Servier has received marketing approval from the European Commission (EC) for Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukaemia (AML) and IDH1-mutated cholangiocarcinoma.
Filtration drove a record quarter for Repligen which says the addition of Spectrum Pharmaceuticals will further grow its bioprocessing portfolio and geographical presence.
Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.
Morphotek Inc has launched an antibody-drug conjugate (ADC) services business incorporating its RESPECT site-specific conjugation technology and eribulin-linker toxin platform.
Catalent has more than doubled its biologics business since it went public in 2014, but the sector still represents less than 5% of the CDMO’s revenues.
Investing in facilities that allow customers to test biomanufacturing equipment and processes is both cost-effective and necessary due to Biopharma's regulatory demands, say Merck, Pall and GE.
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.
Sandoz says gradual uptake of its biosimilar will eat away at Amgen’s filgastrim market share which stands at 76% four months after Zarxio’s entry in the US.
Remsima will soon achieve total market dominance in Norway thanks to a 69% discount on J&J’s Remicade, the man behind a trial studying the impact of biosimilar switching says.
A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
European Provenge contractor PharmaCell BV is looking for new business after completing the acquisition of TiGenix’s biomanufacturing facility in the Netherlands.
