Anti-leukemia drug dasatinib, made by US pharma major Bristol-Myers Squibb and sold in India under the brand name Sprycel, could be in the dock once again, with the Health Ministry requesting anew the grant of a compulsory license for the cancer drug, reports The Pharma Letter's India correspondent. 19 August 2014
The UK’s clinical standards body, NICE, has agreed to re-review Ferring Pharmaceuticals’ Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer. 18 August 2014
Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European Medicines Agency for the use of lenvatinib mesylate in the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC). 18 August 2014
Norwegian photodynamic technologies specialist Photocure has agreed to terminate the global licensing agreement with USA-based Salix Pharmaceuticals for Lumacan (hexamiolevulinate), which is in early stage development to increase the detection rate of colorectal cancer through photodynamic diagnosis. 18 August 2014
USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp (darbepoetin alfa; 500mcg) prefilled syringes from non-US distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. 15 August 2014
Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. 15 August 2014
The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone) from US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen for prostate cancer in people who received hormone therapy but whose disease has spread, who have few symptoms and when chemotherapy would not yet have been given. 15 August 2014
USA-based Amgen, the world’s leading independent biotech firm, and its subsidiary Onyx Pharmaceuticals, have said that their Phase III trial of Kyprolis (carfilzomib) in the treatment of advanced refractory multiple myeloma did not meet its primary endpoint. 14 August 2014
Israeli biotech firm RedHill Biopharma and privately-held German biotech company RESprotect GmbH have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds. 14 August 2014
US biotech firm TNI BioTech has signed a supplemental agreement with China’s Hubei Qianjiang Pharmaceutical on behalf of Cytocom, TNI BioTech's wholly owned subsidiary. 13 August 2014
“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest HER2 positive cancer drug, in the UK comes as no big surprise, as it is the seventh breast cancer drug to be rejected since 2011,” says Jamie Mallinson, GlobalData’s analyst covering oncology and hematology. 13 August 2014
The US subsidiary of French pharma major Sanofi says it has launched an authorized generic version of Eloxatin (oxaliplatin injection) through its generics division, Winthrop US. 12 August 2014
US biotech firm Oncothyreon says that it has acquired Alpine Biosciences, of Seattle, Washington, a privately held biotechnology company. 12 August 2014
Coming from her position as president of Sanofi’s North American pharma division, Anne Whitaker has been named chief executive of Synta Pharmaceuticals. 12 August 2014
The treatment landscape of gastrointestinal stromal tumors (GIST) will not change dramatically through 2023 as no new therapies are expected to launch for this indication. 11 August 2014
Japanese drug major Astellas Pharma is joining forces with Cancer Research UK and its commercial arm, Cancer Research Technology (CRT), to find new drug targets in the fight against cancer, with an initial focus on pancreatic cancer. 9 August 2014
US biotech firm CTI BioPharma (formerly called Cell Therapeutics) says that its pacritinib has been granted Fast Track designation by the US Food and Drug Administration. 8 August 2014
Chinese biotechnology company 3SBio has entered into an exclusive license with Korean DiNonA for the development, manufacturing and marketing of Leukotuximab for acute leukemia. 8 August 2014
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) said this morning that it is very disappointed that Swiss drug pharma major Roche, the manufacturer of Kadcyla (trastuzumab emtansine), has decided not to offer its new treatment at a price that would enable it to be available for routine use in the National Health Service. 8 August 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again on its review of existing guidance on the use of Swiss drug major Roche’s Tarceva (erlotinib) and Anglo-Swedish pharma firm AstraZeneca’s Iressa (gefitinib) for treating non-small-cell lung cancer (NSCLC) that has progressed after prior chemotherapy. 7 August 2014
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