Health

MIVI Neuroscience enrolls first patient in EVAQ clinical trial

MIVI Neuroscience enrolls first patient in EVAQ clinical trial

Health

MIVI Neuroscience has recently confirmed that the first patient has been enrolled in the Investigational Device Exemption EVAQ Clinical Study, which has been approved by the U.S. FDA. The enrollment was done in Toulouse, France at Hôpital de Purpan. The trial is a nulti-center, prospective single arm strudy for evaluating the MIVI Q Revascularization System targeting neurointervention in acute ischemic stroke.

The study sites for this EVAQ clinical trial are situated in the U.S. and France. Based on the innovative design of the Q Aspiration Catheter, the Q Revascularization System is able to leverage the larger lumen of the Super 90 8F Guide Catheter for aspiration.

TeraRecon awarded extended patent for diagnostic imaging with AI

TeraRecon awarded extended patent for diagnostic imaging with AI

Health

The new patent would encompass continuous synchronization of AI findings between image integration view and diagnostic report.

Amidst all the apprehensions being held in the medical industry with inclusion of artificial intelligence, TeraRecon has recently announced receiving a landmark patent for diagnostic imaging with AI. Standing tall as the world leader for AI-driven advanced visualization solutions, TeraRecon’s recent strategic move in the market is expected to bring it positive growth opportunities in the years to come.

Now encompassing a bi-directional, interactive AI-informed reporting experience, this n

Picosun unites with researchers & hospitals to drive ALD application

Picosun unites with researchers & hospitals to drive ALD application

Health

Picosun Group, a leading provider of ALD (Automatic Layer Deposition) thin film coating solutions, has reportedly partnered with prominent hospitals and researchers in China.

The deal was inked with an objective to apply its medical ALD technology to ensure safer surgical procedures. To elaborate, the company’s biocompatible ALD coating solutions will be applied to electrotomes (electrosurgical equipment) for enhanced safety, performance, and service life.

Electrotome is the standard equipment that can replace traditional mechanical scalpels in operations. It utilizes high temperature to separate and cut tissue & coagulated bl

PTC Therapeutics initiates the Phase 1 clinical trial of PTC518

PTC Therapeutics initiates the Phase 1 clinical trial of PTC518

Health

PTC Therapeutics has reportedly disclosed the initiation of a Phase 1 clinical trial for the evaluation of PTC518 amongst healthy volunteers. The candidate was recognized from PTC’s splicing platform and is reportedly being created for the treatment of HD (Huntington’s disease).

According to PTC Therapeutics’ CEO, Stuart W. Peltz, the clinical trial’s initiation for the evaluation of PTC518 for the Huntington’s disease initiative is a significant milestone towards the identification of a potential new Huntington’s disease treatment meant for directly addressing the underlying cause of the disease. Peltz has further stated that PTC518 is

Ascentage unveils clinical study results of BCR-ABL inhibitor HQP1351

Ascentage unveils clinical study results of BCR-ABL inhibitor HQP1351

Health

Ascentage Pharma, a renowned clinical-stage biotechnology firm focused on developing new therapies for CHB (chronic hepatitis B), cancers, as well as age-related illnesses, has reportedly announced that outcomes from two Phase II clinical studies of its new BCR-ABL inhibitor, HQP1351, namely olverembatinib, were accepted for an oral presentation at 62nd ASH (American Society of Hematology) Annual Meeting.

Xiaojun Huang, M.D., Peking University People's Hospital, Hematology Department, and Qian Jiang, M.D., who would be presenting the results at the event, are principal investigators of both studies. This would be the 3rd time the company has unvei

Everest Medicines secures NMPA approval for Trodelvy’s clinical trial

Everest Medicines secures NMPA approval for Trodelvy’s clinical trial

Health

Asian biopharmaceutical major, Everest Medicines, has reportedly secured the approval of China’s NMPA (National Medical Products Administration) for the clinical trial of sacituzumab govitecan (Trodelvy). The candidate will be effectively utilized in the treatment of HR+/HER2- metastatic breast cancer patients having at least two earlier failed chemotherapy regimens.

According to Everest Medicines’ Chief Medical Officer, Oncology, Yang Shi, HR+/HER2- breast cancer is prevalent in over 60 per cent of all breast cancers diagnosed in the country. Despite significant advancements in therapeutic devices, treatment options continue to be extremely limited for women h

Polyphor Completes Enrolment in Phase III Trial of Balixafortide

Polyphor Completes Enrolment in Phase III Trial of Balixafortide

Health

Polyphor, a clinical-stage biopharmaceutical company declared that it has completed enrollment in its FORTRESS Phase III trial of balixafortide in locally recurrent breast cancer. 411 patients are recruited which includes 323 in the third line and 88 patients in the second-line cohort. As Polyphor will allow patients who have already registered to enroll even after closing the recruitment, the final number is estimated to reach 430. According to the reports, the data on the crucial endpoint of FORTRESS, progression-free survival (PFS) in the total population is planned for Q4 2021. A study of the objective response rate (ORR) in appropriate patients in third and later lines of chemo is strategized for Q2 2021

Sequana announces positive interim results from RED DESERT study

Sequana announces positive interim results from RED DESERT study

Health

Sequana Medical has reportedly announced strong interim results from the first five patients registered in its RED DESERT study. The research focuses on the assessment of continual dose treatment of alfapump Direct Sodium Removal amongst patients diagnosed with diuretic-resistant heart failure.

Reports cite that the restoration of diuretic response as an explanatory endpoint of the study has been achieved through a six-hour long excretion of sodium and fluid, carried out after intravenously administering 40mg of furosemide. The RED DESERT recorded all patients to have a fairly poor diuretic response at the baseline.

However, following a

EMA Grants Positive Opinion to Prestige Biopharma on ODD for PBP1510

EMA Grants Positive Opinion to Prestige Biopharma on ODD for PBP1510

Health

Prestige BioPharma Ltd, a Singapore-based biopharmaceutical company, stated that the Committee for Orphan Drug Commission (COMP), a European Medicines Agency’s (EMA) Committee, has granted judgment in its favor for an Orphan Drug Designation (ODD) status to its high-quality PBP1510, an anti-PAUF monoclonal antibody, for pancreatic cancer treatment.

By getting the ODD status, Prestige BioPharma can obtain various benefits like receiving exclusive rights to the sale for ten years after receiving a successful regulatory sanction in the future.

Prestige BioPharma’s CEO Dr. Lisa Park stated that EMA COMP’s positive opinion