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The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Lonza will combine its cell and gene therapy capabilities through four centres of excellence worldwide, following a number of investments in the space.
The need for CDMOs with commercial gene therapy capacity is growing says Fujilfilm Diosynth Biotechnologies, which has opened an 80,000 square-foot plant in Texas.
Spark Therapeutics has received US approval for Luxturna (voretigene neparvovec-rzyl), its one-time gene therapy treatment for an inherited form of vision loss.
Yposkesi will make lentiviral vectors for Orchard Therapeutics’ gene therapies – indicated to treat primary immunodeficiencies – at its facility near Paris, France.
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.
Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.
Hitachi Group subsidiary PCT Cell Therapy Services will provide clinical manufacturing services for Orchard’s autologous gene therapy for the treatment of adenosine deaminase deficiency.
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.
Pfizer pays $150m for Bamboo Therapeutics, and post-merger Shire terminates a Baxalta haemophilia programme. Welcome to Biopharma-Reporter’s gene therapy focus.
Cobra Biologics has teamed up with Touchlight to test an AAV vector production platform they claim will make manufacturing gene therapies for trials cheaper and faster.
The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.
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.
Bristol-Myers Squibb will use uniQure’s insect-cell based technology and manufacturing facilities to develop gene therapies for cardiovascular diseases in a deal potentially worth $2bn (€1.8bn).
Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.
There is an upsurge in biopharma demand for cell and gene therapy applications, says Transposagen as it inks a deal with Janssen to develop allogeneic Chimeric Antigen Receptor (CAR) T-cells.
Baxter has announced plans to buy gene therapy developer Chatham Therapeutics for $70m in a deal focused on the latter’s pipeline of haemophilia candidates and gene therapy delivery platform.
Scientists at Caltech have published a study in Nature Medicine this week demonstrating that a gene therapy technique that boosts a mouse’s protection against HIV also works against HIV that’s transmitted via mucosal surfaces.
Could a genetically engineered adenovirus really spark a simian revolution and make chimps our masters? BioPharma-Reporter.com looks at the ‘science’ of the 2011 movie “Rise of the Planet of the Apes.”
