Takeda Pharmaceutical has announced the opening of a production site for Ninlaro (ixazomib), an innovative drug for patients with multiple myeloma, at its Yaroslavl plant in Russia. 2 August 2018
Japanese pharma major Daiichi Sankyo is offloading 41 of its products in Japan as it prioritizes the stated aim of becoming a ‘global pharma innovator with competitive advantage in oncology’. 1 August 2018
The Korean Ministry of Food and Drug Safety has approved the nausea therapy Akynzeo (netupitant/pelonosetron) for chemotherapy patients, said the drug's manufacturers on Tuesday. 31 July 2018
One year after raising $800 million in a follow-on public offering, BeiGene has announced it will list on the Hong Kong stock exchange with an initial public offering (IPO) expected to bring in an even greater sum for the Beijing-based firm. 27 July 2018
Japan’s Solasia Pharma has won Chinese approval for Sancuso (granisetron transdermal system) for the prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy regimens. 26 July 2018
Takeda has announced that Alunbrig (brigatinib) has passed its primary endpoint for use in anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC). 25 July 2018
South Korean firm Kolon Life Science has agreed a deal to sell cell and gene therapy Invossa (TissueGene-C) in parts of China, pending regulatory approval. 24 July 2018
China’s BeiGene says that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the US Food and Drug Administration for the treatment of patients with Waldenström macroglobulinemia (WM). 24 July 2018
A new GlobalData report suggests that China, already the second-largest market in the acute ischemic stroke (AIS) market, is set to grow even further due to the aging population, giving stem cell therapies a chance to penetrate in the region. 24 July 2018
Changsheng Biotechnology is the subject of an ongoing controversy this week, after an inspection in mid-July found the company had fabricated production and inspection documents related to the production of 250,000 faulty rabies vaccines. 23 July 2018
Four years after its initial approval in moderate to severe Crohn’s disease, Japan’s Takeda Pharmaceutical has finally submitted Entyvio (vedolizumab) for approval in its home country. 18 July 2018
The European Union and Japan have agreed to broaden the range of medicines for which they will recognize each other’s inspections of manufacturing sites. 18 July 2018
Roche and Chugai Pharmaceutical have agreed a licensing deal whereby the latter will develop and market the tyrosine kinase inhibitor entrectinib in Japan. 18 July 2018
Takeda Pharmaceutical chief executive Christophe Weber says his company will look to China for future growth in the wake of his firm’s mega-takeover of rare disease specialist Shire. 18 July 2018
In what might be seen as a benefit of one-party rule, while US President Donald Trump grapples with his apparent powerlessness to reign in drug prices, the Chinese state seems determined to unilaterally reduce costs for cancer meds. 10 July 2018
Amazon's acquisition of PillPack will be troubling to big pharma executives throughout the industry, with the company having such vast existing revenue streams that it could outspend many of the sector's existing inhabitants. 10 July 2018
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company based in Linhai, China. 6 July 2018
Osaka’s Sumitomo Dainippon Pharma has submitted a new drug application in Japan for its candidate DSP-1958 (thiotepa), as a conditioning treatment prior to autologous hematopoietic stem cell transplantation (HSCT) for pediatric solid tumors. 5 July 2018
East Coast, USA-based firm Athenexhas announced several key strategic deals focused on China, aimed at furthering its oncology developments. 3 July 2018
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 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