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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
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Germany’s Lindis Biotech, a specialist in multi-specific antibody platforms, has announced an exclusive licensing agreement with Pharmanovia, for the commercialization of Korjuny (catumaxomab). 19 November 2024
Biotechnology
The US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the Biologics License Application (BLA) for belantamab mafodotin on July 14. 20 June 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications. 19 June 2020
Biosimilars
Innovent Biologics has announced that Byvasda (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by China’s National Medical Products Administration (NMPA) for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. 19 June 2020
Biotechnology
Mixed results for Swiss pharma giant Roche show the Phase III IPATential150 study met one of its co-primary endpoints, while missing the other. 19 June 2020
Biotechnology
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
Pharmaceutical
A new parliamentary committee is to work on a master plan to beat cancer. 18 June 2020
Biotechnology
Californian company Ideaya Biosciences has agreed a strategic partnership with UK pharma major GlaxoSmithKline in synthetic lethality, an emerging field in oncology. 17 June 2020
Biotechnology
Eli Lilly yesterday announced that Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. 17 June 2020
Pharmaceutical
Global drugmakers operating in Russia have called on the national government to lift the existing “third excess,” norm - the rule, limiting the participation of foreign drugmakers in state tenders in Russia. 16 June 2020
Biotechnology
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
Biotechnology
Having risen a percentage point rise in earlier trading, Japanese drugmaker Kyowa Kirin’s shares closed down almost 2% at 2,725 yen, despite announcing the roll-out of its rare blood cancer diseases drug Poteligeo (mogamulizumab) in Europe. 15 June 2020
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
Pharmaceutical
Under the agency’s accelerated review scheme, the US Food and Drug Administration on Friday approved an expanded indication for Gardasil 9 (human papillomavirus 9-valent vaccine) for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. 13 June 2020
Biotechnology
Danish biotech company Genmab closed 4% higher at the end of Wednesday’s trading after announcing an oncology collaboration with US drugmaker AbbVie. 10 June 2020
Biotechnology
San Diego, USA-based biotech DelMar Pharmaceuticals’ shot up 20% pre-market today, as it revealed the signing of a definitive merger agreement with Adgero Biopharmaceuticals, a privately held biopharmaceutical company focused on the development of its late-stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications. 10 June 2020
Biotechnology
A company formed as a spinout from Cancer Research UK-funded science at The Institute of Cancer Research (ICR), London, has been publicly launched. 10 June 2020
Pharmaceutical
Family-owned Swiss drugmaker Debiopharm has announced that the genitourinary (GU) diseases specialist Verity Pharmaceuticals has been granted exclusive US rights to commercialize Trelstar (triptorelin pamoate for injectable suspension). 9 June 2020
Biotechnology
Spanish drugmaker PharmaMar and Taiwanese company TTY Biopharm have announced an exclusive licensing agreement for the import, use, marketing, sale and distribution of the marine-derived anticancer drug Yondelis (trabectedin) in Taiwan, Hong Kong and Macao. 9 June 2020
Biotechnology
It has been a busy day for oncology collaborations between biotechs in Suzhou, China, and pharma majors in Europe. 9 June 2020
Biotechnology
A new strategic research collaboration between Swiss cancer giant Roche and Chinese biotech Innovent Biologics has sent shares in the latter climbing 4% in Hong Kong. 9 June 2020
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