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
Swiss drug major Roche presented positive results from a Phase III study of cobimetinib plus Zelboraf (vemurafenib) in people with advanced melanoma against the use of Zelboraf alone. 29 September 2014
Swiss pharma major Novartis on Saturday presented final results on overall survival (OS) from a Phase III trial of Afinitor (everolimus), showing that this is the first treatment for advanced pancreatic neuroendocrine tumors (NET) to provide overall survival of more than 3.5 years in Phase III trial. 28 September 2014
Some 15 new medicines have been recommended for approval at the September meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 26 September 2014
French privately-held drugmaker Servier is to end its collaboration with Pharmacyclics in the development of the latter’s pan-HDAC inhibitor compounds involving abexinostat outside the USA. 26 September 2014
The non-Hodgkin lymphoma (NHL) treatment market in the Asia-Pacific (APAC) countries of India, Australia, China and Japan will expand from $1.1 billion in 2013 to $1.7 billion by 2020. 26 September 2014
Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that Swissmedic, the regulatory authority for Switzerland, has approved Abraxane as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer 25 September 2014
Medimmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca, has entered into a collaboration to establish a joint lab in Cambridge, UK, with Cancer Research Technology, the commercial arm of Cancer Research UK. 25 September 2014
Adaptimmune, a UK biotech company focused on using T-cell therapy to treat cancer and infectious disease, has completed a $104 million Series A financing round, and plans to use the proceeds to advance the company’s internal programs into the clinic in multiple cancer indications. 25 September 2014
Family-run Swiss oncology specialist Helsinn is to present Phase III data on anamorelin at the 38th European Society for Medical Oncology Congress in Madrid, Spain. 25 September 2014
Baxter International and oncology specialist Merrimack have launched a collaboration to develop and commercialize MM-398 (nanoliposomal irinotecan injection). 24 September 2014
The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending US biotech major Celgene’s Revlimid (lenalidomide) as an option for treating some people with myelodysplastic syndromes on the National Health Service. 24 September 2014
US development stage company TG Therapeutics says it has exercised its option to license the global rights to TGR-1202, the company's novel, next generation PI3K-delta inhibitor from privately-held Swiss firm Rhizen Pharmaceuticals. 23 September 2014
Leading French independent drugmaker Servier and US biotech firm CTI BioPharma have entered into an exclusive license and collaboration agreement to develop and commercialize Pixuvri (pixantrone). 23 September 2014
USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. 22 September 2014
US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase Ib/II clinical trial (S1313). 22 September 2014
France-based Nanobiotix, a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, has announced the opening of its first US office in Boston, Massachusetts. 22 September 2014
Family-owned German drug major Boehringer Ingelheim and German clinical-stage biotech company CureVac have entered into an exclusive global license and development collaboration. 21 September 2014
The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig (idelalisib) 150 mg tablets in the treatment of chronic lymphocytic leukemia and follicular lymphoma. 19 September 2014
US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the US Food and Drug Administration for use in sentinel lymph node detection in patients with cancer of the head and neck. 19 September 2014