US FDA to head off cell/gene therapy manufacturing issues with pre-IND meetings; Republic of Ireland will “chase any opportunities” for business partners stemming from Brexit, even while hoping UK reconsiders EU departure; AMAG won’t follow the flibanserin PR approach with newly submitted female sexual dysfunction drug bremelanotide; United Neuroscience CMO Ajay Verma says Alzheimer’s trial setbacks are “learnings,” with progress toward novel therapies moving faster than it has for cancer and HIV.
The US FDA is rolling out a new program aimed at proactively heading off manufacturing hurdles that could slow the development of cell and gene therapies.
The initiative within the Center for Biologics Evaluation and Research (CBER) will encourage early meetings between sponsors and the agency...
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
Despite initial promise, a novel autologous cell transplant therapy for severe heart failure has faced multiple challenges in gaining full approval in Japan, potentially providing learnings for other developers of regenerative medicines.
In this week's podcast edition of Five Must-Know Things: global CEO remuneration; another late-stage loss for Merch KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models.
The German major is kicking off Phase II trials for a cell therapy and a gene therapy that could be gamechangers for the progressive neurodegenerative disorder that affects more than 10 million people worldwide.
After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.
