Sat.May 27, 2023 - Fri.Jun 02, 2023

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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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ICYMI: PBM exec admits choosing profits over patients

PhRMA

With Congress discussing policy changes that would lower drug costs for patients and rein in powerful middlemen, insurers and their PBMs are dusting off their old playbook and once again threatening to increase costs for employers if required to do their job and actually provide meaningful coverage to patients. But recent remarks by one executive make clear that the PBM industry has a choice: protect its profits or lower costs for patients.

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The Chronic Complications For Children With T1DM

Drug Topics

Part of the risk of developing kidney involvement begins when type 1 diabetes mellitus (T1DM) sets in and establishes itself in the patient, with up to 65% of children experiencing acute kidney injury during T1DM onset, which can further predispose to the development of future chronic kidney disease.

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COVID-19 Infection Could Be Detected in Lungs, Heart, Causing Inflammatory Damage

Pharmacy Times

Investigators found thinner ventricular walls, disorganized and ruptured myocardial fiber, mild inflammatory infiltration, and mild epicardia or interstitial fibrosis in the hearts of mice infected with COVID-19.

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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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Firstline As A City-Wide Platform To Support Antimicrobial Stewardship: Insights From New York City

IDStewardship

In this article the adoption of Firstline as a city-wide platform to support antimicrobial stewardship in collaboration with New York City Department of Health and Mental Hygiene is discussed. Interview with: William Greendyke, M.D. Interview by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 3 June 2023 We have come a long way since the term “ Antimicrobial Stewardship ” first appeared in the medical literature in 1996, brought to us by John McGowan and Dale Gerding.

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Addressing Mental Health: A conversation with Barry Greene, CEO of Sage Therapeutics

PhRMA

As we recognize Mental Health Awareness Month, I had the opportunity to connect with PhRMA board member Barry Greene, CEO of Sage Therapeutics, about the company’s efforts to address mental health.

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Pharma giant Bayer moves deeper into digital health with new business unit

Fierce Healthcare

Pharma giant Bayer is launching a precision health unit as it ramps up its investment in consumer-facing digital health tools. | Pharma giant Bayer is launching a precision health unit as it ramps up its investment in consumer-facing digital health tools.

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STAT+: Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts

STAT

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthri

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FDA Approves Abrysvo to Prevent Respiratory Syncytial Virus in Older Adults

Pharmacy Times

Pfizer Inc’s bivalent respiratory syncytial virus (RSV) vaccine Abrysvo is indicated to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

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Support your Pharmacy’s Just Culture Journey

Drug Topics

Pharmapod’s Incident Management reporting platform + Patient Safety Organization improves processes to enhance medication and patient safety

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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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Medicare to broaden coverage of Alzheimer’s drugs after full FDA approval, but with some restrictions

Fierce Healthcare

The Centers for Medicare and Medicaid Services outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration | CMS outlined plans Thursday to broadly cover a new class of Alzheimer’s drugs once the medications get full approval from the Food and Drug Administration.

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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer

Fierce Pharma

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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The Latest in the Role of Pharmacogenomics in Mental Health Treatment

Pharmacy Times

Pharmacogenomic testing in combination with therapeutic drug monitoring can be a cost effective and efficient way to advance psychiatric drug therapy.

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Drug Manufacturer Coupons: Charitable Assistance or Marketing Tool?

Drug Topics

The frequency of drug manufacturer coupon utilization is associated with more market competition—but not patients’ out-of-pocket costs.

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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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Discrimination, racism, violence are common and weighing heavily on healthcare workers, surveys show

Fierce Healthcare

A pair of new healthcare workforce surveys outline widespread reports of discrimination, racism and workplace violence perpetuated by patients and coworkers alike. | A pair of polls released this week detail the interpersonal difficulties nurses and other healthcare workers face in the workplace.

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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Study: Oral Semaglutide Leads to Significant Weight Loss in 89.2% of Individuals in Trial

Pharmacy Times

Individuals administered oral semaglutide 50 mg achieved a statistically significant weight loss of approximately 17.4% after 68 weeks, according to Novo Nordisk.

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WHO Encourages Caution As AI Becomes More Prevalent In Health Care

Drug Topics

The World Health Organization (WHO) shared their enthusiasm for the “appropriate” use of new technologies, and urged safety and caution as automation becomes normalized in the health care sphere.

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Oak Street Health unveils expansion plans to open centers in 4 new states

Fierce Healthcare

Less than a month after CVS Health acquired Oak Street Health, the primary care provider plans to expand into four more states. | The company plans to open value-based primary care centers in Little Rock, Arkansas; Des Moines and Davenport, Iowa; Kansas City, Kansas and Richmond, Virginia, beginning this summer. Oak Street Health will operate centers in 25 states by the end of the year.

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ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm

Fierce Pharma

As doctors weigh various immunotherapy strategies for the treatment of early-stage non-small cell lung cancer, Merck & Co. | As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care.

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FDA Approves Olaparib Plus Abiraterone, Prednisone for Metastatic Castration-Resistant Prostate Cancer

Pharmacy Times

Investigators previously reported a statistically significant improvement in radiographic progression-free survival in the full intention-to-treat population of adults with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

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Biosimilars Are Not Having a Big Impact on Insulin Prices

Drug Topics

Years of steady price increases have made access to the essential medicine more difficult for millions of Americans with diabetes.

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Missouri nonprofit health systems BJC HealthCare, Saint Luke's targeting $10B merger

Fierce Healthcare

BJC HealthCare of St. | The two organizations are hoping to close their cross-market deal by the end of the year, potentially creating a new 28-hospital, integrated, academic health system.

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STAT+: Tempus launches an AI ‘assistant’ for thousands of oncologists

STAT

Tempus, a company that combines DNA sequencing for cancer with artificial intelligence, said Thursday that it is launching a voice-and-text assistant called Tempus One that will give physicians much easier access to patient data. The AI assistant is being launched ahead of the annual meeting of the American Society of Clinical Oncology in Chicago. Eric Lefkofsky, Tempus’ founder and CEO, told STAT Tempus will be rolling the product, called Tempus One, out to the 6,000 doctors that prescri

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Clinical Overview: Biologic Agents for the Treatment of Crohn Disease

Pharmacy Times

As more becomes known about Crohn disease, treatment modalities have evolved with biologic monoclonal antibodies becoming a key part of guideline- and evidence-based medicine.

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Coherus Biosciences Joins Forces With Mark Cuban’s Online Pharmacy for Humira Biosimilar

Drug Topics

Yusimry (adalimumab-aqvh) is 1 of 9 FDA-approved adalimumab biosimilars and is a low-concentration, citrate-free product.

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Employers hope to weather inflation without shifting healthcare costs to workers: survey

Fierce Healthcare

Employers are bracing for 2024, fearing they’ll face inflation and soaring healthcare costs while still trying to recruit and retain workers in a tight labor market, a new survey shows. | Employers got something of a break last year from inflation when it comes to healthcare costs because most contracts with providers last three years. A survey by the consulting company Mercer says they won’t be so lucky in 2024.

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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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Questionable Drug Studies in Minors Enforced by Regulatory Authorities

Pharmacy Times

Pediatric drug development, which has a complex background and history, has fundamental catches based around how children are defined in the context of clinical studies.

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Efficacy of Therapeutic Cannabis in Patients With Medically Diagnosed Conditions

Drug Topics

A majority of patients say that taking cannabis helps them with chronic pain management and other conditions.

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Attack by notorious ransomware group compromises personal data of 8.9M dental patients

Fierce Healthcare

Data breaches for the year have reached the high-water mark with the data of nearly 9 million individuals being compromised in a reported cyberattack on one of the country’s largest dental health i | Managed Care of North America posted a notice Friday that between Feb. 26 and March 7, a digital intruder stole the data of 8.9 million people. The cyberattack is the largest of its kind in 2023 to date.

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ASCO: AstraZeneca guns for wider ovarian cancer market with Imfinzi-Lynparza combo. Will the FDA buy the plan?

Fierce Pharma

Lynparza may be the most popular PARP inhibitor, but a use restriction in ovarian cancer has been a thorn in AstraZeneca’s side. | AstraZeneca is bringing on Imfinzi to potentially help Lynparza reach a broader ovarian cancer population. But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.

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Early Clinical Data for Combination of Fianlimab, Cemiplimab Shows Clinically Meaningful Results in Advanced Melanoma

Pharmacy Times

In the initial cohort, 63% of patients with advanced melanoma achieved an objective response rate, including 6 who had a complete response and 19 who had a partial response to the combination of fianlimab and cemiplimab.

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Exploring the Link Between Reduced Exercise Capacity and Cardiopulmonary Symptoms in Long COVID

Drug Topics

New research suggests that chronotropic incompetence contributes to exercise limitations in Long COVID.

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