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FDA
#FDA #GLP-1 #Novo Nordisk #Obesity #Weight loss

FDA approves first oral GLP-1 for weight management

The US Food and Drug Administration (FDA) has approved the Wegovy pill (once-daily oral semaglutide 25mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events.  The Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1)… Read More

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European Commission
#EU #European Commission #European Medicines Agency #Personalised medicine #Regulatory

New agreement to reshape EU pharmaceutical legislation

A landmark political agreement has been reached by the European Commission, the European Parliament and the Council of the European Union on a comprehensive reform of the EU pharmaceutical legislation. The agreement represents the most significant overhaul of the regulatory framework in over two decades and… Read More

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UK and US flags
#ABPI #National Institute for Health and Care Excellence (NICE) #Pharmaceutical industry #UK government

UK-US pharmaceuticals deal supports UK life sciences

A trade deal has been agreed between the UK and the US, which the governments says will secure and expand access to drugs, safeguard the medicines supply chain, and “drive crucial investment while supporting UK patients and industries”.   The deal – part of the UK-US… Read More

#Business & Investment #News #Trending News

#Alzheimer's #GLP-1 #Neurodegenerative disorders #Novo Nordisk #Obesity

Semaglutide shows no benefit in Alzheimer’s disease

Novo Nordisk has revealed that its Phase III trials of semaglutide (the active ingredient in Ozempic and Wegovy) did not demonstrate a statistically significant reduction in Alzheimer’s disease progression.  The top-line results from the two-year primary analysis of evoke and evoke+ Phase III trials in early-stage symptomatic… Read More

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FDA headquarters
#Cell and gene therapy #FDA #Personalised medicine #Regulatory

FDA introduces new pathway for personalised medicines

The US Food and Drug Administration (FDA) has laid out the process and requirements of its novel plausible mechanism pathway for personalised medicine in a New England Journal of Medicine (NEJM) editorial by Commissioner Martin Makary and Deputy Vinay Prasad.  The editorial acknowledges that personalised… Read More

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CRISPR gene editing
#Cardiovascular disease #Cholesterol #CRISPR #CRISPR Therapeutics #CRISPR-Cas9 #Phase I trial

In vivo CRISPR gene editing therapy lowers cholesterol

CRISPR Therapeutics has shared positive Phase I data from an ongoing clinical trial evaluating CTX310, an investigational, in vivo CRISPR/Cas9 gene-editing therapy targeting ANGPTL3.   A single-course treatment with CTX310 produced dose-dependent, durable reductions in circulating ANGPTL3 with a mean reduction from baseline of -73% (maximum… Read More

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Metsera logo
#Mergers and acquisitions #Metsera #Novo Nordisk #Obesity #Pfizer #Weight loss

Pfizer finally wins bidding war to acquire Metsera

Following a week-long bidding war with Novo Nordisk, Pfizer has acquired obesity drug specialists Metsera for $10 billion, thanks to an intervention by the US Federal Trade Commission (FTC).  Metsera’s Board of Directors unanimously recommended that Metsera stockholders approve the adoption of the amended Pfizer merger agreement… Read More

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Neurons
#Dementia #Neurodegenerative disorders #Parkinson's #Peptides #University of Bath

Scientists design peptide ‘switch’ to slow Parkinson’s progress

Researchers at the University of Bath, in collaboration with the Universities of Oxford and Bristol, have developed a molecule that prevents the clumping and build-up of alpha-synuclein, a protein linked to Parkinson’s disease and related dementias.   The team has successfully demonstrated it works in an animal model… Read More

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Monoclonal antibody
#Antibody #iBio #Obesity #Preclinical development #Weight loss

Twice-yearly antibody shows strong therapeutic potential for weight-loss

iBio has announced new preclinical data from its obese non-human primate (NHP) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate supported by preclinical data.  The findings will be presented during an oral session at ObesityWeek 2025, taking place 4-7 November in Atlanta, USA. … Read More

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Patient injects Ozempic
#Diabetes #GLP-1 #Innovent #Phase III trial #Weight loss

Mazdutide shows superiority to semaglutide in a head-to-head trial

In the Phase III DREAMS-3 clinical trial of mazdutide, the glucagon-like peptide-1 (GLP-1) and glucagon (GCG) dual receptor agonist showed superior efficacy to semaglutide for body weight reduction.  In Chinese patients with type 2 diabetes (T2D) and obesity, mazdutide performed better than semaglutide on the primary endpoint,… Read More

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Ozempic (semaglutide)
#Cardiovascular disease #GLP-1 #Novo Nordisk #University College London

Semaglutide protects heart beyond weight loss benefits

Anti-obesity medication semaglutide may help to prevent heart attacks and other major cardiac events regardless of how much weight people lose while taking the drug, says a new study led by University College London (UCL).  The finding, the researchers say, suggests there are multiple ways the drug… Read More

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Cell and gene therapy
#Gene therapy #Genetics / genomics #Hearing Loss #Regeneron Pharmaceuticals

Gene therapy brings “new era” in the treatment of hearing loss

New gene therapy trial results have shown dramatic and sustained improvements in hearing and speech perception in children with profound genetic hearing loss.  The updated data for Regeneron Pharmaceuticals’ investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were… Read More

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