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Biotechnology
EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab). 26 July 2024
Pharmaceutical
Beijing, China-based Gan & Lee Pharmaceuticals announced that its independently developed long-acting GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved positive results in a clinical trial for adults with obesity/overweight in China. 23 July 2024
Pharmaceutical
Chugai today announced it will transfer to Maruishi Pharmaceuticals the business in Japan concerning the physiological intestinal function improving and hyperammonemia drug Monilac 22 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
Biotechnology
Shanghai, China-based Rona Therapeutics on Friday announced the completion of $35 million Series A+ financing. 22 July 2024
Pharmaceutical
Full-Life Technologies says it has entered into a license agreement with South Korea’s SK Biopharmaceuticals. 17 July 2024
Biotechnology
SOTIO Biotech, a Czech biopharma owned by PPF Group, and Biocytogen, a Chinese firm focused on the discovery of novel antibody therapeutics, have announced a research collaboration and exclusive option and license agreement. 16 July 2024
Pharmaceutical
Eisai has entered into a license agreement with fellow Japanese drugmaker Sato Pharmaceutical regarding the development and commercialization rights for the antifungal agent fosravuconazole in the Asia/Oceania region. 16 July 2024
Biotechnology
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Biotechnology
French drugmaker Ipsen has entered into an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential, from China-based Foreseen Biotechnology. 11 July 2024
Biotechnology
US biotech Moderna and Japan’s Mitsubishi Tanabe Pharma have entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax. 9 July 2024
Biotechnology
Ascentage Pharma yesterday announced that olverembatinib has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of China. 8 July 2024
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Xpovio (selinexor), from Antengene Corp as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). 8 July 2024
Pharmaceutical
Michigan, USA-based pharma Esperion has entered into a Royalty Purchase Agreement with OMERS Life Sciences (OMERS). 6 July 2024
Pharmaceutical
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for tazemetostat for the treatment of adult patients with relapsed or refractory (R/R ) follicular lymphoma (FL) has been accepted for review and granted Priority Review in China. 4 July 2024
Pharmaceutical
China’s Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved Japanese pharma major Astellas’ Xtandi (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 2 July 2024
Biotechnology
Japanese drugmaker Eisai today announced it is ending its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC). 1 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024
Pharmaceutical
Japanese drugmaker Shionogi announced that the newly-obtained clinical data for the novel COVID-19 oral antiviral Xocova. (ensitrelvir fumaric acid) 1 July 2024
Biotechnology
China has approved 82 innovative drugs and 138 innovative medical devices since 2022, a health official said on Friday (June 28). 1 July 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
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
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Biotechnology
Californian oncology-focused biotech Avenzo Therapeutics has announced a pair of important updates. 19 November 2024
Pharmaceutical
Big pharmas are not deterred by China’s increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. 18 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
Chinese biotech Keymed Biosciences has entered an exclusive licensing agreement with Platina Medicines for its bispecific antibody candidate, CM336. 18 November 2024
Pharmaceutical
In yet another sign of the mounting interest in radiopharmaceuticals, Tongrui Biopharma, a Chinese innovator in this area, has announced the completion of a $100 million series A+ financing round. 18 November 2024
Biotechnology
Shanghai-based biopharma Zai Lab has announced the pricing of its underwritten public offering at $25.50 per share, aiming to raise around $200 million. 15 November 2024
Biosimilars
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Biotechnology
Merck & Co has entered into an exclusive global license to develop, manufacture and commercialize LM-299 from China-based clinical-stage biotech LaNova Medicines, bringing the US pharma giant into the newly attractive PD-1/VEGF bispecific antibody space. 15 November 2024
Biotechnology
Japanese drugmaker Nippon Shinyaku and USA-based Atsena Therapeutics have entered into an exclusive license agreement for the commercialization of ATSN-101 in the USA and Japan for advancing Atsena’s first- in-class, investigational gene therapy ATSN-101 for Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). 13 November 2024
Biotechnology
Anglo-American biotech Apollo Therapeutics and China-based Sunshine Lake Pharma have signed an exclusive license agreement to develop APL-18881, a bi-specific fusion protein aimed at treating metabolic diseases. 13 November 2024
Biotechnology
Dutch firm Argenx and China’s Zai Lab have received an approval from the National Medical Products Administration (NMPA) for Vyvgart Hytrulo (efgartigimod alfa). 13 November 2024
Biotechnology
Although it is seeing a downturn in sales and profits, German biotech BioNTech is continuing to acquire assets with the cash pile it made through the covid pandemic, notably iis Comirnaty vaccine that was developed with Pfizer (NYSE: PFE). 13 November 2024
Biotechnology
Sino-American oncology company BeiGene has announced third-quarter 2024 financials, showing the total revenues was $1,002 million, up 28% compared to $781 million in the same period of 2023. 13 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
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