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Biotechnology
Following the US Food and Drug Administration approval last Friday of its Lenmeldy (atidarsagene autotemcel), Orchard Therapeutics today announced launch plans for the gene therapy. 20 March 2024
Biotechnology
Capping a series of investments designed to increase its manufacturing footprint, Novo Nordisk has said it will spend around $550 million to up output in China. 20 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approved the supplemental new drug application (sNDA) for Iclusig (ponatinib). 20 March 2024
Pharmaceutical
Shanghai-based KeChow Pharma has secured approval in its home country for tunlametinib, a MEK blocker which was discovered and developed by the firm in-house. 19 March 2024
Pharmaceutical
Mitsubishi Tanabe Pharma America has announced the publication of results in The Lancet Neurology from the pivotal, Phase III BouNDless trial. 18 March 2024
Biosimilars
The US unit of South Korea’s Celltrion today announced the availability of Zymfentra (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. 18 March 2024
Biotechnology
A new chief medical officer will take the reins at Shanghai-based biotech Everest Medicines, as the drug and vaccine firm undertakes a minor reshuffle at the top. 18 March 2024
Biotechnology
Clinical-stage biotech Biotheus has entered into a collaboration with fellow China-based Hansoh Pharmaceutical following their current partnership since 2022. 18 March 2024
Pharmaceutical
Japanese drugmaker Sumitomo Pharma and its US subsidiary Sumitomo Pharma America have amended a collaboration with Otsuka Pharmaceuticals. 18 March 2024
Biotechnology
Chinese biopharma CStone Pharmaceuticals has won a fifth approval for Cejemly (sugemalimab) in China. 15 March 2024
Biotechnology
Cartesian Therapeutics has revealed in a stock exchange filing that it has received notice from Japanese pharma major Astellas’ subsidiary Audentes Therapeutic that it is terminating their license and development agreement. 15 March 2024
Biotechnology
More than a year later than expected, Sino-American oncology specialist BeiGene has finally secured US approval for its novel checkpoint inhibitor, tislelizumab-jsgr. 15 March 2024
Pharmaceutical
New real-world data show a positive safety profile for Xcopri (cenobamate), an anti-seizure medication which is offered in a tablet formulation. 14 March 2024
Biotechnology
Politics has entered the scientific realm in the form of new US legislation that has prompted the Biotechnology Innovation Organization (BIO) to come into line with Congress’s position on Chinese companies. 14 March 2024
Biotechnology
Once dubbed as me-too copycats and fast followers, Chinese biotechs are flocking to innovation mix, or combinatorial innovation, hoping to discover a novel therapy based on a mixture of existing resources, according to the consulting firm Clarivate. 13 March 2024
Pharmaceutical
Swiss drugmaker Basilea Pharmaceutica announced yesterday that the continued strong sales performance of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region and China exceeded the sales threshold triggering a $1.25 million milestone payment. 12 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Biotechnology
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Pharmaceutical
Privately-held German firm Boehringer Ingelheim and Japan’s Sosei Group Corporation have entered into a global collaboration and exclusive option-to-license agreement. 11 March 2024
Biotechnology
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 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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