Today Stories

FDA Grants Accelerated Approval to Lynozyfic for Advanced Multiple Myeloma Regeneron Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adults with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing. It is the first FDA-approved BCMAxCD3 bispecific antibody with a response-adapted dosing regimen, allowing for dosing every two weeks starting at week 14, and every fo…

Aurobindo Pharma has secured European Commission marketing authorisation for Dazublys, a biosimilar to trastuzumab, developed by its subsidiary CuraTeQ Biologics. This approval follows the European Medicines Agency’s CHMP positive opinion in April 2025, confirming Dazublys’ comparable quality, safety, and efficacy to Herceptin.  Dazublys is indicated for HER2-positive metastatic and early breast cancers, as well as metastatic gastric cancer. It will be available as a 150 mg powder for infusion across EU member states.  This marks CuraTeQ’s third EMA-approved biosimilar, following Dyrupeg and Zefylti, and the fourth overall in the EU, including Bevqolva approved by the UK’s MHRA. Aurobindo aims to launch at least 10 biosimilars across oncology and immunology by 2030.

Alvotech and Advanz Pharma have announced an expansion of their strategic partnership to include the commercialization of AVT10, a proposed biosimilar to Cimzia® (certolizumab pegol), across Europe. This addition marks the only known biosimilar candidate to Cimzia currently in development globally, targeting chronic rheumatic diseases, particularly in women of childbearing age.  This agreement builds upon their existing collaboration, which now encompasses biosimilars referencing over ten originator biologics, including treatments for autoimmune and inflammatory diseases. The partnership covers all 30 European Economic Area member countries, as well as the UK and Switzerland, with plans to launch the first biosimilars in Europe starting in Q4 2025.  Alvotech will oversee the development an…

Stefan Oelrich, President of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has called for the establishment of a European equivalent to the Nasdaq stock exchange to invigorate biotech innovation across the continent. This proposal aims to address the challenges European biotech companies face in securing funding and scaling operations compared to their U.S. counterparts. Oelrich emphasized that Europe's fragmented regulatory environment and inconsistent drug pricing mechanisms hinder the growth of its biotech sector. He pointed out that many FDA-approved drugs in the U.S. never reach European markets due to these barriers, stifling innovation and patient access to new treatments. The concept of a "European Nasdaq" seeks to provide a centralized platform for…

AbbVie has announced a definitive agreement to acquire Capstan Therapeutics, a clinical-stage biotechnology company, for up to $2.1 billion in cash. This acquisition includes Capstan's lead asset, CPTX2309, a potential first-in-class in vivo CAR-T therapy currently in Phase 1 development for B cell-mediated autoimmune diseases. Unlike traditional ex vivo CAR-T therapies, CPTX2309 utilizes Capstan's proprietary targeted lipid nanoparticle (tLNP) platform to deliver mRNA encoding an anti-CD19 chimeric antigen receptor directly to CD8-expressing cytotoxic T cells within the body, eliminating the need for complex cell harvesting and manufacturing processes. The in vivo approach aims to reprogram T cells to target and deplete pathogenic B cells, potentially resetting the immune system and induc…

Pfizer has discontinued its Phase 1b/2 trial of maplirpacept (PF-07901801), a CD47-blocking agent, in combination with tafasitamab and lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients ineligible for stem cell transplantation. The trial, which began in August 2023, enrolled only six participants before being terminated due to recruitment challenges. Pfizer stated that the decision was not related to safety or efficacy concerns. Maplirpacept, acquired through Pfizer's $2.3 billion purchase of Trillium Therapeutics in 2021, is designed to block CD47—a protein that cancer cells use to evade immune detection. Despite this setback, Pfizer continues to explore maplirpacept's potential in other blood cancers, including multiple myeloma and acute myelocytic leu…

BioNTech has announced the acquisition of fellow German biotech CureVac in an all-stock transaction valued at approximately $1.25 billion. Under the agreement, CureVac shareholders will receive about $5.46 in BioNTech American Depositary Shares (ADS) for each CureVac share, representing a 55% premium over CureVac’s recent share price.  This strategic move aims to bolster BioNTech's capabilities in developing mRNA-based cancer immunotherapies, reflecting its long-term focus on oncology beyond its COVID-19 vaccine success in partnership with Pfizer. The acquisition will also resolve ongoing patent disputes between the two companies, including a significant case involving mRNA technology.  CureVac, headquartered in Tübingen, Germany, had previously shifted its focus towards cancer treatment,…

CSL Behring has achieved a significant milestone with the German Institute for Quality and Efficiency in Health Care (IQWiG) issuing a positive benefit assessment for garadacimab, its once-monthly prophylactic treatment for hereditary angioedema (HAE) in patients aged 12 years and older. IQWiG's evaluation, based on a methodologically sound indirect comparison using placebo as a common comparator, concluded that garadacimab offers a "hint of considerable additional benefit" in reducing monthly HAE attack rates. This marks a precedent in the AMNOG process since its inception in 2011. The assessment also noted minor additional benefits in general health status (EQ-VAS) and disease-specific quality of life (AE-QoL). CSL Behring's submission included data from the VANGUARD study, comparing gar…

Novartis has concluded its tender offer to acquire Regulus Therapeutics, with approximately 74.49% of outstanding shares validly tendered and not withdrawn by the expiration deadline on June 24, 2025. The acquisition, executed through Novartis' subsidiary Redwood Merger Sub Inc., offered $7.00 in cash per share plus a contingent value right (CVR) of an additional $7.00 upon achieving a specified regulatory milestone.  The transaction is set to close promptly following the acceptance of the tendered shares. This move aligns with Novartis' strategic focus on expanding its renal disease portfolio, particularly through Regulus' lead asset, farabursen—a next-generation oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).  The acquisition un…

Compass Pathways has announced that its investigational psilocybin therapy, COMP360, met the primary endpoint in its Phase 3 COMP005 trial for treatment-resistant depression (TRD). The study demonstrated a statistically significant 3.6-point reduction in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo after six weeks . Despite this clinical success, investor response was muted, with shares declining amid concerns over the lack of detailed data and the impact of regulatory scrutiny on psychedelic treatments. The FDA's recent rejection of a similar therapy due to issues with functional unblinding has heightened caution in the sector . COMP360, a synthetic formulation of psilocybin, has received Breakthrough Therapy designation from the FDA and…

AstraZeneca has entered a strategic research collaboration with China's CSPC Pharmaceutical Group, aiming to accelerate the discovery of novel oral therapies for chronic diseases. The partnership, valued at up to $5.33 billion, focuses on leveraging CSPC's AI-driven drug discovery platform to identify pre-clinical candidates, including a small molecule oral therapy for immunological disorders . Under the agreement, CSPC will receive an upfront payment of $110 million and is eligible for up to $1.62 billion in development milestone payments and $3.6 billion in sales-based milestones, along with potential royalties on future sales . AstraZeneca will have the option to exclusively license and commercialize any successful candidates globally. The research will be conducted at CSPC's facilities…

Fortrea and Emery Pharma have announced a strategic collaboration to conduct FDA-compliant drug-drug interaction (DDI) studies utilizing rifampin. This partnership aims to address the regulatory challenges posed by nitrosamine impurities, specifically 1-methyl-4-nitrosopiperazine (MNP), found in rifampin formulations. These impurities had previously led to the suspension of rifampin's use in healthy volunteer DDI studies due to safety concerns. Rifampin is a potent inducer of cytochrome P450 3A (CYP3A) enzymes and has been a cornerstone in evaluating the metabolic interactions of new drug candidates. However, the detection of MNP above acceptable intake limits necessitated the exploration of alternative inducers, such as phenytoin and carbamazepine. These alternatives, while viable, do not…

Eli Lilly has announced its intention to acquire Verve Therapeutics, a biotechnology company specializing in gene-editing therapies for cardiovascular diseases, in a deal valued at up to $1.3 billion. The agreement includes an upfront payment of approximately $1 billion, offering $10.50 per share—a 113% premium over Verve's 30-day average stock price. Additionally, shareholders may receive up to $3.00 per share through a non-tradeable contingent value right (CVR), contingent upon the advancement of Verve's lead therapy, VERVE-102, into a Phase 3 clinical trial within ten years . VERVE-102 is an innovative in vivo gene-editing therapy targeting the PCSK9 gene, which plays a crucial role in regulating cholesterol levels. Currently in Phase 1b clinical trials, the therapy has received Fast Tr…

Accelerate@Babraham has unveiled its 2025 cohort, selecting five pioneering life science ventures from a competitive pool of 37 applicants—marking a 50% surge in interest. Now in its seventh year, the accelerator at Babraham Research Campus continues to nurture early-stage innovation, having already supported 32 companies and helped raise over £100m. This year’s cohort includes: AAB Research, developing EV-based cancer therapies; AmnioCam, offering a scalable stem cell-based solution for chronic wound care; Cycle Therapeutics, innovating endometriosis treatment via menstrual fluid analytics; MabGalaxy, using AI to expedite antibody drug discovery; and Sysora Health, tackling gum disease with precision antibacterial gels. The programme offers an 8-week bespoke curriculum, lab space for a ye…

The International Photodynamic Association (IPA) is pleased to announce that Dr. Stuart Bond, Consultant Antimicrobial Pharmacist and Director of Innovation at Mid Yorkshire Hospitals NHS Trust, has been awarded the prestigious President’s Award at the 19th World Congress of the IPA, held this year in Shanghai, China. The President’s Award is one of the IPA’s highest honours, reserved for individuals whose work is making a transformational impact on healthcare through photodynamic therapy. Dr. Bond received this distinguished honour in recognition of his leadership in advancing the use of antimicrobial photodynamic therapy (aPDT, also known as photodisinfection) for infection prevention within the UK's National Health Service (NHS). His pioneering work led to the first implementation of th…

Cure51, a Paris-based Techbio company decoding the biology of cancer “Outliers” – patients who beat aggressive cancers – has significantly accelerated its genomic data analysis by integrating NVIDIA’s cutting-edge GPU computing. Benchmarking with NVIDIA H100 GPUs and Parabricks tools delivered a 17x speed boost and halved processing costs compared to traditional CPU workflows. This leap is critical to Cure51’s Rosalind Study, launched in 2023, which aims to build the world’s largest dataset of cancer super-responders. With Whole Exome Sequencing (WES) at its core, read alignment was a key bottleneck – until now. GPU acceleration allows Cure51 to process data from thousands of samples efficiently, preserving quality while cutting time-to-insight. By adopting Parabricks, Cure51 seamlessly sc…

Kingston University has secured a Royal Society of Chemistry grant of nearly £10,000 to spearhead a year-long initiative focused on improving sustainability in chemical laboratory research. The project, led by Dr Gemma Shearman from the School of Life Sciences, Pharmacy and Chemistry, involves the development of a web-based app that enables students and researchers to evaluate and enhance the environmental impact of their lab experiments. The innovative tool allows users to input chemicals, consumables, and equipment used in experiments to generate a downloadable sticker summarising the experiment’s sustainability footprint and suggestions for improvement. It addresses a critical gap in undergraduate training by incorporating environmental considerations alongside existing risk assessments…

Northern Gritstone has committed £1.8 million to Apini, a University of Manchester spinout focused on treating chronic inflammatory conditions like Crohn’s disease and Ulcerative Colitis. Apini is the first company to emerge from Syncona’s Slingshot Therapeutics accelerator, which launched in November 2024 with £12.5 million to support promising academic research. Apini's therapeutic approach targets eNAMPT, an enzyme linked to inflammation, aiming to treat disease without inducing immune suppression—a significant advancement over current options. The programme was founded by Professor Sam Butterworth, known for developing the globally used cancer drug Tagrisso. The funding from Northern Gritstone, alongside Syncona, will be delivered in three milestone-based tranches. Northern Gritstone’s…

Oracle has announced major advancements in its Randomization and Trial Supply Management (RTSM) solution, introducing vendor-agnostic interoperability and drug pooling capabilities. These innovations enable real-time drug inventory management across multiple clinical trials and vendors—cutting waste and accelerating timelines. Sponsors and CROs can now use the same investigational product across different studies, with seamless integration to leading supply providers like SAP, Almac, Fisher Clinical Services, Catalent, and PMD. Built on Oracle Cloud Infrastructure, RTSM supports end-to-end automation in drug supply ordering, tracking, and allocation. The enhancements reflect Oracle’s commitment to open, connected systems and its broader vision to unify clinical and health applications. Wit…

GSK has partnered with IT services provider adesso to develop DREAM (Digital Reminders for Adherence of Medicines and Vaccines), a digital solution designed to help patients stay on track with medication and vaccination schedules. Originally launched in five pilot markets, DREAM now operates in 23 countries, including the UK, Spain, and Italy. The system delivers personalised, user-friendly reminders to patients, addressing a key healthcare challenge: improving treatment adherence. DREAM was developed with scalability in mind, allowing it to meet regulatory needs across multiple global markets. GSK praised adesso’s agile, committed approach and technological expertise, which helped bring DREAM to life. The collaboration has been ongoing for 18 months and continues to expand, laying the gro…