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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
China-based Kelun-Biotech Biopharmaceutical announced the placement of 5,918,000 H shares under its general mandate, representing approximately 2.54% of the enlarged share capital of the company post the placement. The shares were placed at HK$331.8 per share, raising net proceeds of around US$250 million. 6 June 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of German pharma major Bayer’s Nubeqa (darolutamide) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). 6 June 2025
Biotechnology
The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). 5 June 2025
Biotechnology
US biopharma Cullinan Therapeutics has entered into an agreement with Genrix Bio for an all-indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T-cell engager for everywhere outside Greater China. 5 June 2025
Pharmaceutical
Bayer’s USA-based subsidiary Vividion Therapeutics has taken over full development and commercialization rights for VVD-214, a clinical-stage Werner helicase (WRN) inhibitor originally discovered under a research collaboration with Roche. 5 June 2025
Biotechnology
The European Commission (EC) has approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. 4 June 2025
Pharmaceutical
The American medicines regulator has approved Bayer’s Nubeqa (darolutamide) for broader use in patients with metastatic castration-sensitive prostate cancer (mCSPC), marking a step forward for the drugmakeFood and Drug Administraton,r’s prostate cancer franchise. 4 June 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) for adults with non-small cell lung cancer (NSCLC). 3 June 2025
Pharmaceutical
Shares in MaaT Pharma, a French microbiome company in oncology, closed 25% higher Tuesday. 3 June 2025
Pharmaceutical
Detailed results from the Phase III OASIS-4 study have found that Bayer’s elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flushes) from baseline to week four and 12 compared to placebo, in women taking endocrine therapy to prevent hormone receptor (HR+) breast cancer. 2 June 2025
Pharmaceutical
Positive results from the SERENA-6 Phase III trial have shown that AstraZeneca’s camizestrant alongside a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) led to a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS). 2 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 2 June 2025
Biotechnology
The Alliance for Clinical Trials in Oncology has announced results from ATOMIC, a Phase III trial evaluating standard chemotherapy alone or combined with Roche’s Tecentriq (atezolizumab) in patients who have surgically resected stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). 2 June 2025
Biotechnology
US pharma major Bristol Myers Squibb has entered into an agreement for the global co-development and co-commercialization of German biotech BioNTech’s (Nasdaq: BNTX) investigational bispecific antibody BNT327 across numerous solid tumor types. 2 June 2025
Biotechnology
US biotech Regeneron Pharmaceuticals has announced detailed analyses from the Phase III C-POST trial, which evaluated PD-1 inhibitor Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. 2 June 2025
Pharmaceutical
Arcus Biosciences is setting the stage for a high-stakes Phase III showdown in kidney cancer, after early results showed that nearly half of patients treated with its experimental therapy had a confirmed response. 2 June 2025
Biosimilars
Swiss generic and biosimilar medicines company Sandoz today announced that Wyost (denosumab) and Jubbonti (denosumab) are available to patients in the USA starting today. 2 June 2025
Pharmaceutical
US drugmaker Protagonist Therapeutics and Japan’s Takeda Pharma announced detailed results from the Phase III, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints. 2 June 2025
Pharmaceutical
Arvinas and Pfizer today announced detailed results from the Phase III VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. 2 June 2025
Pharmaceutical
US pharma giant Pfizer on Saturday announced statistically-significant and clinically-meaningful survival results from the Phase III BREAKWATER trial evaluating Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. 2 June 2025
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