In its initial public offering (IPO) on the Hong Kong Stock Exchange, China’s Innovent Biologics has reportedly sold around $421 million worth of shares priced at the top end of estimates, at about $1.78 per share. 25 October 2018
Chugai Pharmaceutical has concluded a collaborative research agreement with privately held fellow Japanese biopharmaceutical company Anaeropharma Science concerning the creation of novel oncology drugs utilizing characteristic features of Bifidobacterium longum through Anaeropharma's proprietary platform technology, "in situ Delivery and Production System" (i-DPS). 22 October 2018
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). 17 October 2018
Chinese biotech Innovent Biologics wants to raise $422 million in an initial public offering (IPO) to take forward its monoclonal antibodies and other biologics in oncology, ophthalmology, autoimmune, and cardiovascular diseases. 16 October 2018
Shanghai-listed Zhejiang Huahai Pharmaceutical has been placed under close supervision by European authorities, after an inspection uncovered “quality management weaknesses” at the company’s Chuannan site in Linhai, China. 16 October 2018
The firm that calls itself the leading oncology company in Japan strengthened its position on Wednesday with the approval of its breast cancer drug in a new indication in the Asian country. 11 October 2018
The three Japanese drugmakers that launched a program a year ago to discover new treatments using a drug-repositioning compound library have started a second recruitment round to find new researchers. 10 October 2018
Japanese pharma major Astellas Pharma today revealed that it has submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in patients on dialysis. 1 October 2018
Legend Biotech, a subsidiary of reagents services provider Genscript Biotech Corporation, regained some of Thursday’s stock market losses on Friday. 1 October 2018
In an expert view, Maggie Chang, vice president, regulatory affairs, at China-based Hangzhou Tigermed Consulting, takes a look at what is now happening in China’s amended new drug approval system. 28 September 2018
The world’s largest healthcare plan has been launched by Indian Prime Minister Narendra Modi, providing free or subsidized coverage for the poorest 40% of India’s population. 27 September 2018
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 26 September 2018
China’s State Council, the executive body that oversees government operations, has listed a series of improvements that are needed for the selection and adoption of essential drugs. 21 September 2018
A few short months after Merck & Co won its first Chinese approval for flagship immuno-oncology product Keytruda (pembrolizumab), the firm has reportedly agreed a price reduction plan that will enable patients to gain access for around half the US list price. 20 September 2018
China’s public health watchdog, the National Health Commission (NHC), has released three sets of guidelines covering the burgeoning market for internet-based medical services. 17 September 2018
Osaka-based firms Shionogi and Rohto Pharmaceutical have agreed to work together on the Japanese development and possible future commercialization of ADR-001, a candidate for the treatment of liver cirrhosis. 14 September 2018
As the US Food and Drug Administration approves a record number of Abbreviated New Drug Applications (ANDAs) in FY2018, Indian drug makers continue to reel under the regulator's scanner, with many rushing to correct mistakes in manufacturing standards, reports The Pharma Letter’s India correspondent. 12 September 2018
Japanese drug major Daiichi Sankyosaw its share move up 4.3% to 4,563 yen after it revealed its quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labor and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML). 11 September 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