Bristol Myers Squibb Co.

The jab’s availability will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. Credit: Halfpoint/Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national coverage, subject to marketing authorisation. Lilly’s Onswik is a pre-filled injection pen containing insulin that only needs administering once a week. Its availability marks a big advancement for type 2 diabetic patients who rely on daily insulin injections, with initial forecasts that a switch to Lilly’s product could cut the number of injections each patient needs by 85%. It will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. While the recommendation means Onswik will be covered on England’s National Health Service (NHS), an approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) still needs to arrive first for the product to be available. A UK marketing authorisation is largely expected given the pre-emptive NICE recommendation. Onswik already secured a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2026, signifying a welcome sentiment with regulators so far. NICE based its decision on data from Lilly’s Phase III QWINT programme. Results demonstrated that Onswik controls blood glucose levels as well as two widely used long-acting insulins, insulin degludec and insulin glargine, which are taken to keep blood sugar steady throughout the day. It means people switching to the weekly injection can expect similar blood glucose control to their current treatment, NICE said. Type 2 diabetes is a common condition where the body cannot make enough of a hormone called insulin, or the insulin it makes does not work properly. Administering insulin helps the body better regulate glycaemic levels. Helen Knight, director of medicines evaluation at NICE, said: “Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject. This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding.” The relatively straightforward decision for Onswik contrasts a rockier UK reimbursement journey for Lilly’s Alzheimer’s therapy Kisunla (donanemab). In June 2025, NICE rejected NHS use of the drug based on the narrow window of clinical benefits. Lilly appealed the decision, with NICE referring the review back to its appraisal committee in March 2026. The UK’s reimbursement landscape has caused friction with other drugmakers recently. Bristol Myers Squibb (BMS) aligned UK and US prices for schizophrenia treatment Cobenfy, even threatening to walk away from the UK market if NICE did not recognise the drug’s clinical value. Separately, AstraZeneca and MSD have previously halted investment for UK expansion plans in the past year, criticising an unwelcoming and uncompetitive pharmaceutical environment. Given the size of the patient population for insulin products, NICE’s nod for Onswik will be a welcome one for drugmakers. Regardless, insulin represents a product that is far more accessible in the UK than the US. According to research , US prices for insulin products were nearly ten times as high as prices in 33 OECD comparison countries in 2022. The history of insulin coverage in the US has been dominated by complex rebate systems and a prevalence of pharmacy benefit managers.

Roche currently has 13 manufacturing sites, 15 research and development facilities and approximately 25,000 employees across 24 locations in eight states. Credit: Roche Roche’s Oregon investment doubles facility size, adding 250 jobs to expand US injectable medicine and drug delivery device manufacturing 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. Ashley Magargee, CEO of Genentech. Credit: Genentech 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.” “ this expansion deepens our commitment to manufacturing in the US and gives us the flexibility to support a growing pipeline. ” Ashley Magargee CEO of Genentech A critical manufacturing hub Since opening in 2006, Hillsboro has grown into a cornerstone of Genentech's US manufacturing network, producing medicines across therapeutic areas including oncology, immunology and neurology. The facility will introduce device-filling capability to the site, further strengthening domestic production and helping build a more resilient, self-sufficient US pharmaceutical supply chain. With established infrastructure, proven manufacturing capabilities and a skilled local workforce already in place, Hillsboro is well-positioned for the upcoming expansion — building on nearly two decades of collaboration with state and community partners in the region. Genentech and Roche’s Oregon and North Carolina Expansion: By the Numbers US$2.75bn - combined investment across the Holly Springs and Hillsboro facilities 2,250+ new jobs created (750+ manufacturing, 1,500+ construction) US$50bn - Roche and Genentech's wider commitment to US R&D and manufacturing infrastructure Commitment to US Manufacturing Expansion to the Hillsboro facility, as well as the Holly Springs site where investment swelled from an initial US$700m to US$2bn, fits into Roche’s wider multi-billion-dollar commitment to US manufacturing. In April 2026, Roche announced it would invest US$50bn in developing manufacturing infrastructure in the US over the next five years. Thomas Schinecker, CEO of Roche Group, speaking at the time of the announcement, said that the “investments underscore our long-standing commitment to research, development and manufacturing in the US.” “We are proud of our 110-year legacy in the United States, which has been a key driver for jobs, innovation and the creation of intellectual property in the US…Our investments of US$50bn over the next five years will lay the foundation for our next era of innovation and growth, benefiting patients in the US and around the world.” Thomas Schinecker, CEO of Roche. Credit: Roche A recurring pattern Roche's US investment is part of a much larger wave of reshoring in the US pharmaceutical industry, partly driven in response to US President Donald Trump's threats of tariffs on medicines manufactured overseas. Novartis has pledged US$23bn to build or expand ten US facilities, while Johnson & Johnson has committed US$55bn to domestic manufacturing, including three new sites. Eli Lilly , meanwhile, is amidst a US$27bn investment spree that includes four additional plants. Bristol Myers Squibb (BMS) has also deepened its commitment to US biopharmaceutical manufacturing, announcing a $2.3bn "multi-modal manufacturing campus" in Houston, Texas – a milestone step within its broader US$40bn, five-year plan to invest in US research and development, technology and domestic manufacturing. Christopher Boerner, Board Chair and CEO of Bristol Myers Squibb. Credit: Bristol Myers Squibb Discussing BMS' latest move, Christopher Boerner, Board Chair and CEO of BMS, says, "This investment reflects our confidence in America's continued leadership in biopharmaceutical innovation." "As part of our $40bn commitment to the United States, we're building the domestic manufacturing capabilities needed to deliver the next generation of medicines and support future scientific breakthroughs. Houston and the state of Texas offer the talent, infrastructure, and partnership needed to help bring that vision to life." Company portals Bristol Myers Squibb Eli Lilly Genentech Johnson & Johnson Novartis Roche Executives Ashley Magargee Chief Executive Officer Chris Boerner Board Chair and Chief Executive Officer Thomas Schinecker CEO Roche Group

Less than a year after the FDA turned down the resubmitted application for the company’s leukemia prospect Dasynoc, Xspray Pharma has again hit a wall at the U.S. regulator. This week, the FDA handed Xspray another Complete Response Letter on Dasynoc, an “optimized” version of Bristol Myers Squibb’s cancer treatment Sprycel (dasatinib) in development to tackle chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The letter addressed “previously communicated” manufacturing observations at Xspray’s third-party production partner, NerPharMa, and posed a request for additional commercial-scale batch data, which itself follows previous corrective actions, the company said in an Aug. 19 release. NerPharMa, based in Italy, has already wrapped up remediation efforts at its site and alerted the FDA of its progress, per Xspray, which acknowledged that the U.S. regulator “has yet to determine if a reinspection is required for the agency to finalize its assessment of the facility’s status.” When the FDA rebuffed Dasynoc last October, it similarly flagged concerns with Xspray’s manufacturing partner, with the company’s then-CEO Per Andersson reflecting that it was “unfortunate that manufacturing-related issues beyond our control are delaying our launch.” With the latest decision, Xspray says it now plans to resubmit its Dasynoc application as soon as possible, before the end of the year. To meet the FDA’s requests, Xspray noted that it will prioritize production of additional commercial-scale Dasynoc batches—already sewn into its launch strategy—to provide the production data the agency requires. As with the prior rejection, Xspray stressed that the FDA raised no questions around its drug candidate’s clinical data, bioequivalence or stability. The company also stressed that a risk of medication error raised in past rejections “has been resolved.” “The CRL confirms that the remaining uncertainty is now linked to NerPharMa sufficiently addressing the FDA's observations at their manufacturing site and batch data from consecutive manufacturing runs being provided,” Xspray CEO Blake Leitch said in a statement. “As expected, this will require an NDA resubmission.” In the meantime, the company says it will continue to prep for a Dasynoc launch in the U.S., with the hopes that once an approval comes through, the product can reach patients as quickly as possible. Back in February, Sweden-headquartered Xspray announced Leitch’s appointment as the company’s new chief executive, with prior helmsman Andersson transitioning into the role of chief scientific officer. The changes were designed to help with Xspray’s ongoing efforts to evolve into a commercial-stage pharmaceutical company. Xspray, which has yet to secure an FDA approval for Dasynoc or any other asset, leverages a unique business model hinging on its HyNap platform, which the company uses to design “improved versions” of cancer-fighting protein kinase inhibitor (PKI) drugs. Apart from the Sprycel-based Dasynoc, Xspray’s other lead candidate Nilopki—an optimized version of Novartis’ Tasigna—is also under FDA review. The company is also working on so-called optimized versions of Pfizer’s Inlyta and Exelixis’ Cabometyx. Prior to this week, last year’s CRL was not the first Dasynoc received. The company’s first approval effort for the drug was met with a rejection in 2023, with the FDA at the time specifically asking for clarifying information around dosing that would help patients avoid confusion. Another CRL around label comprehension and contract manufacturer concerns surfaced in 2024, but Xspray reiterated Wednesday that it has since resolved those medication error issues. The company’s stock took a sizeable hit this week on news of the latest FDA rebuff.