In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Bayer has entered into a collaboration with MOMA Therapeutics to develop a small molecule oncology program using the latter’s proprietary KNOMATIC platform. 9 October 2024
Genor Biopharma has announced plans for a significant merger with Edding Group, marking one of the first reverse takeovers involving a Hong Kong-listed biopharma company. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
Germany’s Eckert & Ziegler, a specialist in radioisotopes for medical, scientific and industrial applications, has announced a global clinical supply agreement with GlyTherix, an Australian targeted radiotherapy firm specializing in developing antibody radiopharmaceuticals for solid tumors. 8 October 2024
US clinical-stage biotech OnKure Therapeutics has announced the completion of its previously announced merger with Reneo Pharmaceuticals. 8 October 2024
Daejeon-based Orum Therapeutics, a specialist in degrader-antibody conjugates (DAC), has filed for an initial public offering (IPO) on South Korea's Kosdaq market. 7 October 2024
Mosaic Therapeutics, a UK-based oncology therapeutics company dedicated to resolving cancer’s complexity to power new combination therapies for patients, has announced the appointment of Barry Davies as chief scientific officer. 7 October 2024
The US Food and Drug Administration yesterday approved Anglo-Swedish pharma major AstraZeneca’s Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). 14 July 2015
OncoGenex Pharmaceuticals says that its Phase III ENSPIRIT trial evaluating custirsen in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) is continuing as planned per the recommendation of an Independent Data Monitoring Committee (IDMC). 13 July 2015
The European Medicines Agency announced today that it has started a review of human papillomavirus (HPV) vaccines to further clarify aspects of their safety profile. 13 July 2015
The European Commission has approved Janssen-Cilag’s Imbruvica (ibrutinib) capsules as a treatment option for adult patients with Waldenström's macroglobulinemia (WM). 10 July 2015
An advisory panel to the US Food and Drug Administration has informally supported approval of necitumumab, an experimental lung cancer drug from Eli Lilly while recommending mitigating the drug’s risks. 10 July 2015
German biopharma company apceth has announced a partnership with the Center for Molecular Medicine Cologne (CMMC), University of Cologne, to combine technologies and expertise on the development of immunotherapies for solid tumors and haematological malignancies. 10 July 2015
Privately-held US biotech firm Globavir Biosciences has granted an exclusive license to clinical-stage biotech Sorrento Therapeutics for its novel oncology compound, BC001. 9 July 2015
The global castration-resistant prostate cancer (CRPC) therapeutics market is to generate revenue of $9.5 billion by 2020, according to a report by Allied Market Research. 9 July 2015
US firm Sorrento Therapeutics has set up a joint venture with NantBioScience, a majority-owned subsidiary of privately-held NantWorks, to focus on the development of 'first-in-class' small molecules against targets that have eluded the pharmaceutical industry to date and which may address important drivers of cancer growth including cancer stem cells. 9 July 2015
The US Food and Drug Administration has posted briefing documents on its website saying that Eli Lilly’s necitumumab extended overall survival but also raised the risk of potentially fatal thromboembolic events. 8 July 2015
French biotech firm Genticel says that the independent Data Safety Monitoring Board (DSMB) recommends the continuation, per protocol, of its Phase II clinical trial of GTL001 (known in Europe as ProCervix) 8 July 2015
US biotech firm Incyte has entered into a multi-year research support and collaboration agreement with Vanderbilt-Ingram Cancer Center (VICC) at Vanderbilt University Medical Center (VUMC). 8 July 2015
Singapore-based biotech company ASLAN Pharmaceuticals and ACT Genomics have announced a collaboration to perform detailed studies of the genomic background to extreme therapeutic responses in which clinical trial patients show better than expected treatment response rates in certain instances. 8 July 2015
Swiss drug major Novartis has submitted a variation to the Marketing Authorization with the European Medicines Agency for the use of Arzerra (ofatumumab) as a maintenance therapy for patients with relapsed chronic lymphocytic leukemia. 7 July 2015
Innate Pharma says that the co-development and commercialization agreement with AstraZeneca on Innate’s proprietary anti-NKG2A antibody, IPH2201, has received Hart-Scott-Rodino (HSR) antitrust clearance in the USA. 7 July 2015
German family-owned drug major Boehringer Ingelheim has published results showing significant overall survival benefit of Giotrif (afatinib) compared to Tarceva (erlotinib) in patients with previously-treated advanced squamous cell carcinoma of the lung. 6 July 2015
French firm Elsalys Biotech says it has acquired the development and marketing rights of the anti-CD160 antibody from fellow France-based privately-held Mablife. 3 July 2015
US clinical-stage company Provectus Biopharmaceuticals says it has signed a Letter of Intent with a China-based unit of German family-owned pharma major Boehringer Ingelheim. 2 July 2015
The US Food and Drug Administration (FDA) has postponed the action date for the regulatory filing of cobimetinib from Roche and Exelixis by three months. 2 July 2015
USA-based Panther Biotechnology has entered into an agreement to acquire Alchemia Oncology Pty Limited, a wholly owned subsidiary of Australian biotech firm Alchemia Limited. 2 July 2015