Today Stories
Clerkenwell Health has launched the UK’s first fully NHS‑embedded commercial research site dedicated to brain and mental health, in partnership with Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH). Located within an existing NHS facility in Doncaster, the site serves over 1.3 million people across South Yorkshire. This initiative offers NHS patients quicker access to cutting‑edge investigational treatments while addressing long‑standing delays that have discouraged global sponsors from conducting trials in the UK.
By utilising underused NHS infrastructure and collaborating closely with NHS clinicians, the site also creates local jobs, enhances research capability through upskilling, and boosts workforce development. Rather than a pilot, it is the first in a planned nation…
United Therapeutics recently announced that its pivotal TETON-2 clinical trial of nebulized Tyvaso (treprostinil) inhalation solution for idiopathic pulmonary fibrosis achieved its primary endpoint. The study revealed a significant improvement in absolute forced vital capacity compared with placebo. Encouraging results were also seen across most secondary endpoints, such as time to first clinical worsening and quality of life measures. Strong outcomes from TETON-2 are intended to support a supplemental New Drug Application to the US Food and Drug Administration for an expanded indication in IPF. The company also intends to consult with the FDA later this year to explore opportunities to accelerate regulatory review. Additionally, more detailed findings are expected to be shared at the upco…
The National Institute for Health and Care Excellence has approved a novel first‑line treatment for adults with unresectable or metastatic urothelial cancer who are eligible for platinum-based chemotherapy. The regimen combines enfortumab vedotin (Padcev) with pembrolizumab (Keytruda) and is now available on the NHS in England and Wales.
Clinical trials revealed that the new combination nearly doubled progression‑free survival—from 6.3 to 12.5 months—and extended overall survival dramatically, with median overall survival reaching 33.8 months compared to 15.9 months with chemotherapy alone. Around 30 percent of patients had no detectable cancer after treatment, markedly higher than rates seen with traditional chemotherapy.
Oncology experts have hailed the development as a transformational…
Roche, together with its partner Alnylam, is propelling the RNA interference therapy zilebesiran into a Phase III cardiovascular outcomes trial following compelling Phase II results. At the European Society of Cardiology Congress 2025, data from the KARDIA‑3 study were presented. While the trial did not meet its primary endpoint due to statistical constraints, the 300 mg dose achieved a placebo‑adjusted systolic blood pressure reduction of 5 mmHg at Month 3 (p = 0.0431), with sustained benefits through Month 6.
Safety data were encouraging, and subgroup analysis suggested enhanced benefit when zilebesiran was combined with a diuretic. The comprehensive insights from the KARDIA‑1 through KARDIA‑3 studies guided the decision to launch a global Phase III cardiovascular outcomes trial, targete…
Regeneron’s experimental siRNA therapy, cemdisiran, successfully met the main objectives in a Phase III trial for adults with generalized myasthenia gravis. In the 24‑week study, cemdisiran monotherapy led to a 74 percent reduction in complement protein C5 levels and delivered measurable improvement in patients’ daily activities such as talking and eating. When combined with Regeneron’s approved C5 blocker pozelimab (Veopoz), C5 suppression increased to nearly 99 percent, though cemdisiran alone performed slightly better on key disease‑specific outcomes. No patients discontinued treatment due to adverse events. The company now plans to submit an FDA marketing application in early 2026. This development positions cemdisiran as a promising competitor in the field, potentially offering at‑hom…
Moderna has received U.S. Food and Drug Administration approval for its 2025‑2026 COVID‑19 vaccine formulations—namely Spikevax and the new vaccine mNEXSPIKE. These updated vaccines are designed to target the emerging LP.8.1 variant of SARS‑CoV‑2. Spikevax is authorised for individuals aged six months through 64 years with at least one underlying high‑risk condition, as well as all adults aged 65 years and older. mNEXSPIKE, a new lower‑dose vaccine, is approved for those aged 12 through 64 with high‑risk conditions and all adults aged 65 and above .
mNEXSPIKE offers a significant dosage reduction—about one‑fifth of Spikevax—achieved by refining the vaccine’s immune target. This design supports enhanced efficacy with potentially fewer side effects. Clinical data show that mNEXSPIKE demonstr…
Lundbeck is advancing bexicaserin - an oral 5‑HT₂C receptor agonist initially developed by Longboard Pharmaceuticals - for the treatment of severe developmental and epileptic encephalopathies (DEEs), including Dravet syndrome and Lennox–Gastaut syndrome. Lundbeck acquired the asset through a ~$2.6 billion takeover of Longboard in late 2024.
In a 12‑month open‑label extension (OLE) of the Phase 1b/2a PACIFIC trial, bexicaserin delivered a sustained and clinically meaningful reduction in motor seizures—median decrease of 59.3% from baseline. Participants who had been on bexicaserin from the trial start achieved a 60.4% reduction; those switching from placebo saw a 58.2% decrease. The safety profile remained favourable, with most participants completing the year-long study and common adverse…
AbbVie has agreed to acquire Gilgamesh Pharmaceuticals’ lead investigational therapy for major depressive disorder, bretisilocin, in a deal valued at up to $1.2 billion. Bretisilocin is a novel serotonin 5‑HT2A receptor agonist and serotonin releaser that delivers shorter psychoactive effects while offering enduring therapeutic benefits.
This acquisition extends AbbVie’s reach in psychiatric treatment development following a phase failure in schizophrenia—part of the company’s broader strategy to revitalize its neuroscience portfolio amid biosimilar pressures on its blockbuster Humira. Gilgamesh will spin off its remaining programs—including NMDA antagonist, ibogaine analog, and M1/M4 agonist pipelines—into a new company, Gilgamesh Pharma Inc.
This definitive agreement builds on an earlier…
Kite Pharma, a Gilead Sciences subsidiary, has entered into a binding agreement to acquire Interius BioTherapeutics—a privately held biotechnology firm—for $350 million in cash. The strategic acquisition brings to Kite an innovative in vivo CAR‑T platform capable of creating CAR T‑cells directly within patients via a single intravenous infusion. This eliminates the need for the complicated and costly process of harvesting and engineering cells outside the body and may enhance treatment durability by integrating DNA into the patient’s genome.
The deal is anticipated to lower Gilead’s GAAP and non‑GAAP earnings per share for 2025 by about $0.23 to $0.25. Upon closing - subject to antitrust clearance under the Hart‑Scott‑Rodino Act and other standard conditions—Interius’s operations and perso…
Royalty Pharma has struck a landmark agreement to purchase a royalty interest in Amgen’s lung cancer therapy Imdelltra for up to $950 million. The pharmaceutical financier will pay $885 million upfront to BeOne Medicines—which retains the drug’s commercial rights in China—and may acquire additional royalty rights worth $65 million within twelve months. Under the deal, Royalty Pharma will receive roughly 7 percent of global net sales of Imdelltra, excluding the Chinese market.
Imdelltra, approved in the U.S. in 2024 for small cell lung cancer patients whose disease progressed after platinum‑based chemotherapy, has already shown remarkable clinical results. A Phase 3 trial demonstrated a 40 percent reduction in risk of death and a median overall survival of 13.6 months compared to 8.3 months…
Tiziana Life Sciences has reached a key milestone in its Phase 2a clinical trial of intranasal Foralumab for non‑active secondary progressive multiple sclerosis (na‑SPMS). Patient dosing has now commenced at Yale’s Multiple Sclerosis Center, expanding the study’s reach beyond its initial sites and underscoring progress in the multicentre, randomized, double‑blind, placebo‑controlled investigation.
Launched in late 2023, the trial explores two dosing regimens of Foralumab against placebo, assessing effects on microglial activation via PET imaging, alongside standard measures of disability, cognition, fatigue, and quality of life. The inclusion of Yale adds to a network of major US research centres (including Johns Hopkins, UMass, Brigham and Women’s Hospital, and more) enhancing the study’s…
Stoke Therapeutics and Biogen have initiated the global Phase III EMPEROR trial of zorevunersen (previously known as STK‑001) for children and adolescents with Dravet syndrome. This pioneering antisense oligonucleotide is designed to boost expression of the healthy SCN1A gene, potentially addressing not just seizure frequency but also cognitive and behavioral impairments. The study will enroll approximately 150 patients across the United States, United Kingdom, Europe, and Japan. Participants will undergo 8 weeks of baseline monitoring followed by 52 weeks of treatment, beginning with two 70 mg loading doses and transitioning to two 45 mg maintenance doses. The primary outcome measure is the reduction in major motor seizure frequency, with secondary outcomes assessing improvements in behav…
German pharmaceutical company Bayer and U.S.-based Kumquat Biosciences have entered into an exclusive global license and collaboration agreement to develop and commercialize Kumquat’s KRAS G12D inhibitor. Under the deal, Kumquat will initiate and complete the Phase 1a clinical trial while Bayer will assume responsibility for later-stage development and commercialization. The asset received FDA approval for its investigational new drug (IND) application in July 2025 and addresses KRAS G12D mutations—common in pancreatic, colorectal, and non‑small cell lung cancers, yet currently lacking effective therapies. Kumquat stands to receive up to $1.3 billion in milestones, upfront payments, and tiered royalties, plus an option for profit‑loss sharing in the U.S. This partnership aligns Kumquat’s d…
Pfizer and Astellas announced encouraging interim results from a late stage trial combining its antibody drug conjugate Padcev with Merck’s immunotherapy Keytruda in patients with muscle invasive bladder cancer. The combination, administered before and after surgery, delivered significant improvements in both event‑free survival (how long patients remained recurrence‑free) and overall survival compared to surgery alone. Johanna Bendell, Pfizer’s oncology chief development officer, emphasised the potential for this treatment to reshape standard care for this aggressive cancer, which accounts for around 25 percent of new bladder cancer cases. Padcev, approved in 2019 for metastatic urothelial cancer, generated $1.59 billion in sales last year. Pfizer and Astellas now plans to engage with glo…
Eli Lilly and Company has joined forces with the UK Government’s Department for Science, Innovation and Technology (DSIT) to launch an £85 million programme aimed at developing innovative models of care for obesity. Delivered in partnership with Innovate UK, the initiative will run a UK-wide competition inviting NHS organisations to propose novel approaches to obesity management, with selected projects receiving pilot funding.
The programme seeks to improve support for people living with obesity while aligning with the Government’s vision for an ‘NHS fit for the future’. Funding includes up to £50 million from DSIT and up to £35 million from Lilly, with at least £10 million earmarked for projects in Scotland, Wales and Northern Ireland. Models will be assessed for clinical alignment, resou…
Almirall selects second target in AI Drug Creation collaboration
Expanded collaboration builds on Absci’s successful de novo molecule design for difficult‑to‑drug targets in the first stage of the collaboration with Almirall
Barcelona, Spain, August 7, 2025 – Almirall (BME: ALM), a global biopharmaceutical company focused on medical dermatology, and Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative AI, today announced the expansion of their ongoing AI Drug Discovery collaboration with Almirall’s selection of a second target aimed at dermatological indications.
The expansion of the collaboration follows the successful delivery of AI-designed, functional antibody leads against a difficult-to-drug target—the fi…
US Health and Human Services Secretary RFK Jr. has authorised the cancellation of 22 federally backed vaccine development programmes worth nearly $500 million, specifically those using mRNA technology to target respiratory viruses such as influenza, COVID‑19 and H5N1. Kennedy asserts that these vaccines “do not protect effectively” against upper‑respiratory infections and prefers investment in broader, whole‑virus platforms he considers safer.
The affected contracts involve major players like Pfizer, Moderna, Sanofi Pasteur and CSL Seqirus. While HHS says some late‑stage projects will continue to completion to protect prior taxpayer investment, the shift marks a stark contrast to the mRNA‑focused strategies that were central to the COVID‑19 response.
Public health experts, including Mike O…
Paris, August 6, 2025. Sanofi announces the completion of its acquisition of Vigil Neuroscience, Inc. (“Vigil”). This acquisition strengthens Sanofi’s early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase 2 clinical study in patients with Alzheimer’s disease. In addition, the acquisition of Vigil’s preclinical pipeline will further strengthen Sanofi’s research in various neurodegenerative diseases.
In June 2024, Sanofi made a $40 million strategic investment in Vigil that included the exclusive right of first negotiation for an exclusive license, grant, or transfer of rights to research, develop, manufacture, and commercialize VG-3927.
Under the terms of the acquisition agreement, Sanofi and Vigil have agreed to…
Novo Nordisk is confronting intensifying challenges surrounding its blockbuster weight‑loss therapy Wegovy (semaglutide). The company has slashed its 2025 sales growth forecast to 8–14% from an earlier projection of 13–21%, triggering an estimated €60–70 billion drop in market value across stock markets. Rising competition from Eli Lilly’s Zepbound and Mounjaro, coupled with the widespread availability of unbranded compounded versions of Wegovy in the U.S., have significantly dented its market share.
Novo Nordisk has also ended its partnership with telehealth firm Hims & Hers following concerns over the sale of cheaper compounded semaglutide that undercut branded products. New CEO Maziar Mike Doustdar, a long‑time company insider and first non‑Danish leader, is expected to refocus comm…
A new trade framework announced during talks between President Donald Trump and European Commission President Ursula von der Leyen introduces a 15 % tariff on EU exports to the U.S., including branded pharmaceuticals. Pharmaceutical companies in Europe have warned that this move may add between $13 billion and $19 billion in annual costs to the industry.
The tariffs are contingent on a pending U.S. Section 232 investigation into drug imports and will remain on hold until that probe concludes, expected around August . Generic medicines are reportedly excluded from the duties, though ambiguity remains about which specific products qualify.
Industry representatives, including the European Federation of Pharmaceutical Industries and Associations (EFPIA), criticised the policy as a blunt instru…
