Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…
Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times. According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached. “The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,†Jason…
German drugmaker Boehringer Ingelheim will not commercialize its approved adalimumab product Cyltezo in Europe and is discontinuing all biosimilar development activities outside the US. Earlier this month, an article published in Bioprocess Insider considering the impending exit of Big Pharma from the biosimilars space brought a lot of attention from industry and investors. The piece drew on Merck KGaA’s abandonment of its biosimilars programs in 2017 as an example, and now fellow German Big Pharma firm Boehringer Ingelheim is contemplating…
GE Healthcare will open a biomanufacturing center in Stevenage, UK to support production of its fiber-based purification platform, which it acquired last year. In November 2017, bioprocessing equipment and consumables vendor GE Healthcare acquired Puridify – a spin-out from University College London, UK – for an undisclosed fee. The deal added early-stage tech platform FibroSelect, consisting of a nanofiber-based material to which ligands are attached to activate the platform for purification of biologics. A year on and the firm has…
Cobra Biologics and the Cell and Gene Therapy (CGT) Catapult have teamed with Pall to explore continuous manufacturing of gene therapies. The project builds on a concurrent collaboration which looks to reduce the cost of adeno-associated virus (AAV) vectors. The collaboration received a £1.5 million ($1.9 million) shared grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications. “The project is a joint collaboration between Cobra, Pall and the…
With a portfolio approaching 200 products, CDMO WuXi Biologics has begun constructing a 1.6 million square-foot facility in Shanghai, China. Contract development and manufacturing organization (CDMO) WuXi Biologics is building what it calls a ‘Biologics Innovation Center’ in Fengxian, Shanghai. The 1.6 million square-foot facility will include biologics discovery and development laboratories, as well as GMP manufacturing, CEO Chris Chen told BioProcessing Insider. He added the labs will open in 2019, while the GMP plant will open its doors in…
The European Commission (EC) has approved Takeda’s $62 billion acquisition on the proviso the firm divests Shire’s inflammatory bowel disease (IBD) candidate. In May, Japanese firm Takeda struck a deal to acquire Ireland-headquartered rare diseases biopharmaceutical company Shire for $62 billion (€54 billion). Six months on, the merger is one step closer after receiving approval under the EU Merger Regulation, on the condition of divesting Shire’s IBD candidate SHP647. “We can today approve the merger between Shire and Takeda, but…
LG Chem Life Sciences will offer up its biomanufacturing experience and potentially add downstream capabilities for Cue Biopharma’s biologic candidates under terms of the strategic partnership. Korean chemical company LG Chem’s life science business and Massachusetts-based Cue Biopharma have entered into a multi-target strategic collaboration to develop multiple candidates using the Immuno-STAT biologic platform. Cue’s Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells and lead candidate CUE-101 targets human papillomavirus (HPV)-associated cancers. Under terms of the deal,…
Amgen withdrew its membership from advocacy group The Biosimilars Forum in September after disagreeing on how best to support the US biosimilar market. Nonprofit organization The Biosimilars Forum was setup in 2015 “to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care… [by providing] evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars,” according to its mission statement. The founding 11…
Fresh from acquiring CAR-T firm Juno Therapeutics, Celgene is investing in patient treatment centers and building out its manufacturing capacity. In March, Celgene Corporation completed the $9 billion (€7.9 billion) acquisition of Juno Therapeutics, adding chimeric antigen receptor (CAR) T-cell technology and manufacturing capabilities, along with a pipeline of hematology and oncology therapies. Speaking at the Credit Suisse 27th Annual Healthcare Conference last week, CFO David Elkins said its numerous CAR-T collaborations – the firm has a co-development deal with…