Cryoport is supporting a record number of clinical trials driven by rapid growth in regenerative medicine – a space that will continue to grow and outpace the pharmaceutical industry, says CCO.
Novartis is working with the US FDA to solve a manufacturing issue affecting Kymriah, identified as ‘variability in its commercial specifications’, says CEO.
PTC Therapeutics will acquire Agilis Biotherapeutics to continue work on gene therapy for rare monogenic diseases affecting the central nervous system.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Pluristem Therapeutics has announced that it has agreed a strategic collaboration with Thermo Fisher to improve the process by which cell therapies are manufactured.
Infusing CAR T-cells directly into the brain, rather than into the blood intravenously, could improve the immunotherapy’s effectiveness and produce fewer side effects, say researchers.
Plasticell, alongside Great Ormond Street Hospital and the UCL Institute of Child Health, have announced they will collaborate to develop technology to better develop and manufacture gene therapies.
Cellectis has built a switch into a chimeric antigen receptor (CAR) T-cell to provide an efficient way to eliminate the therapy if it becomes a threat to patient safety.
GE Healthcare has announced plans to install its second FlexFactory manufacturing platform for cell therapy, this time at Xiangxue Pharmaceutical’s site in Guangzhou, China.
Cellectis’ third gene-edited, ‘off-the-shelf’ CAR T-cell candidate is set to enter clinical development after the US FDA approved an IND application for UCART22.
AveXis – a Novartis company – has added a manufacturing facility in North Carolina to its site network, where it will make investigational therapies for neurological genetic diseases.
TapImmune would consider a partnership deal with a major pharmaceutical firm in a non-Caucasian country, such as Japan or China, if “very compelling” from a financial standpoint, says CEO.
The US Department of Justice has filed a lawsuit to stop US Stem Cell Clinic from performing autologous stem cell procedures at the request of the US Food and Drug Administration (FDA).
Merck & Co. and Roche have ceased enrolment in separate clinical studies trialling Keytruda and Tecentriq as single therapies, due to a lower rate of survival in patients.
GE Healthcare Life Sciences is expanding powdered cell culture media production in Austria and the US, where it says longer shelf-life and reduced transport costs are driving demand.
Eli Lilly has announced plans to buy AurKa Pharma and its lead oncology compound AK-01, just days after purchasing the immuno-oncology firm Armo Biosciences.
In a move aimed to bolster its immuno-oncology program, Eli Lilly and Company has acquired Armo BioSciences for $50 per share, or approximately $1.6bn.
Agilent's 15,000-square-foot expansion will increase its capacity to meet a growing demand for next-generation sequencing products from its genomics group.
