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
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
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
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
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
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
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
India's pharma landscape has undergone a significant shift towards collaboration and partnership between global big pharma and domestic firms in recent years to drive innovation and expand market reach, according to GlobalData. 21 February 2024
The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. 19 February 2024
Japan’s Ono Pharmaceutical today announced that it has entered into a research collaboration agreement with USA-based artificial intelligence (AI) company to identify novel therapeutic targets by leveraging cutting-edge InveniAI’s AI and machine learning (ML). 19 February 2024
Japanese drugmaker Kyowa Kirin announced that Phozevel Tablets (tenapanor hydrochloride, development code: KHK7791) will be launched in Japan on February 20 for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. 19 February 2024
Japanese drug major Astellas Pharma says its subsidiary Xyphos has entered into research and license agreement with privately-held Boston, USA-based Kelonia Therapeutics, to develop novel immuno-oncology therapeutics. 16 February 2024
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 16 February 2024
Japan’s Ono Pharmaceutical yesterday revealed that it has entered into an option and collaboration agreement with Swiss biotech Numab Therapeutics. 15 February 2024
China-based biotech Brii Biosciences has entered into a second agreement with VBI Vaccines, sending the US firm’s up almost 10% to $0.72 in pre-market activity. 14 February 2024
Japanese drugmaker Ono Pharmaceutical has entered into a drug discovery collaboration and option agreement with USA-based Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. 13 February 2024
Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Shares of Japanese drugmaker Otsuka Pharmaceutical fell more than 5% to 5,359 yen today, as it released top line results of the Phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease. 13 February 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint. 17 September 2024
US biotech Capricor Therapeutics has entered into a binding term sheet with Japanese drugmaker Nippon Shinyaku for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel. 17 September 2024
Women’s health focussed company Organon China today revealed that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s 11 September 2024
Detailed results were released from the TROPION-Lung01 Phase III trial, which showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxe. 10 September 2024
Chinese companies Innovent Biologics and GenFleet have recently secured approval from China’s National Medical Products Administration (NMPA) for Dupert (fulzerasib). 9 September 2024
Summit Therapeutics on Sunday announced data from the primary analysis of the Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab compared to Merck & Co’s) mega blockbuster drug Keytruda (pembrolizumab). 9 September 2024
Organon KK, a Japan subsidiary of Organon & Co, announced that the primary endpoint was achieved in a domestic Phase III clinical trial evaluating the efficacy and safety of OG-8276A 6 September 2024
Targeted alpha therapy (TAT), or radioligand therapy, is a recent hot area that attracted big pharmas like Bristol Myers Squibb and Novartis. 5 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Privately-held Chinese biotech EpimAb Biotherapeutics and Vignette Bio have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06. 5 September 2024
Rigel Pharmaceutical’s shares dipped 4.4% to $12 .85 by late morning, despite announcing what could be a lucrative deal for the company. 3 September 2024
Chinese gene therapy specialist YolTech Therapeutics has entered into an exclusive licensing agreement with Salubris Pharmaceuticals (SHE: 002294). 3 September 2024
Japan’s Nxera Pharma today announced that it will receive a $35 million payment from Neurocrine Biosciences, triggered by the successful completion of the Phase II trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia. 2 September 2024
Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Jacobio Pharma announced that it has granted the China rights to KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals. 2 September 2024