Regenerative Times

Stanford University School of Medicine scientists have definitively linked mast cells, a class of cells belonging to the immune system, to the development of osteoarthritis, one of the world's most common causes of pain and immobility. ...

Semma Therapeutics, Inc., a biotechnology company pioneering the curative use of stem cells in regenerative medicine, today announced the journal Nature published data demonstrating improvements in the production of beta cells (cells that produce insulin) from stem cells. Led by Harvard University researchers in collaboration with scientists from Semma, the study characterized the types of cells produced by the applicable cell differentiation methods, and demonstrated biological and physical separation methods to increase the purity of beta cells...

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the Company’s  marketing authorization application (MAA) for both the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, has been submitted to the European Medicines Agency (EMA). If approved, Nabriva intends to work with a commercial partner to...

A large research team led by senior author Guodong Zhang at the University of Massachusetts Amherst reports that the antimicrobial ingredient triclosan, found in hand soaps and toothpastes among other products, could have adverse effects on colonic inflammation and colon cancer by altering gut microbiota, the microbes found in our intestines. The study reported in Science Translational Medicine suggests that short-time treatment with low-dose triclosan caused low-grade colonic inflammation, and...

AAV-RPE65 met the primary endpoint of safety and tolerabilityStatistically significant improvement demonstrated in vision-guided mobility and visual function in treated eyes compared to untreated eyesDose selected for pivotal study; Company expects to meet with global regulatory authorities in the second half of 2019 MeiraGTx Holdings plc announced positive data from a Phase 1/2 dose escalation trial of AAV-RPE65, the Company’s investigational gene therapy for the treatment of RPE65-deficiency, a condition that ...

PANASH Trial will Evaluate Safety and Early Signs of Efficacy of HepaStem® in F3- F4-grade NASH Patients Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, announced the dosing of a first patient in a Phase 2a clinical study for the company’s HepaStem development program in patients with  late stage non-alcoholic steatohepatitis (NASH). The multicenter, open-label PANASH study will evaluate the safety and preliminary  efficacy of Promethera’s...

Celgene plans to submit sNDA by end of 2019 Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s...

OrthoTrophix, Inc. announced new analyses from a Phase 2 study of TPX-100, the company’s osteoarthritis (OA) drug candidate. The new results indicate slowing or halting of pathological bone shape changes, findings that support structural disease modification by TPX-100 treatment. Previous analysis demonstrated robust and statistically significant clinical benefits of the drug in moderate to severe knee OA. Study TPX-100-5, entitled “Longitudinal Evaluation of Periarticular Bone Area and 3D Shape in...