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Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
Biotechnology
The PROpel Phase III trial showed that AstraZeneca and Merck & Co’s Lynparza (olaparib) alongside Zytiga (abiraterone) significantly improved radiographic progression-free survival (rPFS) versus abiraterone alone as a first-line treatment in metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations. 21 June 2022
Biotechnology
The European Medicines Agency (EMA) has validated the type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic stem cell transplant (HSCT). 21 June 2022
Biotechnology
The National Medical Products Administration (NMPA) of China has recently approved Chinese biotech firm CStone Pharmaceuticals’ sugemalimab (trade name Cejemly) to treat patients with stage III non-small cell lung cancer (NSCLC), whose disease has not progressed following concurrent or sequential or platinum-based chemoradiotherapy. 21 June 2022
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Scemblix (asciminib) for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously-treated with two or more tyrosine kinase inhibitors (TKIs), and without a known T315I mutation. 20 June 2022
Pharmaceutical
Japanese drugmaker Taiho Pharmaceutical today announced it has obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for the oral heat shock protein (HSP) 90 inhibitor Jeselhy (pimitespib; development code: TAS-116), 40mg tablets for the indication of gastrointestinal stromal tumor (GIST) that has progressed after chemotherapy. 20 June 2022
Biotechnology
In a filing with the US Securities and Exchange Commission, Clovis Oncology has revealed it will voluntarily withdraw part of the label for its PARP blocker Rubraca (rucaparib). 20 June 2022
Biotechnology
Pharma can boast a major role in improving the quality of life of patients with diseases such as breast cancer and rheumatoid arthritis in Latin America, writes The Pharma Letter’s local correspondent. 17 June 2022
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended abemaciclib in combination with endocrine therapy, within its marketing authorization, as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumor involvement in: 17 June 2022
Biotechnology
UK drugmaker GSK has welcomed the decision from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to grant Innovation Passport designation to two of its oncology medicines. 16 June 2022
Biotechnology
US biotech Checkpoint Therapeutics today announced positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. 16 June 2022
Pharmaceutical
Aqemia, a next-gen French pharmatech company leveraging artificial intelligence and quantum physics announced, today that it has entered a new research collaboration with pharma major Sanofi. 16 June 2022
Biotechnology
India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug. 16 June 2022
Biotechnology
London-listed Finnish biotech firm Faron Pharmaceuticals today announces 12-month top-line overall survival results from its Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab monotherapy (trade named Clevegen) in 10 different hard-to-treat metastatic or inoperable solid tumor cohorts. 15 June 2022
Biotechnology
Lonza, a large Swiss contract development and manufacturing organization (CDMO), has agreed with French pharma group Pierre Fabre to produce its antibody candidate W0180. 15 June 2022
Biotechnology
Biotech BeiGene has announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to January 20, 2023 for the supplementary new drug application (sNDA) submitted for Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 June 2022
Biosimilars
Recently-launched Organon, a women’s health company with expertise in biosimilar commercialization, made an announcement on Monday. 14 June 2022
Biotechnology
Colorado-based data-driven proteomics technology company SomaLogic has signed a licensing agreement with precision oncology firm OncoHost. 13 June 2022
Biotechnology
Swiss antibody-drug conjugate specialist ADC Therapeutics announced today it has appointed industry veteran David Gilman to the new role of chief business and strategy officer, reporting to chief executive Ameet Mallik effective July 1. 13 June 2022
Biotechnology
Over the past few years, CAR T-cell therapies have also become transformative treatment options for patients with many forms of blood cancers, such as lymphoma and multiple myeloma. The treatment method involves taking a patient's T cells, "re-engineering" them to kill cancer cells, and infusing them back into the patient. 13 June 2022
Biotechnology
Because of the critical roles of cytokines in cancer, there has been considerable interest in harnessing them for diagnosis and treatment over the past decades. Sherlyn Zhou, Product Manager for Sino Biological in the USA, tells The Pharma Letter about the role that they play in cancer and the opportunities and challenges in the field. 13 June 2022
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