Lonza will combine its cell and gene therapy capabilities through four centres of excellence worldwide, following a number of investments in the space.
Cellular Biomedicine Group Inc (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.
Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.
Physicians and patients still lack information about biosimilars says an industry consultant, despite efforts from advocacy groups and national healthcare systems.
Sotera Health – the recently rebranded Sterigenics International – will add extractables and leachables testing services to its Nelson Labs business with the acquisition of Toxikon Europe NV.
Spain has licensed TiGenix NV's expanded Madrid plant paving the way for a potential European launch of Cx601, its cell therapy for the Crohn's disease complications.
US approval for Novartis’s CAR-T cancer treatment Kymriah will help cell and gene therapy firms attract the investors they need to fund development according to International Society for Cellular Therapy (ISCT).
Lonza expects to complete its $5.5bn (€5.2bn) takeover of Capsugel SA in the next few days having secured approval from competition authorities around the world.
The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
update - WHO outlines biosimilarity requirements and inspection plan
The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.
Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.
Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
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.
Takeda has inked a 5-year deal to finance development of T-cell therapy redirection platform from recently founded biotech, Maverick Therapeutics, with exclusive right to buy.
bluebird bio Inc has hired apceth Biopharma GmbH to make its candidate ALD cell therapy Lenti-D and its thalassemia treatment LentiGlobin for the European market.
Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.
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.
The International Society for Cellular Therapy (ISCT) has called for a streamlined manufacturing regulatory pathway for cellular therapies to overcome the high upfront costs of manufacturing such products.
TxCell will develop a CAR-T-based treatment for a rare autoimmune skin disease called bullous pemphigoid in collaboration with researchers at the University of Lubeck in Germany.
Bristol-Myers Squibb (BMS) has completed an expansion of its Devens, MA-based biologics facility to support the company’s growing biologics medicines portfolio.
Brammer Biopharmaceuticals and Florida Biologix have merged to create a cell and gene therapy biologics CDMO in preparation for a “tidal wave” of gene therapy products.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
LeukoDx will develop a cell characterization system for GE Healthcare in a deal designed to bolster the latter’s cell therapy manufacturing technology offering.
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.
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.
Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.
