Therapeutic Class

WuXi on board for Tychan’s yellow fever mAb

Wuxi Biologics will manufacture supplies of Tychan’s developmental yellow fever biologic for clinical trials. The drug in question – known as TY014 – is a first-in-class monoclonal antibody. It targets the envelope (E) protein on the surface of the yellow fever virus and prevents replication by limiting fusion to host cells. Earlier this month Tychan announced it had successfully completed Phase IA/IB safety studies. The firm also said it received regulatory approval to test the drug in a field study…

Fujifilm pumps $120m into US gene therapy development and manufacturing

An innovation center and additional cGMP manufacturing capacity make up Fujifilm Corporation’s plans to bolster its gene therapy capabilities at its site in Texas. It is no secret that the demand for gene therapy services is outstripping supply, with a shortage of viral vector capacity meaning contract development and manufacturing organizations (CDMOs) with manufacturing capabilities are rarely struggling to fill their space. To keep up with industry demand, Fujifilm Diosynth Biotechnologies (FDB) – the CDMO of Fujifilm Corporation – has…

Biolife buys CBS, turns focus on integrating cold-chain acquisitions

Biolife Solutions says cold storage tech firm Custom Biogenic Systems (CBS) is likely to be its last acquisition for a while as integration will be the focus in 2020. The US cell and gene therapy tool firm announced the deal this week, citing CBS’ portfolio of liquid nitrogen lab freezers and cryogenic equipment as well as its design and manufacturing capabilities as motivations. CBS CEO, founder, and sole shareholder John Brothers received $11 million (€10 million) in cash and $4…

German plant fastest option to make approved Ebola vaccine, says Merck

Merck & Co expects to complete production of the first batches of Ervebo – its newly EC-licensed Ebola vaccine – at its Burgwedel plant by late 2020. The European Commission (EC) granted Ervebo conditional marketing authorization for the active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus this week. The decision was based on data submitted for accelerated assessment in March. Merck – which is known as…

Abuse in cell banking services a global problem, says industry consortium

The International Society for Cell and Gene Therapy (ISCT) has formed a consortium to tackle what it says is a rising number of unscrupulous and unproven cell banking players. With the rise of interest in the cell and gene therapy sector, industry and the market have been plagued with unproven products and services from rogue actors looking to profit from ill-informed and sometimes desperate patients. The US Food and Drug Administration (FDA) laid down a framework to tackle unapproved stem…

Pfizer unveils biosimilar launch plans and shares view on US market

Pfizer set out a busy programme of biosimilar launches in its Q3 call and shared its thoughts on the “rebate trough” and other challenges facing the US market. First the numbers. Pfizer finished the three months to the end of September with income of $7.7 billion (€7 billion) – up 87% on the year earlier quarter – and revenue of $12.7 billion, which is down 5% year-on-year. The revenue decline was due to Pfizer’s decision to merge its consumer unit with GSK’s…

Catalent reports 50% y-o-y biologics growth as gene therapy enters the mix

Catalent says the integration of Paragon Bioservices’ gene therapy assets is progressing ahead of expectations. The CDMO reported quarterly sales in its biologics division of $189 million. For the first quarter of fiscal year 2020, Catalent reported revenues of $665 million (€600 million). For the contract development and manufacturing organization’s (CDMO) biologics division the quarter saw sales of $189 million, up 50% on the same period last year. Catalent has grown its biologics offering over the past few years, investing…

LBPs for gene therapies: Thermo Fisher inks deal with another Bamforth biz

Thermo Fisher has invested in Mark Barmforth’s latest venture Arranta Bio and will access live biopharmaceutical products (LBPs) for use in gene therapy production. Thermo Fisher has a profound relationship with biopharma pioneer and Ampersand Capital Operating Partner Mark Bamforth. Bamforth’s contract development and manufacturing organization (CDMO) Gallus BioPharmaceuticals was acquired by the Patheon in 2014, and in 2017 Patheon was picked up by Thermo Fisher for $7.2 billion (€6.5 billion). Then earlier this year, Thermo Fisher expanded its CDMO…

Kite on CAR-T: Growing sales, growing supply chain concerns

Kite Pharma says it is looking to secondary suppliers and other risk mitigation measures to manage its cell therapy cold chain supply amid a growing production network. Since opening a 43,500 square-foot manufacturing plant in Santa Monica, California in 2016, Kite Pharma – and Gilead Sciences, which acquired the firm in October 2017 – has rapidly expanded its production network, to support supply of its chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel). In May 2018, the firm opened a…

From Mylotarg to Polivy: Ebbs and flows, successes and woes of ADCs

Interest in antibody drug conjugates (ADC) is surging with more combined MAb and warhead candidates entering clinical trials than ever before. The biopharmaceutical industry has had a difficult few years with ADCs. There have been successes like Besponsa (inotuzumab ozogamicin) – which Pfizer cited as a driver in 2018 – and Roche and Seattle Genetics’ Polivy (polatuzumab vedotin-piiq) which won fast-track approval in the US this year. Likewise, Kadcyla (trastuzumab emtansine) – also made by Roche – has been cleared…