Clinical & Regulatory
Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) today announced that the U.S. Food and Drug Administration (FDA) approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients
FDA has granted it clearance to proceed with TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma
Clearside Biomedical Announces Advancement of XIPERE® in Asia-Pacific for Suprachoroidal Treatment of Uveitic Macular Edema as Partner Arctic Vision Completes Enrollment in Phase 3 Clinical Trial in China
Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for commercialization and development of XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which they refer to as ARCATUS, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries.
Precision Neuroscience wins FDA breakthrough nod for BCI, buys factory in Texas
Precision Neuroscience announced today that its brain-computer interface (BCI) technology won FDA breakthrough device designation.
Zatolmilast, an Investigational Treatment for Fragile X Syndrome, Receives Rare Pediatric Disease Designation from the U.S. FDA
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced the U.S. Food and Drug Administration (FDA) has granted Tetra Therapeutics Inc. (hereafter "Tetra"), a Shionogi Group Company, Rare Pediatric Disease Designation for zatolmilast (BPN14770), an investigational treatment being studied for Fragile X syndrome (FXS), a leading cause of inherited intellectual disability and autism.
FDA considers temporary cancer drug imports from unapproved companies to ease U.S. shortage
The Food and Drug Administration is considering allowing temporary importation of chemotherapy drugs from overseas manufacturers that are not currently approved to distribute in the United States.
BeiGene Strengthens Global Portfolio and Regains Full Rights from Novartis for Anti-PD-1 Antibody TEVIMBRA® (tislelizumab)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab).
China: The latest medtech access policies and implications
In May 2023, NHSA indicated a change of direction from top-down management to a bottom-up approach, issuing policies requesting NRMDL to be established in all provinces by 2025.
