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
Privately-held Helsinn on Thursday said it has signed a deal with pharma group Mundipharma, allowing it to market Helsinn’s cancer drug candidate, anamorelin, in Switzerland and Liechtenstein. 3 September 2015
The European Commission has approved Revolade (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pre-treated and are unsuitable for hematopoietic stem cell transplant. 2 September 2015
The US Food and Drug Administration has approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). 2 September 2015
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), from US pharma majors Bristol-Myers Squibb and AbbVie. 2 September 2015
After a first early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined whether afatinib offers an added benefit over the appropriate comparator therapy. 1 September 2015
From today (September 1), patients with melanoma have access to breakthrough medicine Keytruda (pembrolizumab), from US pharma giant Merck & Co, on Australia’s Pharmaceutical Benefits Scheme (PBS), Minister of Health Sussan Ley announced . 1 September 2015
Swiss drug major Novartis has received approval from the European Commission for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) to treat adult patients with unresectable or metastatic melanoma with BRAF V600 mutation. 1 September 2015
Belgian biotech company Celyad has entered into a new collaboration and distribution agreement with its Hong-Kong based partner, Medisun International. 31 August 2015
Pharma major Eli Lilly’s experimental lung cancer drug candidate could be priced between $563 and $1309 per cycle following regulatory approval, according to an analysis published in JAMA Oncology. 28 August 2015
US drugmaker Exelixis says that Swissmedic, the Swiss licensing and supervisory body, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma. 27 August 2015
The New England Journal of Medicine has published the full dataset from Danish biotech company Genmab on its Phase I/II study with daratumumab monotherapy in relapsed or refractory multiple myeloma. 27 August 2015
The US District Court for the Southern District of Indiana has ruled in pharma major Eli Lilly’s favor regarding infringement of the vitamin regimen patent for its lung cancer drug Alimta (pemetrexed for injection). 26 August 2015
The US Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. 26 August 2015
The US Food and Drug Administration has granted Breakthrough Therapy designation to cabozantinib, US pharma company Exelixis’ lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. 25 August 2015
Japan’s largest drugmaker Takeda Pharmaceutical suffered a major setback, when US District of Delaware Judge Gregory Sleet ruled against the company on the validity of a patent on its best-selling drug Velcade (bortezomib), according to a report by Bloomberg. 25 August 2015
German biotechnology company MorphoSys has partnered with privately-held Immatics Biotechnologies to develop antibody-based treatments for cancer. 25 August 2015
USA-based Medivation and US biotech firm BioMarin Pharmaceutical have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib. 24 August 2015
Esperance Pharmaceuticals has entered into a strategic alliance agreement with MD Anderson Cancer Center to accelerate the clinical development of its lead anti-cancer candidate EP-100. 24 August 2015
Anglo-Swedish drug major AstraZeneca on Monday said it has partnered with Peregrine Pharmaceuticals for early stage trials for a drug to treat in multiple solid tumors. 24 August 2015