Oral Use Articles & Analysis
23 news found
Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body’s ability to respond to bleeding intact. ...
ByBayer AG
Observed only mild and transient adverse events, with no use of emergency epinephrine Observed 98.4% patient compliance to date with novel OMIT therapeutic modality Safely started patients on dose 4, potentially reducing the time to reach maintenance by several weeks NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage ...
NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox. In recent weeks, randomized, placebo-controlled clinical trials were initiated in ...
The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with STAR-LLD, the plasma lenalidomide concentration (AUC) was 57% lower with STAR-LLD continuous subcutaneous (SC) delivery compared to once-daily Revlimid oral delivery. STAR-LLD was well tolerated in all subjects with no drug-related toxicity or adverse events. ...
This maintenance period allows for the evaluation of safety after long term use of INT301. Additionally, the amendment allows for the inclusion of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC) at the end of treatment. ...
NEW YORK, June 01, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology company developing a patient-friendly treatment platform for peanut and other food allergies, announced the addition of Nandini Murthy as Head of Regulatory. “Ms. Murthy has proven to be an invaluable asset to Intrommune since joining the organization as a consultant ...
Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years, however adverse events, notably neutropenia, have limited its use in certain patient settings. We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used ...
NEW YORK, April 06, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology company developing a patient-friendly treatment platform for peanut and other food allergies, today announced that its ongoing Phase 1 OMEGA Clinical Study of INT301 in adult patients with peanut allergy has been amended to allow determination of the Maximum Tolerated Dose ...
MatTek Life Sciences, a Boston-area tissue engineering company and a part of the BICO Group, announced today its European facility in Bratislava, Slovakia, will begin producing and shipping EpiOral, a lab-grown human oral epithelial tissue used to evaluate consumer product safety and efficacy. ...
There are reports in the literature of the use of alkalization agents, such as sodium bicarbonate, to treat gout. Theoretically, an alkalinizing agent such as sodium bicarbonate (baking soda) may increase the systemic and/or local pH and may allow pH sensitive uric acid crystals to dissolve resulting in temporary relief of pain and shortening duration of a gout flare, however ...
About SOLOSEC SOLOSEC (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in adult women and trichomoniasis, a sexually transmitted infection, in adults.1-4 SOLOSEC is designed to be easy to take and one oral dose contains a complete ...
Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age Convenient liquid formulation advances standard of care for children; alleviates administration ...
ByBayer AG
If approved, INT301 has the potential to be the first oral mucosal immunotherapy (OMIT™) allergy treatment that easily integrates into a person’s daily routine as both first-line and long-term maintenance therapy for peanut allergy. ...
Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for the upcoming global Phase 2 clinical study in gastric cancer with the daily oral chemotherapy candidate drug Oncoral. “We are very happy that the FDA has accepted our IND application to start our Phase 2 study with Oncoral in the US, which ...
The collaboration concerns an upcoming global Phase 2 clinical study in gastric cancer. In this all-oral combination study, Ascelia Pharma’s irinotecan chemotherapy tablet Oncoral (ASC-201) will be evaluated in combination with Taiho Oncology’s LONSURF (trifluridine and tipiracil) film-coated tablets for oral use. The combination of ...
” Intrommune’s lead product in development, INT301, utilizes the oral mucosal immunotherapy platform (OMIT) to decrease allergic immune response in patients through daily tooth brushing. The product delivers allergenic proteins to areas of the oral cavity to naturally trigger an immune system response towards tolerance of the allergen. ...
It also found an increase in pain relief for patients who used Nerivio. "To my knowledge, this is the first study that directly compared remote electrical neuromodulation and standard-care treatment options in adolescents," said Andrew D. ...
Results further support the benign safety profile of VE202 and identify an optimal dosing regimen Vedanta plans to initiate a Phase 2 clinical trial of VE202 in ulcerative colitis patients in the second half of 2021 Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using defined bacterial consortia ...
The presentation will focus on lead product INT301, Intrommune’s peanut allergy treatment administered daily through the brushing of teeth, and the oral mucosal immunotherapy (OMIT) platform upon which the treatment is based. ...
In the preliminary opinion on hydroxyapatite (nano), SCCS considered whether the nanomaterial hydroxyapatite is safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the reported maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions. SCCS states that having considered the data ...