Bepirovirsen Sodium

Roche’s Oregon investment (not pictured) will double facility size, adding 250 jobs to expand US injectable medicine and drug delivery device manufacturing. Credit: Roche This week’s top stories include Roche’s Oregon expansion, TCS’ drug development platform, GSK’s hepatitis approval, and Danaher’s Chief HR appointment 1. Roche Invests US$750m in Oregon Manufacturing Expansion Roche currently has 13 manufacturing sites, 15 research and development facilities and approximately 25,000 employees across 24 locations in eight states. Credit: Roche Just days after Roche announced it had “raised the final beam” to complete its new US$2bn manufacturing facility in Holly Springs, North Carolina, the Swiss firm also announced it will invest US$750m to double the size of its existing manufacturing facility in Hillsboro, Oregon. Genentech , a US subsidiary of Roche, will operate both manufacturing facilities as the Swiss pharma giant builds out its US footprint. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally. It employs over 112,000 people worldwide, generating roughly CHF62 billion (US$77.5bn) in annual revenue. Its current US presence includes 13 manufacturing sites, 15 research and development facilities and approximately 25,000 employees across 24 locations in eight states. Commenting on the expansion, Ashley Magargee, CEO of Genentech, says, “We are proud to make this significant new investment in Hillsboro, building on nearly two decades of Genentech manufacturing in Oregon. “By adding end-to-end filling capabilities, this expansion deepens our commitment to manufacturing in the US and gives us the flexibility to support a growing pipeline.” 2. TCS Brings Audit-Ready Agentic AI to Global Drug Development In drug development, the race to bring life-saving therapies to patients is often held back not by scientific discovery, but by operational complexity. In highly regulated environments, pharmaceutical companies must maintain rigorous auditability at every stage, creating a delicate balance between harnessing AI’s potential and meeting the strict demands of regulatory compliance. Tata Consultancy Services (TCS) is seeking to bridge this gap with AI agents designed to operate within the stringent audit, governance and compliance requirements of clinical operations. Its TCS ADD AgentHub platform is designed to help life sciences organisations scale the use of AI while maintaining human oversight and regulatory control. "TCS ADD AgentHub introduces a role-based AI workforce that supports key drug development functions across pharmacovigilance and clinical operations," says Rachna Malik, Global Head of TCS ADD. "These agents perform specialised tasks while operating within a framework of human oversight, governance, auditability and lifecycle control." 3. GSK Wins First Approval for Hepatitis B Drug Bepirovirsen GSK is a global biopharma company focused on specialty medicines, vaccines and general medicines. Credit: GSK British pharmaceutical giant GSK has received its first global approval for chronic hepatitis B (CHB) drug bepirovirsen from Japanese regulators. Branded in Japan as Hibsago, it is the first and only functional cure treatment for CHB approved in the country. The development is crucial from a global perspective as current CHB treatments can suppress the virus and reduce the risk of complications such as cirrhosis and liver cancer, but generally do not eradicate the infection. Bepirovirsen differs as it is the first treatment designed to deliver a functional cure. CHB remains a major global health challenge and a leading driver of liver cancer. In Japan, nearly one million people are living with CHB, which contributes to around 4,000 deaths each year. Discussing the drug’s approval, Tony Wood , Chief Scientific Officer at GSK, says: “For the first time, a treatment approved for functional cure is available to people living with chronic hepatitis B in Japan with Hibsago. “After 6-months of treatment with Hibsago, patients could be freed from life-long therapy and reduce their risk of long-term liver complications. This is a major advance for CHB management and our innovative hepatology portfolio, and we look forward to further regulatory decisions in other countries.” 4. Heathre Moler Appointed Danaher Chief HR Officer Heathre Moler, Incoming Chief HR Officer at Danaher. Credit: LinkedIn Danaher is set for change at the top of its executive leadership team, with Heathre Moler set to take on the role of Chief HR Officer from 1 October 2026. She will replace Georgeann Couchara, who has held the position since April 2022. Danaher is a global science and technology company focused on biotechnology, diagnostics and life sciences. Its portfolio includes businesses such as Cytiva, Beckman Coulter, Cepheid and Leica Biosystems, providing tools, technologies and services spanning drug development, biomanufacturing and precision diagnostics. Danaher generated around US$25bn in revenue in 2025. Commenting on the appointment, incoming CEO and President of Danaher , Julie Sawyer Montgomery, says, “Heathre is an enterprise-minded leader who understands how talent, culture, leadership and the Danaher Business System connect directly to business performance, and she has earned the trust of teams across multiple Danaher businesses, most recently Diagnostics. “I'm confident she will be a strong partner as we continue strengthening the leadership bench, organisational capability and culture Danaher needs for our next chapter.” 5. Ken Keller Named Daiichi Sankyo Commercialisation Chief Ken Keller, Chief Commercialisation Officer at Daiichi Sankyo. Credit: Daiichi Sankyo Ken Keller will take the reins of an entirely new commercial unit at Daiichi Sankyo from April 2027, when he begins his time as Chief Commercialisation Officer at the Japanese pharmaceutical company. As part of Daiichi Sankyo’s ambition to become a “global top five oncology company” by 2035 and expand its specialty medicine business, the globally integrated “Commercialisation Unit” will centralise and reorganise activities to improve speed, consistency and resource allocation. Daiichi Sankyo is a global pharmaceutical company, with more than 20,000 employees and operations across more than 30 countries. With 120 years of scientific expertise, it focuses on innovative medicines, with oncology at the heart of its growth strategy. “Over the past decade, Ken has played a pivotal role in advancing the commercial capabilities of Daiichi Sankyo,” says Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “His proven track record, strategic insight and leadership make him the right person to serve as our new Chief Commercialisation Officer,” continues Hiroyuki. Company portals Daiichi Sankyo Danaher Genentech GSK Roche Tata Consultancy Services Executives Ashley Magargee Chief Executive Officer Heathre Moler Chief Human Resources Officer (CHRO) Designate Ken Keller Chief Commecialisation Officer Rachna Malik Global Head - TCS ADD - Life Sciences Platforms Tony Wood Chief Scientific Officer

GSK's chronic hepatitis B (CHB) therapy notched its first-ever approval on Monday, nabbing a nod in Japan as its applications in the US, EU and China progress. Japan regulators greenlit Hibsago (bepirovirsen) as a functional cure for adults with a hepatitis B surface antigen (HBsAg) level of ≤3000 IU/mL who have received at least six months of prior nucleos(t)ide analogue (NA) therapy.The antisense oligonucleotide's clearance comes less than three months after GSK presented what it called "unprecedented" results from the Phase III B-Well 1 and B-Well 2 trials at the European Association for the Study of the Liver (EASL) congress.Pooled data from the two studies showed that patients with CHB who received once-weekly injections of Hibsago over the course of six months achieved a 19% functional cure response rate in the overall study population, a statistically significant result given the 0% cure rate for the placebo group, meeting the primary endpoint.Furthermore, in patients with low viral activity — defined as an HBsAg level of ≤1000 IU/mL, making up about 45% of all global CHB cases  — the Hibsago group saw a functional cure rate of 26%. Current NA therapies like entecavir and tenofovir require daily dosing, with patients at risk of relapse if treatment is stopped. They're also associated with a functional cure rate of less than 1% (see – Spotlight On: GSK delivers historic win for hepatitis B patients).After the B-Well readouts, FirstWord spoke with Calvin Pan, a professor of medicine in the Division of Gastroenterology and Hepatology at New York University Grossman School of Medicine, who called the data "a very important milestone" for CHB. "There are no competitors with comparable functional cure rates right now," he said, but noted that GSK will likely have to run strong peer-to-peer campaigns in the US to raise patient and physician awareness of Hibsago (see – KOL Views Q&A: GSK's bepirovirsen is one small step for HBV patients, one giant leap for HBV therapy).A decision from the FDA on Hibsago is expected in "the coming months," GSK said Monday. The UK pharma in-licensed the drug from Ionis Pharmaceuticals in 2019, and recently inked a distribution deal with Sino Biopharmaceutical to help its commercialisation efforts in China.