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…
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 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 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…
Thermo Fisher has invested in Mark Bamforth’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 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…
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…
The high clinical failure rate of antibody-drug conjugates (ADCs) and the tendency to outsource development have driven both Abzena and MilliporeSigma to launch new service offerings. The first ADC, Wyeth’s Mylotarg (gemtuzumab ozogamicin) was approved in 2000, but nearly 20 years on there are only a handful of such therapies on the market. However, ADCs remain a viable and financially tempting oncology treatment and according to MilliporeSigma there more than 300 projects in development. Writing in ADC Directory earlier this…
Avacta Group and cancer drug developer ADC Therapeutics SA have entered into a collaboration agreement. The partnership – financial terms of which were not made public – will develop drugs combining ADC Therapeutics’ pyrrolobenzodiazepine-based cytotoxic warheads with Avacta’s Affimer targeting platform. ADC Therapeutics will cover all Avacta’s costs during the project. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization. Matt Vincent, Avacta’s VP of Therapeutics Business Development, told us:…
Manufacturing is key to bringing ADCs to the clinic faster says AstraZeneca, which stresses the importance of carrying out developability assessments. When a new molecule enters AstraZeneca’s portfolio, one of the first things the Anglo-Swedish biopharma firm does is carry out a developability assessment to understand the challenges in bringing the candidate through the clinic. Like other drug developers, the firm has a series of processes to move a project from lead optimization to candidate profiling, before moving into the…