PharmaFocus Today – Page 322 – media

Sanofi and Sobi’s haemophilia A treatment shows effective bleed protection in children

Sanofi and Sobi’s once-weekly haemophilia A treatment has demonstrated highly effective bleed protection in children with severe forms of the disease, according to late-stage data presented at the International Society on Thrombosis and Haemostasis (ISTH) annual meeting. The phase 3 XTEND-Kids study evaluated a once-weekly 50IU/kg dose of the factor VIII replacement therapy, Altuviiio, for 52 weeks in previously treated patients aged under 12 years. The oral presentation at ISTH detailed results from the study and confirmed that the therapy met the primary endpoint, with no inhibitor development to factor VIII detected. Key secondary endpoints were also met, including annualised bleeding rate and maintenance of factor VIII activity above pre-specified levels. Sanofi added that the therapy was well-tolerated and demonstrated a safety profile similar to the phase 3 XTEND-1 trial, confirming safety and efficacy in both adults and children. Haemophilia A is a rare, lifelong bleeding disorder in which a ...
- Source: drugdu
- 193
- June 29, 2023
Eli Lilly experimental obesity drug helped patients lose up to 24% of their weight, study says

Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
- Source: drugdu
- 112
- June 29, 2023
Lisata shares pipeline update of anticancer lead candidate drug

Lisata Therapeutics aims to start a new Phase Ib/IIa trial of its lead candidate drug LSTA1 in glioblastoma later this year. The trial will study LSTA1’s use alongside the standard of care (SOC) versus the SOC and placebo. According to Lisata CEO David Mazzo, added that the company aims to enrol 30 subjects in the active arm in approximately one year. The study will focus on efficacy endpoints such as progression-free survival and overall survival. The trial will take place in the Baltic region, specifically in Estonia and Latvia. This was initially shaped by the company’s collaboration with a research group from Estonia’s University of Tartu Mazzo commented that Lisata aims to have data from this trial ready by mid-2025. The company’s lead candidate LSTA1 is a cyclic peptide that is designed to modify the tumour microenvironment by binding to alpha-V integrins expressed in tumours, per the company’s website. Once ...
- Source: drugdu
- 101
- June 29, 2023
Pfizer Drops Early-Stage Obesity Drug Following Disappointing Phase I Data

By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
- Source: drugdu
- 162
- June 28, 2023
Biogen Shareholders Elect Susan Langer to Board of Directors Despite Controversy

By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock After a June 12 shakeup of Biogen’s board of directors that included three directors foregoing their re-election, the company announced Monday that shareholders elected Susan Langer, who currently serves as president of Souffle Therapeutics, to the board. Langer will serve on the board for a one-year term, according to the press release. She was nominated by Alex Denner, a former member of the board who did not stand for re-election. According to reporting by Endpoints News and STAT News, Langer is Denner’s romantic partner and the mother of his child. BioPharma Dive reported that during Monday’s annual meeting of stockholders, Biogen management was asked why the company didn’t disclose this potential conflict of interest. Caroline Dorsa, the new chair, replied that Langer’s “personal matters obviously are much less relevant than what she brings to this board.” Langer has previously worked at ...
- Source: drugdu
- 136
- June 28, 2023
Global study shows loneliness can shorten life spans

There is an epidemic of loneliness and isolation today, and the consequences can be deadly, researchers say. Folks who reported that they were socially isolated or felt lonely were more likely to die early from all causes including cancer, according to a sweeping review of 90 studies that included more than 2.2 million people from around the globe. Exactly how loneliness or social isolation affects a person’s health and well-being is not fully understood, but many theories exist, the researchers reported. People who are socially isolated or lonely may be less likely to eat a healthy diet and get regular exercise and more likely to smoke and consume alcohol. In addition, social isolation is linked to inflammation and weakened immune systems. People who are socially isolated may be less likely to receive medical care due to their smaller social networks. Social isolation and loneliness are not one and the same, ...
- Source: drugdu
- 107
- June 28, 2023
Age of those with mismatched biological sex and gender identity (gender dysphoria) is falling, study finds

The age of those who are distressed because of a mismatch between their biological sex and their gender identity—known as gender dysphoria—has been steadily falling, reveals research published in the open access journal General Psychiatry. And it’s lower for those assigned female sex at birth than those assigned male, the findings indicate. Recent studies suggest that gender dysphoria is becoming more common, particularly among those assigned female sex at birth. But these studies have been hampered by small sample sizes, short monitoring periods, or outdated datasets. In a bid to get round these limitations, the researchers drew on data submitted to the TriNetX database Research Network from 49 health care organizations between 30 April 2017 and 30 April 2022 inclusive. This database holds the anonymized medical records of around 66 million people, most of whom (80%) live in the U.S.. The researchers focused on 42 million 4 to 65-year-olds, 66,078 ...
- Source: drugdu
- 285
- June 28, 2023
More than 1.31 billion people could have diabetes by 2050, study says

Dive Brief More than 1.31 billion people worldwide could be living with diabetes by 2050, according to estimates published in the Lancet. In 2021, roughly 529 million people worldwide had diabetes, according to the International Diabetes Federation. The rise in prevalence is expected to be driven by increases in Type 2 diabetes. Overall healthcare spending related to diabetes is expected to rise to $1.054 trillion by 2045, the authors wrote. Global spending in 2021 was estimated at $966 billion by the International Diabetes Federation. Dive Insight With diabetes cases expected to increase globally, current treatment is focused on biomedical interventions and new devices, according to an editorial published in the Lancet that accompanied the researchers’ findings. The authors said people who are marginalized and discriminated against suffer the “most and worst consequences” of diabetes, and “addressing structural racism must become a core component of preventive strategies and health promotion — ...
- Source: drugdu
- 118
- June 28, 2023
Personalized dosing improves outcomes for men with metastatic castration-resistant prostate cancer

By monitoring early-response biomarkers in men undergoing 177Lu-PSMA prostate cancer treatment, physicians can personalize dosing intervals, significantly improving patient outcomes. In a study presented at the Society of Nuclear Medicine and Molecular Imaging 2023 Annual Meeting, early stratification with 177Lu-SPECT/CT allowed men responding to treatment to take a “treatment holiday” and allowed those not responding the option to switch to another treatment. Approved by the U.S. Food and Drug Administration in 2022, 177Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer. However, not all men respond equally to treatment, with some responding very well and others progressing early. “Currently, a standardized dosing interval is used for 177Lu-PSMA treatment,” said Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the Department of Theranostics and Nuclear Medicine at St. Vincent’s Hospital in Sydney, Australia. “However, monitoring early-response biomarkers to adjust treatment intervals may improve patient outcomes.” In the study, researchers sought ...
- Source: drugdu
- 112
- June 28, 2023
Pfizer shelves one oral pill, pivots to another in weight loss drug race

Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
- Source: drugdu
- 108
- June 28, 2023

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