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
China-based WuXi Biologics, a contract development and manufacturing organization (CDMO), will focus on overseas development as well as efficiency improvement in 2020, said the firm’s chief executive Chris Chen at a press meeting in Shanghai on Friday, reports The Pharma Letter’s correspondent Wang Fangqing. 31 March 2020
Jiangsu Alphamab Biopharmaceuticals has established strategic partnership with Simcere and 3D Medicines to advance the development and commercialization of a checkpoint inhibitor for programmed cell death ligand-1 (PD-L1), for oncology indications in mainland China. 30 March 2020
Privately-held USA-based CG Oncology has entered an exclusive license, development and commercialization agreement with Japanese drugmaker Kissei Pharmaceutical for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China. 27 March 2020
US biotech Alector and Chinese company Innovent Biologics have signed a regional licensing agreement to develop and commercialize AL008 for oncology indications in China. 26 March 2020
Italian drugmaker Recordati today announced the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for osilodrostat, an oral inhibitor of 11-beta-hydroxylase for the treatment of patients with Cushing’s syndrome (CS). 26 March 2020
Sino-America immuno-oncology biotech firm BeiGene today announced that, on March 25, 2020, the China National Medical Products Administration (NMPA) suspended the importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene, now a Bristol-Myers Squibb company. 25 March 2020
German biotechnology firm Sartorius has supported CanSino Biologics and Major General Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. 25 March 2020
Ono Pharmaceutical has received manufacturing and marketing approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of recurrent or refractory primary central nervous system lymphoma, in Japan. 25 March 2020
US oncology biotech CytomX Therapeutics and Japan’s Astellas Pharma have entered into a strategic collaboration agreement focused on the discovery, research, development and commercialization of novel T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens for the treatment of cancer. 25 March 2020
Japanese pharma major Takeda Pharmaceutical has picked up an approval in China for Entyvio (vedolizumab), for moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD). 23 March 2020
China’s National Medical Products Administration (NMPA) has granted marketing authorization for Ameile (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy. 19 March 2020
With evidence from Chinese authorities suggesting that Avigan (favipiravir) could be effective in treating the symptoms of COVID-19, shares in the drug’s developer, Fujifilm Toyama Chemical, have surged. 19 March 2020
Germany immunotherapeutics firm BioNTech today provided further details on its R&D effort, “Project Lightspeed,” to develop a potential vaccine to induce immunity and prevent COVID-19 infection in response to the growing global health threat posed by the disease. 16 March 2020
US biotech major Gilead Sciences’ recent $4.9 billion buyout of Forty Seven put a spotlight on the latter’s star asset magrolimab, an anti-CD47 monoclonal antibody (MAb), as well as the target CD47, a protein on cancer cells sending out “don’t eat me” signal to avoid phagocytosis by microphages. 13 March 2020
Chinese small-molecule drug discovery and development company Tyligand Bioscience has signed collaboration agreements with privately-held US company Context Therapeutics for the development, manufacturing, registration and future commercialization of onapristone extended release (ER). 13 March 2020
Chinese biotech Ascletis Pharma today announced the progress of the small sample clinical trial of hepatitis C treatment Ganovo (danoprevir) and ritonavir combination therapy on novel coronavirus pneumonia. The company’s shares edged up 1.63% to HK$3.73 by close of trading. 10 March 2020