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FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
- Source: drugdu
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- March 12, 2024
How Marketing Fueled the Opioid Overdose Crisis and What We Can Learn From It

Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers. By SUZETTE GLASNER-EDWARDSThe recent series of settlements linked with claims against advertising and pharmaceutical manufacturing companies involved in the sales and marketing of opioid drugs are encouraging, demanding accountability for promoting highly addictive drugs such as OxyContin as non-addictive. These settlements, ranging from $350 to $465 million, provide a source of optimism for those living with opioid use disorders, especially given the inclusion of funding to support the treatment of such individuals. Yet questions about the potential future impact of these criminal and civil suit settlements on the opioid overdose epidemic remain. Coupled with the observation that opioid marketing practices have not shifted in the face of lawsuits in the past, under-recognition of addiction and overprescribing of medications with high addiction potential for ...
- Source: drugdu
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- March 12, 2024
MIT study reveals non-invasive treatment holds promise for treating ‘chemo brain’

The gamma treatment also shows potential for treating patients living with neurological diseases Researchers from the Massachusetts Institute of Technology (MIT) have shown that a non-invasive treatment called gamma treatment could protect cancer patients from “chemo brain,” memory impairment and other cognitive effects of chemotherapy. Chemo brain is a term used to describe thinking and memory problems that a patient may experience before, during or after cancer treatment. Originally developed to treat Alzheimer’s disease (AD), the treatment works to stimulate gamma-frequency brain waves, involving exposure to light and sound with a frequency of 40 hertz. In the new study, MIT researchers used mouse models, which evaluated a chemotherapy drug known as cisplatin, often used to treat testicular and ovarian cancers, for five days and then took it off for five days and repeated it. One group received chemotherapy only, while another group was also given 40-hertz light and sound therapy ...
- Source: drugdu
- 134
- March 12, 2024
MHRA approves Marinus Pharmaceuticals’ Ztalmy for CDKL5 deficiency disorder

The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Marinus Pharmaceutical’s Ztalmy (ganaxolone) to treat cyclin-dependant kinase-like 5 (CDKL5) deficiency disorder (CDD). The approval marks Ztalmy as the first anti-seizure medication to be used in the UK to treat the rare epileptic seizure disorder. Affecting around one in 42,000 people in the UK, CDD is a rare genetic disorder that occurs from mutations in the CDLK5 gene, which is crucial for normal brain development, causing seizures as early as the first week of life. Ztalmy, taken orally through a dosing syringe, is a steroid that attaches to specific receptors in the brain and aims to stop epileptic seizures from occurring. The approval was supported by evidence from the phase 3 Marigold randomised, double-blind, placebo-controlled clinical trial, which involved 101 patients – 50 who received ...
- Source: drugdu
- 119
- March 12, 2024
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
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- 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
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- 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
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- 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
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- March 12, 2024
KIHE 2024

Organiser: ITE Group Time:15 – 17 May 2024 address：42 Timiryazev str., Almaty, 050057 Almaty, Kazakhstan Exhibition hall: Atakent International Exhibition Centre Product range: Medical equipment: Medical technology equipment, laboratory equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first aid and emergency equipment, hospital & Dental & medical equipment, dental service equipment and disposable medical products, hospital and home disposable medical products, hospital dentistry, medical data processing systems, dental plastic surgery, rehabilitation equipment Drugs: foreign prescription drugs, herbal preparations, mineral supplements and vitamin and other nutritional health drugs, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumer products, cosmetics Pharmaceutical Industry: Pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, pharmaceutical industry raw materials and ingredients, intermediates, pharmaceutical equipment, pharmaceutical packaging, laboratory ...
- Source: drugdu
- 162
- March 11, 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
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- March 11, 2024

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