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
Japanese pharma major Astellas Pharma has received European Commission approval for a variation to amend the Marketing Authorization for Xtandi (enzalutamide). 3 December 2014
German pharma major Bayer gave a spirited presentation of its pipeline candidates in both pharma and crop sciences at a “Perspective on Innovation 2014” meeting with journalists yesterday at its Leverkusen headquarters. 3 December 2014
Puma Biotechnology will delay the filing of its New Drug Application (NDA) for the approval of PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Its shares dropped 24% on the news yesterday. 3 December 2014
The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib) from Anglo-Swedish drug major AstraZeneca. 2 December 2014
US biotech firm Exelixis has announced top-line results from the final analysis of COMET-2, a randomized, double-blind, controlled trial of cabozantinib, that did not reach its primary endpoint in men with metastatic castration-resistant prostate cancer (mCRPC). 2 December 2014
The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro (obinutuzumab), manufactured by Swiss drug major Roche. 2 December 2014
US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency to vary the marketing authorization for Imbruvica (ibrutinib), to include a new therapeutic indication for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1 December 2014
The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer Ingelheim’s Vargatef (nintedanib), valid for the 28 countries within the European Union. 28 November 2014
UK pharma major AstraZeneca and charity Cancer Research UK have signed a memorandum of understanding through which Cancer Research UK drug discovery investigators would be given access to state-of-the-art drug discovery facilities at the new AstraZeneca MRC UK Centre for Lead Discovery to be built in Cambridge. 28 November 2014
Takeda Pharmaceutical has decided to focus its Osaka plant (Osaka Prefecture, Japan) to become a specialty manufacturing site for prostate and breast cancer and endometriosis treatment Leuplin/Lupron (leuprorelin). 27 November 2014
The UK's Medicines and Healthcare products Regulatory Agency has published a case study outlining the successful collaboration between it and Anglo-Swedish drug major AstraZeneca on a £120 million facility in Macclesfield to manufacture important treatments for prostate and breast cancer. 27 November 2014
Cancer, with a death toll exceeding that of AIDS (acquired immune deficiency syndrome), tuberculosis and malaria collectively, accounted for 8.3 million deaths in 2013. 26 November 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance to the National Health Service NHS) recommending Swiss pharma giant Novartis’ Glivec (imatinib). 26 November 2014
US health care giant Johnson & Johnson’s subsidiary Janssen Research & Development has submitted a New Drug Application for Yondelis (trabectedin) to the US Food and Drug Administration. 25 November 2014
UK biotech firm Oxford BioTherapeutics and Berlin Chemie/Menarini Biotech/Menarini Ricerche (belonging to the family-owned Italian Menarini Group) have initiated the first-in-human clinical study of OBT357 (MEN1112), a novel enhanced antibody for the treatment of acute myeloid leukemia (AML). 25 November 2014
Biomarker driven prescribing is likely to positively influence perceptions of oncology drugs for both oncologists and payers, new research indicates. 25 November 2014
The global acute myeloid leukemia therapeutics market is predicted to increase from $632.6 million in 2013 to $878.6 million by 2020, according to business intelligence provider GBI Research. 25 November 2014