MODAG announced the successful completion of its first clinical trial of anle138b (NCT04208152) in healthy volunteers. Based on the positive Phase I study results, MODAG was also able to obtain additional funding of USD 1.4 million from The Michael J. Fox Foundation for parkinson’s research.
Roche announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® for the treatment of adult and paediatric patients 12 years of age and older with solid tumors expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options.
Although the forecasts and timelines vary, modellers agree on two things: COVID-19 is here to stay, and the future depends on a lot of unknowns, including whether people develop lasting immunity to the virus, whether seasonality affects its spread, and – perhaps most importantly – the choices made by governments and individuals.
Many Asian-Pacific countries have weathered the COVID-19 pandemic remarkably well so far, recording some of the lowest case numbers anywhere and earning praise as models of how to handle the virus. But the sheen is coming off their performance
IMAC Holdings, Inc. announced the United States Food and Drug Administration approved its investigational new drug application, which IMAC submitted in May 2020, for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinson’s disease.
Cynata Therapeutics Ltd. has announced positive results from the two-year follow-up of patients enrolled in the Phase I clinical trial of CYP-001, Cynata’s lead iPSC-derived Cymerus™ mesenchymal stem cell product.
Calidi Biotherapeutics, Inc., announced that the Investigational New Drug application submitted by its partner, Personalized Stem Cells, Inc. They have received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
With multiple COVID-19 vaccines in and approaching Phase III trials, the FDA has released development and licensure guidelines for these products. The 21-page guidelines detail agency recommendations on everything from manufacturing and preclinical data considerations to trial design, efficacy considerations and post-licensure safety.