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 UK’s National Institute for Health and Care Excellence has issued final draft guidance recommending Keytruda (pembrolizumab) from Merck to treat advanced skin cancer not treated with ipilimumab. 9 October 2015
Japanese pharma major Eisai says it has received marketing approval of its novel in-house developed anticancer agent Lenvima (lenvatinib mesylate) from the regulatory authority in South Korea (Ministry of Food and Drug Safety). 9 October 2015
US drug major Eli Lilly on Thursday said the US Food and Drug Administration has granted Breakthrough Therapy designation to its drug candidate for metastatic breast cancer. 8 October 2015
USA-based Sunesis Pharmaceuticals says it intends to submit a Marketing Authorization Application for vosaroxin (proposed trade name Qinprezo) as a treatment for acute myeloid leukemia (AML) with the European Medicines Agency by the end of 2015. 8 October 2015
Concert Pharmaceuticals on Thursday said it has received $8 million in milestone payments from US biotech company Celgene Corp following the completion of early stage trial of the drug candidate to treat for inflammatory diseases and cancer. 8 October 2015
Germany’s Merck KGaA and US pharma giant Pfizer said the US Food and Drug Administration has granted fast track designation to a trial stage immunotherapy for the treatment of rare skin cancer. 8 October 2015
US privately-held biotech firm Theraclone Sciences has joined forces with the University of Texas MD Anderson Cancer Center to launch OncoResponse, an immuno-oncology antibody discovery company. 7 October 2015
US biotech firm Lion Biotechnologies has obtained an exclusive, worldwide license from the National Institutes of Health (NIH) to develop and commercialize TIL therapy in four additional tumor indications. 7 October 2015
Swedish drug developer Oasmia Pharmaceutical says it has shipped Paclical, the company’s lead cancer product, to Pharmasyntez, its distribution partner in Russia which is expected to commence sales efforts promptly. 7 October 2015
Biotech firm Advaxis said the US Food and Drug Administration has put on hold mid-stage trials of its cancer drug candidate following the death of a patient. 7 October 2015
UK-based Horizon Discovery Group says that its leveraged business unit has signed a program in-licensing and option agreement with independent French pharma firm Servier. 7 October 2015
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has in final guidance issued today said “yes” to pembrolizumab for treating advanced skin cancer after treatment with ipilimumab. 7 October 2015
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether ceritinib offers an added benefit over the appropriate comparator therapy. 6 October 2015
Share of US biotech firm Exelixis rose 4.24% to $6.15 in pre-market trading this morning, after the company released encouraging clinical trial results for its melanoma drug candidate. 6 October 2015
Germany’s Federal Joint Committee (G-BA) has published the benefit assessment report for Japanese pharma major Eisai’s Lenvima (lenvatinib) for people with radioactive iodine refractory differentiated thyroid cancer. 6 October 2015
US based Biscayne Pharmaceuticals and Insero Health are merging to create a combined entity with two different research areas. The two companies already have a common executive chairman at the helm. 6 October 2015
Dako, an Agilent Technologies company, on Monday said the US Food and Drug Administration (FDA) approved a new test that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment. 5 October 2015
Provider of development services to drugmakers, Ergomed said it will pay $12 million for the Phase III trial for drug to treat to head and neck cancer following an expanded agreement with CEL-SCI Corp. 5 October 2015
Following the recent deal with the US pharma major Bristol-Myers Squibb to purchase US rights to its breast cancer drug Ixempra (ixabepilone; The Pharma Letter August 18), R-Pharm, one of Russia’s largest pharmaceutical companies, will start the production and distribution of the drug in the USA. 5 October 2015