Therapeutic Class

Seattle Genetics in ‘good shape’ after restoring Adcetris inventory

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

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

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

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

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

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

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

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…

Allele SCM partnership looks to stem cells to treat diabetes

Allele Biotechnology has teamed with SCM Lifescience to develop diabetes therapies using pancreatic beta cells derived from induced pluripotent stem cells (iPSCs). “By nature, pluripotent stem cells like iPSCs can be expanded indefinitely and differentiated into all human tissue types, including pancreatic cells,” a spokesperson from the San Diego-based biotech Allele, told Bioprocess Insider. Therefore, they can be a viable option for diabetes treatment. “iPSC-derived cells are already known to have biological functions, such as blood sugar sensing and insulin…

Enesi and BARDA partner to develop solid dose flu vaccine

The US Biomedical Advanced Research and Development Authority (BARDA) will use Enesi Pharma’s ImplaVax device and formulation technology to develop subcutaneous vaccines against influenza. The public-private collaboration, financials of which have not been divulged, will form part of BARDA’s Division of Research, Innovation, and Ventures (DRIVe) innovative health security technologies portfolio, and looks to provide a cost-effective alternative to traditional vaccines to help improve vaccination uptake. The aim is to help healthcare providers or individuals administer influenza vaccines through the…