Tue.Mar 21, 2023

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PhRMA submits comments to OSTP on enhancing clinical trial diversity

PhRMA

The White House’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments. PhRMA shares OSTP’s recognition of the importance of having a clinical trial infrastructure that supports sites that are ready to respond to emergency situations like COVID-19.

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Perrigo Recalls Gerber Good Start SoothePro Powdered Infant Formula

Drug Topics

Out of an abundance of caution, the infant formula giant has recalled one of their powdered infant formula products because of a potentially dangerous bacteria.

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Tanzania reports a Marburg outbreak, Africa’s second this year

STAT

Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.

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Cleveland Clinic, IBM unveil first quantum computer dedicated to biomedical research

Fierce Healthcare

Cleveland Clinic, IBM unveil first quantum computer dedicated to biomedical research hlandi Tue, 03/21/2023 - 11:49

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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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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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Study finds same small rise in breast cancer risk in many forms of hormonal birth control

STAT

Pills, patches, implants, and injections — the various forms of hormonal birth control have different formulations and doses of estrogen, progestin, or both. One might think, then, that they may have an unequal influence on breast cancer risk, but a new study in PLOS Medicine on Tuesday suggests that’s not so. The analysis found that most forms of hormonal birth control, regardless of their formulation, seem to confer roughly the same, small increase to breast cancer risk.

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More Trending

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STAT+: A new Medicare ruling could give virtual reality companies an easier path to payment

STAT

The path to payment for virtual reality companies working in health care just became slightly smoother. AppliedVR, a company targeting chronic pain, has become the first digital therapeutic to find an easy way to secure reimbursement from the Centers for Medicare and Medicaid Services. CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment.

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Perceived Vaccine Safety, Efficacy, Among Factors That Impact Demand for Vaccines

Drug Topics

According to a recent literature review, various factors have contributed to a shift in vaccine demand, such as perceived vaccine efficacy and safety.

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CMS ruling paves way for virtual reality companies to obtain reimbursement from payers

Fierce Healthcare

CMS ruling paves way for virtual reality companies to obtain reimbursement from payers fdiamond Tue, 03/21/2023 - 15:53

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Many People Still Unaware Of Telehealth's Efficacy

Drug Topics

Despite telehealth’s rise in popularity during the height of COVID-19, many individuals still aren't aware that it's a viable option.

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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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Methadone doses haven’t kept up in the age of fentanyl. A new rule aims to help

STAT

Patients beginning treatment for opioid addiction often face excruciating withdrawal symptoms. But for people struggling to transition from ultra-potent illicit fentanyl to comparatively weaker addiction medications, help may be on the way. A new federal regulation would make it easier for some patients to begin treatment on significantly higher doses of methadone , a key medicine used to treat opioid use disorder.

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Microsoft's Nuance integrates OpenAI's GPT-4 into voice-enabled medical scribe software

Fierce Healthcare

Microsoft's Nuance integrates OpenAI's GPT-4 into voice-enabled medical scribe software hlandi Tue, 03/21/2023 - 21:32

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Opinion: The lab leak conversation shows it’s time to rethink our biosecurity infrastructure, not just policies

STAT

The Covid pandemic exacerbated fear and panic regarding the potential for a future bioterrorism agent. As the lab leak theory continues to cause debate, politicians want to be able to tell their constituents that they are solving the problem by adding more oversight to biological research. But if all they are doing is adding more burden, bureaucracy, and box-checking, is it really making anyone more secure?

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Parent, Health Care Workers Perceptions of Childhood Immunizations Reviewed

Drug Topics

Attitudes, behaviors, and barriers to immunizations are examples of themes that affect perceptions of childhood vaccines.

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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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Do you need to monitor glucose if you don’t have diabetes?

The Checkup by Singlecare

Maintaining good control of blood sugar levels is important to optimizing health. And for those with diabetes, it’s paramount to avoiding potentially serious complications such as cardiovascular disease, kidney disease, nerve damage, and eye problems. People with diabetes are often prescribed a continuous glucose monitor (CGM) to help monitor blood sugar levels with real-time updates—but it’s possible that people without diabetes could see additional benefits from using one of these devices.

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DOJ, state AGs drop appeal to UnitedHealth-Change Healthcare deal ruling

Fierce Healthcare

DOJ, state AGs drop appeal to UnitedHealth-Change Healthcare deal ruling pminemyer Tue, 03/21/2023 - 17:26

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Watch DSN: How digital tools are transforming pharmacists into stewards of community health

Drug Store News

Drug Store News interviewed Brian Owens, Senior Vice President, Commerce Strategy VMLY&R, about how pharmacists can use digital tools to reach more patients to promote healthy behaviors, improve health outcomes and increase the paths of purchase to O

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Have you had difficulty getting access to medications for opioid addiction?

STAT

STAT is reporting on the obstacles that prevent many Americans from accessing methadone and buprenorphine , two key medications used to treat opioid use disorder. People and organizations that sometimes make it difficult to access medication can include doctors, methadone clinics, health insurance companies, recovery groups, law enforcement agencies, jails, prisons, drug courts, and labor unions.

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High-sensitivity CRP beats LDL cholesterol for adverse CV event and mortality risk prediction

Hospital Pharmacy Europe

High-sensitivity C-reactive protein (CRP) levels provide a better risk estimate of adverse CV events and mortality than LDL cholesterol Measurement of the inflammatory marker, high-sensitivity C-reactive protein (CRP) is a much better predictor for the risk of future adverse cardiovascular events and death in comparison to LDL cholesterol (LDLC), according to an analysis of data from three, large, cardiovascular trials by US researchers.

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Employee Spotlight: Rob Moore

InCrowd

Rob Moore the Director of Information Technology for Apollo Intelligence. Get to know more about him below! Tell us about your role: I’m the Director of Information Technology for Apollo Intelligence. Apollo Intelligence supports market insights brands in the life science space. I’m responsible for managing IT infrastructure (on-prem) and in the cloud (Azure Advice Directory) along with establishing and administering security measures within the organization and overall strategies and proc

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STAT+: 8 burning questions Bernie Sanders and other senators should ask Moderna’s Stéphane Bancel

STAT

WASHINGTON — Moderna CEO Stéphane Bancel has some explaining to do. Bancel will appear alone before Sen. Bernie Sanders’ health committee on Wednesday, where he’ll have to defend his company’s suggestion it will likely quadruple the price of its Covid vaccines once sales transition from bulk federal purchases to the open market.

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MHRA approves prostate cancer combination therapy

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combination therapy with abiraterone and prednisone or prednisolone. AstraZeneca and MSD’s treatment is indicated for adults with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

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Steroid drug reduces death rate in severe pneumonia, study shows

STAT

Giving doses of the steroid hydrocortisone to patients with severe pneumonia cut the risk of death by about half, according to a study released Tuesday. In the study, researchers funded by the French Ministry of Health randomly assigned 800 patients who had been placed in the intensive care unit to receive either hydrocortisone or a placebo. In the hydrocortisone group, about 6% of patients died within 28 days.

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Making the leap from the lab to the boardroom

PharmaVoice

Four academics-turned-executives share what they’ve learned about the pivot point between life sciences academia and entrepreneurship.

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STAT+: Altimmune’s obesity drug fails to stand out from blockbuster treatments in early data

STAT

A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market. The drug, called pemvidutide, is part of a growing class of medications that target the GLP-1 receptor, mimicking the effects of a hormone that can help people feel full.

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Recapping the FDA's Cancer Drug Approvals From The Winter

Drug Topics

Here’s a look back at the cancer drugs that gained FDA approval in the winter of 2023.

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Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma

Fierce Pharma

Gilead's Yescarta puts pressure on BMS' Breyanzi with overall survival win in large B-cell lymphoma fkansteiner Tue, 03/21/2023 - 11:14

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Back-to-office means men’s grooming bonanza

Drug Store News

Sales of shaving products, hair removal and hair care are getting a boost from men looking to spruce up for work and social activities.

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STAT+: Patient groups balk at former AstraZeneca official negotiating U.K.-India free trade deal

STAT

More than 200 civil society and patient advocacy groups are urging the U.K. government to remove the key negotiator working on a free trade agreement with the Indian government because of his previous ties to a major pharmaceutical company. A leaked version of the agreement already sparked concerns last year that the proposed deal would impede the supply of affordable generic medicines in poor countries around the world.

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Senators say organ procurement organizations' recent spike in recovered pancreata is hard to digest

Fierce Healthcare

Senators say organ procurement organizations' recent spike in recovered pancreata is hard to digest dmuoio Tue, 03/21/2023 - 13:47

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Biopharma industry lobbies for tax breaks related to US-based manufacturing

Fierce Pharma

Biopharma industry lobbies for tax breaks related to US-based manufacturing kdunleavy Tue, 03/21/2023 - 11:14

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2 health insurance execs make list of the world's 10 most influential CEOs

Fierce Healthcare

2 health insurance execs make list of the world's 10 most influential CEOs pminemyer Tue, 03/21/2023 - 13:10

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Nirvana Water Sciences Corp. unveils Nirvana Super line

Drug Store News

The new suite of beverages features eight flavors across three categories and is available in spring water, sparkling seltzer and shots.

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BioNTech and OncoC4 to partner for development and commercialisation of novel checkpoint antibody

Pharmafile

BioNTech and OncoC4 have entered a strategic collaboration for the co-development and commercialisation of a novel checkpoint antibody for multiple solid tumor indications. BioNTech will receive an exclusive worldwide license from OncoC4 for its anti-CTLA-4 monoclonal antibody candidate, ONC-392.

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