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Biotechnology
After the debacle surrounding Aduhelm (aducanumab), Leqembi (lecanemab) was supposed to be the Alzheimer’s amyloid beta-directed antibody that delivered results for patients and its manufacturers Eisai and Biogen. 8 March 2024
Biotechnology
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
Biotechnology
A key committee of the US Senate has given its stamp of approval for the BIOSECURE Act, which aims to prevent contracts with Chinese biotech companies. 7 March 2024
Pharmaceutical
South Korean vaccine maker SK bioscience today announced that it has broken ground on a major expansion of its vaccine manufacturing plant, L HOUSE, located in Andong, Gyeongsangbuk-do. 7 March 2024
Biotechnology
Marking a fourth deal this year, Japanese drugmaker Ono Pharmaceutical today announced that it has entered into a license agreement with pre-clinical stage Korean biotechnology NEX-I for NXI-101. 6 March 2024
Biotechnology
Japanese drugmaker Shionogi has linked up with fellow Osaka-based FunPep Co regarding the anti-IgE antibody-induced peptide FPP004X. 4 March 2024
Biotechnology
The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in two types of cancer. 4 March 2024
Biotechnology
China-headquartered oncology specialist BeiGene has announced a new matching adjusted indirect comparison (MAIC) of the efficacy of Brukinsa (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase III ALPINE and Phase III ASCEND trials. 1 March 2024
Pharmaceutical
Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka, is to collaborate with Shanghai-based Haihe Biopharma on a new cancer med. 1 March 2024
Biotechnology
British pharma major AstraZeneca has chosen Shanghai as the location for what will become its fifth global strategic center for research and development. 29 February 2024
Biotechnology
Chinese oncology specialist BeiGene has ended its collaboration with privately-held Shoreline Biosciences. 27 February 2024
Pharmaceutical
Japanese drugmaker Shionogi says it has submitted a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan. 27 February 2024
Pharmaceutical
Teva Pharmaceutical Industries has formed a partnership with Jiangsu Nhwa Pharmaceutical for the marketing and distribution in China of Teva’s Austedo (deutetrabenazine). 26 February 2024
Biotechnology
South Korean vaccine developer SK bioscience revealed on Friday that it has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), SKYTyphoid (project name NBP618). 24 February 2024
Biotechnology
Sino-American healthcare-focused venture capital firm ORI Capital has announced the final close of its second fund. 23 February 2024
Biotechnology
Japan’s largest drugmaker Takeda decided to discontinue the development programs of its four oncology assets - Phase III asset modakafusp alfa (TAK-573) and three Phase I chimeric antigen receptor (CAR-T) assets: TAK-102, TAK-103 and TAK-940 - as part of a plan to align its focus on advancing allogeneic cell therapies. 23 February 2024
Biosimilars
South Korea’s Celltrion has presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) of subcutaneous (SC) infliximab in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). 23 February 2024
Pharmaceutical
Japanese drugmaker Shionogi today revealed that it has received approval from the Taiwan Food and Drug Administration (TFDA) for Fetroja (cefiderocol) in the treatment of complicated urinary tract infections. 22 February 2024
Biotechnology
As sales for Daiichi Sankyo and AstraZeneca’s HER2+-targeting antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) continue to skyrocket, the companies are poised for yet another anticipated ADC blockbuster with DS-1062, or datopotamab deruxtecan. 22 February 2024
Biosimilars
South Korean biosimilars company Samsung Bioepis today announced that two new study results for SB17, a proposed biosimilar to Stelara (ustekinumab), marketed by Johnson & Johnson, will be presented at the 19th Congress of European Crohn’s and Colitis Organization (ECCO) being held from February 21 to 24 in Stockholm, Sweden. 22 February 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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