BioTime Inc. (NYSE:BTX) and its subsidiary Cell Cure Neurosciences said today that it is establishing an 800 square meter cell manufacturing facility at the Hadassah University Hospital in Jerusalem. The manufacturing center will be staffed initially by 30 employees, according to the companies, and will be prepared to produce OpRegen for BioTime’s ongoing clinical trial […]
Stem Cells
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
Mesoblast gains on A$29m investment deal with Mallinckrodt
Shares in stem cell company Mesoblast Ltd (ASX:MSB) rose 7% to A$1.51 yesterday after it said that it entered into an equity purchase agreement with US drugmaker Mallinckrodt Pharmaceuticals (NYSE:MNK). Mallinckrodt will buy 20.04 million, or nearly 5%, of Mesoblast’s ordinary shares for A$1.48 apiece. According to the agreement, Mallinckrodt will have 9 months to […]
Brainstorm’s NurOwn stem cell treatment for ALS readies for phase III
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it’s preparing for a phase III trial of its NurOwn stem cell treatment, after meeting with the FDA about a biologic license application. The company is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases, such as ALS. Hackensack, N.J.-based Brainstorm is planning […]
Evotec, Celgene ink drug development deal for stem cell treatments for neurodegenerative diseases
Evotec (ETR:EVT) said today that it inked a 5-year drug discovery and development deal with Celgene (NSDQ:CELG) to identify stem cell therapies for a range of neurodegenerative diseases including amyotrophic lateral sclerosis, Alzheimer’s disease and Parkinson’s disease. According to the agreement, Hamburg, Germany-based Evotec will receive an upfront payment of $45 million and Celgene will hold exclusive […]
TiGenix IPO raises $36m
TiGenix (EBR:TIG) said today that it raised $36 million in an initial public offering from the sale of 2.3 million American depository shares, representing 46 million ordinary shares, at $15.50 apiece. The biopharmaceutical company plans to list on the NASDAQ exchange under the “TIG” symbol by Dec. 15. It is listed on the Euronext Brussels under the same symbol. […]
FDA approves first bioresorbable scaffold with autologous cells for cartilage repair
Vericel Corp (NSDQ:VCEL) shares soared 56% today after the Cambridge, Mass.-based company said the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the 1st FDA-approved implant to use healthy cartilage tissue from a patient’s own knee to grow cells on the scaffold. “Different cartilage defects require different treatments, so therapy must be […]
Bayer, Versant close $225m Series A to launch stem cell company
Bayer (ETR:BAYN) and Versant Ventures said today that the 2 groups closed a $225 million Series A financing round to launch BlueRock Therapeutics, a regenerative medicine company focused on developing induced pluripotent stem cell therapies. The funds are estimated to support the company for 4 years as it advances cell therapy clinical programs for cardiovascular and degenerative diseases. “Accessing […]
Researchers develop insulin-producing artificial beta cells
Researchers from ETH Zurich have developed artificial beta cells that can measure blood glucose concentration and respond by producing insulin. The team’s work was published this week in Science. The ETH researchers used the natural glucose transport proteins and potassium channels found in the membrane of human kidney cells and modified them with a voltage-dependent calcium channel, […]
InGeneron inks collaboration with German Accelerator Life Sciences
InGeneron said today that it landed a collaboration with the German Accelerator Life Sciences program, establishing an additional U.S. presence in Cambridge, Mass. The initiative is supported by the German Federal Ministry for Economic Affairs & Energy. The GALS program will provide InGeneron with a group of mentors to help leverage its network within the […]