Japan’s largest drugmaker Takeda has completed the post-marketing commitment and data submissions to regulators including the US Food and Drug Administration and the European Medicines Agency from a 10-year epidemiology study for pioglitazone-containing medicines. 29 August 2014
Australian biotech company Minomic International will join forces with Catalent Pharma to develop its MIL-38 antibody drug conjugate as a potential therapy for prostate cancer. 29 August 2014
After failing to meet the primary endpoint of its trial of rigosertib (IV), oncology specialist Onconova has informed the investment community that it will be pursuing an indication of the drug in patients where primary hypomethylating agents (HMA) fail. 29 August 2014
South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing authorization for Neulapeg (pegteograstim), a treatment for abnormally low level of neutrophils in patient undergoing chemotherapy. 28 August 2014
UK specialist health care company BTG and its partner, China-focused US specialty drugmaker SciClone Pharmaceuticals have received approval for their DC Bead from the China Food and Drug Administration in the embolization of malignant hypervascularized tumors. 28 August 2014
Oncology biopharma specialist Kite Pharma has seen its share price soar as much as 49.5% on the back of positive early-stage tests showing the potential to treat aggressive non-Hodgkin’s lymphoma with an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. 27 August 2014
US pharma giants Pfizer and Merck & Co have inked an agreement to explore the therapeutic potential of the combination of Pfizer’s Xalkori (crizotinib) with Merck’s investigational anti-PD-1 antibody pembrolizumab. 26 August 2014
Swedish contract development and manufacturing group Recipharm and Isofol Medical AB, a Gothenburg-based pharma company developing novel products for unmet needs within oncology, have formed a collaboration to strengthen the development program of Isofol’s lead drug candidate Modufolin 26 August 2014
US cancer immunotherapies firm Advaxis has entered into a clinical trial collaboration agreement with US pharma giant Merck & Co, through its subsidiaries, to evaluate the combination of Advaxis' Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. 26 August 2014
The glioblastoma multiforme therapeutics market in the four Asia-Pacific markets of Australia, China, India and Japan was worth $49.4 million in 2013, and is expected to grow at a compound annual growth rate (CAGR) of 11.5% to $105.8 million by 2020. 26 August 2014
Anglo-Swedish drug major AstraZeneca is to collaborate with gene sequencing company Illumina to develop its next-generation sequencing platform for companion diagnostic tests, applicable to AstraZeneca’s oncology portfolio. 21 August 2014
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care examined whether Swiss drug major Novartis’ Jakavi (ruxolitinib) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee for the treatment of adults with myelofibrosis. 20 August 2014
US pharma major Bristol-Myers Squibb and biotech firm Celgene are to collaborate on a combination regimen of B-MS’ Opdivo (nivolumab), and Celgene’s Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound), in a Phase I study. 20 August 2014
US biopharmaceutical firm Emergent BioSolutions and Germany’s MorphoSys have entered into an agreement for the joint development and commercialization of Emergent’s preclinical bi-specific antibody, ES414, targeting prostate cancer. 20 August 2014
UK-based Clinigen Group has acquired the global rights to the oncology support therapy Ethyol (amifostine) from Anglo-Swedish drug major AstraZeneca (LSE: AZN) 20 August 2014
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending US biotech firm Celgene’s Revlimid (lenalidomide) as an option, for treating myelodysplastic syndromes, reversing an earlier negative decision. 20 August 2014
Russia’s largest drugmaker Pharmstandard has signed an agreement with Swiss pharma major Novartis on the local of production of Tasigna (nilotinib), a drug for the treatment of cancer, in Russia. It is planned that the production of the drug will be at the facilities of Pharmstandard’s plant in Ufa. 19 August 2014
US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food and Drug Administration for its breast cancer drug candidate palbociclib. 19 August 2014
US developmental stage company Provectus Biopharmaceuticals has entered into a memorandum of understanding (MOU) with Sinopharm-China State Institute of Pharmaceutical Industry (Sinopharm-CSIPI) and Sinopharm A-THINK Pharmaceutical. 19 August 2014
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