News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Theravectys has outlined a 1-year plan to fix GMP deficiencies at its Paris facility and said the current manufacturing ban will not delay its clinical programmes.
New facilities and a successful CMO tech transfer have helped turnaround the manufacturing of cell therapy product Ovasave, says TxCell after production was suspended last year.
With more than 130 biotech and 20 pharmaceutical companies currently developing immuno-oncology (I/O) therapies, the global oncology market could reach $40bn by 2020, says Tufts.
It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio.