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
USA-based biotech firm Amgen and its subsidiary Onyx Pharmaceuticals have announced the interim results of a Phase III head-to-head trial evaluating Kyprolis (carfilzomib) and dexamethasone versus Velcade (bortezomib) and dexamethasone. 2 March 2015
Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing authorization application to the European Medicines Agency for TAS-102 (trifluridine and tipiracil hydrochloride) for refractory metastatic colorectal cancer. 2 March 2015
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the use of Swiss pharma giant Roche Avastin (bevacizumab) for cervical cancer. 28 February 2015
Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 27 February 2015
The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib) from US biotech company Amgen and its subsidiary Onyx Pharmaceuticals for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. 27 February 2015
The UK’s National Institute for Health and Care Excellence has recommended Inlyta (axitinib), marketed by Pfizer as a second-line treatment for kidney cancer. 25 February 2015
Generic drugmakers Taiwan-based TWi Pharmaceuticals and Israeli company Teva Pharmaceutical Industries have reached an agreement that will transfer the US sales and distribution rights of TWi's generic versions of Megace ES (megestrol acetate oral suspension, 625 mg/ 5 ml) and Lidoderm (lidocaine patch, 5%) from Teva to TWi. 24 February 2015
The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat, previously known as LBH589) capsules in combination with bortezomib (Takeda’s Velcade) and dexamethasone for the treatment of patients with multiple myeloma. 24 February 2015
US pharma major Bristol-Myers Squibb has signed a definitive agreement to acquire all of the outstanding capital stock of Flexus, a privately held US biotechnology company focused on the discovery and development of novel anti-cancer therapeutics, established in 2013. 23 February 2015
Biocad, one of Russia’s largest biotech companies, has officially announced its plans to invest up to $120 million in the expansion of production during the next several years. 23 February 2015
USA-based Foundation Medicine and privately-held US biopharma company H3 Biomedicine have announced a multi-year collaboration for the discovery and development of precision medicines in oncology. 23 February 2015
Swiss pharma giant Roche will probably lose one of its major contracts in Russia for the next several years, which involves the supply of bevacizumab, the active ingredient of its blockbuster cancer drug Avastin, for state needs. 23 February 2015
US biotech firm Celgene’s European subsidiary has received approval from the European Commission for Revlimid (lenalidomide) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. 20 February 2015
Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted priority review for its New Drug Application for cobimetinib in combination with Zelboraf (vemurafenib) in BRAF V600 mutation-positive advanced melanoma. 20 February 2015
Merck Serono, the biopharmaceutical business of Germany’s Merck KGaA, announced today that the first liquid biopsy RAS biomarker testing center has opened in Vall d’Hebron’s Institute of Oncology, Barcelona, Spain, and will initially test patients as part of its research program. 20 February 2015
Danish biotech company Genmab has entered into a co-development and commercialization agreement with Netherlands-based BioNovion to evaluate a number of its DuoBody product candidates targeting immune checkpoints. 19 February 2015
UK-based cellular immunotherapy company Cell Medica has announced the start of commercial cell therapy manufacturing at its facility at the Max-Delbrück-Center of Molecular Medicine in Berlin-Buch, Germany. 19 February 2015
Australian stem cell company Cynata Therapeutics is set to scale up manufacturing of its mesenchymal stem cells (MSC) for therapeutic use. 19 February 2015
US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly-diagnosed with multiple myeloma (NDMM). 18 February 2015