Author Archives: Dan Stanton

GSK injects $100 in Montana plant to support Shingrix vaccine

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GlaxoSmithKline will expand its adjuvant system production capacity at a site in Hamilton, Montana to help feed the high demand for shingles vaccine Shingrix. The $100 million (€90 million) investment at the Hamilton plant will be used to expand the production capacity of key components of the adjuvant system used in several of GSK’s vaccines. “The project involves construction of facilities required to increase adjuvant production, which is a component of some of our vaccines, like Shingrix,†GSK spokesperson Sean…

April 26, 2019

Biogen reports steep European adoption of Humira biosimilar

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Biogen and Samsung Bioepis’ Imraldi has exceeded 200,000 doses in its first full quarter since launch and, in one example, has captured 14% of the German market. Approved in August 2017, Imraldi launched in the European Union in October 2018. Imraldi is one of several biosimilars of AbbVie’s best-selling monoclonal antibody Humira (adalimumab) competing in the region. Others include Amgen’s Amgevita and Sandoz’s Hyrimoz, both also launched in Q4 2018 following the expiration of AbbVie patents. In the first full…

April 26, 2019

Novartis prepped for ‘unprecedented’ Zolgensma demand

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With over one million square-feet of manufacturing space, Novartis says it is prepared for the imminent approval of AveXis’ SMA gene therapy Zolgensma. Speaking during its Q1 2019 results, Novartis said it is set for the imminent arrival of gene therapy Zolgensma (onasemnogene abeparvovec), added to the firm’s pipeline through the acquisition of AveXis. The one-time therapy targeting spinal muscular atrophy (SMA) Type 1, will be reviewed by the US Food and Drug Administration in May, despite the recent news…

April 25, 2019

Gilead’s Kite building MD plant to support commercial CAR-Ts

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A 20-acre site in Frederick, Maryland will support the production of Kite’s commercial CAR-T therapies, including Yescarta, from 2021. Kite, acquired by Gilead Sciences for US$11.9 billion in August 2017, is one of only two firms to so far see regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Yescarta (axicabtagene ciloleucel) joined Novartis’ Kymriah on the market after being approved in October 2017. To support Yescarta and its pipeline of CAR-T and T-cell therapies, the firm announced it is…

April 24, 2019

Waters: Strength in biopharma as it takes small molecule hit

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Chromatography and measurement company Waters Corporation experienced a volatile Q1 but its biopharma business remains high, backed by significant investments in the space. For the first quarter 2019, Waters Corporation reported sales of $514 million (€458 million), a drop of 3% on the same period last year. Waters CEO Chris O’Connell attributed the unexpected fall in sales to “greater-than-expected macro impacts in China and Europe, as well as a slow release of budgets by key pharmaceutical and industrial customers,†but…

April 24, 2019

Emerson buys Bio-G, adding modeling and scheduling software

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Analytics and modeling tools can help deliver more effective and safer therapies to patients says Emerson, fresh from its acquisition of Bioproduction Group (Bio-G). Terms of the acquisition have not been divulged, but technology and engineering company Emerson extends its life sciences technology portfolio through the addition of Bio-G. “Many of biopharma’s biggest companies use Bio-G’s modeling and scheduling software for de-bottlenecking and optimization, and many of these same companies trust Emerson expertise and software to control their production and…

April 24, 2019

GSK expects normal HPV vaccine supply to resume in June

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Manufacturing constraints have led to supply issues concerning GlaxoSmithKline’s HPV vaccine, Cervarix, which are set to continue until June. In a letter sent to French health professionals last month, GlaxoSmithKline (GSK) reported supply issues regarding its product Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant affecting the first half of this year. According to the letter, published by the French authorities the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week, the shortage…

April 23, 2019

Danaher’s bioprocess biz bright with China and GE on horizon

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With continued double-digit growth in China and the future addition of GE Healthcare’s Biopharma business, Danaher Corporation is poised to strengthen its position in the bioprocess space. Danaher Corporation reported a robust first quarter last week, with 4% year-on-year sales growth across all businesses to $4.9 billion (€4.4 billion). Core revenue from Life Sciences grew 7%, which included contributions from Pall Corporation, a major vendor in the bioprocess space. The firm does not report financials from its individual businesses. “In…

April 23, 2019

Novasep boosts viral vector offering with access to DNA Flap tech

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An agreement between Novasep and Theravectys gives the French CDMO access to the Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical. The DNA Flap tech allows efficient lentivector-mediated gene transfer either ex vivo or in vitro. It consists of a specific DNA sequence derived from the lentiviral genome, which includes the cPPT and CTS cis-active sequences, required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells. Theravectys holds a license…

April 19, 2019

Egg beater: Seqirus goes fully cell-based for seasonal flu vaccine

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Seqirus’s vaccine offering for the 2019/20 season will be uniquely cell-base, but the firm says traditional egg-based production still plays a role in fighting influenza. Provided each year by the World Health Organization (WHO) Global Influenza Surveillance and Response System (GISRS), candidate vaccine viruses (CVVs) are the basis for the development and production of seasonal influenza vaccines. For the 2019/20 season, Seqirus has decided to use a cell-based CVV for all four influenza strains recommended by the WHO for its…

April 19, 2019