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Pharmaceutical
Encouraging results for Bayer’s targeted radionuclide therapy 225Ac-PSMA-Trillium in prostate cancer
Germany’s Bayer has announced encouraging results from the ongoing global Phase I first-in-human dose-escalation PAnTHa study of 225Ac-PSMA-Trillium, a targeted alpha therapy in advanced metastatic castration-resistant prostate cancer (mCRPC). 27 February 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval to Hernexeos (zongertinib), from German family owned Boehringer Ingelheim, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. 27 February 2026
Biotechnology
US biotech Earendil Labs has entered a strategic collaboration with Hong Kong-listed WuXi XDC, securing an exclusive global license to the company’s WuXiTecan-2 payload-linker technology for multiple targets. 27 February 2026
Pharmaceutical
Swiss pharma Novartis is to build a 46,000-square-foot radioligand therapy manufacturing facility in Texas, its fifth RLT-focused site in the USA and the first in the state. 26 February 2026
Biotechnology
Japan’s Astellas Pharma and USA-based Vir Biotechnology have entered into a global strategic collaboration to advance VIR-5500, an investigational PRO-XTEN dual-masked CD3 T-cell engager (TCE) targeting PSMA for the treatment of prostate cancer. 25 February 2026
Pharmaceutical
The US Food and Drug Administration (FDA) has granted full approval to pharma giant Pfizer’s Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase III BREAKWATER trial. 25 February 2026
Pharmaceutical
The days of flying under the radar are over for Isotope Technologies Munich (ITM), a privately-held German radiopharmaceutical company. 25 February 2026
Biotechnology
Protara Therapeutics has announced updated interim results from its ongoing Phase II open-label ADVANCED-2 trial assessing intravesical TARA-002 in patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve. 24 February 2026
Biotechnology
The European Commission (EC) has approved an extension of Johnson & Johnson’s Rybrevant (amivantamab) marketing authorization to include additional subcutaneous (SC) dosing regimens. 23 February 2026
Biotechnology
Gilead Sciences today announced that it has entered into a definitive agreement to acquire Arcellx for $115 per share in cash at closing and one contingent value right of $5 per share, which represents an implied equity value of $7.8 billion payable at closing. 23 February 2026
Biotechnology
Last week, USA-based biotech Candel Therapeutics,, which is focused on developing multimodal biological immunotherapies to help patients fight cancer, announced the pricing of an underwritten public offering of 18,348,624 shares of its common stock at a price to the public of $5.45 per share. 23 February 2026
Pharmaceutical
In an interview with journalists at Peri Ygias, Michalis Chimonas, general director of Greek pharm trade organization SFEE, said the group is “increasingly emphasizing the role we can play as an industry in shaping policies for critical Public Health issues. As an industry, we have substantial expertise and we consider it our mission to co-shape a sustainable health system and adopt policies for the benefit of Greek patients, leading to improved therapeutic outcomes.” 23 February 2026
Pharmaceutical
Regulatory news last week included US drug developer Cytokinetics gaining European Commission approval for its cardiomyopathy drug Myqorzo. Swedish biotech Hansa Biopharma said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for imlifidase for review and the FDA approved UK pharma major AstraZeneca’s Calquence plus venetoclax for lymphocytic leukemia. Also of note, US major Eli Lilly entered a licensing deal with Australia’s CSL Limited for the commercialize clazakizumab, an anti-interleukin-6 (IL-6) monoclonal antibody (MAb) for the prevention of cardiovascular events in patients with end-stage kidney disease (ESKD). 22 February 2026
Pharmaceutical
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. 20 February 2026
Pharmaceutical
UK pharma major AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax has been approved in the USA as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 20 February 2026
Pharmaceutical
Swiss pharma giant Novartis today announced that Pluvicto (plutetium-177 vipivotide tetraxetan) has received MHRA approval for a new indication for adult patients with prostate specific membrane antigen (PSMA)–positive metastatic castration resistant prostate cancer (mCRPC) who have progressed on or after androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane based chemotherapy. 19 February 2026
Pharmaceutical
The Russian government has begun a procedure for the creation of the list of vital and essential drugs for 2026. It is expected, the list will include up to 800 drugs used for free hospital care and subsidized patient care, while pharmacies will prohibited from selling them at prices higher than the "state" price, reports The Pharma Letter’s local correspondent. 19 February 2026
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Ziihera (zanidatamab) for use in adults to treat biliary tract cancer (cancer of the structures that store and transport bile) whose cancer has high levels of a protein called HER2 and has progressed after previous treatment. 19 February 2026
Biotechnology
Swiss contract development and manufacturing organization (CDMO) Lonza (SWX: LONN) has bolstered its advanced synthesis offering to increase phase-appropriate support for the discovery and development of antibody-drug conjugates (ADCs) and other bioconjugates. 19 February 2026
Pharmaceutical
SpringWorks Therapeutics, a subsidiary of German drugmaker Merck KGaA, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Ogsiveo (nirogacestat) for the treatment of adults with progressing desmoid tumors who require systemic treatment. 19 February 2026
Biotechnology
Oxford, UK-based Alethio Therapeutics, a biopharmaceutical company developing novel treatments for myeloproliferative neoplasms (MPN), today announced the unveiling of ATX 011, a first in class, mutation agnostic antibody with potential to disrupt the $2 billion essential thrombocythemia (ET) market. 16 April 2026
Biotechnology
US biotech Terremoto Biosciences, a firm developing highly-targeted small molecule medicines, has announced the closing of a $108 million Series C financing round. 16 April 2026
Biotechnology
UK-based STORM Therapeutics, a biotech targeting RNA modifications to reprogram cells and develop novel cancer therapies, has announced a successful $56 million Series C financing. 16 April 2026
Pharmaceutical
US-based Sonire Therapeutics has secured $18 million in Series A financing to advance clinical development of its non-invasive cancer therapy, with a focus on pancreatic cancer. The round was led by Santé Ventures, with participation from Fast Track Initiative, Nomura SPARX Investment and SBI Investment. 16 April 2026
Pharmaceutical
In what looks to be the largest follow-on stock offering in biopharma history, US oncology company Revolution Medicines priced 10.56 million shares to raise $1.5 billion and $500 million in convertible senior notes due 2033. 16 April 2026
Biotechnology
Privately-held Swiss drug firm Ewopharma has reported that sugemalimab, licensed from Chinese partner CStone Pharmaceuticals, has received I, A recommendation in the European Society for Medical Oncology (ESMO) Early and Locally Advanced Non-Small-Cell Lung Cancer Living Guideline. 16 April 2026
Pharmaceutical
Johnson & Johnson has announced its financial results for the first quarter of 2026. 15 April 2026
Biotechnology
USA-based Galera Therapeutics and Obsidian Therapeutics, a privately-held clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor infiltrating lymphocyte (TIL) cell therapies, announced that they have entered into a definitive merger agreement to combine in an all-stock transaction. 15 April 2026
Biotechnology
San Diego, USA-based biotech Neomorph has announced the closing of a $100 million Series B financing. The round was led by Deerfield Management with participation from new investors Regeneron Ventures, Longwood Fund, Alexandria Venture Investments, Binney Street Capital of Dana-Farber Cancer Institute, and others. 15 April 2026
Biotechnology
Texan pre-clinical stage biotech CrossBridge Bio, a developer of dual-payload antibody-drug conjugates (ADCs), has announced a definitive agreement to be acquired by US pharma major Eli Lilly. 14 April 2026
Biotechnology
Eli Lilly has announced positive top-line results from the Phase III BRUIN CLL-322 trial. 14 April 2026
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $75 million Series C financing round. 14 April 2026
Biotechnology
Anglo-Irish biopharma SynOx Therapeutics announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to emactuzumab for the treatment of tenosynovial giant cell tumors (TGCT) patients that are not amenable to or who would not benefit from surgery. 14 April 2026
Biotechnology
Dutch biotech Laigo Bio, which is pioneering novel and highly differentiated therapies using its proprietary SureTACs precision membrane protein degradation platform, has appointed Dr Richard Sainson as its new chief scientific officer (CSO). 14 April 2026
Biotechnology
US biotech major Regeneron Pharmaceuticals and Australian radiopharmaceuticals specialist Telix Pharmaceuticals have announced a collaboration, sending the latter company’s shares up by 8% in Monday’s trading. 13 April 2026
Pharmaceutical
Revolution Medicines today announced positive top-line results from its global, randomized, controlled Phase III RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated. 13 April 2026
Generics
The Russian Ministry of Health has begun more active cancelling of tenders for drug procurements, waiting for the launch of cheaper generics, as the federal budget experiences a shortage of funds for procurements of expensive original drugs. 13 April 2026
Biotechnology
UK pharma major GSK has announced positive findings from its global Phase I BEHOLD-1 clinical trial for mocertatug rezetecan (or Mo-Rez for short), a novel antibody-drug conjugate (ADC) targeting the B7-H4 antigen. 13 April 2026
Biotechnology
Chinese clinical-stage biotech OriCell Therapeutics announced the cumulative closing of a pre-initial public offering (IPO) financing round in excess of $110 million. 13 April 2026
Biotechnology
US biotech Replimune has suffered a fresh blow after the US Food and Drug Administration rejected its lead cancer therapy RP1 (vusolimogene oderparepvec), sending shares sharply lower and casting doubt over the program’s future. 13 April 2026
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