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
The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation by Taiho Oncology. 20 October 2014
US biotech firm NewLink Genetics saw its share price rocket 21.2% in morning trading today, after it announced a deal with Genentech on an early-stage cancer program which could earn NewLink more than $1.15 billion. 20 October 2014
US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Imbruvica (ibrutinib) in the treatment of Waldenstrom’s macroglobulinemia (WM). 20 October 2014
US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica (ibrutinib) throughout the 28 member states of the European Union. 17 October 2014
USA-based biopharma company Pharmacyclics has entered into a master clinical drug supply agreement with Swiss drug major Roche to evaluate the safety, tolerability and preliminary efficacy of Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab). 17 October 2014
Australian biotechnology company Virax Holdings will acquire US oncology company AKTivate Therapeutics and its novel TCN-P cancer drug pending shareholder approval. 17 October 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance proposing to recommend Swiss pharma major Novartis’ Glivec (imatinib) people who have had a gastro-intestinal stromal tumor (GIST) removed and who are at high risk of the cancer recurring. 17 October 2014
Privately-held US cancer immunotherapy developer Aduro BioTech has entered into its second agreement with Janssen Biotech, a unit of US health care giant Johnson & Johnson. 17 October 2014
Generium Group of Companies, one of Russia’s largest producers of innovative drugs, has commissioned a new plant for the production of pharmacological substances and drugs in the Petushinsky area of the Vladimir region. 16 October 2014
Swiss pharma giant Novartis and the US University of Pennsylvania's Perelman School of Medicine (Penn) has said that positive preliminary results from two pilot clinical trials were published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (ALL). 16 October 2014
Russian pharmaceutical companies are actively squeezing out foreign therapeutic manufacturers from the government tenders, according to leading Russian biotech firm Biocad. 16 October 2014
In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has not recommended US biotech firm Dendreon’s Provenge (sipuleucel-T) for prostate cancer. 16 October 2014
There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted priority review for two of the companies products. 15 October 2014
US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for solid tumor cancers, says that the DCVax-L hospital exemption program that was approved by the German regulatory authority earlier this year is now under way. 15 October 2014
UK medical costs watchdog the National Institute for Health and Care Excellence (NICE) has issued preliminary draft guidance not recommending US biotech firm Celgene’s Imnovid (pomalidomide) for treating multiple myeloma. 15 October 2014
A consortium funded by the European Union is to advance a new class of fully personalized cancer vaccines into clinical trials for brain cancer. 14 October 2014
The specialized cancer agency of the World Health Organization, the International Agency for Research on Cancer (IARC), has launched the fourth edition of the European Code Against Cancer with the participation of the European Commission today. 14 October 2014
Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib has been accepted for filing and granted Priority Review by the US Food and Drug Administration. 13 October 2014
US drug major Bristol-Myers Squibb, US-based biopharma company Pharmacyclics and Janssen Research and Development, the Europe-based subsidiary of US health care giant Johnson & Johnson have entered into a clinical trial collaboration agreement to evaluate B-MS’ Opdivo (nivolumab) in combination with Imbruvica (ibrutinib). 13 October 2014
The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant and palonosetron) to treat chemotherapy-induced nausea and vomiting (CINV). 13 October 2014