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Bavarian Nordic has confirmed a substantial new contract to supply its MVA‑BN® smallpox/mpox vaccine to an undisclosed European nation, strengthening the region’s readiness against biological threats. The recurring order, part of Europe’s growing focus on public health security, is valued at over DKK 200 million. With this latest agreement alongside other global deals, Bavarian Nordic has now secured over DKK 3 billion (approx. USD 400 million) in public preparedness contracts for 2025, meeting its full-year guidance. Paul Chaplin, CEO of Bavarian Nordic, stated the deal underscores Europe’s commitment to vaccine preparedness amid evolving geopolitical risks. The MVA‑BN® vaccine, already approved in the U.S. and EU, continues to be a cornerstone of government immunisation strategies. In ad…
AstraZeneca’s experimental hypertension drug, baxdrostat, has achieved a major milestone. The company announced that its BaxHTN Phase III trial met both primary and secondary endpoints, demonstrating a statistically significant and clinically meaningful reduction in systolic blood pressure after 12 weeks in patients with uncontrolled or treatment-resistant hypertension. The trial involved two once‑daily doses (1 mg and 2 mg) alongside standard therapy, compared to placebo, and showed strong efficacy and favourable safety profiles. Developed through AstraZeneca’s 2023 acquisition of CinCor Pharma, baxdrostat represents a novel class of aldosterone synthase inhibitors that target hormonal drivers unrelated to traditional ACE inhibitors. The treatment‑resistant hypertension market affects ove…
Takeda’s investigational oral orexin receptor 2 agonist, oveporexton (TAK‑861), achieved significant success in two pivotal Phase III trials—FirstLight and RadiantLight—targeting narcolepsy Type 1. Data released on 14 July 2025 showed the drug met all primary and secondary endpoints, delivering notable improvements in wakefulness, daytime sleepiness, cataplexy control, attention, quality of life and overall daily functioning versus placebo. Jefferies analysts highlighted the high statistical significance (p < 0.001), and project peak sales of around $3 billion for this agent alone, with broader orexin-targeted therapies potentially doubling that  This marks a major turnaround for Takeda’s orexin agonist strategy following the 2021 discontinuation of TAK‑994 due to safety issues. Ovepore…
AbbVie has entered into an exclusive licensing agreement with Ichnos Glenmark Innovation (IGI), a joint venture between Glenmark Pharmaceuticals and Ichnos Sciences, to develop and commercialize ISB 2001—a trispecific T-cell engager targeting BCMA, CD38, and CD3—for relapsed or refractory multiple myeloma.  Under the terms, AbbVie will acquire rights to ISB 2001 across North America, Europe, Japan, and Greater China, providing IGI with a $700 million upfront payment and up to $1.225 billion in milestone payments.  ISB 2001, currently in Phase 1 trials, has demonstrated an overall response rate of 84% in patients naive to CAR-T or T-cell engager therapies, and 71% in those previously treated, including those refractory to anti-CD38 therapy. This collaboration enhances AbbVie's oncology pipe…
ScienceMachine, a biotech startup founded in 2024, has secured funding from investors including Basis (VC), Opal Ventures, and Vento. The company, headquartered in San Francisco with a presence in London, has developed 'Sam', an AI-powered platform designed to automate and accelerate bioinformatics research.  'Sam' functions as an AI data scientist, capable of structuring and analyzing complex biological data to uncover new insights, thereby enhancing R&D capabilities. The platform aims to support biotech and pharmaceutical companies in expediting their research processes and achieving breakthroughs more efficiently. With a small team of 2-10 employees, ScienceMachine is poised to expand its operations and further develop its AI technologies.
Epitopea, a transatlantic cancer immunotherapeutics company, has announced the formation of a dedicated clinical team and the expansion of its research team as it accelerates the development of its RNA-based immunotherapies. The company is focused on creating off-the-shelf treatments targeting Cryptigen™ tumor-specific antigens (TSAs), which are aberrantly expressed antigens derived from non-coding regions of the genome, commonly referred to as "junk DNA." The establishment of a clinical team marks a significant milestone in Epitopea's transition from a preclinical to a clinical-stage company. This move is supported by the company's proprietary CryptoMap™ platform, which enables the identification of novel Cryptigen™ TSAs shared across patients with the same tumor type. These antigens serv…
Novo Nordisk is set to invest €2.34 billion in upgrading its pharmaceutical facility in Anagni, near Rome, aiming to enhance production of diabetes and weight loss medications. Acquired through Novo Holdings' 2024 takeover of Catalent, the Anagni site is central to Novo Nordisk's strategy to meet growing global demand for treatments like semaglutide-based therapies.  To expedite the project, Italian authorities have appointed Francesco Rocca, president of the Lazio region, as a special commissioner, granting him powers to streamline administrative processes. The initiative has been designated as a project of "pre-eminent strategic interest," facilitating faster approvals. Production is expected to commence between late 2026 and early 2027, with full completion anticipated by 2029.  The exp…
Merck (known as MSD outside of the US and Canada) has announced plans to acquire London-based Verona Pharma for approximately $10 billion, aiming to bolster its respiratory treatment offerings. The acquisition centers around Verona's flagship drug, Ohtuvayre, an inhaled, non-steroidal therapy for chronic obstructive pulmonary disease (COPD), approved by the U.S. FDA in June 2024. Since its U.S. launch in August 2024, Ohtuvayre has generated significant sales, contributing over 96% of Verona's Q1 2025 revenue of $76 million.  Merck will pay $107 per American Depository Share, representing a 23% premium over Verona's recent NASDAQ closing price. This move aligns with Merck's strategy to diversify its portfolio ahead of the anticipated 2028 patent expiration of its cancer drug, Keytruda. The…
Actithera, a radiopharmaceutical biotech pioneering precision radioligand therapies, has closed an oversubscribed Series A round of $75.5 million. The financing was co-led by founding investor M Ventures alongside new leads Hadean Ventures, Sofinnova Partners and 4BIO Capital, with participation from Bioqube Ventures, Surveyor Capital and others. Proceeds will underwrite the clinical development of Actithera’s lead fibroblast activation protein (FAP)-targeting radioligand candidate across multiple oncology indications and fuel expansion of its proprietary three-pillar discovery platform. This chemistry-driven platform combines covalent-targeting strategies, rational drug design and isotope-agnostic radiochemistry to maximize tumour residence time, ensure rapid systemic clearance and enhanc…
ANGLE plc has announced a significant milestone: the 100th peer-reviewed publication supporting its Parsortix® system, a liquid biopsy platform designed to isolate and analyse circulating tumour cells (CTCs) from blood samples. This achievement underscores a decade of research across 24 cancer types, including breast, ovarian, and prostate cancers, conducted by 42 institutions in 15 countries. The landmark study, conducted by Italy's Fondazione IRCCS, focused on triple-negative breast cancer. Researchers utilised the Parsortix system to harvest intact cancer cells from patient blood samples, enabling whole genomic sequencing (WGS). The sequencing data, analysed using machine learning algorithms, identified key cancer genes associated with DNA proliferation and repair. The authors concluded…
Announced as part of the government’s 10 Year Health Plan and Plan for Change, the NHS has proposed an 'innovator passport' to streamline the nationwide adoption of medical technologies. This initiative addresses the current system where each of the 215 NHS trusts must individually assess and approve new technologies, leading to administrative inefficiencies. Under the new scheme, once a technology is approved by one NHS trust, it can be adopted by others without redundant evaluations. This change aims to reduce bureaucracy, cut costs, and ensure patients across the UK have equitable access to life-saving innovations. The 'innovator passport' is part of a broader 10-year plan to modernize the NHS, improve patient care, and support the UK's life sciences sector. Health Secretary Wes Streeti…
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…