Thu.Sep 26, 2024

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Bridging the gap between islet allotransplantation and regulatory reform

Drug Discovery World

Dr Rita Bottino Director of Islet Programs at Imagine Pharma, discusses the need for regulatory reform in islet allotransplantation for type 1 diabetes. Islet allotransplantation – the transplantation of isolated pancreatic islets from a deceased donor to a living recipient with type 1 diabetes – has emerged as a promising therapy for patients with type 1 diabetes, particularly those experiencing hypoglycemia unawareness.

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Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

BioPharma Drive: Drug Pricing

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

FDA 130
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Triple combination treatment shrinks lung cancer tumours in mice

Drug Discovery World

Researchers at the Francis Crick Institute, in collaboration with Revolution Medicines, have shown that a combination of treatments in mice with lung cancer allow immunotherapies to target non-responsive tumours. Their findings show that targeting tumours in different ways simultaneously might increase response to treatments. The researchers combined a newly identified KRAS G12C inhibitor, with a compound that blocks a protein called SHP, which inhibits cancer cells and can also activate tumour

Treatment 147
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Synthesis, Antioxidant Activity, and Molecular Docking of Novel Paeoniflorin Derivatives

Chemical Biology and Drug Design

Compound 22 might become a novel antioxidant for the treatment of oxidative stress-related diseases. ABSTRACT Paeoniflorin (PF) is one of the active constituents of the traditional Chinese medicine Paeoniae Radix Rubra and has been actively explored in the pharmaceutical area due to its numerous pharmacological effects. However, severe difficulties such as limited bioavailability and low permeability limit its utilization.

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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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Novartis and Generate partner on AI-created protein therapeutics

Drug Discovery World

Novartis and Generate:Biomedicines have announced a multi-target collaboration to discover and develop protein therapeutics across multiple disease areas. The collaboration leverages Generate’s generative AI platform, ​‘The Generate Platform’, to create potentially first- and best-in-class molecules through AI-based optimisation and de novo generation.

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Arch raises another $3B biotech fund in pursuit of ‘coolest’ new science

BioPharma Drive: Drug Pricing

Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.

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These fish use legs to taste the seafloor

Science Daily: Pharmacology News

Sea robins are unusual animals with the body of a fish, wings of a bird, and walking legs of a crab. Now, researchers show that the legs of the sea robin aren't just used for walking. In fact, they are bona fide sensory organs used to find buried prey while digging.

Research 118
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FDA approves two treatments for Niemann-Pick Disease

Drug Discovery World

This week, the US Food and Drug Administration (FDA) has approved both Zevra Therapeutics’ Miplyffa (arimoclomol) and IntraBio’s Aqneursa (levacetylleucine) for Neimann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children two years of age and older.

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Researchers discover new bacterium that causes gut immunodeficiency

Science Daily: Pharmacology News

Researchers have discovered a new bacterium that weakens the immune system in the gut, potentially contributing to certain inflammatory and infectious gut diseases. The team identified the bacterium, Tomasiella immunophila (T. immunophila), which plays a key role in breaking down a crucial immune component of the gut's multi-faceted protective immune barrier.

Research 112
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Immunotherapy: Opportunities and advances

Drug Discovery World

Immunotherapies are at the cutting edge of therapeutics research, offering some of the most advanced treatments for cancer and other diseases. This eBook, sponsored by Sino Biological, examines the latest innovations that are driving the market and overcoming the challenges associated with these treatments. The post Immunotherapy: Opportunities and advances appeared first on Drug Discovery World (DDW).

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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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Gum Disease Germs Could Help Trigger Cancer

Drugs.com

THURSDAY, Sept. 26, 2024 -- Bacteria that causes gum disease can also raise a person’s risk of head and neck cancers, a new study says.More than a dozen bacterial species have been linked to a collective 50% increased risk of head and neck cancer, r.

Disease 111
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ESO telescope captures the most detailed infrared map ever of our Milky Way

Science Daily: Pharmacology News

Astronomers have published a gigantic infrared map of the Milky Way containing more than 1.5 billion objects -- the most detailed one ever made. Using the European Southern Observatory's VISTA telescope, the team monitored the central regions of our Galaxy over more than 13 years. At 500 terabytes of data, this is the largest observational project ever carried out with an ESO telescope.

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Powering the Future: Key Highlights from PPCC24 and What’s Next for Power Platform

Perficient: Drug Development

The energy was electric last week as thousands of attendees invaded MGM Grand along the Las Vegas Strip for the 3rd Annual Power Platform Community Conference (PPCC24). From groundbreaking announcements to new features unveiled during keynotes from Microsoft’s Charles Lamanna, Corporate Vice President of Business Industry and Copilot, and Jeff Teper, President of Apps and Platforms, PPCC24 offered an electrifying three days of innovation and collaboration.

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'Weekend warrior' physical activity may help protect against more than 200 diseases

Science Daily: Pharmacology News

Compared with inactivity, a weekend warrior pattern of exercise (concentrating most moderate-to-vigorous physical activity in one to two days during the week) or a more evenly distributed physical activity pattern were associated with similarly lower risks of diseases across 16 categories -- from heart and digestive conditions to mental health and neurological illnesses.

Disease 109
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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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Most Pregnant Women Will Become Iron Deficient, Study Finds

Drugs.com

THURSDAY, Sept. 26, 2024 -- Four out of five pregnant women will become deficient in an essential nutrient, iron, by their third trimester, a new study finds.The researchers and other experts are now advocating that iron levels be routinely checked.

Research 105
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This rocky planet around a white dwarf resembles Earth -- 8 billion years from now

Science Daily: Pharmacology News

A 2020 microlensing event was caused by a planetary system with an Earth-like planet and brown dwarf. The star type was uncertain. The team has determined that the star is a white dwarf, a system resembling what our sun-Earth system will look like in 8 billion years. The good news: the planet survived its star's red giant phase, so maybe Earth will too.

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Forget BMI, 'Body Roundness' Measure Could Spot Heart Risk

Drugs.com

THURSDAY, Sept. 26, 2024 -- “Body roundness” could be a better measure than BMI at predicting how excess weight might affect a person’s heart health, a new study finds.People who developed a high Body Roundness Index during a six-year period had a 1.

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NASA's Hubble finds that a black hole beam promotes stellar eruptions

Science Daily: Pharmacology News

In a surprise finding, astronomers using NASA's Hubble Space Telescope have discovered that the blowtorch-like jet from a supermassive black hole at the core of a huge galaxy seems to cause stars to erupt along its trajectory. The stars, called novae, are not caught inside the jet, but apparently in a dangerous neighborhood nearby.

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Health Concerns Around Fluoride in Water Merit EPA Action, Judge Rules

Drugs.com

THURSDAY, Sept. 26, 2024 -- -- The Environmental Protection Agency must address concerns about potential health risks posed by the recommended levels of fluoride in the country's drinking water, a federal court in California has ruled.While.

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A method of 'look twice, forgive once' can sustain social cooperation

Science Daily: Pharmacology News

Using mathematical modeling, researchers found a way to maintain cooperation without relying on complex norms or institutions.

Research 117
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U.S. Restarts Free COVID Test Program

Drugs.com

THURSDAY, Sept. 26, 2024 -- Starting today, the U.S. government is offering another round of free COVID tests."U.S. households will be eligible to order 4 free COVID-19 tests at COVIDTests.gov," according to the Department of Health and Human.

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Scientists uncover a critical component that helps killifish regenerate their fins

Science Daily: Pharmacology News

Spontaneous injuries like the loss of a limb or damage to the spinal cord are impossible for humans to repair. Yet, some animals have an extraordinary capacity to regenerate after injury, a response that requires a precise sequence of cellular events. Now, new research has unveiled a critical timing factor -- specifically how long cells actively respond to injury -- involved in regulating regeneration.

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U.S. Suicide Death Rate Is Rising Again

Drugs.com

THURSDAY, Sept. 26, 2024 -- U.S. suicide rates are ticking back upward again after a dip during the pandemic, new statistics show.Suicide deaths per 100,000 people had fallen from 14.2 recorded in the pre-pandemic year of 2018 to 13.5 in 2020.

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Pfizer to pull sickle cell drug from market, shut down trials

BioPharma Drive: Drug Pricing

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.

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Being a 'Weekend Warrior' Can Cut Your Odds for 200 Diseases

Drugs.com

THURSDAY, Sept. 26, 2024 -- There’s good news for folks who struggle to fit regular exercise into their busy workweek.“Weekend warrior” workouts are just as beneficial as daily exercise to a person’s overall health, a new study says.People who get a.

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How to Conduct Effective Generic Drug Market Analysis

Drug Patent Watch

The generic drug market is a complex and dynamic environment where multiple factors influence the availability, quality, and pricing of generic drugs. Conducting an effective market analysis is crucial for pharmaceutical companies, policymakers, and healthcare professionals to understand the market dynamics and make informed decisions.

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Know What 'Chroming' Is? TikTok Fad Could Harm Your Kids

Drugs.com

FRIDAY, Sept. 27, 2024 -- Chroming, where toxic fumes from common household items are inhaled for a quick high, is on the rise among youth and TikTok may be to blame, new research suggests.In findings that are to be presented Saturday at the.

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Plasmids 101: Sequence and Ligation Independent Cloning (SLIC)

addgene Blog

If cloning methods had personalities, SLIC (sequence- and ligation-independent cloning) would be a true rebel. Not only does this system not use site-specific recombination, it also doesn’t require a ligation step. Based on the robust system of homologous recombination found in E. coli , SLIC is a cheap, standardized, and rapid multi-part DNA assembly method.

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One Gun Law Reduces School Shooting Deaths

Drugs.com

FRIDAY, Sept. 27, 2024 -- Laws that ban assault weapons do indeed protect children from dying in mass shootings, but the same can't be said for more common types of gun restrictions and regulations, new research shows.“Mass shootings are horrific e.

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Scientists design new drug to fight malaria

Science Daily: Pharmacology News

A team has designed a new drug against malaria and identified its mechanism of action.

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One More Death Tied to Listeria From Boar's Head Deli Meats

Drugs.com

THURSDAY, Sept. 26, 2024 -- There's been one more death linked to listeria illness from tainted deli meats made by Boar's Head, bringing the death toll to 10.The latest update from the U.S. Centers for Disease Control and Prevention recorded an.

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The Competitive Edge of Biosimilars

DrugBank

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. The primary advantage is cost-effectiveness. Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts.

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Airports Take Big Toll on Sleep of Those Living Nearby

Drugs.com

THURSDAY, Sept. 26, 2024 -- As people living near airports probably already know, all that overhead traffic can take a huge hit to their sleep, a new study confirms.Night-time aircraft noise increases a person’s risk of tossing and turning in bed a.

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Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who? Breakthrough Device That Can’t Get to Market

FDA Law Blog: Biosimilars

By Jennifer D. Newberger — We can all acknowledge that the title of this post is not that funny-at least, not to anyone other than medical device regulatory nerds, such as the author of this post. What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock.