PharmaFocus Today – Page 147 – media

Further HIV progress needed among heterosexual women

More awareness is needed to encourage women to take up HIV testing amid slow progress in tackling transmission, the UK Health Security Agency’s Chief Medical Adviser has warned today. Despite a significant fall in cases among gay and bisexual men between 2019 and 2022, heterosexual groups are not following the same trajectory. Since 2021, progress has slowed in reducing HIV transmission among heterosexual women, with cases rising by 26% from 447 to 564 in 2022. And in 2022, 40% of women attending sexual health services were not offered an HIV test compared to 27% of heterosexual men and 23% of gay and bisexual men who weren’t offered a test. Factors including a fall in the number of heterosexuals testing since the COVID-19 pandemic and a focus on groups other than women are among the reasons believed responsible. Women were also less likely to start or continue PrEP, according to the ...
- Source: drugdu
- 74
- March 12, 2024
BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy. The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines. Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not ...
- Source: drugdu
- 75
- March 12, 2024
Ascletis Announces Poster Presentation of Phase II Study Final Results of FASN Inhibitor ASC40 for Treatment of Acne at 2024 AAD Annual Meeting

Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States. The summary of the poster is shown as below: Title: First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial Method: This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed. Background: ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de ...
- Source: drugdu
- 122
- March 12, 2024
TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial ...
- Source: drugdu
- 71
- March 12, 2024
FDA Approves Fresenius Kabi’s Tyenne, a Biosimilar of Actemra for the Treatment of Autoimmune Diseases

Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
- Source: drugdu
- 171
- March 11, 2024
An Entire Flu Strain Was Seemingly Wiped Out During COVID-19 Pandemic

Mike Hollan Researchers are debating whether to still include protection for this strain in vaccines. A new victim of the COVID-19 pandemic has been revealed, and it’s a strain of the flu. Every year, multiple strains of the flu make their way through the population. There are four main strains that generally impact the population: two strains of the A variant and two strains of the b variant. Typically, flu vaccines are designed to protect against these four strains. However, after the pandemic, researchers believe that they made no longer need to protect against one of the B strains. The specific strain, known as the Yamagata clade, has not been detected since 2020, according to a report from CNN.1 It’s not yet known if the strain has been wiped out or if instances of infection are so low that they haven’t been reported. Due to this, researchers are still uncertain ...
- Source: drugdu
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- March 11, 2024
Sleep Meds Don’t Work for 9 out of 10 People with Chronic Insomnia – Here’s What Does

Sleeplessness in America is on the rise, due to many external factors including increasingly negative news cycles, international conflicts and economic uncertainty. Collectively, these factors have caused more Americans to have more recurrent sleepless nights. When those nights reach three or more a week for three or more months, it’s considered chronic insomnia, which affects more than 25 million Americans. The condition can lead to both mental and physical health issues, ranging from trouble concentrating to sleep apnea and heart attacks. As we approach Sleep Awareness Week® 2024, which emphasizes the importance of sleep as a major contributor to a person’s overall health, it is also an important reminder to prioritize getting enough quality sleep. Sleep Awareness Week, which starts this year on March 10, always begins at the start of Daylight Saving Time. That’s when the clocks go forward by one hour and Americans lose an hour of sleep ...
- Source: drugdu
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- March 11, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a once-weekly injection, was not part of this clinical trial. Published clinical trial results for that drug show it led to weight loss of 5.9% measured at 12 weeks. Wegovy, whose main ingredient is the peptide semaglutide, offers one mechanism of action: activating the GLP-1 receptor to ...
- Source: drugdu
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- March 11, 2024
BIO-THERA’s BAT8010 (ADC-HER2) for injection in combination with BAT1006 (HER2) for injection for the treatment of locally advanced or metastatic solid tumors was approved in clinical trial

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors. BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells’ heterogeneity of tumor cells. Meanwhile, BAT8010 has ...
- Source: drugdu
- 167
- March 10, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
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- March 10, 2024

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