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
Continuing its progress in addressing different cancer types across different geographies, immuno-oncology blockbuster Tecentriq (atezolizumab) has secured Chinese approval in extensive-stage small cell lung cancer (ES-SCLC). 14 February 2020
Should any drugmakers still be in doubt about the extent of the opportunity that China presents them with, a report from consultancy firm LEK Insights has laid bare the size of the market. 13 February 2020
Shares in US biotech CytoDon were 7% up after Wednesday morning's trading following news of a development and licensing deal for leronlimab in China. 13 February 2020
As the Office of the US Trade Representative (USTR) prepares its annual “Special 301 Report,” the US pharmaceutical industry has submitted comments calling for an end to market access barriers globally. 10 February 2020
Israeli drugmaker Teva Pharmaceutical Industries and its partner for the Japanese market, Otsuka Pharmaceutical, have edged closer to approval for Ajovy (fremanezumab) in the Asian country. 3 February 2020
China-based generics drugmaker Qilu Pharmaceutical received approval in December 2019 for QL-1101 under the trade name Ankada, a biosimilar to Avastin (bevacizumab), to treat advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). 3 February 2020
Shanghai, China-based WuXi Biologics says it has increased efforts in enabling the development of multiple neutralizing antibodies for the current outbreak of a novel coronavirus (2019-nCoV), centered in Wuhan, China. 29 January 2020
Japanese drugmaker Otsuka Pharmaceutical has announced positive preliminary results from two, Phase II/III trials for fremanezumab as a prophylactic migraine drug. 28 January 2020
As the general public and drugmakers alike scramble to find out more information about the emerging coronavirus outbreak in Wuhan, China, the US regulator has provided an update on critical actions to advance medical countermeasures. 28 January 2020
The Japanese health authorities have approved Cimzia (certolizumab pegol) to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective. 28 January 2020
Japan Tobacco and Torii Pharmaceutical have received manufacturing and marketing approval for Corectim Ointment 0.5% (delgocitinib; formerly JTE-052), a Janus kinase (JAK) inhibitor, for an indication of atopic dermatitis in Japan. 27 January 2020
Propess (dinoprostone) has been approved by the Minister of Health, Labour and Welfare in Japan for initiation of cervical ripening in patients at term. 23 January 2020
In November 2019, China updated its National Reimbursement Drug List (NRDL) to include 70 new medicines, with an average price cut of 61% agreed by pharma companies. 23 January 2020
Asian-Pacific contract research organization (CRO) Novotech has issued a report describing a record year for clinical trials, as defined by numbers of studies, investigators, and patient enrollment. 22 January 2020
The second round of China’s national generics procurement, which ended on January 17, saw 53% price cuts on average of the 32 drugs that treat diseases including cancer and type II diabetes. 22 January 2020