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
Danish biotech company Genmab has been granted accelerated assessment for daratumumab in double refractory multiple myeloma by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. 25 September 2015
BIND Therapeutics says pharma giant Pfizer has exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors. 24 September 2015
US cell therapy specialist Caladrius Biosciences has entered into a collaboration agreement with Sanford Research to develop the company’s T regulatory cell therapy product candidate, CLBS03, for the treatment of adolescents with recent-onset type 1 diabetes (T1D). 24 September 2015
Despite few products having so far reached the market and captured strong revenues, the gene therapy pipeline remains large, with 906 products in active development across all stages. 24 September 2015
The UK medicines cost watchdog the National Institute for Health can Care Excellence (NICE) today issued final draft guidance recommending that US biotech giant Gilead Sciences’ Zydelig (idelalisib) should be made available on the National Health Service in England and Wales for some adults with chronic lymphocytic leukemia (CLL). 24 September 2015
Shares in OncoGenex Pharmaceuticals closed down over 14% on Nasdaq after the company announced its combination therapy to treat pancreatic cancer failed in mid-stage trials. 24 September 2015
When prescribing newly-approved drugs, physicians rely on data from clinical trials to understand the benefits and risks of those drugs for patients. 24 September 2015
Swiss pharma giant Novartis today announced the launch of “Novartis Access,” a portfolio of 15 medicines to treat chronic diseases in low- and low-middle-income countries. 24 September 2015
US biotech major Amgen and Allergan has announced that the biosimilar ABP 215 met its primary and secondary endpoints in a Phase III trial. 23 September 2015
The US Food and Drug Administration on Tuesday approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies, from Japanese drugmaker Taiho Pharmaceutical. 23 September 2015
Edison Investment Research said it has raised its valuation on Germany’s Medigene to 208 million euros ($231.5 million) or 10.60 euros per share from 175 million euros, following the company’s fund raising program. 23 September 2015
H3 Biomedicine and Poland’s leading biotech company Selvita have extended their strategic collaboration to develop breakthrough precision medicines for cancers through September 2016. 22 September 2015
Brentuximab vedotin is an effective and safe first course of treatment for older Hodgkin lymphoma patients unfit for chemotherapy, according to a study published on-line n Blood, the Journal of the American Society of Hematology. 22 September 2015
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). 20 September 2015
The US Food and Drug Administration has accepted for priority review the supplemental New Drug Application (sNDA) for biotech major Amgen’s Kyprolis (carfilzomib) for Injection for patients with relapsed multiple myeloma. 19 September 2015
An Australian Senate Committee inquiry has issued its findings and has recommended the government reviews the way in which new medicines are approved and subsidized. 18 September 2015
The US Food and Drug Administration has granted Israel-based biotech company Can-Fite BioPharma's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. 17 September 2015
Privately-held Nurix has entered into a strategic collaboration with US biotech major Celgene Corp for the discovery, development and commercialization of novel small molecule therapeutics in oncology, inflammation and immunology, including the rapidly evolving field of immuno-oncology. 17 September 2015
The UK’s National Audit Office has published the findings from its investigation into the Cancer Drugs Fund, concluding it is no longer sustainable in its current form, and NHS England should develop proposals for reform. 17 September 2015
The product pipeline for non-Hodgkin lymphoma (NHL) exhibits a lower degree of innovation than both the industry and oncology average, with just 28% of all pipeline products, or 33% of the pipeline for which there is a disclosed molecular target, categorized as first-in-class. 17 September 2015