The US Food and Drug Administration has approved US biotech Incyte’s Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 19 June 2025
Cambridge, USA-based Immuneering Corporation late yesterday announced positive data from its ongoing Phase IIa clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients. 18 June 2025
US pharma firm Lisata Therapeutics has teamed up with tech-bio company GATC Health in a strategic alliance aimed at using artificial intelligence to streamline drug development and improve success rates. 18 June 2025
Japanese companies NEC Corporation and Chugai Pharmaceutical have entered a collaboration to conduct an experiment using AI to predict drug combinations that can possibly enhance the effectiveness of certain cancer treatments. 18 June 2025
Pharma majors AbbVie and Roche were both trading lower early Tuesday after top-line results were announced from the global Phase III VERONA trial. 17 June 2025
Shares of USA-based NextCure slumped 26% to $0.50 on Monday, after the company announced a strategic partnership with China-based Simcere Zaiming, subsidiary of Simcere Pharmaceutical Group Ltd to develop a therapy for the treatment of solid tumors. 17 June 2025
Israel’s Teva Pharmaceutical Industries and Shanghai Fosun Pharmaceutical have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. 17 June 2025
Scientists at The Institute of Cancer Research, London, claim to have discovered what may cause some treatments to stop working in people living with bowel cancer. 16 June 2025
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Sino-American oncology company BeOne Medicines is presenting new clinical data from cornerstone hematology assets at the European Hematology Association (EHA) Congress. 12 June 2025
Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced new data from the pivotal AUGMENT-101 trial of Revuforj (revumenib), the company’s first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML). 12 June 2025
US antivirals specialist Gilead Sciences’ Kite, unit today presented the latest results that demonstrate a 79% overall response rate (ORR) and 74% overall survival (OS) at six months follow-up, for Yescarta (axicabtagene ciloleucel) as second-line treatment for relapsed/refractory (R/R) large B-cell lymphoma (LBCL), from the largest real-world study in this patient population. 12 June 2025
The US Food and Drug Administration (FDA) yesterday approved Nuvation Bio’s Ibtrozi (taletrectinib), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 12 June 2025
French biotech Enterome has secured $19 million in private funding to accelerate development of its OncoMimics immunotherapy platform, as it continues to show encouraging early signs of clinical activity across both solid and blood cancers. 12 June 2025
Switzerland-based Philochem and Bristol Myers Squibb radiopharma subsidiary RayzeBio have announced a definitive agreement under which Philochem will license the exclusive worldwide rights to develop, manufacture, and commercialise OncoACP3, a clinical stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio. 11 June 2025
Florida, USA-based Summit Therapeutics saw its share rise 6.2% to $23.50 pre-market on the news of a clinical trial collaboration with Pfizer to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of the US pharma giant’s antibody drug conjugates (ADCs) across multiple solid tumor settings. 25 February 2025
The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. 25 February 2025
In this episode, we’ll take a look at the role of Japanese pharmaceutical groups in the UK, with Jackie Davis, general manager at Astellas Pharma. 24 February 2025
Earlier this month, the Norwegian government launched the cancer strategy Joint Efforts Against Cancer, with five national goals and 17 new ten-year goals, which set ambitions for the cancer area up to 2035. 24 February 2025
India's pharmaceutical market is witnessing a surge in new drug launches, particularly in the oncology segment, fueled by a rising cancer burden and demand for cutting-edge treatments. Leading the charge are big domestic pharma spearheading the launch of breakthrough oncology drugs. 23 February 2025
Privately-held Austria firm pharmaand GmbH (pharma&) today announced that the National Institute of Health and Care Excellence (NICE) has issued a positive recommendation for its Rubraca (rucaparib). 21 February 2025
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending the use Breyanzi (lisocabtagene maraleucel) for National Health Service (NHS) in England. 21 February 2025
South Korea-based Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars. 20 February 2025
Japanese drugmaker Chugai Pharmaceutical today announced gaining regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq intravenous infusion (atezolizumab) for an additional indication of unresectable alveolar soft part sarcoma. 20 February 2025
CSPC Megalith Biopharmaceutical has entered into a license agreement with Radiance Biopharma for the development and commercialization of SYS6005, a recombinant anti-human receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC). 20 February 2025
February 20, 2025
New Jersey, USA-based Imunon announced new translational data from the Phase II OVATION 2 Study of IMNN-001, an interleukin-12 (IL-12) DNA-based immunotherapy in development for the treatment of newly diagnosed advanced ovarian cancer. The firm’s shares edged up 3.3% to $0.90 on the news, although they fell back by close of trading 20 February 2025
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Dutch clinical-stage drug developer Merus for its petosemtamab. 19 February 2025
Barcelona, Spain-based biotech Ona Therapeutics today announced key leadership appointments to support its rapid growth and pipeline advancement. 19 February 2025
Israel-based clinical-stage company Purple Biotech today announced it is advancing into a Phase II study with NT219 in patients with recurrent/metastatic squamous cell carcinoma. of the head and neck (R/M SCCHN), with the news pushing its shares up as much as 10% to 6.50 shekels. 18 February 2025
Epitopea, an Anglo-Canadian company developing accessible, off-the-shelf RNA-based immunotherapies for cancer, has announced a license and research collaboration deal with US pharma giant Merck & Co to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. 18 February 2025
US pharma giant Merck & Co today announced that the European Commission (EC) has conditionally approved two indications for Welireg (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. 18 February 2025
California-based Arcus Biosciences, a biopharma developing differentiated molecules and combination therapies for people with cancer, has presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in metastatic kidney cancer. 18 February 2025
AstraZeneca, Moderna and Novo Nordisk have breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. 17 February 2025