Respiratory Syncytial Virus Vaccine (GSK)

GlaxoSmithKline (GSK) has announced that Arexvy, its respiratory syncytial virus (RSV) vaccine, has received expanded approval from the European Commission (EC) for use in adults aged 18 and over. Arexvy was previously approved for use in adults aged 60 and older, as well as adults aged 50 to 59 who presented an increased risk for RSV. It was the first RSV vaccine to receive authorisation in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV. RSV is a virus that impacts the lungs and breathing passages. It is contagious and affects around 64 million people around the world annually. Chronic conditions, advanced age or immunocompromised status can increase the risk of getting RSV. Additionally, RSV can make many chronic conditions worse, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure. Serious cases of RSV can cause pneumonia, hospitalisation and death. On average, 158,000 adults over the age of 18 are hospitalised for RSV infections annually in the EU. Adults hospitalised for RSV run a higher risk of severe complications and fatality than children. They also need more expensive treatments, placing a financial burden on healthcare systems. A lack of routine testing for RSV means that there are likely more annual cases than are identified. Arexvy has already received approval for the prevention of RSV-caused LRTD in adults over 60 in more than 65 countries around the world. It is approved for use in high-risk individuals between 50 and 59 in more than 60 countries, including the US and Japan. Sanjay Gurunathan, head of vaccines and infectious diseases R&D at GSK, said: “This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalisation and even death, particularly for those with certain underlying health conditions.”

GSK's RSV vaccine wins broader EU approvalGenmab halts recruitment for ProfoundBio ADC studyCormorant's third SPAC reels in $150MUCB to invest £500M in R&D, manufacturing at UK siteUK drug cost watchdog backs Dupixent for COPDGSK's RSV vaccine wins broader EU approvalThe label of GSK's adjuvanted recombinant respiratory syncytial virus (RSV) vaccine Arexvy has been expanded in the EU to cover all adults 18 years and older. The shot was previously approved for use in adults aged 60-plus, as well as in those aged 50 to 59 years at increased risk for RSV disease.Arexvy's broadened indication matches that previously awarded to Pfizer's RSV vaccine Abrysvo. Despite bringing in considerable first-year sales following its initial approval in 2023, GSK was forced to scale back long-term forecasts for Arexvy when it became apparent that re-vaccination was not required on an annual basis, and after a move by US authorities to narrow their recommendations for RSV shots.Genmab halts recruitment for ProfoundBio ADC studyGenmab has halted enrollment in a Phase I/II advanced solid tumour trial of GEN1286, an EGFR/cMet-targeting antibody-drug conjugate (ADC). According to a ClinicalTrials.gov update dated Jan. 15, the study stopped recruiting after enrolling just 23 patients, far short of the roughly 260 participants originally planned.Genmab did not respond to a request for comment from FirstWord at the time of publication. If the company has no further plans for development, GEN1286 would be the third ADC from its $1.8-billion ProfoundBio takeout in 2024 to be scrapped.Last September, Genmab terminated development of GEN1107, a Phase I/II PTK7-targeted ADC, after concluding that its overall benefit-risk profile no longer supported continuation. Roughly two months later, it also pulled the plug on the CD70-targeted ADC GEN1160, which was in Phase I/II testing for relapsed/refractory non-Hodgkin lymphoma, saying it was ending clinical development "due to slow enrolment."Meanwhile, another investigational compound from the ProfoundBio acquisition — an FRα-targeted ADC called rinatabart sesutecan (Rina-S, GEN1184) — remains in the pipeline. It is in a Phase III trial for endometrial cancer and platinum-resistant ovarian cancer, according to the company's website.Cormorant's third SPAC reels in $150M Cormorant Asset Management's third blank-cheque company, Helix Acquisition III, raised $150 million in an IPO on Friday through the sale of 15 million shares at $10 apiece. The deal exceeded the firm's original goal of $125 million.The crossover investor will now be looking to merge its SPAC with a private biotech.Cormorant's latest SPAC follows the success of two prior public vehicles, which merged with MoonLake Immunotherapeutics and BridgeBio Oncology Therapeutics in 2022 and 2025, respectively. UCB to invest £500M in R&D, manufacturing at UK siteUCB confirmed an investment of £500 million ($684 million) in R&D and manufacturing at its site in Windlesham, Surrey, further strengthening claims of a recovery in the UK life sciences sector. The commitment is supported by the government's Life Sciences Innovative Manufacturing Fund (LSIMF)."The LSIMF grant strengthens our collaboration with government to support the life sciences sector and we are delighted to be able to deliver a campus and scientific capability that…cements drug discovery here," said Alistair Henry, UCB's chief scientific officer. The investment means the biopharma will continue developing a range of medicines for immunological diseases in the UK.A recent report by the Medicines and Healthcare products Regulatory Agency (MHRA) showed that clinical trial applications in the UK rose by 9% between January and November last year, suggesting that efforts by the government to reignite the country's life sciences sector may be starting to pay off.UK drug cost watchdog backs Dupixent for COPDThe National Institute for Health and Care Excellence (NICE) has recommended Sanofi and Regeneron Pharmaceuticals' Dupixent (dupilumab) for patients with chronic obstructive pulmonary disease (COPD) who have raised blood eosinophil levels. NICE said the injectable therapy could benefit nearly 30,000 people in England whose COPD remains uncontrolled despite standard inhaler treatment, particularly those with elevated eosinophils.In the Phase III BOREAS and NOTUS trials, Dupixent reduced COPD flare-ups by about a third and improved lung function, outcomes that could translate into fewer hospitalisations and less reliance on steroid treatments. NICE estimates that if half of eligible patients receive the drug, that could avoid about 3600 flare-ups annually, saving the National Health Service (NHS) roughly £16.5 million ($22.6 million).NHS England has negotiated a commercial agreement with Sanofi to support rollout of the therapy, which patients self-administer at home every two weeks using a pre-filled pen.