Search Results for “immune” – Page 21 – media

FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
- 126
- July 30, 2024
FDA committee proposes overhaul of perioperative lung cancer trials

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has called for changes in how clinical trials are conducted for treatments involving surgery for early-stage non-small cell lung cancer (NSCLC). In the 25 July meeting, the ODAC highlighted that it’s important to separately evaluate the effectiveness of each part of the treatment process, which includes pre-operative and post-operative phases. The committee meeting – which ended with a 11–0 vote in favour of changing how perioperative trials are run– came after AstraZeneca proposed to use Imfinzi (durvalumab) as a treatment with chemotherapy both before and after surgery. The pharma giant conducted the Phase III AEGEAN study (NCT03800134) to support this label expansion. The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Following a lengthy discussion as to whether there should be another trial, Ravi Madan, medical ...
- Source: drugdu
- 97
- July 29, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 120
- July 29, 2024
Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adjusting the marketing authorisation of Bavarian Nordic’s smallpox and mpox vaccine Imvanex (MVA-BN), based on the inclusion of real-world effectiveness data. The recommendation is following a type II variation request by the Danish vaccine maker, as per a 26 July press release. A type II variation is when a major change is needed in the marketing authorisation for a medicine approved in Europe. Bavarian Nordic originally received approval for the vaccine, also known under the brand names Jynneos and Imvamune, in 2013 for smallpox prevention, which was then extended in 2022 to include mpox. The approval was before the mpox outbreak in 2022 and was therefore based on data in non-human primates and immunogenicity insights from healthy volunteers. The results demonstrated that Imvanex had a good safety profile and induced immune responses that were non-inferior to ...
- Source: drugdu
- 83
- July 29, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 86
- July 26, 2024
SINOPHARM’s first batch of antibody products officially shipped! Will bring new treatment options for lymphoma patients

On July 22, the first batch of SINOPHARM’s first antibody drug Sanglijian® (rituximab injection) was officially shipped, marking the company’s antibody drug formally entered a new journey of commercialization. Patient’s Gospel, First-line Targeted Drugs for Hematologic Tumors Lymphoma is a malignant tumor originated from lymphohematopoietic system, which belongs to immune system diseases. Malignant lymphoma is mostly non-Hodgkin’s lymphoma, accounting for about 80%-90% of all lymphoma cases. According to the data released by the National Cancer Center, the current incidence rate of lymphoma in China is about 6/100,000, with nearly 100,000 new cases every year, causing serious harm to patients’ lives, health and quality of life. Sanglijian® (rituximab injection) is mainly used for the treatment of non-Hodgkin’s lymphoma (follicular non-Hodgkin’s lymphoma, CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma), chronic lymphoma cell leukemia (CLL) indications, and it is the first-line targeted drug of hematological tumors. According to the research, SUNLIFE® combined with CHOP ...
- Source: drugdu
- 94
- July 24, 2024
Exhaled-Breath Test Shows Promise for Detection of Lung Cancer

Researchers are advancing the development of an exhaled-breath test to detect lung diseases, including lung cancer. Two pivotal studies published in the Journal of Extracellular Vesicles detail their success in isolating and analyzing lung biomarkers from human breath and utilizing animal models to further explore and possibly identify crucial markers for the early and non-invasive detection of metastatic lung tumors. While substantial efforts are needed to identify a spectrum of biomarkers and validate their clinical relevance for human patients, these publications provide a scientific framework for continued research. The research by scientists at Hackensack Meridian Health (Edison, NJ, USA) focuses on capturing and characterizing extracellular vesicles (EVs), nanoparticles released by cells into fluids like blood and serum. Cancer cells release these particles abundantly, making them prime targets for early disease detection. The researchers have initiated biomarker discovery projects for several cancers, including lung, prostate, cervical, and bladder cancers, using liquid ...
- Source: drugdu
- 91
- July 23, 2024
New Analytical Tool Could Replace Traditional Biopsies with Liquid Biopsies for Disease Diagnosis

Biopsies are important clinical tools used to diagnose various diseases or monitor tissues for abnormal growth or transplant rejection. Typically, this involves removing tissue samples from the body for closer examination, which can be invasive depending on the tissue required. Researchers have developed a new analytical method that could enable the use of “liquid biopsies” as an alternative to traditional biopsies for certain patients or diseases. This new tool, developed by researchers from Vanderbilt University’s School of Medicine Basic Sciences (Nashville, TN, USA), is known as EV Fingerprinting, where EV stands for extracellular vesicles. EVs are membrane-bound particles filled with biologically active materials that play a crucial role in cell-cell communication in both health and disease. Although EVs have been studied since the 1980s, their origins and functions have not been fully defined. Research on EVs has intensified over the last two decades, revealing their involvement in processes such as ...
- Source: drugdu
- 98
- July 19, 2024
Trial finds over-the-counter nasal sprays could reduce RTIs and antibiotic use

A new trial led by researchers from the University of Southampton in partnership with the University of Bristol has revealed that over-the-counter nasal sprays could help to reduce upper respiratory tract infections (RTIs), as well as the use of antibiotics. The study, published in the Lancet Respiratory Medicine and funded by the National Institute for Health and Care Research, found that nasal sprays could prevent severe symptoms of RTIs from developing. Affecting one in five people in England, RTIs are infections of parts of the body involved in breathing, including the sinuses, throat, airways or lungs. Affecting the upper areas of the respiratory system, such as the sinuses and throat, upper respiratory infection symptoms include a runny nose, sore throat and cough. Researchers analysed data from nearly 14,000 adults from 322 GP practices who experienced health problems or risk factors for infections that included either two existing health problems, a ...
- Source: drugdu
- 72
- July 18, 2024
Nature Medicine publishes latest results of combination chemotherapy with Benmelstobart and anlotinib, with a median OS of 19.32 months in SCLC

On July 11, encouraging news came from the ETER701 study completed by 72 centers nationwide led by Professor Cheng Ying of Jilin Cancer Hospital. The academic paper Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial was published online in the international authoritative medical journal Nature ETER701 was a study of Chiatai Tianqing’s Benmelstobart and anlotinib in combination with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. The study showed that the median progression-free survival (mPFS) and median overall survival (mOS) of patients included in the current study were the highest in the history of the registry study, and that the combination chemotherapy regimen of Benmelstobart and amlotinib is expected to provide a survival benefit for patients with extensive-stage small cell lung cancer (ES-SCLC). This is another authoritative recognition of Benmelstobart in combination with amlotinib and chemotherapy in the field of extensive-stage small ...
- Source: drugdu
- 82
- July 18, 2024

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