration and states, which said the company’s tests led to too many false negatives, meaning the tests may have told patients th

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Heart supplements offer hope with solid studies to back up promises

Drug Store News

From CoQ10 to omega-3s, supplements for the heart are supported by compelling research.

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Inizio acquires Evolution Road

PharmExec

The move bolsters Evoke’s digital innovation and omnichannel offering.

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Federal appeals court strikes down Biden admin's transgender care mandate

Fierce Healthcare

Federal appeals court strikes down Biden admin's transgender care mandate. hlandi. Mon, 12/12/2022 - 06:58.

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Utrogestan accepted as HRT in Scotland

European Pharmaceutical Review

The Scottish Medicines Consortium (SMC) has accepted Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.

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Amgen’s AMG-133 shows potential in competing with GLP-1RA obesity therapies

Pharmaceutical Technology

Pipeline therapies within the cardiometabolic space have recently gathered interest following the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference, which took place on 1–3 December. The spotlight was placed on many up-and-coming pharmacotherapies within the space, one of which was Amgen’s obesity therapy, AMG-133, following the company’s announcement of its Phase I therapy results last week, on 1 December.

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Amgen agrees $26bn for Horizon following Sanofi withdrawal

pharmaphorum

In a fresh update, Bloomberg has reported that US biotech Amgen Inc. has agreed to purchase Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26bn), in a deal which could yet see further delays or a breakdown in negotiations. Following Sanofi’s withdrawal from the running, stating that “transaction price expectations do not meet [their] value creation criteria” – for the purposes of Rule 2.12 of the Irish Takeover Rules in response to Horizon’s announcement under Rule 2.4 of the I

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Kite and Arcellx enter partnership for multiple myeloma therapy development

Pharmaceutical Technology

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite.

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Empowering MSLs to be the kings of Pharma’s New Frontier

pharmaphorum

The demand for high-calibre, sharply-focussed clinical knowledge and data is increasing as HCPs streamline and recalibrate their engagements with the pharmaceutical sector. But, although open opportunities are diminishing and time slots are being squeezed, MSLs are emerging as the ideal ambassadors to ensure the science and data reaches the right targets and makes connections.

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Home ovulation diagnostic startup Proov brings hormone insights to Google Health Connect

Fierce Healthcare

Home ovulation diagnostic startup Proov brings hormone insights to Google Health Connect. aburky. Mon, 12/12/2022 - 13:11.

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STAT+: Ongoing problems with a new European clinical trial registry could cause ‘catastrophe’

STAT

A coalition of pharmaceutical industry and academic medical research associations based in Germany is calling for the indefinite suspension of a new European system to register clinical trials, citing “serious shortcomings” that need to be fixed. In a strongly worded statement released late last month, the organizations expressed concern that the clinical trial information system, or CTIS, suffers from “deficiencies” that have only worsened since it debuted this past

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Utrogestan approved as HRT in Scotland

European Pharmaceutical Review

The Scottish Medicines Consortium (SMC) has approved Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.

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STAT+: Amgen’s $27.8 billion Horizon merger is latest industry bet on pricey rare disease drugs

STAT

Amgen said Monday it would purchase Horizon Pharmaceuticals for $27.8 billion, marking the latest bet by a large pharmaceutical company on the lucrative market for treating a rare disease. The deal is the largest pharma merger announced this year, and it represents the most that Amgen has spent on an acquisition since its $16 billion purchase of Immunex in 2001.

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Curology’s personalized skin care products hit Target shelves

Drug Store News

Curology will launch seven of its bestselling and dermatologist-formulated products, as well as an exclusive Starter Set, at Target.

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