Mon.Oct 14, 2024

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Lundbeck to buy brain drug developer Longboard for $2.6B

BioPharma Drive: Drug Pricing

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

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A Boozy Night Out Could Upset Your Heart's Rhythm

Drugs.com

MONDAY, Oct. 14, 2024 -- Binge drinking at a party or club could feel great when the music's beating, but it's your heart beat that might pay the price.Researchers in Germany found that 1 in every 20 young Munich revelers developed "clinically.

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Pfizer drug for hemophilia approved by FDA

BioPharma Drive: Drug Pricing

The approval of Hympavzi Friday was a dose of good news for Pfizer, which is dealing with research setbacks and a challenge from an activist investor.

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1 in 4 U.S. Adults Suspect They Have Undiagnosed ADHD

Drugs.com

MONDAY, Oct. 14, 2024 -- Alison Burke wanted to be there for her daughter following the girl’s diagnosis with attention-deficit/hyperactivity disorder (ADHD).Then she noticed that a lot of what she was learning about ADHD sounded awfully f.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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The Role of Risk Assessment in Generic Drug Development

Drug Patent Watch

Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy. The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy.

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Most ERs Not Fully Equipped to Treat Pediatric Patients

Drugs.com

MONDAY, Oct. 14, 2024 -- New findings may worry many parents: Nearly 8 in 10 emergency rooms lack the supplies and training needed to treat pediatric patients, new U.S. research shows.To be ready to address children’s emergencies, ERs need “key ped.

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Long-Term Care Out of Reach for 6.5 Million 'Near Dual' American Seniors

Drugs.com

MONDAY, Oct. 14, 2024 -- About 6.5 million “Near Dual” seniors are struggling to afford long-term care as they grow older and more frail, a new study warns.“Near Dual” seniors are those who are eligible for Medicare but are only at the cusp of eligi.

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FDA, facing pressure, to review position on Zepbound, Mounjaro shortage

BioPharma Drive: Drug Pricing

The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.

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GLP-1 Weight-Loss Meds, Wegovy, Zepbound, Won't Raise Teens' Suicide Risk, May Even Lower It

Drugs.com

MONDAY, Oct. 14, 2024 -- As with any new drug, parents and doctors may worry that the use of GLP-1 weight-loss meds by children and teens might raise psychiatric risks, including the risk for suicide and suicidal thoughts. But a new study involving.

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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog: Biosimilars

By Steven J. Gonzalez — On September 27, 2024, in U.S. v. California Stem Cell Treatment Center, Inc., a Ninth Circuit panel unanimously held that a stem cell clinic’s Stromal Vascular Fraction (SVF) procedure constitutes a “drug” under the Food, Drug and Cosmetic Act (FDCA) and does not meet the “same surgical procedure” (SSP) exception to FDA’s regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) contained in 21 C.F.R.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Ozempic Plus Intestinal 'Zap' Therapy May Eliminate Need for Insulin in Type 2 Diabetics

Drugs.com

MONDAY, Oct. 14, 2024 -- Results from a very small study suggest that a combination of the diabetes drug Ozempic and an innovative new intestinal procedure could help erase the need for insulin in folks with type 2 diabetes.The new trial hasn't.

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Avenciguat

New Drug Approvals

Avenciguat, 1579514-06-9 BI-685509, 582.7 g/mol, C 34 H 38 N 4 O 5 UNII ZA7KTB4PSP 5-ethoxy-1-[6-[3-methyl-2-[[5-methyl-2-(oxan-4-yl)-3,4-dihydro-1 H -isoquinolin-6-yl]methoxy]phenyl]pyridin-2-yl]pyrazole-4-carboxylic acid Avenciguat (BI-685509) is a potent and orally active sGC activator. Avenciguat restores cyclic guanosine monophosphate (cGMP) and improves functionality of nitric oxide (NO) pathways.

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Change in Alzheimer's Drug Vial Size Could Be Big Money-Saver for Medicare

Drugs.com

MONDAY, Oct. 14, 2024 -- A simple tweak in available vial sizes of the breakthrough Alzheimer’s drug Leqembi could save Medicare hundreds of millions of dollars each year, a new analysis claims. About 6% of Leqembi (lecanemab) is discarded.

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Exploring Apigee: A Comprehensive Guide to API Management

Perficient: Drug Development

APIs, or application programming interfaces, are essential to the dynamic world of digital transformation because they allow companies to communicate quickly and efficiently with their data and services. Consequently, effective management is essential to ensure these APIs function correctly, stay safe, and provide the desired benefits. This is where Google Cloud’s top-tier API management product, Apigee, comes into play.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Learn Another Language to Boost Your Brain's 'Efficiency'

Drugs.com

MONDAY, Oct. 14, 2024 -- Bilingual people have more active and flexible brains, a new study has discovered.Brain scans revealed that folks who speak two languages have increased connectivity between their brain regions, researchers reported Oct. 10.

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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Conversations in Drug Development Trends

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

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Exercise in Pregnancy Might Lower Baby's Odds for Asthma Later

Drugs.com

MONDAY, Oct. 14, 2024 -- A child’s risk of asthma can be cut by nearly half if their mother regularly works out while expecting, a new study says.Exercising three or more times a week while pregnant reduces a child’s risk of asthma by about 46%, res.

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Impact of Item Classification (Oracle PDH Cloud) on Oracle Procurement Cloud

Perficient: Drug Development

In today’s fast-paced business environment, efficient procurement processes are essential for maintaining a competitive edge. Organizations must manage a myriad of products and services, ensuring that they are sourced, purchased, and delivered efficiently. Oracle Product Data Hub (PDH) Cloud and Oracle Procurement Cloud are two powerful tools that facilitate this process.

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More Bystanders Are Using Naloxone to Save Folks From Overdose

Drugs.com

MONDAY, Oct. 14, 2024 -- More bystanders are stepping in to administer naloxone to people who’ve overdosed on opioids, a new study shows.Nearly 25,000 OD patients received naloxone from an untrained bystander before paramedics arrived, according to.

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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Conversations in Drug Development Trends

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

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Bridging science and technology: a biotech CEO’s perspective

Drug Target Review

We interviewed Dr Neil Wilkie, CEO of Mironid Ltd., who shared his thoughts on the challenges faced by biotech companies in drug discovery, highlighting the critical role of data and technology in overcoming inefficiencies in the pharmaceutical industry. With over three decades of experience spanning both big pharma and venture capital, Wilkie provided a seasoned perspective on the intersection of business leadership, innovation, and technology adoption.

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GSK says antibody drug succeeds in testing for chronic nasal condition

BioPharma Drive: Drug Pricing

The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma.

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Drug Patent Expirations for the Week of October 13, 2024

Drug Patent Watch

BYDUREON (exenatide synthetic) Astrazeneca ab Patent: 9,238,076 Expiration: Oct 15, 2024 See More … Source

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Successful COA selection paves the path to drug development

BioPharma Drive: Drug Pricing

Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.

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From maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success

BioPharma Drive: Drug Pricing

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Choosing the right hub partner: A blueprint for decision-makers

BioPharma Drive: Drug Pricing

An effective drug launch requires a hub partner with key capabilities, as outlined in the 2024 Patient Services Report by CareMetx.

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