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2024 AAD ︱ Hengrui’s Self-exempt Class 1 Innovator Emacetinib Phase III Study for Moderate to Severe Atopic Dermatitis Debuts in Oral Presentation

The 82nd Annual Meeting of the American Academy of Dermatology (AAD) was held from March 8 to 12, 2024 in San Diego, USA. This is one of the largest and most influential international events in the field of dermatology in the world. on the afternoon of March 10, Professor Zhang Jianzhong, a well-known dermatologist and professor of Peking University People’s Hospital, delivered an oral report in the Late-Breaking Research session of the conference, introducing Hengrui Pharmaceuticals’ innovative drug, Emaxitinib ( SHR0302) in the treatment of moderate-to-severe atopic dermatitis (AD). “Emaxitinib is a highly selective JAK1 inhibitor originally developed in China, which is a major breakthrough for us in the field of innovative drug development.” Prof. Zhang Jianzhong explained that the Phase III clinical study showed that patients with moderate-to-severe AD treated with emaxitinib for 16 weeks showed significant improvement in skin lesions and itching symptoms, and the 52-week long-term follow-up ...
- Source: drugdu
- 146
- March 13, 2024
【EXPERT Q&A】Is there a requirement for the registration address of the second type of medical device business filing?

Drugdu.com expert’s response: There are usually requirements for the registered address when applying for the record-filing of the distribution of Class II medical devices. The registered address is typically required to be a legally operated premises that complies with relevant regulations, ensuring that the storage, sales, and management of medical devices meet the standards. Specific requirements may include the area of the premises, environmental conditions, storage facilities, safety measures, etc.
- Source: drugdu
- 254
- March 12, 2024
Rapid AST Platform Provides Targeted Therapeutic Results Days Faster Than Current Standard of Care

Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care. Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies. The Selux PBC Separator streamlines the process for ...
- Source: drugdu
- 166
- March 12, 2024
First Ever Prototype Applies AI to Colorectal Diagnosis

The incidence and mortality rates of colorectal cancer (CRC) are on an alarming rise, with predictions showing a continuous increase until at least 2040. Currently, CRC ranks as the third most diagnosed (10.7% of all cancer cases) and the second deadliest cancer type. Despite the effectiveness of imaging and endoscopic techniques in CRC detection, the final cancer diagnosis always relies on a pathologist’s assessment of histological samples. Grading dysplasia is still routinely performed by pathologists worldwide when assessing colorectal tissue samples. Computer-aided diagnosis (CAD) systems for colorectal pathology face challenges due to the high data volume and the massive resolution of images, leading to a bottleneck in deep learning (DL) approaches that extract patches from the whole slides. Now, researchers at INESC TEC (Porto, Portugal) and IMP Diagnostics (Porto, Portugal) have created a pioneering prototype that employs artificial intelligence (AI) for colorectal diagnosis. This prototype is a result of a ...
- Source: drugdu
- 159
- March 12, 2024
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
- 147
- 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
- 132
- 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
- 143
- 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
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- 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
- 81
- March 12, 2024

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