Drug Topics

FEBRUARY 20, 2023

United States leaders work together to create bipartisan solutions for the youth mental health crisis.

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The FDA Law Blog

FEBRUARY 20, 2023

By Jeffrey N. Wasserstein — GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal Trade Commission (FTC) and its partners at DOJ’s Consumer Protection Branch recently file a civil complaint against GoodRx for data privacy breaches.

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Drug Topics

FEBRUARY 20, 2023

Not only were people with newly diagnosed type 2 diabetes less likely to develop dementia if they took pioglitazone, but the benefit was stronger among patients with a history of ischemic heart disease or stroke.

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STAT

FEBRUARY 20, 2023

As a physician caring for chronically ill individuals recently released from incarceration, I’ve become accustomed to working as a detective of sorts, trying to piece together the care they received while incarcerated in an attempt to recreate their medical histories and treatment plans. Since they are often released without medical records, prescriptions, and other lifesaving information, I ask questions like, “Do you remember your doctor’s name?

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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

Patient Care

Drug Topics

FEBRUARY 20, 2023

Federal regulators need to address potential policy changes that could affect primary care.

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STAT

FEBRUARY 20, 2023

Heather Rendulic yearns to use both hands to fill up her plate at a hotel buffet, or slice up her own steak. She wants to pull her hair into a ponytail. She’s tried to teach her husband, but it always comes out a bit messy. Almost nine years after a stroke paralyzed the left side of her body at age 23, Rendulic sat in a lab at the University of Pittsburgh and used her left hand to cut a steak.

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STAT

FEBRUARY 20, 2023

Dan Brickey was stunned when he learned the news. The cost of the cystic fibrosis medicine that his 2-year-old daughter, Ali, had recently started taking was about to climb from just $180 out of pocket each year to a whopping $43,600 in 2023. The dramatic change was due to a decision by the drug’s manufacturer, Vertex Pharmaceuticals, to slash the amount of financial assistance that it offers to patients this year.

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The Checkup by Singlecare

FEBRUARY 20, 2023

Insulin resistance vs. diabetes | Causes | Progression | Outlook When you hear the term insulin resistance, you probably think of diabetes. But while insulin resistance can lead to diabetes, it’s not the same thing. Insulin resistance refers to the inability of your body’s cells to respond to insulin, whereas diabetes (and prediabetes) happens when your pancreas doesn’t make enough insulin to regulate your blood sugar.

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Immunization 98

Outsourcing Pharma

FEBRUARY 20, 2023

A survey conducted to understand whether supply issues over amoxicillin have persisted in the US found that an overwhelming majority of pharmacists are still struggling to source the commonly-used antibiotic.

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Pharmaceutical Technology

FEBRUARY 20, 2023

Many have turned their attention to frontotemporal dementia (FTD) as the family of famed action star Bruce Willis announced his diagnosis last week. While there is no cure to this neurodegenerative condition, academics and companies are pushing through with research that could help patients and their families. Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials.

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Medical Schools FDA 98

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.

The Guardian - Pharmaceutical Industry

FEBRUARY 20, 2023

Ian Sample speaks to Guardian science correspondent Nicola Davis about the news that Wegovy, an appetite suppressant popular with celebrities in the US, will soon be sold at UK pharmacies. It’s a prescription drug aimed at helping people with obesity lose weight, but some argue it doesn’t tackle the root cause Clips: BBC, abc7NY Continue reading.

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Outsourcing Pharma

FEBRUARY 20, 2023

The partners will collaborate on a study of sustained drug delivery to the suprachoroidal space in the eye.

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OctariusRx

FEBRUARY 20, 2023

The 2023 controlled substance assessment quiz is about to be released! This is our first annual competency assessment focused on controlled substances and regulatory compliance. Ongoing education and assessments of staff in the handling of controlled substances not only helps with compliance, it’s also a great way to enhance patient safety. How are you assessing your staff?

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Outsourcing Pharma

FEBRUARY 20, 2023

The Dutch company Pharming Group N.V. has switched its rare disease drug leniolisib from an accelerated assessment to a regular review with the European Medicines Agency (EMA).

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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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Pharmafile

FEBRUARY 20, 2023

Medtronic has received CE mark for its extravascular defibrillator. The Aurora EV-ICD™ MRI SureScan™ and Epsila EV™ MRI SureScan™ defibrillation lead treat abnormally fast heart rhythms which can lead to sudden cardiac arrest. Implantable cardioverter-defibrillators (ICDs) are a highly effective treatment for sudden cardiac arrest (SCA). They detect when the patient is experiencing an abnormally fast heart rate and deliver therapy to terminate a potentially fatal arrhythmia.

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Communication 59

Pharma Times

FEBRUARY 20, 2023

VLA1553 is a single-dose, live-attenuated vaccine candidate targeting the highly dangerous chikungunya virus

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Vaccines 55

Pharmafile

FEBRUARY 20, 2023

Apellis’ Syfovre (pegcetacoplan injection) is indicated for patients with geographic atrophy (GA) with or without subfoveal involvement, and has received approval from the FDA. GA is an advanced form of age-related macular degeneration (AMD), which can lead to permanent loss of vision, affecting over 8 million people worldwide. Syfovre is claimed to be the first treatment to be approved for GA and offers dose flexibility for patients and physicians with a schedule of every 25 to 60 days.

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FDA Immunization Communication 59

Pharma Times

FEBRUARY 20, 2023

Research concerns the effect of niraparib when combined with abiraterone acetate plus prednisone

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Pharmacy Management Software

PharmExec

FEBRUARY 20, 2023

When a company reaches late-stages of clinical trials testing new drugs, systems need to be created to manage the manufacturing, sales, costs, internal controls, and more. A successful transition into commercializing a new drug depends on putting in place the right infrastructure and systems.

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Outsourcing Pharma

FEBRUARY 20, 2023

The Indian company begins production of APIs and HPAPIs, after expanding capacity at its Riverview site.

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indispensable health

FEBRUARY 20, 2023

Sunlight, vitamin D, and seasonal affective disorder (SAD) are all interconnected. Sunlight is a primary source of vitamin D, which is essential for the body to absorb calcium and maintain healthy bones. When the skin is exposed to sunlight, it produces vitamin D. However, during the winter months or in areas with limited sunlight, such as in the polar regions or during extended periods of time indoors, people can experience a vitamin D deficiency.

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PharmExec

FEBRUARY 20, 2023

Move enables FINN to address pressing health priorities in developed and developing nations and expands Hyderus global service capabilities and client offerings and Hyderus co-founders Mark Chataway and Christopher Nial join FINN global health leaders team.

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Communication 52

indispensable health

FEBRUARY 20, 2023

There are many productivity habits that successful CEOs use to manage their time and stay productive. Here are seven of the best productivity habits that successful CEOs useto support their effectiveness: 1. Prioritizing tasks: Successful CEOs prioritize tasks based on their level of importance and urgency. This helps them stay focused on the most critical tasks and ensures they make the most of their time.

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PharmExec

FEBRUARY 20, 2023

A new study shows that a growing number of younger generations are turning to social media platforms such as TikTok and Instagram influencers for health advice.

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Outsourcing Pharma

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has accepted Merckâs Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in kidney transplant patients for priority review.

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Pharmafile

FEBRUARY 20, 2023

Stryker, a medical technology company, has announced that its Q Guidance System with Cranial Guidance Software received 510(k) clearance from the FDA. Its system for spinal applications is currently on the market.

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Pharmaceutical Technology

FEBRUARY 20, 2023

Felzartamab is a monoclonal antibody commercialized by I-Mab, with a leading Phase II program in IgA Nephropathy (Berger's Disease).

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Pharmafile

FEBRUARY 20, 2023

Valneva and Pfizer have seen their Lyme disease vaccine study cut down after some clinical trial sites were revealed to be not adhering to Good Clinical Practice (GCP) standards. Almost half of the trial’s participants will be withdrawn following these GCP violations. The protocol violations took place in trial sites run by third-party trial operator, Care Access, meaning that approximately half the patients in the VALOR study will be withdrawn from testing.

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Vaccines Communication 52

Pharmaceutical Technology

FEBRUARY 20, 2023

Epetraborole is a small molecule commercialized by AN2 Therapeutics, with a leading Phase III program in Mycobacterium avium Infections.

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Therapeutics Education Collaboration

FEBRUARY 20, 2023

In episode 534, Mike and James bring Jamie Falk to go through all the evidence for continuous glucose monitors that use subcutaneous sensors. There certainly seems to be evidence of benefit for T1DM but when it comes to T2DM the evidence for a benefit is not clear at all. Have a listen to get all the details. Show Notes Tools for Practice Come Spy with Me: Continuous glucose monitoring in diabetes Annual MEME talk Vancouver May 12/13, 2023 REGISTER NOW In episode 534, Mike and James bring Jamie

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Pharmaceutical Technology

FEBRUARY 20, 2023

Cavatak is an oncolytic virus commercialized by Merck, with a leading Phase II program in Transitional Cell Cancer (Urothelial Cell Cancer).

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PharmaShots

FEBRUARY 20, 2023

Shots: The company highlights results from the preclinical study evaluating the impact of ExoPTEN on the motor, reflex, and sensory recovery of rats following the complete serving of the spinal cord The results depicted that 75% of the rats in the ExoPTEN-treated group responded to treatment and recovered hind limb reflex, rehabilitated some motor function & recovered sensory control.

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Pharmaceutical Technology

FEBRUARY 20, 2023

ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ABN-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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