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Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Generics
Sino-American oncology company BeOne Medicines, until now known as BeiGene, has entered into a settlement agreement with MSN Pharmaceuticals and MSN Laboratories Private resolving patent litigation related to MSN’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Brukinsa (zanubrutinib) in the USA. 25 November 2024
Pharmaceutical
UK pharma major AstraZeneca today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Biotechnology
Japanese drugmaker Takeda has launched Fruzaqla (fruquintinib) in its home country. 22 November 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has announced a strategic commercial collaboration with Pharmalink Store, a prominent pharmaceutical company based in the United Arab Emirates (UAE). 22 November 2024
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). 17 October 2018
Pharmaceutical
Shares in Johnson & Johnson rose 2% within an hour's trading on Tuesday after the US healthcare giant presented its third-quarter financial results, which saw the Janssen pharma unit post particularly impressive sales figures. 16 October 2018
Pharmaceutical
After what chief executive Stefan Oschmann said had been a “challenging year” for Germany’s Merck KGaA, the company is targeting a return to profitable growth in 2019. 16 October 2018
Biotechnology
Roche might be facing increased competition to its well-established breast cancer drug Herceptin (trastuzumab), but the Swiss pharma giant is not sitting still as biosimilars start to take market share. 16 October 2018
Biotechnology
Swedish firm Medivir has announced that Uli Hacksell will replace Christine Lind as chief executive, with immediate effect, just 18 months after she took up the position. 16 October 2018
Biotechnology
Combinations involving checkpoint therapies are starting to be used as the standard of care in certain metastatic cancer types, such as Merck & Co’s Keytruda (pembrolizumab) with chemotherapy in advanced squamous non-small cell lung cancer. 16 October 2018
Biosimilars
Japan’s Chugai Pharmaceutical filed a lawsuit to the Tokyo District Court as of October 12, and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the biosimilar of anti-HER2 monoclonal antibody Herceptin (trastuzumab). 15 October 2018
Biotechnology
Shares in West Coast, USA-based oncology specialist Immune Design have fallen more than a third since it announced an unfavorable early analysis of a Phase II trial of its cancer vaccine candidate CMB305. 15 October 2018
Pharmaceutical
Regulatory news of interest last week included the US Food and Drug Administration’s approval of Akcea Therapeutics rare disease drug Tegsedi, but it came with a black box warning, and FDA acceptance of Karyopharm’s selinexor New Drug Application for multiple myeloma. On the deal making front, there was Roche's agreement to access Ionis Pharmaceuticals’ age-related macular degeneration research program, while in terms of drug trials, safety concerns caused Affimed to discontinue its AFM11 leukemia study. 14 October 2018
Biosimilars
Russia’s largest biotech company is seeking to become a major player in overseas markets, too, as shown by its bold new targets and a series of recently-signed deals and discussions. 12 October 2018
Biotechnology
Privately-owned Austrian biotech Themis Bioscience has bought in additional assets from a German research group to expand its immunomodulation platform into oncology. 12 October 2018
Biotechnology
The USA’s MEI Pharma has lined up with China’s BeiGene on a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies. 12 October 2018
Biotechnology
The firm that calls itself the leading oncology company in Japan strengthened its position on Wednesday with the approval of its breast cancer drug in a new indication in the Asian country. 11 October 2018
Pharmaceutical
Shares in Affimed have fallen more than a quarter since the firm announced it was putting on hold development of AFM11, after the occurrence of Serious Adverse Events (SAEs) in three patients. 10 October 2018
Pharmaceutical
American PARP inhibitor specialist Clovis Oncology will present four posters related to the Rubraca (rucaparib) development program at the 2018 European Society of Medical Oncology congress. 10 October 2018
Pharmaceutical
Germany’s Bayer will present new data from the company's growing oncology portfolio at the 2018 congress of ESMO this year. 10 October 2018
Pharmaceutical
Tokyo’s Eisai will provide clinical updates regarding its selective TKI Lenvima (lenvatinib), also marketed as Kisplyx, at the forthcoming annual meeting of the European Society for Medical Oncology (ESMO). 10 October 2018
Pharmaceutical
Roche is to supply new results from a number of studies at the European Society for Medical Oncology (ESMO) congress this year. 10 October 2018
Pharmaceutical
Zug, Switzerland-based oncology specialist Tesaro says it will present six abstracts at the upcoming annual meeting of the European Society for Medical Oncology (ESMO) in Munich, Germany. 10 October 2018
Pharmaceutical
The Russian government plans to provide access to imported drugs that have not undergone clinical trials within Russia, according to recent statements by some senior officials of the Russian Ministry of Health. 10 October 2018
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