Therapeutic Class Archives - Page 35 of 53 - BioProcess InternationalBioProcess International

FDA pledges to support cell and gene therapy manufacturing innovation

Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods. A US Food and Drug Administration (FDA) spokesman told Bioprocess Insider the agency’s emerging technology team has been tasked with working with cell and gene therapy firms to “identify innovative approaches for efficient product manufacturing.” The move is part of a wider FDA effort to support modernization of drug manufacturing…

AAV, easy as M-A-b? CEVEC fundraiser to scale-up production

by Dan Stanton

Germany’s CEVEC claims it can produce adeno-associated viral (AAV) vectors as easily as monoclonal antibodies (MAbs), and has raised funds to expand and commercialize its production platform. While the total raised from new and existing investors in the Series D financing has not been disclosed, Cologne, Germany-based CEVEC says it will be used to advance its CAP GT-based stable AAV vector production platform and move it towards commercialization. As more gene therapies enter the clinic, there is high demand for…

Seattle Genetics in ‘good shape’ after restoring Adcetris inventory

by Dan Stanton

After suffering an $18 million inventory write off, Seattle Genetics says its business as usual for the manufacturing of its lead antibody-drug conjugate (ADC) Adcetris. In its fourth quarter 2018, Seattle Genetics reported an increase in its cost of sales attributed to an $18.1 million (€16.2 million) inventory write-off related to in-process production that did not meet manufacturing specifications and did not impact availability of product supply required to meet demand for its ADC product Adcetris (brentuximab vedotin). Three months…

Success for Bioepis as FDA approves a second Enbrel biosimilar

by Dan Stanton

The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo. Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo. This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received…

Lilly inks potential $440m antibody oligo conjugate deal

by Dan Stanton

Eli Lilly has teamed with Avidity Biosciences for the development of a new class of RNA-based drugs, antibody oligonucleotide conjugates (AOCs). The deal sees Big Biopharma firm Eli Lilly pay Avidity Biosciences $20 million (€18 million) upfront and invest a further $15 million into the L Jolla, California-based company. Depending on development, regulatory and commercialization milestones, Avidity could receive a further $405 million. Lilly hopes to use Avidity’s AOC tech platform to generate “new therapeutic targets in disease areas that…

Thermo Fisher allots $125m to expand CDMO buy Brammer

by Dan Stanton

The gene therapy space is growing at an annual rate higher than 25% says Thermo Fisher, which recently agreed to buy CDMO Brammer Bio for $1.7 billion. Thermo Fisher announced last month the agreement to buy contract development and manufacturing organization (CDMO) for $1.7 billion (€1.5 billion), propelling the life sciences services firm into the gene therapy production space. While the deal has not yet closed (expected by end of Q2 2019), Thermo Fisher said on its first quarter financials…

Biogen reports steep European adoption of Humira biosimilar

by Dan Stanton

Biogen and Samsung Bioepis’ Imraldi has exceeded 200,000 doses in its first full quarter since launch and, in one example, has captured 14% of the German market. Approved in August 2017, Imraldi launched in the European Union in October 2018. Imraldi is one of several biosimilars of AbbVie’s best-selling monoclonal antibody Humira (adalimumab) competing in the region. Others include Amgen’s Amgevita and Sandoz’s Hyrimoz, both also launched in Q4 2018 following the expiration of AbbVie patents. In the first full…

Gilead’s Kite building MD plant to support commercial CAR-Ts

by Dan Stanton

A 20-acre site in Frederick, Maryland will support the production of Kite’s commercial CAR-T therapies, including Yescarta, from 2021. Kite, acquired by Gilead Sciences for US$11.9 billion in August 2017, is one of only two firms to so far see regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Yescarta (axicabtagene ciloleucel) joined Novartis’ Kymriah on the market after being approved in October 2017. To support Yescarta and its pipeline of CAR-T and T-cell therapies, the firm announced it is…

Novasep boosts viral vector offering with access to DNA Flap tech

by Dan Stanton

An agreement between Novasep and Theravectys gives the French CDMO access to the Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical. The DNA Flap tech allows efficient lentivector-mediated gene transfer either ex vivo or in vitro. It consists of a specific DNA sequence derived from the lentiviral genome, which includes the cPPT and CTS cis-active sequences, required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells. Theravectys holds a license…

J&J keeping Remicade biosimilars at bay through price drops

by Dan Stanton

Johnson & Johnson’s Remicade continues to hold 92% of the market by volume three years since infliximab biosimilars arrived in the US. Johnson & Johnson (J&J) opened the first quarter 2019 reporting season this week by announcing an 8% year-on-year growth in its pharmaceutical’s division to $10.2 billion (€9 billion). For its immunosuppressive monoclonal antibody Remicade (infliximab), US sales – representing 70% of global sales for the firm – fell 15.5% compared to the same period last year, to $774…