Global Markets Archives - Page 28 of 41 - BioProcess InternationalBioProcess International

Novartis wins approval for $2.1m gene therapy Zolgensma

Novartis says it is ready to launch Zolgensma (onasemnogene abeparvovec) within the next few weeks after receiving FDA approval for its spinal muscular atrophy (SMA) single-dose gene therapy. Zolgensma, a single-dose, one-time gene therapy has been approved to treat children less than two years of age with spinal muscular atrophy (SMA). “Today’s approval marks another milestone in the transformational power of gene and cell therapies to treat a wide range of diseases,” acting US Food and Drug Administration (FDA) commissioner…

WuXi scouts single-use site for Chinese vaccine joint venture

by Dan Stanton

WuXi Biologics has formed a vaccine production division to service a $3 billion strategic partnership with an unnamed global pharma. WuXi Vaccines is a joint venture between contract development and manufacturing (CDMO) WuXi Biologics and Shanghai-based Hile Bio-Technology. The new entity has been formed to service a Letter of Intent (LOI) inked with a multinational vaccine company. The client has not been disclosed, but WuXi Biologics CEO Chris Chen told Bioprocess Insider the strategic partnership will allow the vaccine developer…

Pfizer urges FDA for flexibility in considering interchangeability studies

by Dan Stanton

The US FDA has published long-awaited final guidance on the interchangeability of biologics, calling biosimilar developers to carry out switching studies. At the last count, there were 19 biosimilar products approved by the US Food and Drug Administration (FDA) US though only a handful have been launched. None of these products have been deemed interchangeable, meaning they cannot be substituted for the reference biologic at the pharmacy level without the involvement of a physician. However, this theoretically could change going…

Training and ‘sea turtles’ support WuXi Biologics’ growing China footprint

by Dan Stanton

WuXi Biologics talks Chinese talent recruitment as it begins building an eighth biomanufacturing facility in the country, this one with 48,000 L of single-use bioreactor capacity. The latest addition to contract development and manufacturing organization (CDMO) WuXi Biologics’ bioproduction network is a 1.3 million square-foot center in Chengdu, Southwest China. The facility will include drug development and commercial manufacturing capabilities and boast 48,000 L in bioreactor capacity. According to CEO Chris Chen, the capacity breaks down to 12 x 4,000…

MilliporeSigma and Thermo contribute to Biolife’s ‘blowout’ Q1

by Dan Stanton

Distributors STEMCELL Technologies and VWR also cited as sales of Biolife Solutions’s bio-preservation media and automated thawing products increased 51% year-on-year. For the first quarter 2019, Biolife, which makes and supplies biopreservation media and automated cell thawing media devices for cell and gene therapies, reported record revenues of $5.8 million (€5.2 million). “Dead cells don’t cure cancer, and the combined therapeutic, and economic risks our customers are facing should broaden use of our products as a best practice in the…

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

by Dan Stanton

Roche’s subcutaneous Herceptin (trastuzumab) recently became the third product to be approved using Halozyme Therapeutics’s ENHANZE drug delivery tech. However, Halozyme’s royalties have been hit by biosimilar competition. Halozyme Therapeutics reported what it described as a “strong start to 2019” with revenues of $57 million (€51 million) – up 84% year-on-year – attributed to $30 million upfront license fee from a license agreement struck with argenx in February. That deal gives argenx access to Halozyme’s ENHANZE drug delivery technology to…

Paragon buy and buildouts tipping Catalent’s business mix in favor of biologics

by Dan Stanton

The addition of Paragon Bioservices places biomanufacturing at around 31% of Catalent’s business mix. The CDMO expects it to be “north of 40%” by 2024 as high demand continues. Catalent reported revenues of $617.5 million (€552 million) for its third quarter FY2019 revenues, a slightly down on the same period last year. Traditionally a small molecule encapsulating contract development and manufacturing organization (CDMO), the firm’s Softgel Technologies segment dropped 6% year-on-year to $214.5 million. However, business was buoyed by its…

Biogen reports steep European adoption of Humira biosimilar

by Dan Stanton

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…

Waters: Strength in biopharma as it takes small molecule hit

by Dan Stanton

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…

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

by Dan Stanton

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…