Search Results for “Clinical Trial” – Page 26 – media

Wegovy shown to reduce risk of heart attack, stroke in major cardiovascular trial

By Meg Tirrell, CNN The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart-related death by 20% in what’s being called a landmark clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects. Novo Nordisk studied Wegovy against placebo in addition to standard of care for prevention of major adverse cardiac events in 17,604 adults with heart disease and obesity or who were overweight, but who didn’t have diabetes. It called the five-year trial “Select.” The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes. “Historically, trials ...
- Source: drugdu
- 125
- August 11, 2023
Bavarian Nordic’s chikungunya vaccine candidate shows promise in late-stage trial

Bavarian Nordic has shared positive top-line results from a late-stage study of its chikungunya virus vaccine candidate in adults and adolescents. Chikungunya is a mosquito-borne viral disease for which there is currently no approved vaccine or effective treatment. Infection leads to symptomatic disease after four to eight days following the bite of an infected mosquito, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. More than 3,200 people aged 12 to 64 years were enrolled and randomised to receive either a single intramuscular injection of Bavarian Nordic’s virus-like particle-based vaccine candidate, CHIKV VLP (PXVX0317), or placebo. Results showed that the vaccine was highly immunogenic in healthy adolescents and adults at up to 22 days post-vaccination, as demonstrated by the strong induction of chikungunya neutralising antibodies in 98% of those in the active group. CHIKV VLP induced significant neutralising antibodies in ...
- Source: drugdu
- 101
- August 9, 2023
unrNektar Flags Lilly’s Miscalculations in Rezpeg Atopic Dermatitis Trials

By Tristan Manalac Pictured: Nektar signage at its headquarters in California/iStock, Sundry Photography Nektar Therapeutics on Monday revealed that former partner Eli Lilly had incorrectly calculated efficacy data for its investigational regulatory T-cell stimulator rezpegaldesleukin (rezpeg), which the company is developing as a treatment for atopic dermatitis. At the 31st Congress of the European Academy of Dermatology and Venereology (EADV), held in September 2022, Lilly presented data from a Phase Ib study of rezpeg, showing that while the candidate elicited positive and dose-dependent improvements in key efficacy measures, these effects ultimately fell short of statistical significance. At 12 weeks, Lilly erroneously reported the 12-µg/kg and 24-µg/kg doses of rezpeg were associated with a 53% and 66% improvement in Eczema Area and Severity Index (EASI) scores, respectively, whereas placebo induced a 49% improvement relative to baseline, Nektar reported. Neither dose was significantly superior to placebo, according to the company. However, Nektar’s ...
- Source: drugdu
- 104
- August 9, 2023
Sumitomo, Otsuka’s Schizophrenia Candidate Fails Phase III Trials

Pictured: Woman in mental anguish/iStock, Marina Demeshko Sumitomo Pharma and Otsuka Pharmaceutical announced Monday that two Phase III studies of ulotaront failed to meet primary endpoints for acutely psychotic adults living with schizophrenia. The studies, DIAMOND 1 and DIAMOND 2, pitted the trace amine-associated receptor 1 (TAAR1) agonist against a placebo. After six weeks, the studies showed improvement on the Positive and Negative Syndrome Scale (PANSS), but results were not superior to placebo. A “large placebo effect” was present in both studies “which may have masked the molecule’s therapeutic effect,” according to the press release. While placebo responses are frequently higher in psychiatric studies, Sumitomo CEO Hiroshi Nomura pointed to COVID-19 as a potential culprit for the high placebo effect as the studies were conducted throughout the pandemic. The molecule was part of a four-compound deal forged between Otsuka and Sunovion, a subsidiary of Sumitomo, nearly two years ago. The former made an upfront payment of ...
- Source: drugdu
- 98
- August 2, 2023
Merck, Moderna Launch Pivotal Cancer Vaccine Trial for High-Risk Melanoma

Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
- Source: drugdu
- 138
- July 28, 2023
Trial Investigating Peanut Allergy Immunotherapy Hits Final Milestone

A trial investigating desensitisation immunotherapy delivered as toothpaste for adults with peanut allergy reached a final milestone after Intrommune Therapeutics completed the last patient’s last visit. The Phase I OMEGA clinical trial (NCT04603300) is a multi-centre, randomised, placebo-controlled double-blind study involving splitting 32 participants with peanut allergy into two groups to receive either an escalating dose of the company’s candidate INT301 or placebo. The primary outcome is the safety of the drug compared to placebo. Safety is measured by the percentage of participants able to tolerate the highest dose and incidence of adverse reactions. Intrommune Therapeutics’ candidate utilises the company’s oral mucosal immunotherapy (OMIT) platform to deliver the therapy in fully functional toothpaste. OMIT’s simple administration allows for improved adherence, which is important for desensitising a patient to a specific allergy. Allergy immunotherapy requires consistent exposure. Peanut allergy is one of the most common allergies that ...
- Source: drugdu
- 120
- July 28, 2023
ADC Discontinues Zynlonta Trial in DLBCL After Seven Deaths

Pictured: Doctor checking a patient’s neck/iStock, stefanamer ADC Therapeutics is discontinuing the Phase II LOTIS-9 trial testing Zynlonta (loncastuximab tesirine-lpyl) in combination with Genentech and Biogen’s Rituxan (rituximab) for patients with previously untreated diffuse large B-cell lymphoma, the company announced Thursday afternoon. The decision to discontinue comes after the Swiss biotech decided last week to voluntarily halt enrollment in LOTIS-9 after seven patients died of extreme respiratory events. While six of the fatalities were deemed “unlikely or unrelated to the study drug,” the company nevertheless elected to suspend the entry of patients into the study. In connection with the deaths, the FDA has also placed a partial clinical hold on enrollment into LOTIS-9, according to ADC’s Thursday press release. However, the company can continue dosing diffuse large B-cell lymphoma (DLBCL) patients who were seeing clinical benefit from the experimental treatment regimen, as long as these patients have given their consent again. Once ...
- Source: drugdu
- 233
- July 25, 2023
Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial

Pictured: Flu vaccine vials and syringe/iStock, vchal Topline data from the Phase II PENINSULA study showed that Vir Biotechnology’s investigational flu shot VIR-2482 fell short of its primary and all secondary efficacy endpoints, the biotech announced Thursday. Patients inoculated with the highest 1,200-mg dose of the vaccine candidate saw a 16% drop in influenza A-like illness as compared with placebo, an effect that did not satisfy statistical significance, according to Vir’s news release. PENINSULA defined this primary endpoint as PCR-confirmed influenza A infection with at least one respiratory and one systemic symptom. Phil Pang, Vir’s chief medical officer, called these findings “disappointing” in a statement, but nevertheless said that the company needs to conduct further analysis to “better understand these outcomes.” Vir plans to present these analyses at a future major medical congress. PENINSULA is double-blinded, randomized and placebo-controlled study with approximately 3,000 adult patients enrolled. VIR-2482 was given as a ...
- Source: drugdu
- 147
- July 25, 2023
Pfizer Group B Strep Vaccine for Infants Returns Encouraging Mid-Stage Trial Results

Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
- Source: drugdu
- 107
- July 21, 2023
InnoCare and ArriVent Announce Clinical Development Collaboration

Companies will collaborate on investigating a novel SHP2 inhibitor in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR inhibitor, in patients with advanced non-small cell lung cancer BEIJING and NEWTOWN SQUARE, Pa., July 13, 2023 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases and ArriVent Biopharma, a clinical stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced a clinical development collaboration to evaluate the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor. Under the agreement, InnoCare and ArriVent will jointly conduct a clinical study to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). Furmonertinib ...
- Source: drugdu
- 229
- July 17, 2023

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