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Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
French drugmaker Ipsen today presented sales for the first quarter of 2025. The company did not release any earnings figures. 16 April 2025
Pharmaceutical
Shares in Johnson & Johnson were 1% lower in the early stages of Tuesday’s trading after the US health conglomerate presented its first-quarter 2025 financial results. 15 April 2025
Biotechnology
Spanish biotech Reveal Genomics has formed a strategic partnership with oncology firm Ona Therapeutics to support the clinical development of ONA-255, a novel antibody-drug conjugate designed to target therapy-resistant tumor cells in advanced solid cancers. 15 April 2025
Biosimilars
Shares of California-based Coherus BioSciences (Nasdaq: CHRS) rose more than 5% to $0.88 in pre-market activity today as it completed a transformative transaction. 14 April 2025
Biotechnology
The European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT), Swiss pharma giant Roche announced this morning. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
Johnson & Johnson has announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients given Darzalex (daratumumab)-subcutaneous (SC) therapy alongside bortezomib, lenalidomide and dexamethasone (VRd). 11 April 2025
Biotechnology
US biotech giant Amgen today announced a significant breakthrough with its global Phase III DeLLphi-304 clinical trial evaluating Imdelltra (tarlatamab-dlle). 11 April 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Biotechnology
US biotech Atossa Therapeutics has entered into a research collaboration with China-backed Nona Biosciences, aiming to identify next-generation antibody therapies for breast cancer using Nona’s proprietary platform technology. 10 April 2025
Pharmaceutical
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025
Biotechnology
Solu Therapeutics, a US biotech developing therapies to eliminate disease-driving cells in cancer, immunology and other therapeutic areas, has announced the successful completion of a $41 million Series A financing. 10 April 2025
Biotechnology
Privately-held Finland-based Valo Therapeutics (ValoTx), an immunotherapy company developing novel, adaptable treatments for cancer, today announced the appointment of Marcella Origgi as its chief executive (CEO) of its Helsinki headquarters and Naples, Italy, subsidiary. 9 April 2025
Biotechnology
Myricx Bio, a UK biotech focusing on the discovery and development of a novel class of payloads for antibody-drug conjugates (ADCs), is expanding its team. 8 April 2025
Biotechnology
Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. 8 April 2025
Biotechnology
Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer. 8 April 2025
Biotechnology
China-based biotech DualityBio has named Hua Mu as its global chief medical officer, as the company prepares to ramp up its international clinical development efforts and advance toward key capital market milestones. 7 April 2025
Biotechnology
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
Biosimilars
South Korea-based Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars. 20 February 2025
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
Barcelona, Spain-based biotech Ona Therapeutics today announced key leadership appointments to support its rapid growth and pipeline advancement. 19 February 2025
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biosimilars
Germany’s Formycon has decided today to prematurely terminate the Phase III trial (Lotus) for its biosimilar candidate FYB206. 17 February 2025
Biotechnology
US drugmaker Corbus Pharmaceuticals Holdings closed Friday’s trading 10% lower. 17 February 2025
Pharmaceutical
Pharmsynthez, one of Russia’s largest drugmakers, will build a large-scale plant for the production of anticancer drugs in the city of Moscow by 2026. 17 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Romvimza (vimseltinib), from Deciphera Pharmaceuticals, a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. 17 February 2025
Biotechnology
Shares of US clinical-stage biotech Allogene Therapeutics rocketed 41% to $1.99 on Friday, as it announced the publication of data from its Phase I ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the Journal of Clinical Oncology. 15 February 2025
Biotechnology
Bristol Myers Squibb today announced the Phase III RELATIVITY-098 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). 14 February 2025
Pharmaceutical
US pharma giant Pfizer has announced positive results from the Phase III TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). 13 February 2025
Biotechnology
South Korea's DAAN Biotherapeutics has entered an exclusive deal with LigaChem Biosciences to develop a novel tumor-targeting antibody. 13 February 2025
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