Mon.Jun 17, 2024

article thumbnail

New data showcase promise, growing pains of CAR-T in autoimmune disease

BioPharma Drive: Drug Pricing

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Disease 139
article thumbnail

A high-fat diet may fuel anxiety

Science Daily: Pharmacology News

New research shows when animals are fed a diet high in saturated fat for nine weeks, their gut bacteria change in ways that influence brain chemicals and fuel anxiety.

Research 134
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Abortion pill ruling offers measure of relief for FDA, biotech

BioPharma Drive: Drug Pricing

One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

FDA 107
article thumbnail

Extended maternal care central factor to human other animal, longevity

Science Daily: Pharmacology News

The relationship between mother and child may offer clues to the mystery of why humans live longer than expected for their size -- and shed new light on what it means to be human -- according to a new study.

130
130
article thumbnail

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.

article thumbnail

Surgeon General Calls for Warning Labels on Social Media Sites

Drugs.com

MONDAY, June 17, 2024 -- The U.S. Surgeon General announced Monday that he will push for warning labels on all social media platforms, stating that they may harm teens' mental health."The mental health crisis among young people is an emergency --.

105
105
article thumbnail

Ancient polar sea reptile fossil is oldest ever found in Southern Hemisphere

Science Daily: Pharmacology News

An international team of scientists has identified the oldest fossil of a sea-going reptile from the Southern Hemisphere -- a nothosaur vertebra found on New Zealand's South Island. 246 million years ago, at the beginning of the Age of Dinosaurs, New Zealand was located on the southern polar coast of a vast super-ocean called Panthalassa. 'The nothosaur found in New Zealand is over 40 million years older than the previously oldest known sauropterygian fossils from the Southern Hemisphere.

More Trending

article thumbnail

Bedtime battles: 1 in 4 parents say their child can't go to sleep because they're worried or anxious

Science Daily: Pharmacology News

One in four parents describe getting their young child to bed as difficult -- and these parents are less likely to have a bedtime routine, more likely to leave on a video or TV show, and more likely to stay with their child until they're asleep.

118
118
article thumbnail

There May Be 6 Types of Depression, and Brain Scans Can Sort Them Out

Drugs.com

MONDAY, June 17, 2024 -- Depression can be sorted into six distinct types using brain scans, a revelation that could improve treatment for many suffering the debilitating mood disorder.Researchers analyzed brain scans to identify six different.

article thumbnail

Wear it, then recycle: Designers make dissolvable textiles from gelatin

Science Daily: Pharmacology News

Researchers hope their DIY machine will help designers around the world experiment with making their own, sustainable fashion and other textiles from a range of natural ingredients -- maybe even the chitin in crab shells or agar-agar from algae.

Research 118
article thumbnail

Inherited Alzheimer's: Whether It's From Mom or Dad Could Matter

Drugs.com

MONDAY, June 17, 2024 -- Genetics can play a role in a person's odds for Alzheimer's disease, and new research suggests differences in that risk are based on which parent had the illness.In a study of 4,400 people still "cognitively unimpaired,".

Disease 98
article thumbnail

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.

article thumbnail

A new way to measure aging and disease risk with the protein aggregation clock

Science Daily: Pharmacology News

Could measuring protein clumps in our cells be a new way to find out our risk of getting age-related diseases? Researchers propose the concept of a 'protein aggregation clock' to measure aging and health.

Disease 115
article thumbnail

Syncona melds two gene therapy biotechs for better shot at new nervous system treatments

BioPharma Drive: Drug Pricing

The new company, Spur Therapeutics, is getting another $50 million from Syncona to support its broadened pipeline, which targets Parkinson’s disease as well as heart conditions.

article thumbnail

Direct evidence found for dairy consumption in the Pyrenees in the earliest stages of the Neolithic

Science Daily: Pharmacology News

A study on the remains of the Chaves and Puyascada caves, both located in the province of Huesca, Spain, yields the first direct proof of the consumption and processing of dairy products in the Pyrenees already at the start of the Neolithic period, approximately 7,500 years ago, as well as the consumption of pig. The results lead to doubts about the belief that these products were first used much later in the Pyrenean mountain range.

article thumbnail

Pet Bearded Dragons Pose Salmonella Danger, CDC Warns

Drugs.com

MONDAY, June 17, 2024 -- Lizards called bearded dragons may not breathe fire, but they can be a source of one nasty infection: Salmonella.So warned the U.S. Centers for Disease Control and Prevention in a health advisory on Friday, noting there.

Disease 98
article thumbnail

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

article thumbnail

Investigating the origins of the crab nebula

Science Daily: Pharmacology News

A team of scientists used NASA's James Webb Space Telescope to parse the composition of the Crab Nebula, a supernova remnant located 6,500 light-years away in the constellation Taurus.

109
109
article thumbnail

Getting Your Exercise in Nature May Bring Added Benefits

Drugs.com

MONDAY, June 17, 2024 -- Exercising in natural surroundings -- a jog through a park, a bicycle ride along a trail -- could be more beneficial than working out indoors, a new review suggests.However, access to natural areas that are public varies.

98
article thumbnail

Modified gravity theory: A million light years and still going

Science Daily: Pharmacology News

In a breakthrough discovery that challenges the conventional understanding of cosmology, scientists have unearthed new evidence that could reshape our perception of the cosmos. New research shows that rotation curves of galaxies stay flat indefinitely far out, corroborating predictions of modified gravity theory as an alternative to dark matter.

Research 108
article thumbnail

Innovative Approaches to Extend the Life of Drug Patents

Drug Patent Watch

Pharmaceutical companies employ various strategies to extend the commercial life and patent protection of successful drugs. Here are some key approaches with examples: New Formulations One common strategy is to develop and patent new formulations of the existing drug compound to provide benefits like reduced dosing frequency, easier administration, improved bioavailability, or reduced side effects.

article thumbnail

Pair of merging quasars at cosmic dawn

Science Daily: Pharmacology News

Astronomers have discovered a double-record-breaking pair of quasars. Not only are they the most distant pair of merging quasars ever found, but also the only pair confirmed in the bygone era of the Universe's earliest formation.

108
108
article thumbnail

Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies

Drug Patent Watch

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

article thumbnail

Breakthrough approach enables bidirectional BCI functionality

Science Daily: Pharmacology News

Brain-computer interfaces or BCIs hold immense potential for individuals with a wide range of neurological conditions, but the road to implementation is long and nuanced for both the invasive and noninvasive versions of the technology. Scientists have now successfully integrated a novel focused ultrasound stimulation to realize bidirectional BCI that both encodes and decodes brain waves using machine learning in a study with 25 human subjects.

105
105
article thumbnail

The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials

BioPharma Drive: Drug Pricing

Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.

article thumbnail

A Practical Guide to FtO Analysis for Drug Repurposing Ventures

Drug Patent Watch

A recent whitepaper by Hermann Mucke summarizes the steps to performing an FTO for drug repurposing: Overview An FtO analysis determines if a new product or process can proceed without infringing third-party intellectual property (IP) rights, especially patents. It is crucial for drug repurposing projects involving known compounds that may still be patent-protected.

Drugs 80
article thumbnail

An earthquake changed the course of the Ganges: Could it happen again?

Science Daily: Pharmacology News

A major earthquake 2,500 years ago caused one of the largest rivers on Earth to abruptly change course, according to a new study. The previously undocumented quake rerouted the main channel of the Ganges River in what is now densely populated Bangladesh, which remains vulnerable to big quakes.

82
article thumbnail

What Are Nicotine Pouches, and Are They Less Harmful Than Smoking?

Drugs.com

MONDAY, June 17, 2024 -- Nicotine pouches might be less harmful than smoking or chewing tobacco, but they still pose an addiction risk to users, a new review finds.These pouches are filled with crystallized nicotine, and are placed between the gums.

64
article thumbnail

Takeda drug for rare types of epilepsy misses goal in late-stage trial

BioPharma Drive: Drug Pricing

Called soticlestat, the drug had seemed promising in earlier studies for people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to take on full rights to the drug.

Trials 62
article thumbnail

Women in Stem with Danielle Meyrick

Drug Target Review

Can you tell us about your journey in the field of STEM and the challenges you encountered along the way? I didn’t apply a lot of thought to my early career choices in STEM; my inquisitive nature drew me to the physical sciences, and I have always felt very comfortable among scientists and in the global scientific community. There is a sense of a meeting of the minds, and a pursuit of causes that affect us all.

Science 59
article thumbnail

Early patient engagement can improve medication adherence. Here’s how.

BioPharma Drive: Drug Pricing

Research shows that 20% of patients have failed to fill a script in the past, and one-third aren’t confident managing their illness. Engaging patients as soon as a medicine is prescribed can help.

article thumbnail

New patent expiration for Siga Technologies drug TPOXX

Drug Patent Watch

Annual Drug Patent Expirations for TPOXX Tpoxx is a drug marketed by Siga Technologies and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. This drug has ninety-one patent family members in twenty-three countries. The generic ingredient in TPOXX is tecovirimat.

Drugs 59
article thumbnail

OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers)

FDA Law Blog: Biosimilars

By Kalie E. Richardson & John W.M. Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. are safe, effective, and meet appropriate quality standards. While no office at FDA truly works in a vacuum, we can safely call OPQ the tip of FDA’s quality spear.

article thumbnail

New patent expiration for Cephalon drug NUVIGIL

Drug Patent Watch

Annual Drug Patent Expirations for NUVIGIL Nuvigil is a drug marketed by Cephalon and is included in one NDA. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges. NUVIGIL drug price trends. Drug patent litigation for NUVIGIL. The generic ingredient in NUVIGIL is armodafinil.

Drugs 59
article thumbnail

Another monoclonal antibody for early Alzheimer’s sees strong advisory committee support

Agency IQ

BY AMANDA CONTI This week, FDA’s Peripheral and Central Nervous System (PCNS) Advisory Committee met to consider the Eli Lilly’s donanemab as a disease-modifying treatment for early Alzheimer’s disease. The committee weighed unique trial design features and known safety signals, voting unanimously in favor of its risk-benefit profile. Now, potential donanemab approval could curb regulatory uncertainty for the class.

Disease 59
article thumbnail

New patent for Chiesi drug MYCAPSSA

Drug Patent Watch

Annual Drug Patent Expirations for MYCAPSSA Mycapssa is a drug marketed by Chiesi and is included in one NDA. It is available from two suppliers. There are thirteen patents protecting this drug. This drug has fifty-nine patent family members in twenty-six countries. The generic ingredient in MYCAPSSA is octreotide acetate.

Drugs 59
article thumbnail

A year into the EPA’s PFAS framework for new chemicals, what is the agency approving?

Agency IQ

BY WALKER LIVINGSTON, ESQ In late June 2023, the EPA published a new framework for how it would handle new per- and polyfluoroalkyl substances (PFAS). A year later, the agency has published a few different Significant New Use Rules on that include PFAS. Here, we dive into exactly what the EPA is approving for use. Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetic organic chemicals that have been utilized in variety of commercial, industrial, and consumer applications sinc

59