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Eli Lilly's Orforglipron Approved in China, Gaining Edge in Oral GLP-1 Obesity Market

Eli Lilly's Orforglipron Approved in China, Gaining Edge in Oral GLP-1 Obesity Market

Eli Lilly's Orforglipron Approved in China, Gaining Edge in Oral GLP-1 Obesity Market

Novo Nordisk Engages DJ Khaled for Wegovy Campaign Amidst Oral Weight Loss Drug Competition

Novo Nordisk Engages DJ Khaled for Wegovy Campaign Amidst Oral Weight Loss Drug Competition

Novo Nordisk Engages DJ Khaled for Wegovy Campaign Amidst Oral Weight Loss Drug Competition

Exclusive-US FDA shelves commissioner's voucher program for speedy drug reviews, sources say

Exclusive-US FDA shelves commissioner's voucher program for speedy drug reviews, sources say

By Patrick Wingrove and Yasmeen Abutaleb NEW YORK, Nov 12 (Reuters) - The US Food and Drug Administration has shelved the fast-track drug review initiative launched during the Trump administration by former Commissioner Marty Makary, according to six sources familiar with the matter and internal

Novo Nordisk Submits Etavopivat for U.S. and EU Approval as Sickle Cell Treatment

Novo Nordisk Submits Etavopivat for U.S. and EU Approval as Sickle Cell Treatment

Novo Nordisk has submitted New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Applications (MAA) to the European Medicines Agency (EMA) for etavopivat, an investigational once-daily oral therapy for sickle cell disease (SCD). These submissions are based on positive results from a Phase 3 trial, which demonstrated a 27% reduction in painful vaso-occlusive crises (VOCs) compared to placebo and met both primary endpoints. The trial also showed a significant hemoglobin response, with 48.7% of etavopivat recipients achieving an increase greater than one gram per decilitre at week 24, versus 7.2% in the placebo group. Etavopivat is designed to improve red blood cell energy production and reduce sickling by activating pyruvate kinase red blood cell isozyme (PKR). Regulatory action from the FDA and European Commission is anticipated in 2027.

Gene Therapy for Rare Diseases Dominates Approved Products and Clinical Trials

Gene Therapy for Rare Diseases Dominates Approved Products and Clinical Trials

A recent cross-sectional registry analysis has revealed that rare disorders account for 80% of approved gene therapy products and over 44% of all registered gene therapy clinical trials. The study, which analyzed 1,464 registered clinical investigations, identified 646 studies specifically targeting rare conditions, spanning 175 distinct rare diseases. The findings indicate a substantial and sustained growth in rare disease research over the past decade, with annual trial initiations more than tripling from 21 in 2015 to 73 in 2024. The research team integrated data from multiple public registries, including the United States Food and Drug Administration (FDA), Orphanet, and ClinicalTrials.gov. Of the 30 FDA-approved gene therapy products, 24 (80%) carried at least one rare disease indication, covering 16 distinct rare diseases. Despite this progress, early-phase trials still constitute nearly two-thirds of the investigational pipeline, and there is a significant geographic concentration of trials, with th...

New Study Reveals Resistance Training Mitigates Lean Mass Loss in GLP-1 Users

New Study Reveals Resistance Training Mitigates Lean Mass Loss in GLP-1 Users

A recent study, the Tirzepatide and Resistance Exercise (T-REx) trial, published in Nature Medicine on November 9, 2026, indicates that resistance training can significantly reduce lean mass loss in adults using tirzepatide, a GLP-1 medication. The trial involved 120 sedentary adults, aged 50 to 70, with overweight or obesity but without diabetes or cardiovascular disease. Participants were divided into two groups: one received tirzepatide alone, and the other received tirzepatide combined with supervised resistance training three times a week for 40 weeks. While both groups experienced similar weight and fat loss, the group that incorporated resistance training lost less lean soft tissue (3.57 kg vs. 4.67 kg) and showed increased strength across various exercises, whereas the medicine-only group experienced a decrease in strength. The training program progressed through five 8-week phases, from light technique work to vigorous strength and hypertrophy training, with high adherence.

Kaiser Permanente Secures $55.8 Million Grant for Brain Aging Research to Combat Dementia

Kaiser Permanente Secures $55.8 Million Grant for Brain Aging Research to Combat Dementia

Kaiser Permanente has received a significant funding boost of $55.8 million from the National Institute on Aging to extend its landmark Adult Changes in Thought Study. This study, which has been ongoing for over 30 years, focuses on understanding and preventing dementia. More than 7,000 Kaiser Permanente members aged 65 and older in Washington state participate, undergoing biennial study visits. The research has already yielded crucial insights, such as the role of regular exercise in lowering dementia risk and the potential impact of high blood sugar levels, hearing and vision loss, air pollution, and certain medications in increasing it. Over 1,000 participants have also donated their brains to the study, providing invaluable data for scientists to examine age-related brain changes and dementia progression. The new funding will support the study through June 2031, allowing researchers to delve deeper into the interplay between heart and blood vessel conditions (like high blood pressure and diabetes) and ...

GLP-1 Weight Loss Drugs Show Mixed Results in Alzheimer's Trials, Promising for Brain Health in Metabolic Conditions

GLP-1 Weight Loss Drugs Show Mixed Results in Alzheimer's Trials, Promising for Brain Health in Metabolic Conditions

New research published in Science indicates that GLP-1 weight loss drugs, such as semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro, Zepbound), are being investigated for their potential effects on brain health. While observational studies have linked these drugs to a reduced risk of cognitive impairment and dementia, and animal studies suggest they can influence learning and memory, clinical trials present a more nuanced picture. Specifically, Novo Nordisk's EVOKE and EVOKE+ Phase 3 trials found that semaglutide did not slow the clinical progression of Alzheimer's disease in individuals already experiencing early symptoms, despite showing positive changes in some disease-related biomarkers. Researchers, including Stina Börchers and Christoffer Clemmensen, suggest that the effect on Alzheimer's progression might be too small, with semaglutide lowering nerve-cell damage markers by about 10 percent compared to 30 percent for other drugs known to slow Alzheimer's. The review highlights that these drugs ...

Eli Lilly becomes first drugmaker to have a GLP-1 weight loss pill approved in China

Eli Lilly becomes first drugmaker to have a GLP-1 weight loss pill approved in China

By Andrew Silver SHANGHAI, Nov 12 (Reuters) - Eli Lilly on Thursday became the first company to have a GLP-1 weight-loss pill approved in China, gaining a leg up on Danish rival Novo Nordisk in the world's second-largest pharmaceutical market.

Roche Initiates Phase II Clinical Trial for Alzheimer's Drug Targeting Neuroinflammation

Roche Initiates Phase II Clinical Trial for Alzheimer's Drug Targeting Neuroinflammation

Roche has announced the initiation of a new Phase II clinical trial, TARBELA-AD, to evaluate RG6434, an investigational oral NLRP3 inhibitor, for early symptomatic Alzheimer's disease. This study is part of Roche's broader strategy to address Alzheimer's by targeting various biological mechanisms, specifically focusing on neuroinflammation as a key driver of pathology in addition to amyloid aggregation. The announcement was made in anticipation of the 19th Clinical Trials on Alzheimer's Disease (CTAD) Congress in Boston, scheduled from November 16-19, 2026. According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, this trial aims to test additional therapeutic hypotheses to potentially halt or prevent disease progression, complementing their ongoing trontinemab programs. Roche's diagnostics division is also expanding access to earlier and more accurate Alzheimer's diagnosis through its blood-based biomarker portfolio, including the FDA-cleared Elecsys pTau217 and Elecsys pTau181 tests.

BridgeBio Pharma to Present Extensive New Data on Acoramidis for ATTR-CM at International Symposium

BridgeBio Pharma to Present Extensive New Data on Acoramidis for ATTR-CM at International Symposium

BridgeBio Pharma to Present Extensive New Data on Acoramidis for ATTR-CM at International Symposium

Verapamil, a Blood Pressure Drug, Shows Promise in Preserving Insulin-Producing Cells for Type 1 Diabetes

Verapamil, a Blood Pressure Drug, Shows Promise in Preserving Insulin-Producing Cells for Type 1 Diabetes

Verapamil, a calcium channel blocker traditionally used for blood pressure and heart rhythm issues, is being investigated for its potential in treating Type 1 diabetes. Previous small trials in 2018 involving adults with newly diagnosed Type 1 diabetes and a larger trial in children (CLVer) indicated that Verapamil helped preserve insulin-producing β-cells. However, the largest adult trial to date, Ver-A-T1D, which included 136 participants, narrowly missed its primary objective in 2025. This was partly attributed to the placebo group experiencing a slower-than-anticipated decline in β-cell function. Despite this, further trials are currently underway, including WAVE T1D, which is examining Verapamil's efficacy following immune therapy in young individuals with new-onset Type 1 diabetes. The drug's mechanism in diabetes is believed to involve lowering TXNIP, a gene that contributes to glucose-induced stress and β-cell death, and increasing CaMK4, which supports β-cell survival.