Search Results for “EC” – Page 106 – media

FDA teams with Veterans Health Administration to make medtech supply chains more resilient

Dive Brief The U.S. Food and Drug Administration and the Veterans Health Administration have signed an agreement to increase medical product manufacturing capacity and flexibility in times of crisis. The agencies will create “digital stockpiles” to improve the resilience of domestic supply chains during emergencies, shortages and pandemics. The digital stockpiles will store electronic plans, instructions and methods to make and test medical products to enable trusted suppliers to quickly scale up production when needed, according to the agencies. Dive Insight The COVID-19 pandemic exposed the shortcomings of existing supply chains. When the crisis struck, the U.S. and other countries struggled to meet demand for personal protective equipment and other medical devices used in the response to the coronavirus. The experience led officials to consider how to make supply chains more resilient and able to cope with crises. Now, the FDA has signed a memorandum of understanding with the VHA. ...
- Source: drugdu
- 107
- May 26, 2023
FDA Delays Decision on Sarepta’s DMD Gene Therapy

By Heather McKenzie https://www.biospace.com/ Pictured: Sarepta logo on a building/courtesy of Sarepta Therapeutics Those in the Duchenne muscular dystrophy and gene therapy spaces hoping for a milestone decision by May 29 will have to wait approximately three more weeks as the FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease. The FDA told the company Wednesday “it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions,” according to Sarepta’s announcement. The company went on to say that the FDA indicated it is “working toward potentially granting an accelerated approval for SRP-9001” for DMD patients aged 4-5 years. If approved, SRP-900 would be the first FDA-authorized gene therapy for DMD. Sarepta’s shares were down 14% in pre-market trading Wednesday.
- Source: drugdu
- 117
- May 26, 2023
Research finds fever to be the most common non-respiratory feature of SARS-CoV-2 infection

Fever was found to be the most common non-respiratory feature of infection with SARS-CoV-2, the virus that causes COVID-19, according to research published at the ATS 2023 International Conference. The finding held true regardless of which COVID variant patients had, and whether or not they were fully vaccinated or not fully vaccinated. The researchers, who also looked at mortality risk, found that patients who were not fully vaccinated had a higher risk of dying when infected with either the Omicron or Delta variant. The study was based on the examination of the University of California Health Covid Research Data Set’s (UC CORDS) medical records of 63,454 patients who had been treated in a University of California medical center for COVID-19. The scientists applied statistical tests to determine the relationship between non-respiratory features, vaccination status and differences in mortality between infection with the Omicron and Delta variants. We determined that we ...
- Source: drugdu
- 106
- May 25, 2023
Roche Terminates Second Phase II Schizophrenia Trial

By Kate Goodwin https://www.biospace.com/ Pictured: Blue Roche logo on white building/Smith Collection/Gado/Getty Images Roche has terminated a second Phase II trial of its investigational schizophrenia drug ralmitaront, leaving an uncertain future for the company’s program targeting the psychiatric disorder. The first trial, which was canceled last year, was studying the effects of ralmitaront as a monotherapy in patients with an acute exacerbation of positive symptoms of schizophrenia or schizoaffective disorder. The second trial, which was recently terminated, was investigating the impact of the treatment on negative symptoms associated with the two conditions. “In a preliminary analysis, the primary endpoint was negative, and ongoing portions of the study have therefore been discontinued,” according to an update on the second Phase II trial posted to the ClinicalTrials.gov website. Roche’s latest first quarter 2023 pipeline presentation included the asset, pushing its New Molecular Entity submission back into the “2026 and beyond” category. No ...
- Source: drugdu
- 102
- May 25, 2023
Study reveals unique molecular machinery of woman who can’t feel pain

The biology underpinning a rare genetic mutation that allows its carrier to live virtually pain-free, heal more rapidly and experience reduced anxiety and fear, has been uncovered by new research from UCL. The study, published in Brain, follows up the team’s discovery in 2019 of the FAAH-OUT gene and the rare mutations that cause Jo Cameron to feel virtually no pain and never feel anxious or afraid. The new research describes how the mutation in FAAH-OUT “turns down” FAAH gene expression, as well as the knock-on effects on other molecular pathways linked to wound healing and mood. It is hoped the findings will lead to new drug targets and open up new avenues of research in these areas. Jo, who lives in Scotland, was first referred to pain geneticists at UCL in 2013, after her doctor noticed that she experienced no pain after major surgeries on her hip and hand. ...
- Source: drugdu
- 95
- May 25, 2023
Crick Institute announces new molecular glue discovery to treat different diseases

A combined investment of £11.2m that includes a prosperity partnership grant from the Engineering and Physical Sciences Research Council (EPSRC) and funds from AstraZeneca (AZ) has enabled researchers at the Francis Crick Institute, Imperial College London and AZ to discover new ‘molecular glues’ to treat multiple diseases. Widely used as protein degraders, molecular glues bring together proteins that would not usually interrelate. The glues manage the modification and degradation of disease-causing target proteins by redirecting them to the cell’s natural waste disposal system. By facilitating the interaction between target protein and a cellular enzyme, the target protein is deactivated or broken down by additional proteins that are recruited by the enzyme. Group leader at the Crick Institute, Ed Tate, said: “Challenges arise when we can’t find a small molecule with the ability to interact with certain proteins. “If we can redirect these harmful proteins towards the cell’s own waste disposal ...
- Source: drugdu
- 109
- May 25, 2023
A larger dose of vitamin D may decrease psychiatric symptoms at school age

It is estimated that every eighth child suffers from a mental health disorder. Several predictors of children’s mental problems have been identified, but much remains uncharted. Previous research suggests that low vitamin D levels in early childhood may be one factor increasing the risk of mental health problems in later life. A recent Finnish study, now published in JAMA Network Open, presents new information on the association between vitamin D intake and mental health. A new study by a team of Finnish researchers has investigated whether a daily vitamin D3 supplement higher than the recommended dose in early childhood reduces the risk of psychiatric symptoms at school age. The study is part of the Vitamin D Intervention in Infants (VIDI) clinical trial, which investigates how early vitamin D3 intervention affects children’s growth and development. In the research, children were randomized as two groups, one receiving the daily standard dose of ...
- Source: drugdu
- 138
- May 25, 2023
Ironwood to Pay $1B to Acquire VectivBio, Late-Stage Digestive Therapy

By Jef Akst Pictured: Illustration of a human body with the intestines highlighted/iStock, Rasi Bhadramani At $17 per share, Ironwood Pharmaceuticals has agreed to buy VectivBio for around $1 billion in a cash deal. In doing so, the Boston-based company, which already markets Linzess for irritable bowel syndrome and constipation with AbbVie, will expand its gastrointestinal drug portfolio. The Swiss biotech’s most advanced product is apraglutide, being developed for short bowel syndrome with intestinal failure (SBS-IF) that affects some 18,000 adult patients in the U.S., Europe and Japan, according to the Ironwood press release. People with the disorder are unable to absorb adequate nutrition from their food, leading to impaired quality of life and sometimes death. Takeda Pharmaceuticals has an approved drug, Gattex, that aims to treat short bowel syndrome but requires daily injections. Apraglutide is being tested in a Phase III study involving weekly injections. “There’s certainly challenges with ...
- Source: drugdu
- 134
- May 24, 2023
Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says

An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
- Source: drugdu
- 147
- May 24, 2023
A clever way to detect narcissism

A team of psychologists at the University of Helsinki, working with a colleague from Millsaps College, has discovered, via experimentation, a clever, new way to detect narcissism in a person. In their study, reported in the journal Psychophysiology, the group measured physical responses to certain stimuli in people identified as having a narcissistic personality. People with a narcissistic personality see the world as an extension of themselves, and because of that, they regard the needs of others as less important. Narcissists, it has been noted, tend to be stubborn and envious and behave in ways that suggest they feel entitled to whatever they desire. Psychologists have also found that such traits can make a person uncomfortable to be around and that others tend to respond negatively to such behavior. They also note that narcissistic traits can be problematic for relationships, and for that reason, they have suggested that non-narcissists learn ...
- Source: drugdu
- 117
- May 24, 2023

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