News
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD).
Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma
Innovent Biologics and IASO Biotechnology announce that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® (Equecabtagene Autoleucel, co-developed and co-commercialized by Innovent and IASO Bio.
Pharming CEO Sijmen de Vries wins Chief Executive of the Year Award
Pharming CEO Sijmen de Vries wins Chief Executive of the Year Award
Temasek-backed Tessa Therapeutics to cease operations after failure to raise funding
TESSA Therapeutics, one of the top-funded biotech startups in Singapore, will soon enter liquidation after failing to find investors to continue funding the development of its cancer treatment cell therapies.
Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan
Guardant Health, Inc. (Nasdaq: GH) announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare for its Guardant360® CDx liquid biopsy test for comprehensive genomic profiling for patients with advanced or metastatic solid tumor cancers.
I-Mab Announces Publication of Claudin18.2 x 4-1BB Bispecific Antibody Givastomig in JITC
I-Mab (Nasdaq: IMAB) announced the publication of a manuscript entitled "CLDN18.2 and 4-1BB bispecific antibody givastomig exerts antitumor activity through CLDN18.2-expressing tumor-directed T-cell activation" in the latest issue of The Journal for Immuno-Therapy of Cancer (JITC).
Moderna signs deal in Shanghai with view to developing mRNA medicines
Vaccine maker Moderna Inc (MRNA.O) said on Wednesday it had signed a memorandum of understanding and a land collaboration agreement to work towards opportunities for it to research, develop and manufacture mRNA medicines in China.
SK bioscience- Government Pharmaceutical Organization Sign Memorandum of Understanding to Strengthen Vaccine Infrastructure in Thailand
SK bioscience announced that the company has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand's vaccine infrastructure.
Pfizer to end development of experimental obesity pill due to elevated liver enzymes
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, lotiglipron, due to elevated liver enzymes in patients who took the drug once a day in midstage clinical studies.
Regulatory logjam in China offshore listings hits firms’ funding plans
Chinese companies are finding it challenging to get timely regulatory approvals for overseas share offerings as scrutiny of their proposals has intensified under new listing rules, frustrating potential issuers and investment bankers.
