Therapeutic Class

Individualized gene therapy: FDA considering device-like manufacturing approval process

CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…

Vaccines, plasma and stem cells: How industry hopes to take on COVID-19

The biopharma space has stepped up its efforts to both prevent and treat the coronavirus (SARS-CoV-2) that is threatening to bring the world to its knees. A month is a very long time when it comes to infectious diseases. The first cases and deaths from the novel coronavirus (COVID-19) led to a response to contain the virus, but the difficulties of containment and the nature of international travel means cases and deaths have become global. The latest statistics place the…

Staffing: Cell and gene therapy sector needs reinforcements

Cell and gene therapy manufacturers need staff with laboratory skills and GMP know-how, according to an expert from Texas A&M. Cell and gene therapies attract a lot of attention. In recent years products like Yescarta, Kymriah and Zolgensma and the debate about their prices – $373,000, $475,000 and $2.1m respectively – have dominated the headlines. In industry circles the focus has shifted to the manufacture of such therapies. Developers are working to ensure there are sufficient vectors, or to make…

Coherus eyes ophthalmology biosimilars prize

In-licensing a Lucentis biosimilar goes “hand-in-hand” with its internally developed Eylea biosimilar, says Coherus BioSciences. Californian biosimilar developer Coherus acquired the US commercial rights in November to commercialize a version of Lucentis (ranibizumab) from Bioeq, a joint venture between Polpharma Group and Strüngmann Group. The ophthalmic monoclonal antibody pulled in US sales of CHF 1.83 billion ($1.9 billion) for Roche/Genentech in 2019. Concurrently, Coherus has a biosimilar candidate looking to take on Regeneron’s Eylea (aflibercept) in the form of CHS-2020.…

Ori biotech adds traceability to cell therapy platform in deal with TrakCel

Ori Biotech has partnered with software firm TrakCel to add supply chain monitoring technology to its cell and gene therapy manufacturing system. The non-exclusive deal – financial terms of which were not disclosed – will allow cell and gene therapy developers and contract development and manufacturing organizations (CDMOs) that use the Ori platform to monitor manufacturing processes in real-time using Trakcel’s technologies. The firms plan to develop “suitable points of integration in order for a shared data platform to be…

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others. In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze. The technology consists of…

Orgenesis teams with Johns Hopkins’ in first post Masthercell sale PoC deal

Johns Hopkins University will use Orgenesis’ point-of-care processing technology for cell and gene therapy research in a collaboration announced this week. The US research University has licensed access to Orgenesis’s ‘point-of-care’ (PoC) platform which – as the name suggests – is used to develop and process cell therapies in the clinic Orgenesis CEO Vered Caplan said, “Our POCare platform is designed to provide unique cell and gene therapy solutions in a cost effective, high quality and scalable manner, using closed…

First J&J, now Sanofi teams with BARDA to tackle coronavirus

Sanofi Pasteur has joined Johnson & Johnson as the second firm to team up with BARDA to take on coronavirus (COVID-19). According to a statement, Sanofi Pasteur will use recombinant DNA tech to make a vaccine against the virus that has sickened tens of thousands and resulted in hundreds of deaths since it emerged in China last year. The plan is to use the Sanofi technology to reverse engineer proteins isolated from the virus to produce DNA sequences. These sequences…

Charles River eyeing up HemaCare expansion and more CGT acquisitions

Charles River Laboratories says it is “seriously pursuing” geographical expansion of its recently acquired HemaCare business as it assesses further opportunities in the cell and gene therapy space. In December last year, contract research organization (CRO) Charles River picked up HemaCare for $380 million, bolstering its cell therapy services portfolio. The firm predicted the acquisition would add at least $50 million to its 2020 consolidated revenue and expects revenue growth for the business to substantially increase over the next five…

Catalent’s $315m Masthercell buy: Frothy exuberance or the new CMO norm?

Catalent has completed its $315 million takeover of cell therapy manufacturer Masthercell. But is this latest CMO acquisition a sign of frothy exuberance, or consolidation of the new normal? Dark Horse Consulting’s Anthony Davies thinks the latter. Last week, Catalent announced it had entered into an agreement to buy Orgenesis’ third-party cell and gene therapy business Masthercell for $315 million (€285 million). Yesterday the deal closed, bringing autologous and allogeneic cell therapy manufacturing and analytical services to Catalent’s capabilities. The…