Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
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
UK privately-held biotech firm Immunocore has signed an oncology research collaboration and licensing agreement with MedImmune, the global biologics R&D unit of Anglo-Swedish pharma major AstraZeneca. 8 January 2014
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether UK pharma giant GlaxoSmithKline’s drug Tafinlar (dabrafenib) offers an added benefit over the appropriate comparator therapy. 7 January 2014
US biotech company Celgene’s European subsidiary today announced that the European Commission has granted approval for Abraxane in combination with gemcitabine for first-line treatment of adult patients with metastatic pancreatic cancer. 7 January 2014
UK-based Horizon Discovery and AstraZeneca have entered into a research, collaboration and license agreement to explore a range of oncology-relevant genotypes with the aim of identifying and validating a number of novel drug targets. 7 January 2014
Cancer research in the US received a critical boost as the six Ludwig Centers at Johns Hopkins University, Harvard University, the Massachusetts Institute of Technology, Memorial Sloan-Kettering Cancer Center, Stanford University and the University of Chicago received a total of $540 million as part of a gift from Ludwig Cancer Research. 6 January 2014
US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) has received Fast Track designation from the US Food and Drug Administration for its investigational immunotherapy bavituximab for the treatment of second-line non-small cell lung cancer (NSCLC). 6 January 2014
USA-based RNAi-based drug discover Marina Biotech and privately-held biotech firm Mirna Therapeutics have amended their license agreement on the development and commercialization of microRNA-based therapeutics. 6 January 2014
A possible new method for treating pancreatic cancer which enables the body’s immune system to attack and kill cancer cells has been developed by researchers at the UK’s Cambridge University. 6 January 2014
Privately-held German company Probiodrug says it has transferred its experimental cyclin-dependent kinase 9 (CDK9) inhibitor program to Anglo-Swedish drug major AstraZeneca. 6 January 2014
US biotech firm Cell Therapeutics has received notification from the US Food and Drug Administration that the partial clinical hold on tosedostat (IND 075503) has been removed and all studies underway with the drug may continue. 2 January 2014
China’s Walvax Biotech has revealed it plans to acquire a controlling 64% equity stake in Shanghai’s Genor BioPharma via two transactions, paying a total of 290 million renminbi (around $49 million), according to news sources including GenePool. 31 December 2013
USA-based biotech firm Senesco Technologies has agreed to terms and executed a non-binding Letter of Intent to merge with Fabrus, a privately-held, biotechnology company focused on expanding the clinical impact of antibodies by addressing drug targets resistant to traditional antibody discovery methods. 31 December 2013
US biotech firm Cell Therapeutics’ Pixuvri (pixantrone), a treatment for an aggressive type of cancer that develops in the body’s immune system, has been given the green light in final draft guidance from UK drugs watchdog the National Institute for Health and Care Excellence (NICE). 31 December 2013
Japanese drugmaker Ono Pharmaceutical has filed an application to obtain a manufacturing and marketing approval in Japan for its nivolumab (ONO-4538/BMS-936558) for treatment of malignant melanoma. 30 December 2013
UK drugs watchdog the National Institute for Health and Care Excellence has issued new draft guidance recommending National Health Service use of privately-held Swiss drugmaker Ferring Pharmaceutical’s Firmagon (degarelix) as an option for treating prostate cancer in people with spinal metastases who are at risk of impending spinal cord compression. 27 December 2013
Cancer Research UK and Cancer Research Technology (the charity’s development and commercialization arm) have reached an agreement with Anglo-Swedish drug major AstraZeneca to take AZD2098, an experimental drug originally designed for asthma, into a clinical trial to treat kidney cancer. 27 December 2013
The renal cell cancer market is expected to peak at a value of $2.7 billion in 2019, before significantly declining to $1.6 billion within three years, according to independent analysts Datamonitor Healthcare. 24 December 2013
Merck Serono, the biopharmaceutical division of Germany’s Merck KGaA, has gained European Commission approval for the Type II variation to amend the Erbitux (cetuximab) product information, updating the indication for the drug to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC). 24 December 2013
Privately-held Swiss drugmakers Helsinn and Mundipharma have signed a new, exclusive license and distribution agreement, covering China, Hong Kong and Macao, for netupitant-palonosetron fixed dose combination (NEPA), a Helsinn product under development for the treatment of chemotherapy-induced nausea and vomiting. 23 December 2013
Leading global pharmaceutical producers may suffer significant losses in Ukraine, as the country’s government has introduced a mechanism of compulsory licensing, allowing local drugmakers to produce drugs that are patented by foreign manufacturers. 23 December 2013