Search Results for “immune” – Page 19 – media

Study identifies new disease-inducing mechanism for inflammatory bowel disease

Researchers from Newcastle University, Great North Children’s Hospital, Cambridge University Hospital and the universities of Cambridge and Oxford have identified a new disease-inducing mechanism for inflammatory bowel disease (IBD). The study published in the New England Journal of Medicine found that self-directed antibodies attacked interleukin-10 (IL10), an anti-inflammatory protein that controls intestinal immunity, in two patients with early-onset severe IBD. Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people in the UK, according to Crohn’s & Colitis UK. Supported by the National Institute for Health and Care Research (NIHR), Cambridge Biomedical Research Centre, NIHR Oxford BRC and the Leona M. and Harry B. Helmsley Charitable Trust, and part-funded by the Wellcome Trust, scientists discovered that these antibodies prevented IL10 from binding to its receptor, ultimately causing an increased inflammatory response in patients. The team found ...
- Source: drugdu
- 92
- August 20, 2024
CMS Touts First Negotiated Drug Prices, But Greater Impact Expected in Future Rounds

The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
- Source: drugdu
- 107
- August 19, 2024
Pfizer’s RSV vaccine shows benefit in immuno-compromised adults in study

Pfizer said on Monday its respiratory syncytial virus (RSV) vaccine Abrysvo generated a strong immune response in a late-stage study of four groups of adults aged 18 and older with a compromised immune system. A single 120 microgram dose of the vaccine generated strong neutralising antibodies against both subtypes of RSV, called RSV-A and RSV-B, across all groups in the study, Pfizer said. Abrysvo was well-tolerated in the study and showed a safety profile consistent with findings from other studies of the vaccine, it added. The drugmaker plans to submit the data to regulatory agencies for review. The study tested two doses of Abrysvo in 203 adults across four groups – those with a type of lung cancer, end-stage kidney disease, autoimmune inflammatory disorder, and solid organ transplant recipients – all of whom have compromised immunity and are at risk of developing severe RSV-associated disease. Pfizer’s vaccine is currently approved ...
- Source: drugdu
- 103
- August 19, 2024
Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Granted Breakthrough Therapy Designation by China’s NMPA

SHANGHAI, Aug. 12, 2024 /PRNewswire/ — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. ...
- Source: drugdu
- 60
- August 19, 2024
Gilead’s PBC therapy Livdelzi bags accelerated approval

Gilead Sciences’ Livdelzi (seladelpar) has received an accelerated approval from the US Food and Drug Administration (FDA) to treat primary biliary cholangitis (PBC). The approval is based on results from the Phase III RESPONSE trial (NCT04620733), which demonstrated Livdelzi to be the first treatment yielding significant reductions in alkaline phosphatase (ALP) normalisation and pruritus—significant markers of PBC progression. ALP levels normalised at 12 months for 25% of Livdelzi-treated patients compared to none on placebo. Change in pruritus score at six months was significantly reduced among Livdelzi-treated patients compared to those taking placebo. Overall, 62% of patients on Livdelzi achieved composite biochemical response at 12 months, achieved by just 20% of placebo patients. With this regulatory nod, Livdelzi enters a space dominated by other approved therapies like Ocaliva (obeticholic acid) and ursodeoxycholic acid. Ocaliva was developed by Intercept Pharmaceuticals, which was acquired by Alfasigma in late 2023. Gilead gained the rights ...
- Source: drugdu
- 67
- August 17, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 83
- August 16, 2024
Replimune kickstarts Phase III melanoma trial studying RP1 immunotherapy

Replimune has announced the first patient in the Phase III melanoma trial with its lead immunotherapy RP1 or vusolimogene oderparepvec has been dosed and randomised. The IGNYTE-3 study (NCT06264180) will investigate the use of RP1 plus Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are ineligible for anti-CTLA-4 therapy. Massachusetts-based biotech Replimune’s CMO Kostas Xynos stated that the trial will serve to, “advance of our planned BLA submission of RP1 in advanced melanoma later this year”. In spite of slowing research, the wider oncolytic virus-based market has been projected to grow from $114mn in 2023 to $2.4bn in 2029 according to GlobalData analyst Kevin Marcaida. Marcaida expects that within this period, Replimune’s RP1 could claim a 74% market share. The IGNYTE-3 trial comes as Replimune continues a downward financial trend. Despite announcing $100m in private placement ...
- Source: drugdu
- 66
- August 16, 2024
Francis Crick scientists reveal how cells ‘raise the alarm’ when damaged or infected

Scientists at the Francis Crick Institute have revealed how cells ‘raise the alarm’ when acids leak out of their compartments if damaged or infected with bacteria or a virus, which could be useful in developing new drugs. The study published in Molecular Cell reveals that one protein known as V1H, which brings in machinery required for autophagy – the degradation of parts of the cell – is involved in this process. Cells in the body need acidic compartments for digestion and recycling nutrients, of which acid is pumped into them by a group of proteins called the V-ATPase or the ‘proton pump’. When the cells are damaged or infected, acid leaks out of these compartments and cells need to be able to detect this. The new study has revealed how cells are able to detect acid leaks and that the V-ATPase complex is able to raise the alarm if the ...
- Source: drugdu
- 84
- August 15, 2024
Pfizer touts positive topline data for RSV vaccine Abrysvo

Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
- Source: drugdu
- 74
- August 14, 2024
First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
- Source: drugdu
- 119
- August 12, 2024

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