Japan’s Sumitomo Dainippon Pharma has received approval in its home country for Trerief (zonisamide) as a treatment for parkinsonism in dementia with Lewy bodies (DLB). 3 July 2018
There was good news for Anglo-Swedish pharma major AstraZeneca and its partners, with fast-track approval from Japan’s regulator for their breast cancer and lung cancer drugs. 2 July 2018
I-Mab Biopharma, a Chinese biotech company focusing on innovative biologics in therapeutic areas of immuno-oncology and immuno-inflammation, has completed a Series C financing for $220 million, representing one of the largest amounts ever raised in Series C by an innovative biotech company in China. 2 July 2018
The Japanese medicines regulator has approved Tokyo-based Takeda Pharmaceutical’s application to market Entyvio (vedolizumab) in ulcerative colitis (UC). 2 July 2018
Earlier this month, Jiao Hong, Commissioner of the National Drug Administration of China (CNDA), met with the visiting deputy Secretary General of the United Nations and the executive director of the UNAIDS Program, Michel Sidibe, and his party. 25 June 2018
Independent mitochondrial DNA specialist Stealth BioTherapeutics has raised $100 million from Nan Fung Technology’s Pivotal Beta and other new and existing investors. 20 June 2018
Following a deal late last year that gave Bayer access to valuable customer data, Chinese e-commerce platform Alibaba has entered into another collaboration with a German pharma major, this time Darmstadt’s Merck,. 20 June 2018
Bristol-Myers Squibb has announced that the Chinese National Drug Administration (CNDA) has approved Opdivo (nivolumab) for lung cancer patients, the first immuno-oncology therapy ever to be approved in the country. 15 June 2018
A ruling in the Supreme Court of the United States (SCOTUS) on Thursday found that foreign law deserves ‘respectful consideration’ but should not determine a class action’s outcome. 15 June 2018
US clinical-stage biotech Sage Therapeutics has entered into a strategic collaboration for the clinical development and commercialization of SAGE-217 for the treatment of major depressive disorder (MDD) and other indications in Japan, Taiwan and South Korea. 14 June 2018
Indian pharma majors selling copycat drugs in the USA are facing the heat given the steep competition and pricing pressure, and President Donald Trump's new policy on lowering drug prices, reports The Pharma Letter’s India correspondent. 12 June 2018
Privately-held Chinese biopharma CStone Pharmaceuticals has paid $40 million upfront for a license to develop and commercialize three drugs from US biotech Blueprint Medicines Corporation in China, either as monotherapies or combination therapies. 5 June 2018
The China State Drug Administration (CSDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 30 May 2018
As the high price of orphan drugs continues to be a major issue, the Indian government is looking to exempt orphan drugs from price control. The government has decided to take legal and other measures to control the price of drugs for rare diseases in order to ensure their affordability and health system sustainability, reports The Pharma Letter’s India correspondent. 30 May 2018
Japanese drugmaker Astellas has announced a restructuring of operations in its home country, involving a reduction of the workforce by around 600. 23 May 2018
Multinationals (MNCs) were thrilled by China’s recent policies on opening up the domestic pharmaceutical market to the world, notes The Pharma Letter’s local correspondent, Wang Fangqing, in her latest report from the ChinaBio partnering forum held recently in Suzhou. 21 May 2018
GC Pharma, a South Korean biopharma formerly known as Green Cross Corporation, has set up a USA-based company dedicated to the development of new vaccines. 21 May 2018
For the 14th consecutive year, the USTR has put China on a ‘priority watch list' on its annual analysis of countries’ adherence to standards governing intellectual property rights. 17 May 2018
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