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
Companies developing cell therapies for heart failure, compounds to treat obesity and peptide vaccines for cancer were among those that presented their pitches as part of a Japanese program to boost start-ups in the pharmaceutical sector. 9 May 2019
Swiss pharma giant Roche’s non-Hodgkin’s lymphoma treatment MabThera (rituximab) is facing a strong rival in China - its biosimilar version Hanlikang from Fosun Pharma’s biotech arm Henlius. 7 May 2019
Researchers at the Beijing Institute of Genomics (BIG) have been to Fiocruz for the Brazil-China seminar on Bioinformatics, Big Data and Precision Medicine. 7 May 2019
An executive and another employee at Korean biosimilars powerhouse Samsung Bioepis have been arrested, according to The Financial Times and other sources. 30 April 2019
US pharma major Eli Lilly has agreed to sell Chinese rights to two legacy antibiotic medicines, Ceclor (cefaclor) and Vancocin (vancomycin), as well as a manufacturing facility in Suzhou. 23 April 2019
Hutchinson China MedTech Limited has never downplayed the extent of its ambition to put Chinese drug development on the map, so clearly it has not held back with the hyperbole on announcing its upcoming global offering on the Stock Exchange of Hong Kong (SEHK). 15 April 2019
Chinese drugmaker Hansoh Pharmaceutical Group has re-filed its application for an initial public offering (IPO) in Hong Kong, according to sources quoted by Reuters. 15 April 2019
Daiichi Sankyo says that valemetostat (DS-3201), an investigational and potential first-in-class EZH1/2 dual inhibitor, has received Sakigake designation from the MHLW. 9 April 2019
China’s biopharma start up Ascentage Pharma has entered into a strategic collaboration with Shanghai Junshi Biosciences to explore the synergies of Ascentage's inhibitor of apoptosis proteins (IAP) inhibitor APG-1387, and Junshi Biosciences' anti-PD-1 therapy toripalimab in clinical trials in solid and hematological tumors in China. 9 April 2019
Shares in Japanese oncology specialist Oncolys Biopharma closed 18% up on Monday after the announcement of a deal with Chugai Pharmaceutical, part of Swiss pharma giant Roche. 8 April 2019
Japanese pharma major Eisai says that its in-house discovered fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor E7090 has been granted the Sakigake designation by Japan’s Ministry of Health, Labor and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion. 8 April 2019
Chinese biotechs will seek more cross-border licensing deals in the coming years, especially for early-stage assets, said speakers at the annual China Healthcare Investment Conference (CHIC) held in late March in Shanghai. 8 April 2019
The year-long US-China tension demands a fairer Chinese market access for global companies, and it might benefit China’s drug innovation, said speakers at the annual China Healthcare Investment Conference (CHIC) event held in Shanghai on March 27. 4 April 2019
China’s state council last August announced reform goals, which included speeding up the approval process for imported drugs, and seeking to include more oncology drugs in the national reimbursement drug list. 2 April 2019
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D). 27 March 2019
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 26 March 2019
Organizers of the CPhI Japan have said that a consensus coming out of the event among drugmakers was for the removal of long-list products. 26 March 2019
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kymriah (tisagenlecleucel) for the treatment of two distinct indications – CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL). 26 March 2019
Smyraf (peficitinib hydrobromide) 50mg and 100mg tablets, an oral Janus kinase (JAK) inhibitor, received manufacturing and marketing approval in Japan for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies. 26 March 2019
Teijin Pharma, the core company of the Teijin Group’s healthcare business, announced today that it has acquired marketing approval for Revcovi (elapegademase [genetical recombination]) from the Ministry of Health, Labor and Welfare (MHLW). 26 March 2019