Search Results for “Clinical Trial” – Page 25 – media

AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. SEQUENCE was designed to establish the non-inferiority of Skyrizi compared to Stelara in terms of clinical remission. AbbVie’s IL-23 inhibitor not only met this bar, but also demonstrated signals of superiority: 59% of Skyrizi-treated patients achieved remission, as opposed to only 40% among Stelara comparators. Remission, the study’s primary endpoint, was defined as scores lower than 150 in the Crohn’s Disease Activity Index, measured at week 24. “These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease,” Roopal Thakkar, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs, said in a statement. SEQUENCE’s results also highlight the role Skyrizi can play ...
- Source: drugdu
- 106
- September 15, 2023
Acelyrin’s Lead Asset Izokibep Fails in Late-Stage Hidradenitis Suppurativa Trial

By Tristan Manalac Pictured: Close-up of a skin lesion in a patient with hidradenitis suppurativa/iStock, krblokhin Top-line data from a Phase IIb/III trial showed that Acelyrin’s investigational IL-17A inhibitor izokibep fell short of its primary endpoint in patients with hidradenitis suppurativa, a chronic inflammatory skin condition, the company announced Monday. In patients who were being treated with 160-mg izokibep once-weekly, 39% demonstrated at least a 75% decrease in the hidradenitis suppurativa clinical response (HiSCR75) score at 16 weeks, while 29% of placebo comparators achieved a similar level of clinical response. This did not result in a significant treatment effect, with a p-value of 0.3278, according to the company’s announcement. Even the twice-weekly izokibep schedule was unable to significantly distinguish itself from placebo, with only 34% of patients achieving HiSCR75 at 16 weeks. These findings were calculated using a non-responder imputation (NRI) method. Acelyrin’s shares tanked 64% in after-hours trading in ...
- Source: drugdu
- 106
- September 14, 2023
J&J dumps high-dose Opsumit trial upon failure in rare type of pulmonary hypertension

Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag.J&J’s Janssen has decided to stop a phase 3 trial for a 75-mg dose of macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH). The company pulled the plug after an independent data monitoring committee performed an interim analysis and figured the trial wouldn’t succeed. Macitentan, given at 10 mg daily, won approval in 2013 under the brand name Opsumit for treating pulmonary arterial hypertension (PAH). PAH and CTEPH are slightly different diseases, but both feature abnormally high blood pressure in the arteries of the lungs. The results from the high-dose trial, dubbed MACiTEPH, won’t affect the marketed product, J&J said. Separately, J&J is trying to show that the higher dose works better than the FDA-approved 10-mg version in PAH. That study, coded UNISUS, remains ongoing with an estimated primary completion date next month, according to ...
- Source: drugdu
- 97
- September 9, 2023
Guardant abandons cancer blood test trial early, restates confidence in product line

Dive Brief Guardant Health has stopped a trial of a minimum residual disease (MRD) test early after seeing the results of an interim analysis. The study, called COBRA, was evaluating the ability of Guardant’s MRD blood test to improve outcomes in patients with stage II colon cancer after surgery. Patients underwent circulating tumor deoxyribonucleic acid testing to inform further treatment. Guardant, which collaborated with NRG Oncology on the study, has yet to share data from the trial but confirmed it stopped early after the news leaked on social media. Shares in Guardant fell around 13% to below $35 on Friday. Dive Insight Guardant and NRG Oncology, a clinical trial group funded by the National Cancer Institute, began the trial in 2020 on the strength of evidence that the LUNAR-1 blood test may help identify patients who are likely to benefit from chemotherapy after surgery. The test, the product of a ...
- Source: drugdu
- 122
- September 8, 2023
Bayer and BlueRock announce positive results from Parkinson’s cell therapy trial

Bayer and BlueRock Therapeutics have announced positive results from their phase 1 stem cell clinical trial, showing that the treatment improved symptoms of Parkinson’s disease. The trial results were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Copenhagen, Denmark. Parkinson’s disease is the fastest-growing neurodegenerative disease in the world and causes parts of the brain to become progressively damaged over many years. The condition affects around 145,000 people in the UK. As part of the trial, a total of 12 people with Parkinson’s underwent surgery to receive either a high or low dose of bemdaneprocel (BRT-DA01), an experimental therapy involving dopamine-producing cells developed from stem cells. Stem cells develop different types of specialised cells, including skin, muscle or brain cells. For years, researchers have been working to find a way to convert stem cells into dopamine-producing brain cells to be used to replace those that are ...
- Source: drugdu
- 98
- September 1, 2023
Novocure Fails Phase III Ovarian Cancer Trial for Tumor Treating Fields Therapy

By Tristan Manalac Pictured: Magnifying glass focusing on a tumor in an ovary/iStock, Mohammed Haneefa Nizamudeen In the Phase III INNOVATE-3 trial, Novocure’s investigational ovarian cancer therapy Tumor Treating Fields was unable to significantly improve overall survival, the company announced Monday. Patients who received Tumor Treating Fields (TTFields) treatment combined with paclitaxel had a median overall survival (OS) of 12.2 months, which was only marginally higher than the 11.9-month median OS in comparators treated with paclitaxel alone. In terms of safety, TTFields remained well-tolerated and showed no new signals of concerns or systemic toxicities. Its adverse event profile in INNOVATE-3 was consistent with what had previously been reported. TTFields is an investigational oncology therapy that uses electric fields that act via many different mechanisms to kill cancer cells. Because it works via several pathways, the approach can be combined with other treatment modalities—such as PARP inhibitors and immune checkpoint inhibitors—to ...
- Source: drugdu
- 272
- August 31, 2023
Merck, Eisai Drop Phase III Keytruda-Lenvima Trial for Head and Neck Cancer

By Connor Lynch Pictured: Merck logo on building/iStock, Sundry Photography Merck and Eisai have dropped another joint drug trial after disappointing Phase III results. The companies announced Friday that they would be ending their combination treatment of Keytruda and Lenvima, respectively, after a second interim analysis found no improvement in overall survival. The LEAP-010 trial was evaluating the safety and effectiveness of Merck’s anti-PD-1 therapy in combination with Eisai’s multiple receptor tyrosine kinase inhibitor for metastatic or unresectable head and neck squamous cell carcinoma (HNSCC). An independent monitoring committee conducted two interim analyses over the course of 11 months. Initial results from the first analysis were promising: the therapy combo met two of the trial’s three primary endpoints of progression-free survival and objective response (OS) rate. However, the treatment failed to show evidence of meeting the third endpoint, overall survival, in the second analysis. The companies in Friday’s announcement said ...
- Source: drugdu
- 105
- August 29, 2023
Microbiome company Enterome plans $108m raise to fund Phase II cancer trials

Enterome is planning to raise EUR100m ($108m) as part of its latest fundraising round to power its clinical studies, said CEO Pierre Belichard in an interview with Pharmaceutical Technology. The company has already started speaking to investors in Europe and plans to start contacting those in the US in early September, he said. The funding will go towards the company’s clinical trials, which include two new Phase II studies, said Belichard. Enterome’s E02463 is an off-the-shelf immunotherapy that is made of four bacterial peptides of B lymphocyte-specific lineage markers. These peptides are based on the company’s OncoMimics approach, which uses specific peptide combinations derived from bacteria in the gut microbiome. The company had previously raised EUR 46.3m as part of its Series E round, based on a June 2020 release, while Belichard added that Enterome has raised EUR 116m to date. While Enterome is not actively looking to go public ...
- Source: drugdu
- 116
- August 28, 2023
Moderna says new Covid vaccine was effective against Eris variant in early trial

Moderna’s new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. Moderna’s vaccine and new shots from Pfizer and Novavax are slated to roll out within weeks, pending potential approvals from the U.S. Food and Drug Administration. Meanwhile, Covid-related hospitalizations fueled by Eris and other variants continue to accelerate but remain below the summer peak that strained hospitals this time last year. Eris, also known as EG.5, accounted for 17.3% of all cases as of earlier this month, ...
- Source: drugdu
- 102
- August 20, 2023
Thermo Fisher Scientific Selected as the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) for the U.S. National Institute of Allergy and Infectious Diseases

T-SCCC will support initiatives seeking to ensure success of organ transplants for patients WILMINGTON, N.C.–(BUSINESS WIRE)– The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research. According to the United Network for Organ Sharing, the non-profit serving as the nation’s transplant system under contract with the federal government, more than 40,000 organ transplants were performed in 2022, setting an annual record, with total kidney transplants exceeding 25,000 for the first time ever. Meanwhile, the Health Resources & Services Administration within the U.S. Department ...
- Source: drugdu
- 110
- August 14, 2023

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