Author Archives: Dan Stanton

Fresenius awaiting success before investing further in biosimilars

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Having acquired a portfolio of biosimilar candidates in 2017, Fresenius Kabi says it needs “to earn the right to spend†further in the space through commercial sales. Fresenius Kabi entered the biosimilar space in 2017 through the €656 million ($645 million) acquisition of Merck KGaA’s pipeline and Swiss-based R&D staff. The total number of molecules in development have not been divulged, but Fresenius has said it is in the high single-digits and includes versions of AbbVie’s Humira (adalimumab), Amgen’s Neulasta…

February 26, 2019

Orgenesis brings CDMO MasTherCell to US with Texas plant

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Orgenesis has begun building a 30,000 square-foot cell and gene therapy manufacturing plant in Houston to be run by its CDMO subsidiary MasTherCell. Late last year, cell therapy contract development and manufacturing organization (CDMO) MasTherCell essentially doubled its capacity through the opening of a 6,500 square foot wing at its site in Gosselies, Belgium. Now the firm is looking to bring its services to the US through the construction of a 30,000 square foot manufacturing facility in Houston, Texas. According…

February 26, 2019

Danaher absorbing GE’s bioprocess biz in $21.4bn deal

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Danaher Corporation will consolidate its position in the supplier space through the $21.4 billion acquisition of GE Healthcare’s biopharma division. The business will not be integrated with Pall. The deal, expected to be completed in the fourth quarter of 2019, will see Danaher Corporation buy the full BioPharma portion of GE Healthcare’s Life Sciences business for a cash purchase price of approximately $21.4 billion (€18.9 billion). The business, which pulls in about $3 billion in annual revenue, provides tools to…

February 25, 2019

Roche to buy gene therapy firm Spark for $4.3bn

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The acquisition of Spark Therapeutics will add commercial product Luxturna to Roche’s portfolio, along with a pipeline of gene therapies. Swiss pharma firm Roche has announced today it is set to buy Spark Therapeutics for approximately $4.3 billion (€3.8 billion). “The merger agreement has been unanimously approved by the boards of Spark Therapeutics and Roche,†Roche spokesperson Simone Oeschger told BioProcess Insider. “Under the terms of the merger agreement, Roche will promptly commence a tender offer, to acquire all outstanding…

February 25, 2019

Allogene building Cali allogeneic CAR-T facility

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Allogene has confirmed it is building a 118,000 square foot cell therapy manufacturing facility in Newark, California to support its AlloCAR T candidates. Last month, Allogene Therapeutics revealed to BioProcess Insider its intentions to establish a manufacturing facility in the San Francisco Bay area. The firm did not provide projections at the time, but has now said it has entered a lease agreement at a site in Newark, California to build a 118,000 square foot cell therapy manufacturing facility. “This…

February 22, 2019

Big data-science for cell therapies: Mogrify boosted by $3.7m funding

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All current cell therapies are failing on at least one of three key performance indicators: efficacy, safety and scalability, says Mogrify’s new CEO Darrin Disley. Cambridge, UK-based firm Mogrify is looking to transform the cell therapy space through its technology platform that it claims makes it possible to transform – or ‘transmogrify’ – any mature human cell type into any other without going through a pluripotent stem cell or progenitor cell state. The firm has bolstered its position by raising…

February 21, 2019

From Sartorius to VC, Dynamk’s new MD talks life science investment

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AI, regenerative medicine enabling technologies, and clinical diagnostics are major investment opportunities, says life science executive Reinhard Vogt who has joined Dynamk Capital. Reinhard Vogt served as an executive at Sartorius AG for over 35 years. During his tenure, he was responsible for the strategic development of the firm’s Bioprocess Division that grew from around $30 Million to around $1.2 billion today, reached through a combination of strong organic growth and a strong focus on M&A and the integration of…

February 20, 2019

AGC Bio ‘CHOsen’ to make Interleukin-15 inhibitor for Serono spin-off

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CDMO AGC Biologics will develop the process and manufacture Calypso’s CALY-002, a humanized monoclonal antibody manufactured in a CHO cell line, from its site in Denmark. Calypso Biotech, a spin-off from Merck Serono, has selected contract development and manufacturing organization (CDMO) AGC Biologics for the process development and cGMP production of its lead candidate CALY-002. The work will be undertaken at AGC Bio’s site in Copenhagen, Denmark. Financials of the deal have not been divulged, but Calypso’s CEO Alain Vicari…

February 19, 2019

AveXis on gene therapies: ‘We’ll get better at this and it will get cheaper’

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AveXis has spent about $1 billion in preparing to launch its spinal muscular atrophy (SMA) gene therapy later this year. The Novartis subsidiary is pumping a further $60 million into its North Carolina facility. In May 2018, Gene therapy firm AveXis announced a $55 million (€49 million) investment to establish a manufacturing center in Durham County, North Carolina. Nine months on, and AveXis is doubling down on the site, revealing plans to invest a further $60 million and create 200…

February 19, 2019

Immunomedics: Data integrity and quality issues cited in FDA 483

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The US FDA found antibody-drug conjugate developer Immunomedics to have manipulated data during an inspection last year. In January 2019, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Immunomedics for its antibody-drug conjugate (ADC) candidate sacituzumab govitecan, being developed to treat breast cancer. The firm said at the time: “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need…

February 18, 2019