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
Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine deiminase) from the US Food and Drug Administration. 19 December 2014
Cardinal Health and German drug major Bayer have signed a 15-year agreement for the contract manufacturing of Xofigo (radium Ra 223 dichloride). 19 December 2014
US pharma giant Merck & Co said yesterday that it has acquired, through a subsidiary, Swiss-based privately held biotech company OncoEthix, which specializes in oncology drug development. 19 December 2014
Swiss pharma giant Roche has agreed to acquire Dutalys, a privately held biotechnology company based in Vienna, Austria, in a deal that could cost it as much as $489 million. 19 December 2014
Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission for Lynparza (olaparib) capsules for certain kinds of ovarian, fallopian tube, or primary peritoneal cancer. 18 December 2014
USA-based Amgen has revealed its intended pricing for its immunotherapy Blincyto (blinatumomab), which was approved earlier this month by the US Food and Drug Administration to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). 18 December 2014
The Colorectal Cancer (CRC) therapeutics market in Asia-Pacific (APAC) is set to increase in value, from $1.9 billion in 2013 to $2.9 billion by 2020, at a compound annual growth rate (CAGR) of 6.5%, says a new report. 18 December 2014
The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured by Ipsen for adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. 17 December 2014
The announcement that Cyclacel Pharmaceuticals’ (Nasdaq: CYCC) Phase III trial of sapacitabine was unlikely to meet its primary endpoint caused shares in the company to fall as much as 69%. 17 December 2014
Curie-Cancer, the body responsible for developing Institut Curie’s industry partnership activities, and GamaMabs Pharma, a company specialized in the development of monoclonal antibodies for cancer, are extending their partnership to develop the 3C23K antibody. 16 December 2014
US development-stage biophama company Anthera Pharmaceuticals has entered into an exclusive licensing agreement with Japan’s Zenyaku Kogyo for the development and commercialization of subcutaneous blisibimod in Japan and potentially other countries throughout Asia. 16 December 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance recommending National Health Service use of US pharma giant Pfizer’s Inlyta (axitinib), for advanced kidney cancer. 16 December 2014
UK-based antibody therapeutics specialist Crescendo Biologics has received another equity investment from Astellas Venture Management to support the discovery and development of new Humabody antibody fragment therapeutics in oncology. 16 December 2014
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) have recommended German pharma major Bayer’s Xofigo (radium 223 dichloride) in their preliminary Appraisal Consultation Document (ACD). 15 December 2014
Oncology specialist Sorrento Therapeutics has entered into a binding agreement with medical technology company NantWorks founder, Patrick Soon-Shiong. 15 December 2014
Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application for cobimetinib to the US Food and Drug Administration for treatment, in combination with Zelboraf (vemurafenib). 15 December 2014
US oncology focused biotech firm Ignyta has agreed to an amendment to its license agreement with Italy’s Nerviano Medical Sciences, relating to its entrectinib (formerly RXDX-101) product candidate. 15 December 2014
Novartis announced that its BOLERO-1 trial of Afinitor (everolimus) in combination with Herceptin (trastuzumab) and paclitaxel as first-line treatment in HER2-positive advanced breast cancer did not demonstrate statistically significant benefits. 15 December 2014