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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
Biotechnology
The US Food and Drug Administration (FDA) has approved Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy, Boston, said USA-based. Verastem Oncology, whose shares rose 3.7% to $6.94 on the news. 9 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Biotechnology
Massachusetts-based PAQ Therapeutics, a biotech developing KRAS degraders for cancers lacking effective treatment options, has completed a $39 million Series B funding round. 8 May 2025
Biotechnology
Privately-held Italian firm Sibylla Biotech today announced the appointment of Dieter Weinand as chairman of its board of directors. 8 May 2025
Pharmaceutical
US pharma major Bristol Myers Squibb is planning a massive $40 billion investment in the country over the next five years. 7 May 2025
Biotechnology
Sino American biotech BeiGene, a global oncology company that will change its name to BeOne Medicines, today announced financial results and corporate updates from the first quarter 2025. 7 May 2025
Biotechnology
UK-based pharma major AstraZeneca and its Japanese partner Daiichi Sankyo are moving to expand the reach of their blockbuster antibody-drug conjugate Enhertu (trastuzumab deruxtecan) into early-stage breast cancer, building on momentum from a recent Phase III trial in the metastatic setting. 7 May 2025
Biotechnology
California-based Atara Biotherapeutics revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold on its active Investigational New Drug (IND) applications for the Ebvallo (tabelecleucel) program, sending the firm’s share up 5.8% to $7.67. 7 May 2025
Pharmaceutical
US pharma major Bristol Myers Squibb is set to lay off another 516 employees at its New Jersey, USA site, continuing a series of workforce reductions that have marked its sweeping restructuring campaign. 6 May 2025
Pharmaceutical
UK pharma major AstraZeneca today revealed that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. 6 May 2025
Biotechnology
Portugal-based Hovione and Firstgene Life Sciences, a portfolio company of the Swiss incubator Xlife Sciences, today announced a strategic collaboration to advance Hovione’s proprietary virus-like particle drug delivery platform for the targeted treatment of hepatocellular carcinoma (HCC), a therapeutic indication developed by Firstgene. 6 May 2025
Biotechnology
Priothera today announced the appointment of Jens Hasskarl, as its chief medical officer (CMO). 6 May 2025
Biotechnology
German biotech BioNTech saw its shares dip 3.4% to $101.44 today, after it reported financial results for the three months ended March 31, 2025 and provided an update on its corporate progress. 5 May 2025
Biotechnology
T-cell immunotherapies (TCI) are redefining cancer care, with chimeric antigen receptor T-cell (CAR-T) therapies witnessing significant momentum. 5 May 2025
Biotechnology
Sweden’s Mendus, a clinical-stage drug developer, has announced the appointment of Dr Tariq Mughal as chief medical officer, effective today, May 5. 5 May 2025
Biotechnology
Shares in Kronos Bio, a US biotech that has been developing small molecule therapeutics to address cancers and other diseases driven by deregulated transcription, closed 20% lower Thursday. 2 May 2025
Biotechnology
US biotech major Amgen late Thursday announced financial results for the first quarter of 2025, revealing that total revenues increased 9% to $8.15 billion, 2% above consensus estimates of $8.025 billion. 2 May 2025
Biotechnology
US biotech Akari Therapeutics, which is developing novel payload antibody drug conjugates (ADCs), today announced the appointment of Mark Kubik as head of business development - oncology. 1 May 2025
Pharmaceutical
Shares in US drug major Eli Lilly were a hefty 8% down early Thursday after the Indianapolis firm announced its first quarter financial results and latest guidance for 2025. 1 May 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s Opdivo (nivolumab) in a new formulation associated with a different route of administration (subcutaneous use), an alternative pharmaceutical form (solution for injection) and a new strength (600mg/vial). 1 May 2025
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