Japanese pharmaceutical company Shionogi has announced the first peer-reviewed publication of its phase 3 study investigating ensitrelvir to treat patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam.
Adults and children in the US with congenital thrombotic thrombocytopenic purpura (cTTP) can now access Adzynma for prophylactic and on-demand treatment.
The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.
Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.
The Japanese firm Astellas Pharma will apply for planning permission to construct a drug manufacturing facility in Tralee, Co. Kerry, Ireland worth around €330 million ($352 million).
The first patient has been enrolled in a phase 3 clinical trial of leniolsib a treatment for a rare inherited condition affecting how the immune system works.
The Japanese company Shionogi has taken over the US biotech Qpex Biopharma for up to $140 million in a bid to expand its pipeline of antimicrobial drugs and boost its R&D muscle in infectious disease.
Positive phase 3 results from a trial studying fruquintinib, in patients with previously treated colorectal cancer (CRC) were announced by Hutchmed and Takeda on Friday (June 16).
A collaboration will unlock Japan’s research and development (R&D) and boost the adoption of new technologies, experts in the Japanese pharmaceutical sector and a not-for-profit alliance say.
The AI technology firm and pharma services company are joining to help one of the country’s leading pharmaceutical firms develop a promising drug candidate.
The digital health company AMRA has entered into an exclusive agreement with the largest imaging CRO in Japan as part of its work to provide ‘critical informatics’ to the drug development industry.
Biopharmaceutical companies are increasingly relying on CROs in Japan, says an executive with PRA, which recently established a new subsidiary in the country.
Takeda and Sosei both have a proud heritage in Japan and recently entered a billion-dollar partnership with Sosei to discover, develop, and commercialize molecules for patients in need around the world.
Astellas agrees a deal for the ex-US rights of Frequency’s lead drug candidate, FX-322, after the latter company posted positive results in a Phase I/II trial.
CMIC Group is the first Japanese CRO to join the Align Clinical group and expects to improve execution of clinical trials and collaboration with life sciences companies as the industry grows globally.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
Phastar expands globally, adding offices in Japan and the US, and enters a partnership with Medidata to transform its increasing data points into insights.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
Scientist.com has more than 70 employees across the globe, with offices in San Diego, Boston, the UK – and soon, Japan, with plans to open several satellite offices across the country.
Japan’s proximity to China, pharmaceutical infrastructure, and workforce capabilities helped inform Biorasi’s decision to launch regional headquarters in Tokyo, says executive.
Clinigen Group plc has acquired the Japanese unlicensed medicines supplier International Medical Management Corporation (IMMC) in order to further develop its market access, says CEO.
Japanese regulators are investigating allegations API firm Yamamoto Chemical Industry gave inspectors false information and improperly bulked-up batches of acetaminophen and zonisamide.
Sanofi will tap Japanese academics' personalised medicine knowhow under a new collaboration with the University of Tokyo's translational research initiative (TR).
Dr Reddy’s has set out to build in the Japanese market days after revealing that higher generic and API sales elsewhere had been pegged back by currency fluctuations.
Wilmington, North Carolina-based CRO (contract research organization) PPD (Pharmaceutical Product Development) and Tokyo-based Shin Nippon Biomedical Laboratories (SNBL) have closed an agreement to form a joint venture to provide clinical development...
The European Investment Bank (EIB) has loaned Innocoll AG €25m to support development of a post-surgical painkiller and diabetes-related infection drug delivered using its collagen-based tech.
PPD and SNBL will set up a clinical services joint venture (JV) in Japan and collaborate on preclinical and Phase I bridging studies under a new agreement.
A new report says the Japanese CRO market is seeing more growth as Japanese pharma firms, which traditionally kept research in-house, are now broadening their horizons to use more outsourcing partners.
CRO INC Research opened two new locations in Osaka and Tokyo, Japan, to further expand the company’s reach to conduct trials in the highly sought-after Asian region.
Takeda says it will help Nihon Pharmaceuticals bring manufacturing operations up to code after Japanese regulators order the CMO to halt production and recall one lot of its vitamin B1 shot.
