Bavarian Nordic names new CEO; Abivax and ProQR add key leaders. Every Friday, The Leadership Edit looks at the people taking new roles across European biotech and what their moves may tell European Biotechnology about the companies they join. European Biotechnology'll follow chief executives, scientific and medical leaders, and other appointments that mark a change in direction or a new stage of growth. For this first edition: a new CEO for Bavarian Nordic, launch preparations at Abivax and an AI push at ProQR. Bavarian Nordic: Tarja Stenvall to become CEO. The Danish vaccine maker has chosen the former Sanofi executive to succeed Paul Chaplin on Oct. 15. Stenvall brings commercial and vaccine experience to a company that grew under Chaplin from a research-focused biotech into a global vaccine supplier. Go deeper. Abivax: Two hires ahead of a possible launch. Chris Rabbat, who has led global medical affairs since 2023, has become chief medical officer. He succeeds Fabio Cataldi, who will leave in the fourth quarter. Abivax also appointed former Caribou Biosciences executive Tim Kelly as chief technical officer, overseeing manufacturing, quality and IT. The French biotech is building these functions as it prepares for the potential commercialization of its ulcerative colitis drug obefazimod. Go deeper. ProQR: AI expertise moves into the leadership team. The Dutch RNA editing biotech named former Eli Lilly executive Chris Hart chief data and AI officer. It also brought Hugging Face co-founder Thomas Wolf onto its board as a strategic AI adviser. Hart will lead work to apply AI across drug discovery and development. The appointments come as ProQR tests AX-0811, its first clinical program identified through an AI-enabled discovery process. Go deeper. Nuclera: Carl Raimond takes over from a co-founder. Raimond, formerly president of Olink Proteomics, is the new CEO of the Cambridge, UK-based protein technology company. Co-founder Michael Chen moves to the role of chief scientific and business officer. Nuclera is expanding applications for its protein production platform, including antibody screening; Raimond's will focus on attracting more customers and growing the business. Go deeper. Ona Therapeutics: Aleix Prat becomes CMO. The Barcelona-based ADC developer appointed the oncologist as its lead candidate, ONA-255, advances through a Phase 1a study. Prat has chaired Ona's scientific advisory board since 2025 and helped identify and validate the target behind the drug. Jutta Amersdorffer moves from the medical role to chief development officer and will continue to lead development execution. Go deeper. Lift Therapeutics: Daniel Passeri becomes CEO. The London-based cancer immunotherapy company hired the former Cue Biopharma CEO as it prepares to take its neutrophil-based treatment into a first human study, planned for early 2027. Bo Rode Hansen, who had served as interim CEO, becomes president and remains on the board. The company has also changed its name from LIfT BioSciences to Lift Therapeutics. Go deeper. | (C) european biotechnology | Joachim Eeckhout 25 September 2026 |

FDA approves Lilly's Onswik for type 2 diabetes in adults. Salong Debbarma Updated Fri, September 25, 2026 at 1:38 AM PDT * The FDA has approved Eli Lilly and Company's Onswik, a once-weekly basal insulin injection for adults with type 2 diabetes, to improve blood sugar control. The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D). This treatment is approved for use alongside diet and exercise to improve blood sugar control. Onswik is intended to provide steady basal insulin levels for seven days. The FDA decision was supported by Lilly's QWINT Phase III clinical programme, which enrolled more than 3,400 adults with T2D across four registration trials. In each trial, once-weekly Onswik met its primary endpoint for non-inferior reductions in A1C from baseline, compared with daily insulin glargine U-100 or insulin degludec U-100. The programme included patients new to insulin treatment and those already using basal insulin. QWINT-1 enrolled 795 participants in Argentina, Mexico and the US, while QWINT-2 enrolled 928 people in Brazil, Canada, China, Czechia, Germany, Greece, Korea, Japan, Mexico, Puerto Rico and the US. QWINT-3 involved 986 participants in Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain, Taiwan and the US. QWINT-4 enrolled 730 participants in Argentina, Germany, India, Italy, Mexico, Puerto Rico, Spain and the US. The studies compared efsitora with insulin degludec or insulin glargine, with QWINT-4 also using insulin lispro. Lilly said the trials showed an overall safety profile for Onswik similar to that of the daily basal insulins assessed. Reported common side effects include allergic reactions, injection-site reactions, itching, lipodystrophy, low blood sugar, rash, swelling of the hands and feet, and weight gain. Lilly executive vice-president and cardiometabolic health president Kenneth Custer said: "For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing T2D. "Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes." Lilly plans to make the Onswik KwikPen available in the US in the coming months. It will be supplied in 500 units/mL pens containing 1,500 units and 1,000 units/mL pens containing 3,000 units. The FDA approval is the fourth global approval for Onswik in adults with type 2 diabetes, following regulatory actions by the European Medicines Agency, Mexico's Federal Commission for the Protection against Sanitary Risks and Japan's Pharmaceuticals and Medical Devices Agency. Earlier this week, Eli Lilly partnered with China-based InnoCare Pharma in a five-drug research and licensing agreement. "FDA approves Lilly's Onswik for type 2 diabetes in adults" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.

Lilly breaks ground on $6.5-Bn Houston API manufacturing facility. Eli Lilly and Company has broken ground on its previously announced $6.5-billion small-molecule medicines and advanced therapeutics manufacturing facility in Houston, Texas. The facility is part of the company's previously announced $50-billion US-based capital expansion plan. The new facility will manufacture Lilly's Foundayo (orforglipron), an oral small-molecule (non-peptide) glucagon-like peptide-1 (GLP-1) for weight management in adults with obesity or adults with overweight and a weight-related condition, along with other small-molecule medicines and advanced therapeutics. Foundayo is currently under regulatory review in more than 40 countries, with a full global rollout targeted for 2027. Lilly is also studying Foundayo for other uses, including Type 2 diabetes and obstructive sleep apnea, with data expected later this year (2026). In addition to Foundayo, the Houston site will focus on advanced therapeutics, which includes oligonucleotides. Since 2020, Lilly has announced investments for 10 sites. Five will produce APIs - Richmond, Virginia; Huntsville, Alabama; Houston, Texas - and two sites in Lebanon, Indiana (Lebanon API and Lilly Medicine Foundry) will focus on new production methods and making medicines for clinical trials. Four will make injectable medicines and manufacture devices: Research Triangle Park and Concord, North Carolina; Kenosha, Wisconsin; and Lehigh Valley, Pennsylvania. One will make genetic medicines, Lebanon Advanced Therapies. Details of some of these investments are further outlined below. * Virginia: $5 billion for a new API and drug-product manufacturing facility, including for the company's emerging bioconjugate platform and monoclonal antibody portfolio; * Alabama: $6 billion in a small-molecule API and peptide manufacturing facility; * Puerto Rico: $1.2 billion to expand an existing facility for oral solid medicines, including for manufacturing orforglipron; * Pennsylvania: $3.5 billion for an injectable medicine and device manufacturing facility that will produce weight-loss therapies; and * Indiana: $4.5-billion investment across two of its three sites in Lebanon, Indiana, for API manufacturing and genetic medicine manufacturing. Lilly expects the new site in Houston will create 600 high-skilled jobs, including engineers, scientists, operations personnel, and lab technicians. The company is also providing $12.5 million to support a relationship with San Jacinto College to support advanced chemical synthesis manufacturing careers, with no prior experience required. This relationship will focus on developing training pathways and expanding the equipment and facility capacity needed to produce technicians, operators, maintenance professionals, and other manufacturing talent, while also leveraging Lilly experts to support curriculum development and instructor readiness and preparation. Separately, Lilly is providing a $2.5-million charitable donation to the San Jacinto College Foundation to support scholarships for eligible students.