Search Results for “Clinical Trial” – Page 24 – media

J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
- Source: drugdu
- 108
- October 12, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
- 169
- October 10, 2023
Ocular launches ocular implant trial to combat macular degeneration

US biopharmaceutical firm, Ocular Therapeutix has announced the start of its first clinical trial of an intravitreal eye implant intended to combat macular degeneration. Named OTX-TKI, the axitinib intravitreal implant is intended to treat wet age-related macular degeneration (wet AMD). Alongside the announcement the company has requested a Special Protocol Assessment (SPA) from the US Food and Drug Administration (FDA) as to how the trial is designed. Overall, the trial will recruit approximately 300 evaluable wet AMD patients. Antony Mattessich, CEO of Ocular Therapeutix said: “With the activation of our first clinical site in the US, we believe we are on target to enrol our first subject before year-end. “The trial is a crucial step forward for our clinical program as we make progress toward our goal of bringing a transformative new treatment that can truly make a difference for wet AMD to patients coping with vision loss.” The company ...
- Source: drugdu
- 144
- October 9, 2023
analysts

Six months after Travere Therapeutics’ Filspari won an accelerated nod to treat patients with a rare kidney disease, the first-of-its-kind drug narrowly failed its confirmatory trial. While the results bode poorly for a full FDA approval anytime soon, Travere may take some solace in the fact that the drug’s removal from market looks unlikely, at least according to two groups of analysts. The readout comes from Travere’s phase 3 PROTECT study pitting Filspari (sparsentan) against the popular angiotensin II receptor blocker irbesartan in patients with primary immunoglobulin A nephropathy (IgAN). In the study, Filspari failed to reach statistical significance over irbesartan when it came to kidney function outcomes as measured by the estimated glomerular filtration rate (eGFR). It wasn’t all bad news for Filspari, which demonstrated long-term kidney function preservation and achieved a clinically meaningful difference on the eGFR slope versus irbesartan. The drug also hit statistical significance on its ...
- Source: drugdu
- 152
- October 1, 2023
Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner. By FRANK VINLUAN Ionis Pharmaceuticals has revenue from commercialized medicines, but those products reached the market in the hands of biopharma industry partners. The genetic medicines company does have wholly owned assets, and one of them now has preliminary Phase 3 data that put it on the path for an FDA submission. The drug, olezarsen, is a potential treatment for familial chylomicronemia syndrome, or FCS. The rare, inherited disease leads to the inability to break down triglycerides, which are fats consumed from food. High triglyceride levels can lead to acute pancreatitis, severe inflammation of the pancreas that can become fatal. Patients ...
- Source: drugdu
- 100
- September 28, 2023
Acesion wins €45m in Series B funding to develop atrial fibrillation therapy

Danish biotech Acesion Pharma has raised €45m in an oversubscribed Series B financing round. The money will go towards funding the clinical development of the company’s atrial fibrillation therapy, AP31969. The investors that took part in the Series B financing round include Canaan, Alpha Wave, Global BioAccess Fund and Novo Holdings. AP31969 is an oral SK ion channel inhibitor that is being developed as a maintenance treatment to prevent the recurrence of atrial fibrillation. In March, Acesion announced that more than 50% of the participants in the Phase II AP31969 trial (NCT04571385) reported atrial fibrillation conversion to normal sinus rhythm within 90 minutes of infusion start, compared to zero participants in the placebo group. Atrial fibrillation is the most common form of arrhythmia or abnormal heart rhythm in which the top chambers of the heart (the atria) quiver or twitch, which is known as fibrillation. The US Centers for Disease ...
- Source: drugdu
- 99
- September 28, 2023
J&J starts trial of pulsed field ablation catheter with mapping feedback

Dive Brief Johnson & Johnson has begun a clinical trial of another investigational pulsed field ablation (PFA) device, opening a new front in its pursuit of a potentially significant cardiovascular opportunity. The treatment of the first patients with the Omnypulse catheter comes months after J&J posted data on Varipulse, another PFA device to treat atrial fibrillation. J&J also has a PFA and radiofrequency dual energy device in late-phase development. Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data to support mapping. Analysts have identified the combination of PFA and mapping, which J&J sees as a key feature of its systems, as a threat to Abbott’s electrophysiology unit. Dive Insight It has been only three weeks since Boston Scientific notched a milestone in the race for the first-generation PFA market with positive clinical trial results. Boston Scientific and Medtronic are leading the way. Stifel analysts ...
- Source: drugdu
- 612
- September 21, 2023
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

By Tristan Manalac Pictured: Illustration of a blood clot in a blood vessel/iStock, libre de droit Anthos Therapeutics is ending the Phase II AZALEA-TIMI 71 study ahead of schedule after its investigational monoclonal antibody abelacimab demonstrated an “overwhelming reduction” in bleeding compared to Bayer and Johnson & Johnson’s Xarelto (rivaroxaban), the company announced Monday. Patients treated with abelacimab saw a sharp reduction in the composite endpoint of major and clinically relevant non-major bleeding events compared with counterparts given rivaroxaban, the current standard-of-care oral anticoagulant. The Massachusetts-based biopharma did not provide specific data in Monday’s announcement but said that the Data Monitoring Committee stopped the study early following these data. Anthos will share the full results and analysis of the trial in an upcoming medical meeting. Due to the “overwhelming reduction in bleeding” reported in AZALEA-TIMI 71, abelacimab may represent a “paradigm shift” in atrial fibrillation care particularly in the prevention ...
- Source: drugdu
- 95
- September 20, 2023
Bristol Myers Squibb reveals plans to double number of drugs in registrational trials

Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
- Source: drugdu
- 98
- September 19, 2023
BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
- Source: drugdu
- 203
- September 16, 2023

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