Novo Nordisk shares positive phase 3 results for Ozempic in diabetes and chronic kidney disease

Novo Nordisk has announced positive results from a phase 3 trial evaluating Ozempic (semaglutide) in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). Results from the FLOW trial were presented at the 84th Annual Scientific Sessions of the American Diabetes Association. According to Diabetes UK, out of the 5.6 million people living with diabetes in the UK, 90% have T2D. Approximately 40% of people living with T2D will eventually go on to develop CKD, a gradual loss of kidney function over time that affects more than 800 million people worldwide. Read

What is type 2 diabetes?

It is a chronic condition characterized by insulin resistance, leading to elevated blood sugar levels. It is influenced by genetic and lifestyle factors such as obesity, poor diet, and physical inactivity. Symptoms include increased thirst, frequent urination, fatigue, and blurred vision, and it is managed through lifestyle changes and medications. If not controlled, it can lead to severe complications like cardiovascular disease, nerve damage, and kidney problems.

What is chronic kidney disease?

CKD is a long-term condition where the kidneys gradually lose function over time, leading to a buildup of waste and fluids in the body. It can result from conditions such as diabetes, high blood pressure, and other diseases that damage the kidneys. Symptoms may include fatigue, swelling in the legs and ankles, frequent urination, and high blood pressure. Management focuses on controlling underlying conditions, lifestyle changes, and medications to slow progression and prevent complications.

In Other News

Eisai and Biogen have launched their Alzheimer's treatment Leqembi in China, the third country after the United States and Japan, the companies said on Friday. Leqembi, which works by removing a toxic protein called beta amyloid from the brain, is the first Alzheimer's treatment proven to alter the course of the fatal, brain-wasting disease. Read

Scientists discover new form of gene editing to recombine and rearrange DNA: Researchers from the Arc Institute have discovered a new form of gene editing that can recombine and rearrange DNA without requiring CRISPR.Published in Nature, the first DNA bridge recombinase mechanism allows researchers to edit, delete and convert DNA recombinase in a programmable way.Gene editing occurs when scientists change the DNA of an organism to help lead to new developments to cure genetic diseases. Read

ARS Pharmaceuticals said on Friday the European Medicines Agency (EMA) has recommended the approval of its needle-free emergency treatment, EURneffy, for allergic reactions. EURneffy is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions. Read

AbbVie and Genmab’s Epkinly (epcoritamab-bysp) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL).The regulator’s decision, which specifically applies to patients who have received at least two lines of prior therapy, makes Epkinly the first and only subcutaneous T-cell engaging bispecific antibody to be approved for this patient population. Read

AstraZeneca (AZ) has shared positive results from a late-stage study of its Imfinzi (durvalumab) combination in muscle-invasive bladder cancer (MIBC).The phase 3 NIAGARA trial randomised more than 1,000 MIBC patients to receive Imfinzi plus chemotherapy or chemotherapy alone prior to bladder removal surgery, followed by Imfinzi or no further treatment.The Imfinzi/chemotherapy combination demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy, AZ said. Read

China has approved the use of AstraZeneca's blockbuster cancer drug Tagrisso in combination with chemotherapy as a first line of treatment for adults with a type of advanced lung cancer, the company said on Wednesday.AstraZeneca said the approval by China's National Medical Products Administration (NMPA) was based on trials which showed that patients given the combination treatment lived without the disease getting worse longer than those given just Tagrisso. Read

Researchers from the University of Sheffield’s Institute of Translational Neuroscience (SITraN) and scientists from the UK Dementia Research Institute, Cambridge, have revealed how a protein interaction with a hallmark of Alzheimer’s disease (AD) can increase the risk of developing it. Published in the journal Nature, the findings from the study open up potential new therapies to treat the neurological condition. Affecting more than 944,000 people in the UK, dementia is a general term for the impaired ability to think, remember or make decisions on a daily basis.Currently the most common form of dementia in the UK, AD is caused by a build-up of proteins in the brain, which damage the brain cells’ ability to transmit messages. Read

The largest repository of transcription factor binding data in human tissues compiled to date: Transcription factors (TFs) are proteins that bind to specific DNA sequences, regulating the transcription of genetic information from DNA to messenger RNA (mRNA). These proteins play a pivotal role in the regulation of gene expression, which in turn impacts a wide range of biological processes and brain functions.While TFs have been the topic of numerous research studies, their binding dynamics in human tissue remain poorly understood. Shedding light on these binding dynamics could help to better understand how the expression of different genes contributes to the development of specific diseases, including neurodegenerative and psychiatric disorders. Read

Biogen’s Tofidence (tocilizumab), a biosimilar referencing Roche’s RoActemra, has been approved by the European Commission (EC) to treat certain forms of arthritis and COVID-19.The intravenously administered monoclonal antibody, developed by Bio-Thera, has been approved to treat moderate-to-severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Read

Researchers from the University of Bristol have revealed a new disease-driving mechanism that could help treat the development of atherosclerosis. The new therapeutic, IMSET, is being developed by researchers at the Bristol Medical School: Translational Health Sciences (THS) and is being supported by funding through beLAB1407, one of Evotec’s global portfolio of BRIDGE partnerships.Affecting 42% of adults without heart disease, atherosclerosis is characterised by the build up of atherosclerotic plaques (fatty deposits) in the arteries, which can lead to heart attacks, strokes and peripheral arterial disease. Read

Roche’s subcutaneous (SC) formulation of its Ocrevus (ocrelizumab) has been granted marketing authorisation by the European Commission (EC) to treat relapsing and primary multiple sclerosis (MS). Ocrevus SC is a ten-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, providing an additional treatment option for patients without the need for IV facilities.Affecting approximately 2.9 million people globally, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body, causing symptoms such as weakness, fatigue and vision problems. Read

A recent study led by researchers at Tampere University investigated whether a transglutaminase 2 inhibitor has potential as a drug to treat celiac disease. Previous tissue studies have shown that the ZED1227 transglutaminase 2 inhibitor prevents gluten-induced intestinal damage.The results of the new study, based on an analysis of the molecular activity of more than 10,000 genes, provide very strong evidence that the first successful drug to treat celiac disease may be at hand.The study was published in Nature Immunology on 24 June 2024. The publication is part of Doctoral Researcher Valeriia Dotsenko's dissertation, which will be examined at Tampere University's Faculty of Medicine and Health Technology in August.Consuming gluten-containing cereals, i.e. wheat, barley, and rye, leads to an abnormal immune response in the small intestine and the development of celiac disease in up to 2% of the population. Read

The LENS trial has demonstrated that fenofibrate, a drug usually used to lower cholesterol, reduces the risk of progression of diabetic retinopathy by 27%. The results were announced at the American Diabetes Association Scientific Sessions and published in a paper titled, "Effect of Fenofibrate on Progression of Diabetic Retinopathy," published in NEJM Evidence.Diabetes can cause damage to the small blood vessels at the back of the eye, a condition called diabetic retinopathy. Diabetic retinopathy is among the top five causes of visual loss worldwide and the only major cause to increase in recent decades. Read

Bristol Myers Squibb’s (BMS) KRAS inhibitor Krazati (adagrasib) has been granted accelerated approval by the US Food and Drug Administration (FDA) as part of a combination treatment for a subset of colorectal cancer (CRC) patients.The drug has been authorised for use alongside cetuximab as a targeted treatment option for adults with locally advanced or metastatic cases of the disease who are carrying the KRASG12C mutation, which occurs in approximately up to 4% of CRC patients and has historically been challenging to treat.Eligible patients will also have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Read

Takeda’s Fruzaqla (fruquintinib) has been approved by the European Commission (EC) to treat adults with previously treated metastatic colorectal cancer (CRC). Patients eligible for the VEGF inhibitor will have received available standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, and anti-VEGF and anti-EGFR agents, and will have progressed on or been intolerant to either trifluridine-tipiracil or regorafenib.CRC, which begins in either the colon or rectum, was the second most common cancer in Europe in 2022, with approximately 538,000 new cases of the disease diagnosed that year. Read

Brain health is rooted in state of mind, finds study: Having more positive experiences in life is associated with lower odds of developing brain disorders like Alzheimer's disease, slower cognitive decline with age, and even a longer life.But how feelings and experiences are translated into physical changes that protect or harm the brain is still unclear.A study from Columbia researchers now suggests that the brain's mitochondria may play a fundamental part. The study is published in the journal Proceedings of the National Academy of Sciences. Mitochondria supply energy to the brain, and the new study shows that the molecular machinery used by mitochondria to transform energy is boosted in older adults who experienced less psychological stress during their lives compared with individuals who had more negative experiences. Read

Upcoming Events & Webinars

Lyo-Modellling [JUL 10, 2024]: Join

2024 Transparency & Aggregate Spend Survey - WEBINAR: Join

Innovative Solutions in Pre-Filled Syringes for Biologics and Ophthalmic Applications [JUL 11]: Join

4th Chief Patient Officer [JUL 15 - 16]: Join * Save 15% off with discount code PHARMEMED

5th Clinical Trial Agreements, Philadelphia, USA [AUG 21 -22] : Join * Save 15% off with discount code PHARMEMED

Med Dev day (Medical Devices)[07 - 08 October 2024]: Join

Regulatory Careers Live 2024 [11 September 2024]: Join

Digital Healthcare & Innovation Conference [SEP 12]: Join

NPL Summit - [SEP 24 - 26]: Join

Cleaning Validation Summit 2024 [OCT 01 - 2]: Join

Pharmaceutical Technology for Non-Biotechnologists [OCT 09-10]: Join

Pharma & Patient USA 2024 - Boston - [OCT 15-16]: Join

Pharma Customer Engagement USA 2024 [OCT 22-23]: Join

Cancer Biology and Therapeutics - Paris - [NOV 18-19]: Join

BioHealth 2024 - nCopenhagen - [NOV 20 -21]: Join

Company Spotlight: Vertex Pharmaceuticals

Vertex Pharmaceuticals, founded in 1989 and based in Boston, is a global biotech company specializing in innovative therapies for serious diseases. Renowned for its cystic fibrosis treatments (Kalydeco, Orkambi, Symdeko, Trikafta), Vertex also focuses on sickle cell disease, beta-thalassemia, pain, and kidney diseases. Utilizing rational drug design, Vertex targets disease-related proteins for precise therapies. The company collaborates with academic institutions and pharmaceutical firms to advance research. With a global presence, Vertex is publicly traded (NASDAQ: VRTX) and emphasizes corporate social responsibility, patient access, community engagement, and sustainability.