Health

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

US Researchers to Conduct the Largest Eating Disorders Genetics Study

US Researchers to Conduct the Largest Eating Disorders Genetics Study

Health

Researchers from the University of North Carolina (UNC) are looking for over 6,000 participants age 18 and above who have directly experienced eating disorders to join the world’s largest-ever genetic research study in 3 complexes, devastating mental illnesses.

The innovative Eating Disorders Genetics Initiative (EDGI) focuses on identifying the numerous genes that influence an individual’s risk of developing anorexia nervosa, binge-eating disorder, and bulimia nervosa to enhance treatment and ultimately save lives.

As per the latest survey results examining the impact of coronavirus on Americans living with eating disorders

Gannex Pharma secures IND approval for NASH drug candidate ASC42

Gannex Pharma secures IND approval for NASH drug candidate ASC42

Health

Wholly owned subsidiary of Ascletis Pharma Inc., Gannex Pharma Co., Ltd., has reportedly obtained the IND approval of the U.S. Food and Drug Administration for its Non-Alcoholic Steatohepatitis (NASH) drug candidate ASC42.

According to Handen He, the Chief Scientific Officer of Ascletis, the organization is thrilled to witness that FDA has cleared ASC4 IND application for NASH, which is becoming increasingly prevalent with no presently approved therapies, adding that this represents a significant milestone that permits the company to begin with its clinical trials. The company will be consistently dedicated to patient-centric innovation and the development of new medicines

Genomenon partners with RCIGM to accelerate diagnosis of infants

Genomenon partners with RCIGM to accelerate diagnosis of infants

Health

Rady Children’s Institute for Genomic Medicine (RCIGM), a non-profit organization focused on advancing disease-specific healthcare for newborns, has reportedly partnered with Michigan-based health IT firm Genomenon Inc. to boost the diagnosis of critically-ill infants with rare genetic disorders. The partnership combines Genomenon’s Mastermind Genomic Search Engine with RCIGM’s genomic research expertise to advance precision medicine for newborns in an intensive care setting.

With this partnership, the use of Mastermind has become part of the institute’s analysis and interpretation workflow. The use of Mastermind has improved rWGS (rapid Whole Genom

Greater Manchester and Sectra ink major imaging initiative deal

Greater Manchester and Sectra ink major imaging initiative deal

Health

Greater Manchester, UK, has reportedly signed an agreement with the popular medical imaging IT and cybersecurity firm, Sectra. Through this enterprise imaging initiative, NHS trusts in the Greater Manchester area seem to have taken an important step ahead, by means of a region-wide imaging approach which will aid faster diagnoses and enhanced outcomes for patients.

As per sources familiar with the knowledge of the matter, eight NHS hospital trusts across Greater Manchester will be able to benefit from this medical imaging solution which has been designed to transform the way doctors and other NHS healthcare personnel access as well as review images from patient scans which

Basilea Commences Phase 1/2 Study FIDES-03 with Derazantinib

Basilea Commences Phase 1/2 Study FIDES-03 with Derazantinib

Health

Basilea Pharmaceutica has started the phase 1/2 study, FIDES-03, along with the FGFR inhibitor derazantinib. The research is assessing derazantinib in people suffering from advanced gastric cancer along with FGFR genetic abnormality. Derazantinib is reported to be evaluated as monotherapy coupled with extra cancer treatments; for example, Roche’s PD-L1 checkpoint inhibitor, atezolizumab.

The Chief Medical Officer of Basilea, Dr. Marc Engelhardt stated that their development strategy for derazantinib focuses on solidifying the clinical evidence on the difference against other FGFR inhibitors. Derazantinib’s exceptional kinase inhibition profile results from prec