Chinese cancer specialist BeiGene has entered into a second collaboration with SpringWorks Therapeutics, a spin-out from US pharma giant Pfizer. 18 June 2019
Much of the dialogue surrounding Roche’s oncology drugs is currently about the big-selling products at the end of their patent life, but the company has provided a timely reminder that its new innovations are a big deal too. 18 June 2019
Tumor drug resistance specialist Deciphera Pharmaceuticals has inked a deal with Shanghai-based Zai Lab to advance the development and commercialization of ripretinib in China. 18 June 2019
Germany’s Merck KGaA has been building a multi-dimensional ecosystem with its two pharmaceutical sectors - healthcare (formerly known as Merck Serono) and life sciences - to propel its future advances in China. 13 June 2019
It is been more than a year since China and the USA are engaged in an escalating trade battle involving mutual placement of punitive tariffs. However, in the latest round, the USA has excluded pharmaceuticals as a category from the list of trade war tariffs. 12 June 2019
Patients should get more of a say on the drugs that their taxes pay for, states one of the recommendations in a report launched in Australia on Monday. 3 June 2019
Mere statistics cannot describe the changes that have taken place, and are taking place, between employees and their employers in Japan’s pharma companies, writes long-time Japan pharma watcher and president of International Alliances Limited P Reed Maurer in his exclusive column for The Pharma Letter. 31 May 2019
Japanese pharma Daiichi Sankyo has denied that it is negotiating the sale of its subsidiary, Daiichi Sankyo Healthcare, despite media reports that talks are underway. 24 May 2019
China must take measures to largely improve its clinical data quality to be a competitive player in the global biotech market, said speakers at China’s recent clinical development summit held in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing. 24 May 2019
GlaxoSmithKline today announced that China’s National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. 23 May 2019
A new study on the Chinese pharmaceutical market, the CPhI Annual Report, highlights an increase in API manufacturing, innovation, competitiveness and finished product manufacturing. 23 May 2019
Tokyo-based Chugai Pharmaceutical is to close two research centers and transfer their functions to a new facility that it will build in Yokohama. 23 May 2019
Less than a year after Japanese drugmaker Takeda’s Entyvio was approved in the company’s home country to treat ulcerative colitis, a further indication for the drug has been authorized. 22 May 2019
As China is becoming an incubator for an increasing number of innovative biotech startups, multinationals are actively seeking potential novel assets to enrich their global pipelines, said speakers at the ChinaBio forum held recently in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing. 20 May 2019
A draft issued on March 29 by China’s National Health Commission (CNHC), which regulates hospitals in China, allows qualified 3 Jia ( meaning top-level) public hospitals to develop and commercialize somatic cell therapies within their own hospitals. 17 May 2019
Chuikyo, Japan’s Central Social Insurance Medical Council, on May 15 approved the listing of Swiss pharma giant Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) on May 22, with a National Health Insurance (NHI) price tag of some 33.5 million yen ($305,800), according to media reports. 15 May 2019
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