Global Markets

Bluebird Skysona approval: ‘A resurgence for HSC gene therapy’

The US approval of bluebird bio’s Skysona (eli-cel) marks a resurgence for the wider hematopoietic stem cell (HSC) gene therapy sector, says AVROBIO. Following the endorsement by an Advisory Committee in June, the US Food and Drug Administration (FDA) granted approval of bluebird bio’s Skysona (elivaldogene autotemcel, or eli-cel) Friday for the treatment of active cerebral adrenoleukodystrophy (CALD). Skysona uses ex vivo transduction with a Lenti-D lentiviral vector (LVV) to add functional copies of the ABCD1 gene into a patient’s…

AbbVie: Manufacturing consistency will affect Humira biosimilar uptake

AbbVie says payors will look to consistent global supply as a key differentiator among the many Humira biosimilar makers poised to enter the US market. AbbVie’s autoimmune monoclonal antibody (mAb) Humira (adalimumab) is the bestselling drug of all time, clocking in over $193 billion for AbbVie (and previously Abbott) since its launch in 2003 to the end of 2021. Last year alone it pulled in $20.7 billion (though lost out to the industry’s top seller spot due to $36.9 billion…

BMS confident Breyanzi capacity issues will be resolved in 2023

Bristol Myers Squibb will apply the same strategy used to increase Abecma supply to increase capacity for Breyanzi as it pushes back projected timelines into next year. Bristol Myers Squibb (BMS) has with its chimeric antigen receptor (CAR) T-cell therapy Breyanzi (liso-cel) “a best-in-class profile,” Christopher Boerner, EVP & chief commercialization officer told stakeholders at the Morgan Stanley Global Healthcare Conference last week. Having been approved in February 2021 for Large B-cell Lymphoma, the therapy won second-line approval for relapsed…

Biden pledges $2bn to launch US biomanufacturing initiative

The US government will invest over $2 billion to launch its biomanufacturing initiative, which aims to expand manufacturing capacity in the country and ensure pandemic preparedness. The Executive Order was signed by President Biden on Monday and outlines the key goals of the biomanufacturing initiative. Overall, the Order looks to strengthen the country’s supply chain in the biopharma space and to reduce reliance on foreign manufacturing for the drug industry. Biden said it is the policy of his Administration to…

Rubius weighs up RI plant sale as part of pipeline restructure

Rubius Therapeutics will also cut 75% of its staff as it discontinues its solid tumor programs in favor of developing a next-generation red blood cell-based cell conjugation platform. Massachusetts-based Rubius announced yesterday it is scrapping clinical programs RTX-240 and RTX-224 for solid tumors and instead focusing on improving the efficacy of the tech platform they were based on. “Following careful review of recent technical progress in an alternative format for making Red Cell Therapeutics, we believe that this process has…

Novartis looks beyond mAbs with $270m manufacturing spending spree

Novartis is making a multi-year investment across three European manufacturing sites to support a growing early-stage pipeline of next-generation biologics. Pharma giant Novartis announced the investments this week, with facilities in Switzerland, Slovenia, and Austria set to see increased drug substance and drug product capabilities. Specifically, $110 million will be injected in clinical manufacturing and technical development capabilities at the firm’s Mengeš, Slovenia site, while $60 million will be used to add technical manufacturing capacity at the Schaftenau campus in…

Avid points at mammalian and CGT expansions for drop in margins

Avid Bioservices says mammalian expansions and a move into the cell and gene therapy space has put pressure on its margins, which fell 12% in the first quarter of fiscal 2023. For the first quarter FY2023, Avid reported revenues of $36.7 million, a 19% increase compared to the $30.8 million recorded the previous year. However, despite CEO of Avid, Nick Green stating that this is the contract development manufacturing organization’s (CDMO’s) highest quarterly revenue on record, the firm’s margins fell…

Biotimize looks to build first biological CDMO in Brazil

Biotimize has opened a $30 million Series A funding round and says the investment will allow the firm to build the first biological CDMO in Brazil. Biotimize, a growth-stage biotechnology as a service (BaaS) firm, claims its fundraising round – if successful – will enable it to build the first biological contract development manufacturing organization (CDMO) facility in Brazil, which they claim will make it the first end-to-end biological CDMO in South America. The city of Piracicaba (about 100km northwest…

TCR² lauds positive work culture to overcome staff bottlenecks

T-cell receptor firm TCR² Therapeutics told delegates at Advanced Therapies Europe it is key to embed culture into your employees to attract and retain talent in the life science space. Angela Justice, chief people officer at TCR², told attendees that the key three ways to scale your culture lie in “anchor[ing] your culture through the employee life cycle, focus[ing] on retention, and find[ing] your force multipliers.’ Justice noted that a challenge of anchoring culture typically derives from the values of…

Beyond the peak: Catalent prepped for two-third cut in COVID revenues

Increased cell and gene therapy, drug product, and drug substance demand will offset the considerable decline in COVID-19 revenues in FY 2023, says CDMO Catalent. The contract development and manufacturing organization (CDMO) reported its results this week, with its Biologics division – which represents over 50% of its business – pulling in $667 million in Q4 (up 14% year-on-year) and $2.55 billion for the full fiscal year 2022 (up 34%). Catalent’s Biologics segment includes the development and manufacturing for biologic…