An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.
LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.
There is a growing trend among vendors to integrate automation technologies into their offerings says a bioprocessing expert, as GE Healthcare invests in its partner Zenith.
Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.
Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
CellGenix GmbH has started expanding its cell and gene therapy reagents facility in Freiburg, Germany citing the progression of customer projects into clinical development and commercial launch.
Biocon's second fill/finish line at Bangalore site to come online later this year
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
With increased interest in cell and gene therapies, BioLife Solutons has reported a 28% year-on-year growth in sales of biopreservation media, while Cryoport has struck another logistics deal.
Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.
PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.
Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.
The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.
An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.
While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.
A technology developed to reduce time and increase safety when reconstituting lyophilised biologics has been put for up for sale after XstalBio's insolvency.
The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
Bespak says the availability of the autoinjector version of UCB’s Cimzia on the UK National Health Service (NHS) is a validation of its delivery technology.
Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.
AstraZeneca says it will use the acquired plant as a warehouse to support biomanufacturing operations at a nearby facility, previously purchased from Amgen.
European stand-alone guidelines for the manufacture of Advanced Therapy Medicine Product (ATMP) could lead to disparities in GMP standards, says the Alliance for Regenerative Medicine.
Ambition, hard work and a focus on quality has made Celltrion the ‘pioneers of the mAb biosimilar industry,’ the firm told Biopharma-Reporter during a tour of its biomanufacturing site in Songdo, Korea.
