Tue.Oct 01, 2024

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Patients show 91% response to allogeneic CAR-T therapy

Drug Discovery World

Investigators saw a 91% overall response rate (ORR) in patients with relapsed/refractory multiple myeloma (RRMM) following treatment with allogeneic CAR-T therapy P-BCMA-ALLO1 and lymphodepletion. The interim data from an ongoing Phase I trial in patients who have previously received three or more prior lines of therapy were presented at the 21 st International Myeloma Society (IMS) Annual Meeting in Rio de Janeiro.

Therapies 147
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Research in 4 continents links outdoor air pollution to differences in children's brains

Science Daily: Pharmacology News

A research team systematically analyzed 40 empirical studies, the majority of which had found that outdoor air pollution is associated with differences in children's brains. These differences include volumes of white matter, which is associated with cognitive function, connections throughout the brain and even early markers for Alzheimer's.

Research 116
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Register now for DDW’s first Neuroscience Showcase

Drug Discovery World

In this free online event at 3pm BST on 24 October, hosted by DDW and co-sponsored by ApconiX and AxoSim, leading industry figures will outline the areas of opportunity and challenges in the neuroscience drug discovery & development sector. The showcase will include a panel discussion looking at the use of new drug discovery and development technology, concepts and tools in neuroscience, as well what the future looks like for neuroscience therapies.

Science 130
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GLP-1 Weight-Loss Meds Could Interfere With Endoscopy, Colonoscopy

Drugs.com

TUESDAY, Oct. 1, 2024 -- Food left in the stomach or stool left in the bowel can impede a doctor's ability to successfully perform an endoscopy or colonoscopy.Now, research finds this scenario is more likely if the patient is taking popular new.

Doctors 111
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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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Neuroscience Showcase

Drug Discovery World

In this free online event, hosted by DDW and co-sponsored by ApconiX and AxoSim, leading industry figures will outline the areas of opportunity and challenges in the neuroscience drug discovery & development sector. The showcase will include a panel discussion looking at the use of new drug discovery and development technology, concepts and tools in neuroscience, as well what the future looks like for neuroscience therapies.

Therapies 130
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COVID Shot Lowers Your Odds for COVID-linked Heart Trouble

Drugs.com

TUESDAY, Oct. 1, 2024 -- While rare, heart-related side effects sometimes follow a COVID-19 vaccine shot, new research shows that's more than offset by heart-healthy benefits.Folks who are fully vaccinated are significantly less likely to develop.

Vaccine 107

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Airborne plastic chemical levels shock researchers

Science Daily: Pharmacology News

A new study documents how Southern Californians are chronically being exposed to toxic airborne chemicals called plasticizers, including one that's been banned from children's items and beauty products.

Research 110
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GLP-1 receptor agonists: Buying into the hype

Drug Discovery World

As further news comes out about the benefits that the diabetes and weight-loss drug Ozempic offers patients, it’s hard not to get caught up in the hype surrounding a therapy many are calling a ‘wonder drug’ Of course, it’s not the first time the pharmaceutical industry has produced a therapy that entered into the public discourse. Both Covid-19 vaccines and the introduction of CAR-T cell therapies are recent drugs that garnered lots of attention within their specific sectors.

Therapies 130
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Calculating the Regulatory Review Period for Patent Term Extension: A Comprehensive Guide

Drug Patent Watch

In the complex world of intellectual property and pharmaceutical development, understanding the intricacies of patent term extension (PTE) is crucial for innovators and businesses alike. One of the most critical aspects of PTE is calculating the regulatory review period, which can significantly impact the lifespan and profitability of a patented product.

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Access to medicines vital in tackling AMR, world leaders agree

Drug Discovery World

Global leaders have approved a plan to reduce the estimated 4.95 million human deaths associated with bacterial antimicrobial resistance (AMR) annually by 10% by 2030. The political declaration was agreed at the 79th United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance (AMR). Acknowledging that AMR is a complex problem, the declaration recognises the need for a multisectoral response combining human, agricultural, animal, and environmental sector-specific interve

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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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When Do Drug Patents Expire: Understanding the Lifecycle of Pharmaceutical Innovations

Drug Patent Watch

Have you ever wondered why some medications seem to cost an arm and a leg, while others are surprisingly affordable? The answer often lies in the complex world of drug patents. Let’s dive into the fascinating realm of pharmaceutical intellectual property and explore when drug patents expire. Drug patents are a crucial aspect of the pharmaceutical industry.

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Outbreak of Ebola-Like Marburg Virus in Rwanda Has Killed 8 People

Drugs.com

TUESDAY, Oct. 1, 2024 -- A rare, highly contagious Ebola-like virus has claimed eight lives in Rwanda, and U.S. health officials are closely monitoring the outbreak.Marburg virus causes a rare hemorrhagic fever that has no authorized vaccine or.

Virus 91
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How are prescription drug prices determined?

Drug Patent Watch

In the world of healthcare, few topics spark as much debate and confusion as prescription drug pricing. Have you ever wondered why that little pill in your medicine cabinet costs so much? Let’s dive into the intricate world of pharmaceutical economics and uncover the factors that determine the price tags on our prescriptions.

Drugs 96
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Stronger together: miniature robots in convoy for endoscopic surgery

Science Daily: Pharmacology News

Miniature robots on the millimeter scale often lack the strength to transport instruments for endoscopic microsurgery through the body. Scientists are now combining several millimeter-sized TrainBots into one unit and equipping them with improved 'feet'. For the first time, the team was able to perform an electric surgical procedure on a bile duct obstruction experimentally with a robotic convoy.

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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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Kailera Therapeutics emerges from stealth with $400M for obesity drugs

BioPharma Drive: Drug Pricing

The company’s official launch comes five months after major investors such as Atlas Venture and Bain Capital filed a Shanghai stock exchange filing for a biotech named “Hercules CM NewCo.

Drugs 75
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Scientists discover planet orbiting closest single star to our Sun

Science Daily: Pharmacology News

Astronomers have discovered an exoplanet orbiting Barnard's star, the closest single star to our Sun. On this newly discovered exoplanet, which has at least half the mass of Venus, a year lasts just over three Earth days. The team's observations also hint at the existence of three more exoplanet candidates, in various orbits around the star.

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5 FDA decisions to watch in the fourth quarter

BioPharma Drive: Drug Pricing

Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.

FDA 73
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Squid-inspired fabric for temperature-controlled clothing

Science Daily: Pharmacology News

Inspired by the dynamic color-changing properties of squid skin, researchers have developed a method to manufacture a heat-adjusting material that is breathable and washable and can be integrated into flexible fabric. The composite material operates in the infrared spectrum and consists of a polymer covered with copper islands. Stretching the material separates the islands and changes how it transmits and reflects infrared light; this innovation creates the possibility of controlling the tempera

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The top biopharma conferences in 2025

BioPharma Drive: Drug Pricing

Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies' research progress. Here’s a list of conferences to watch in 2025.

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Using antimatter to detect nuclear radiation

Science Daily: Pharmacology News

Discerning whether a nuclear reactor is being used to also create material for nuclear weapons is difficult, but capturing and analyzing antimatter particles has shown promise for monitoring what specific nuclear reactor operations are occurring, even from hundreds of miles away. Researchers have developed a detector that exploits Cherenkov radiation, sensing antineutrinos and characterizing their energy profiles from miles away as a way of monitoring activity at nuclear reactors.

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Outpatient CAR-T Cancer Therapy Can Be Safe, Effective

Drugs.com

TUESDAY, Oct. 1, 2024 -- Patients with a fast-spreading blood cancer respond well to outpatient treatment with CAR-T therapy, the largest study examining its use in a community setting has found.CAR-T is shorthand for chimeric antigen receptor.

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Feet first: AI reveals how infants connect with their world

Science Daily: Pharmacology News

Researchers explored how infants act purposefully by attaching a colorful mobile to their foot and tracking movements with a Vicon 3D motion capture system. The study tested AI's ability to detect changes in infant movement patterns. Findings showed that AI techniques, especially the deep learning model 2D-CapsNet, effectively classified different stages of behavior.

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California Bans 6 Artificial Dyes in Foods Served at Public Schools

Drugs.com

TUESDAY, Oct. 1, 2024 -- A new law just passed in California makes it the first state to tell public schools they may no longer serve foods that contain six artificial dyes linked to health and behavior problems among children.Gov. Gavin Newsom.

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Climate scientists express their views on possible future climate scenarios in a new study

Science Daily: Pharmacology News

A new survey of climate experts reveals that a majority believes the Earth to be headed for a rise in global temperatures far higher than the 2015 Paris Agreement targets of 1.5 to well-below 2 degrees Celsius. It also shows that two-thirds of respondents believe we may succeed in achieving net zero CO2 emissions during the second half of this century.

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Women in STEM with Gilda Ascione

Drug Target Review

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? Since I was a child, I always wanted to be a doctor. From a scientific point of view, I liked the possibility of studying and learning about the human body, its vital functions, how it gets sick, and how to treat it. From a human point of view, I have always considered doctors’ work as a sort of mission for the good of others.

Doctors 64
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Carbon dioxide and hydrogen peroxide on Pluto's moon Charon

Science Daily: Pharmacology News

Astronomers have detected carbon dioxide and hydrogen peroxide on the frozen surface of Pluto's largest moon, Charon, using observations from the James Webb Space Telescope. These discoveries add to Charon's known chemical inventory, previously identified by ground- and space-based observations, that includes water ice, ammonia-bearing species and the organic materials responsible for Charon's gray and red coloration.

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IGM lays off staff in autoimmune pivot; Metsera ramps up obesity drug supply

BioPharma Drive: Drug Pricing

IGM is the latest biotech to focus on the potential for T cell engagers to treat inflammatory conditions. Elsewhere, Metsera signed a manufacturing deal and UCB started a first-of-its-kind trial.

Trials 60
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Sourcing the Key Starting Materials (KSMs) for pharmaceutical Active Pharmaceutical Ingredients (APIs)

Drug Patent Watch

To find Key Starting Materials (KSMs) for pharmaceutical Active Pharmaceutical Ingredients (APIs), you can follow these steps: Remember that the availability and sourcing of KSMs can vary depending on the specific API and regulatory requirements in different countries. It’s essential to ensure that any KSMs used in pharmaceutical manufacturing meet the necessary quality and regulatory standards.

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CVS to lay off 2,900 employees amid reports of strategic review

BioPharma Drive: Drug Pricing

As CVS pursues a massive cost-cutting plan — and reportedly considers a potential breakup of its businesses — the healthcare behemoth has decided to cut 1% of its workforce.

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Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government

FDA Law Blog: Biosimilars

By Kurt R. Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. But unlike the fictitious Vandelay Industries of Seinfeld that George Costanza claims to have been interviewed for as a latex salesman, Vanda Pharmaceuticals, Inc.

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American College of Medical Toxicology and the American Academy of Clinical Toxicology position statement: nalmefene should not replace naloxone as the primary opioid antidote at this time

Common Sense for Drug Policy Blog

American College of Medical Toxicology and the American Academy of Clinical Toxicology position statement: nalmefene should not replace naloxone as the primary opioid antidote at this time "As physicians, pharmacists, scientists, and specialists in poison information, we are experts in pharmacology, toxicology, and the management of opioid overdose and addiction.

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Strategies to Optimize Expression Challenges of Multi-chain and Bispecific Antibodies

Fierce BioTech

Strategies to Optimize Expression Challenges of Multi-chain and Bispecific Antibodies Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects. jpiatt Tue, 10/01/2024 - 16:39 Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future di

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Naloxone vs Nalmefene

Common Sense for Drug Policy Blog

Naloxone vs Nalmefene "While the addition of stronger, longer-acting opioid overdose reversal agents expands the options available to combat the fatal opioid overdose crisis, their inception is perhaps without clinical grounds. Data supports continued practice without these stronger, longer acting nalmefene agents, and it is unclear whether any benefits nalmefene offers outweigh the apparent risks of its use.

Drugs 52
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Decoding the data

Fierce BioTech

Decoding the data Understanding refrigerator, freezer, and incubator performance claims is no easy feat. This guide helps decode key metrics, explains why they're difficult to compare, and provides tips for interpreting claims. Gain insights for more confident purchasing decisions in laboratory equipment. jpiatt Tue, 10/01/2024 - 16:01 Need the superpowers to select the right lab equipment?