Author Archives: Dan Stanton

With capacity stretched, GSK says limited growth for Shingrix vaccine until 2024

With demand for shingles vaccine Shingrix continuing to outstrip supply, GSK says there is limited opportunity for further growth until extra capacity comes online. Meanwhile, the firm is investing $564 million at its vaccine operations in Belgium For GlaxoSmithKline’s vaccine business, sales grew 21% year-on-year to £7.2 billion ($9.3 billion). The firm attributed this primarily to the growth in sales of Shringrix, its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). The vaccine has continually seen quarterly…

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…

Merck’s biosimilar business to power NewCo spinoff

Merck & Co. reported biosimilar sales of $250 million in 2019 and says the revenues will be used to grow its spinout company NewCo, also comprising of its women’s health and legacy brands. Merck & Co. (known as MSD outside North America) announced the creation of NewCo in line with its Q4 and full year 2019 results. The new entity will group the company’s women’s health assets and legacy brands together, along with its biosimilars business. Left alone, Kevin Ali…

Iovance internal network aims to tweak TIL manufacturing process

Having its own facility will help Iovance intensify manufacturing of its tumor infiltrating lymphocyte (TIL) cell therapies and help to reduce the 22-day process, the firm says. In May last year, Iovance Biotherapeutics announced plans to construct a 136,000 square-foot facility in Philadelphia, Pennsylvania for the clinical and commercial production of its autologous TIL products, including its lead candidate lifileucel in Phase II trials for metastatic melanoma. Speaking last month at the Phacilitate conference in Miami, Florida, Michelle Simpson-Abelson, principle…

Catalent to buy Orgenesis’ cell therapy CDMO biz for $315m

Last year Catalent entered the gene therapy space, now the CDMO will expand into cell therapies through the acquisition of Masthercell from Orgenesis. The deal includes a plant in Belgium and a site under construction in Texas. The deal sees contract development and manufacturing organization (CDMO) Catalent paying $315 million (€285 million) for Orgenesis’ third-party cell and gene therapy business Masthercell. Orgenesis will receive around $127 million of this with Masthercell’s backers Great Point Partners and SFPI-FPIM presumably receiving the…

Takeda divesting former-Shire $400m plant with 200 staff in Ireland

Takeda has identified a biomanufacturing facility in Dunboyne, Ireland as no longer required in a strategic review of its production network following the acquisition of Shire. In January 2019, Takeda completed its $62 billion (€56 billion) acquisition of Shire. As part of its integration, the firm said it intended to divest up to 25% of the combined business. Part of this strategy includes a biologics facility in Dunboyne, County Meath Ireland. “A strategic review of Takeda’s global biologics manufacturing network,…

Potential Oklahoma anti-vax bill danger to health and industry

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

CAR-T at the Crossroads: Is Allogeneic the Way to Go?

As cell therapies move through the clinic toward commercialization, respondents to an Informa Connect industry survey are beginning to look to allogeneic — or off-the-shelf — products as “the next big thing.” Almost 200 people contributed to the Cell Therapy Analytics Report, revealing their current positions within the burgeoning cell and gene therapy space and offering their thoughts and predictions for the future. Most survey respondents work within companies developing oncology products. Of those, the largest group (41%) said that…

Sartorius ready to snap up more Danaher and GE’s assets, if required

Sartorius is poised to further expand its life science portfolio to help facilitate the Danaher and GE Healthcare merger if antitrust authorities deem more divestments necessary. In February 2019, Danaher entered an agreement to acquire the BioPharma portion of GE Healthcare’s Life Sciences business for $21.4 billion (€19.4 billion). Nearly a year on and the deal is yet to have been approved by antitrust regulators. Danaher has had to divest various life science assets to help ease the merger, with…

VGXI to make DNA vaccine in global effort to stymie coronavirus

VGXI will make Inovio Pharmaceuticals’ investigational vaccine as part of a collaborative effort to halt the progress of the coronavirus that has recently emerged in Wuhan, China. At the time of publication, 170 people have died and almost 8,000 people infected by the novel coronavirus (2019-nCoV). Wuhan, the Chinese city where the outbreak began, is under lockdown but cases of infection have been reported across the globe, including in Australia, France, and the US. There is no specific treatment for…