Japan’s Sumitomo Pharma, formerly known as Sumitomo Dainippon Pharma, says it has decided to construct a cGMP-compliant cell processing center (CPC) in the USA. 22 April 2022
Japanese drugmaker Astellas Pharma has announced that it will book an impairment loss in both the fourth quarter of the fiscal year ended on March 31, and in the subsequent quarter. 22 April 2022
Top-line data for an mRNA-based COVID-19 vaccine from Arcturus Therapeutics have failed to impress investors, with the firm reporting 55% efficacy in the prevention of symptomatic disease. 21 April 2022
The Japanese business of Swiss biotech Idorsia has launched Pivlaz (clazosentan), a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm. 20 April 2022
Japanese drugmaker Ono Pharmaceutical has signed a collaboration agreement with France’s Domain Therapeutics and Université de Montréal (UdM) to discover novel small molecules targeting G-protein coupled receptors (GPCRs) in the metabolic disease area. 19 April 2022
Japan’s largest drugmaker Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Nuvaxovid intramuscular injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. 19 April 2022
Shionogi and fellow Japan-based NEC Corporation have executed a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. 19 April 2022
Japanese companies Teijin Limited and JCR Pharmaceuticals have decided to terminate their co-development and Japan licensing agreement aimed at developing JTR-161, an allogeneic regenerative medical product containing dental pulp stem cells (DPCs) for the intended purpose of helping patients recover from acute cerebral infarctions (strokes). 19 April 2022
Sino-American biotech firm BeiGene has announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. 19 April 2022
China-based biotech BeiGene has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 April 2022
The European Commission (EC) has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. 14 April 2022
Japan’s largest drugmaker Takeda today announced that the Phase III SHP643-301 study evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients aged two to 13 April 2022
US biotech Seagen announced that a jury in the US District Court for the Eastern District of Texas found that Japanese pharma major Daiichi Sankyo infringed Seagen’s US Patent No 10,808,039 by selling its cancer drug Enhertu (trastuzumab deruxtecan; DS-8201) in the USA. 11 April 2022
China and USA-based Harbour BioMed saw its shares rocket as much as 65% on Thursday, after it announced a global out-license agreement with AstraZeneca for CLDN18.2xCD3 bispecific antibody (HBM7022), a novel bispecific antibody generated from Harbour's HCAb based immune cell engagers (HBICE) platform. 8 April 2022
A Feature on the Japanese pharma market from Patrick Branch, a Partner in LEK's Tokyo office and a member of the firm’s Life Sciences practice. 8 April 2022
Japan’s SanBio Group has announced that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase II STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). 8 April 2022
Ondexxya (recommend andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 29 March 2022
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