Author Archives: Gareth Macdonald

Bluebird welcomes CHMP nod for CALD gene therapy

Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

Thermo teams with UCSF on San Fran cell therapy center

Thermo Fisher Scientific has teamed up with the University of California, San Francisco (UCSF) to set up a cell therapy manufacturing center. The facility – which will be at USCF’s Mission Bay campus in San Francisco – will offer clinical and commercial cGMP cell therapy manufacturing services and technology development support. According to Thermo Fisher, the facility, which is due to open next year, will serve as a central location where customers and UCSF researchers will have access cell therapy systems, reagents,…

Canada pays $164 million to add Resilience to pandemic prep effort

Canada has called on Resilience Biotechnologies to boost local COVID-19 shot capacity. The Canadian Government has given contract development manufacturing organization (CDMO) Resilience Biotechnologies $164 million to modernize its recently acquired Ontario plant as part of a wider pandemic preparedness effort. The CDMO – which is part of San Diego, US based headquartered firm National Resilience – announced further details this week. It said the investment will increase manufacturing capacity for vaccines and therapeutics, including those based on mRNA that…

Charles River to boost CDMO offering through $300m Vigene acquisition

Charles River Labs plans to buy gene-therapy focused CDMO Vigene Biosciences for $300 million, further expanding its presence in the manufacturing space. The deal – which values Vigene at $292.5 million – will add viral vector-based gene delivery solutions to the contract research organization’s (CRO) expanding contract manufacturing offering. The transaction is expected to close in the beginning of the third quarter. Charles River CEO James Foster said the purchase would “expand our comprehensive cell and gene therapy portfolio to…

Merck: COVID-related work helped German firm grow revs in Q1

COVID-19 will continue to drive growth according to Merck KGaA, which says demand from vaccine makers helped its life science business revenue grow 20.4% to € 2.1 billion in Q1. The German drug and processing tech firm unveiled its results for the first quarter this week, explaining that group sales increased 6% to € 4.6 billion ($5.6 billion) “mainly thanks to the high organic growth of the Life Science business.” Merck’s process solutions business – the part of the life sciences…

CDMOs need to invest in innovation to make complex meds, says Resilience CEO

Biopharma CDMOs need to rethink production according to Resilience CEO Rahul Singhvi, who says industry must learn to make a new generation of complex products. Advances in biological science in recent years are helping the biopharmaceutical industry to start unlocking the potential of cell and gene therapies. For example, in the past few months the US FDA has approved two cell based cancer meds – Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) – further underlining the cell therapy sector’s potential.…

Laronde aims to turn cells into drug production facilities using eRNA

Venture capital backed biotech Laronde has created a new type of RNA it claims can be used to create programmable protein therapeutics. The Massachusetts based firm unveiled its “Endless RNA” platform this week, while also confirming it had secured a $50 million investment to support development and an initial pipeline of medicines from Flagship Pioneering. Endless RNA – or eRNA – is based on of long non-coding RNA (lncRNA), which is naturally abundant in circular form within mammalian cells. Unlike…

Charles River sets sights on cell therapy manufacturing after Cognate buy

US contract research firm Charles River says its expanded manufacturing business will focus mainly on cell therapy production. CEO Jim Foster outlined Charles River’s plan this week, telling analysts the firm’s recent acquisition Cognate BioServices would boost the contract research organization’s (CRO) biologics business. “Cognate gives us the ability, and particularly in combination with HemaCare and Cellero, to provide the cells to do the process development, to do the clinical trial scale up, and ultimately, to provide commercial quantities specifically…

Biosimilars: Roche and Biogen talk competition, price, opportunities

The complexity of the biosimilar market was much in evidence last week with Roche and Biogen both citing competition as challenges in Q1. Roche saw group revenues of CHF 14.9 billion ($16.3 billion) in the first three months of 2021, up 3% year-on-year. The contribution from diagnostics grew 55% to CHF 4.5 billion due to a surge in demand for COVID-19 testing. In contrast, revenue from medicines fell 9% to CHF 10.6 billion. Roche said the decline was mainly because…

Autologous therapy firms should use tech to cut COGS, says expert

Autologous therapy developers should consider “turnkey” manufacturing systems and robotic arms to minimize costs and manual handling, says an expert. The medical benefits of patient-specific, autologous cell therapies are proven according to Greg Russotti, Century Therapeutics’ CTO who told BPI West attendees the challenge now is reducing the cost of making such products. “Autologous [therapies] are proven to make major differences in patients’ lives. And, you know, no one can say they’re cures yet, but in some cases they are…