FDA Law Blog: Biosimilars

MARCH 29, 2023

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Antidote

MARCH 29, 2023

The annual Kidney Action Week is a virtual event put on by the American Kidney Fund designed to bring the entire kidney health community together for a week of amazing and informative content on all things related to kidney health. The event is filled with discussions, Q&As, webinars, and more — and this year, Antidote was thrilled to be involved!

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NIOSH Science Blog: Drugs

MARCH 15, 2023

Employers can play a vital role in suicide prevention. Historically, suicide, mental health, and well-being have been underrepresented in workplace health and safety efforts, but this is changing. In some European countries, there are workplace standards for workplace psychosocial hazards that put workers at risk for suicide. Additionally, in France, employers have been made accountable for toxic workplaces and management practices that contributed to worker suicides.[1] Some of the latest workp

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FDA Law Blog: Drug Discovery

MARCH 19, 2023

Hyman, Phelps & McNamara, P.C.’s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. The article arose out of work conducted by the Pathway Development Consortium , a partnership between stakeholders in the AAV gene therapy space.

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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

Treatment

Advarra

MARCH 10, 2023

Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African American population. Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

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Drug Channels

MARCH 28, 2023

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies.

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Antidote

MARCH 24, 2023

The rare, inherited blood disorder hemophilia is estimated to impact approximately 20,000 individuals in the United States , and over 400,000 worldwide. Currently, there is no cure for hemophilia — but through ongoing research, medical experts are continually learning more about the disease.

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Drug Patent Watch

MARCH 12, 2023

This chart shows the companies which have received the most pediatric exclusivities in the past five years. Pediatric exclusivity is granted to drug companies for conducting pediatric studies on their… The post Pharmaceutical companies with the most ‘Pediatric Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

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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Eye on FDA

MARCH 5, 2023

In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the outcomes were increasingly negative. Just to recap, for the entire year of 2022 there were only 14 meetings held to consider whether new medicines should be recommended for approval, a slight increase over the 10 the year before, but considerably lower fewer than 2018

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Drug Channels

MARCH 8, 2023

Next week, Drug Channels Institute will release our 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 14th edition of our popular and comprehensive examination of the entire U.S. drug pricing, reimbursement, and dispensing system. The exhibit below—one of 241 in our new report—provides a first look at the 15 largest organizations, ranked by total U.S. prescription dispensing revenues for calendar year 2022.

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The Pharma Data

MARCH 31, 2023

If subsequently approved, Entresto will be the first and only approved therapy for the treatment of symptomatic chronic heart failure patients aged 1 to <18 years in the European Union Pediatric heart failure is an important cause of childhood morbidity and mortality – up to a third of all pediatric cardiac admissions are due to heart failure; these hospitalizations are associated with a 20-fold increase in the risk of death 1, 2 The positive opinion is based on final data from the 52-week P

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Antidote

MARCH 20, 2023

Hepatitis B , sometimes abbreviated to HBV, is a liver infection that is one of the most serious in the world. If left untreated, hepatitis B can cause fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.

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Drug Patent Watch

MARCH 4, 2023

This chart shows the drugs with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trials

NIOSH Science Blog: Drugs

MARCH 6, 2023

The construction sector includes a diverse population of workers exposed to many different types of hazards. An important way to prevent occupational illness and injury related to these hazards is by implementing the hierarchy of controls. Personal protective equipment (PPE) is the last control in the hierarchy, but PPE is particularly important when the other controls cannot sufficiently reduce or eliminate hazards.

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FDA Law Blog: Biosimilars

MARCH 30, 2023

By Larry K. Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? Maybe you identify and report suspicious orders or thefts/losses. Or you obtain import or export permits, submit import or export declarations or listed chemical DEA-486s. Do you want to learn more? You have your chance. DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical r

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Drug Channels

MARCH 14, 2023

I am pleased to announce our new 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers , available for purchase and immediate download. Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Analyzes Impact of Inflation Reduction Act on U.S.

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BenchSci

MARCH 31, 2023

As Women’s History Month comes to a close, I wanted to share some of the events and takeaways we learned on behalf of the BenchShe+ leadership team. We had the honor of putting together programming not just for members of the BenchShe+ employee resource group (ERG), but also hosting events company-wide to help educate and inspire our team throughout the month.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

Antidote

MARCH 15, 2023

Idiopathic pulmonary fibrosis , or IPF, can be a frightening diagnosis. IPF is a rare, progressive lung disease that develops differently for everyone, and managing its development can be difficult. However, some individuals are able to live with the disease and stay active for many years.

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Drug Patent Watch

MARCH 26, 2023

This chart shows the pharmaceutical companies with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.

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FDA Law Blog: Biosimilars

MARCH 22, 2023

By JP Ellison & Faraz Siddiqui — On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal interpretation of an ambiguous provision of law and no authoritative guidance from the government warned the defendant away from its interpretation.

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Drug Channels

MARCH 7, 2023

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook This event will be broadcast live on Friday, March 31, 2023, from 12:00 p.m. to 1:30 p.m. ET. This page describes the event and explains how to purchase a registration.

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Crucial Data Solutions

MARCH 30, 2023

In a time with lots of hype surrounding decentralized clinical trial (DCT) solutions, let's not lose sight of the importance of a dependable and secure electronic data capture (EDC) system. This blog post walks you through the basics to keep in mind when selecting an EDC platform for your studies. The post Electronic Data Capture – The Basics appeared first on Crucial Data Solutions.

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Antidote

MARCH 14, 2023

Lung cancer, the leading cause of cancer deaths in the United States , occurs when cells within the lung begin growing in an uncontrolled way, forming tumors or lesions. It typically begins in the cells lining the bronchi, and can eventually spread throughout the lung and to other parts of the body.

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Drug Patent Watch

MARCH 3, 2023

Annual Drug Patent Expirations for NORMOCARB+HF+25 Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug. This… The post New patent expiration for Dialysis Sups drug NORMOCARB HF 25 appeared first on DrugPatentWatch - Make Better Decisions.

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PLOS: DNA Science

MARCH 30, 2023

In “The Last of Us,” a video game and recently-wrapped HBO series , giant mutant fungi turn much of humanity into zombies. In real life, another fungus, the yeast Candida auris , is spreading, just as COVID finally fades. Candida auris is the first multi-drug resistant fungus identified. It is deadlier than familiar relative Candida albicans , which lies behind common vaginal and throat infections.

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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services.

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Drug Channels

MARCH 6, 2023

Informa Connect’s Drug Pricing Transparency Congress May 16-17, 2023 in Washington, DC Drug Channels readers can save 10% with code 23DRCH10 www.informaconnect.com/drug-pricing-transparency Join Informa Connect on May 16-17, 2023 in Washington, DC at the Drug Pricing Transparency Congress to stay on the pulse of federal and state reporting requirements, policy initiatives and strategic best practices for compliance.

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Crucial Data Solutions

MARCH 30, 2023

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. Yet, this is not the case. While most clinical researchers have embraced the use of specialized software platforms to help stay on top of study data, there are still some who continue to collect, store, access and analyze data using old-school pen and paper or with software (like spreadsheets) that are not fit for purpo

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Antidote

MARCH 27, 2023

Each year in March, the National Institute of Diabetes and Digestive and Kidney Diseases puts on National Kidney Month , a month dedicated to raising awareness about kidney health and conditions. Chronic kidney disease, a grouping of conditions that damage the kidneys , impacts around 37 million Americans, and millions of others are considered to be at an increased risk.

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Drug Patent Watch

MARCH 23, 2023

This chart shows the pharmaceutical companies with the most patents in Serbia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Serbia? appeared first on DrugPatentWatch - Make Better Decisions.

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Predictive Oncology

MARCH 28, 2023

Predictive Oncology announces it is partnering with Integra Therapeutics, a company focused on engineering the next generation of gene writing tools to cure diseases. The collaboration was created to pursue a novel method to enhance Integra Therapeutics’ ability to use gene editing for future cancer therapies. Read about the news here. The post Predictive Oncology announces collaboration to advance gene therapy appeared first on Predictive Oncology.

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