Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Easyendo Surgical Inc. has won the South Korean Ministry of Food and Drug Safety’s (MFDS) latest breakthrough device designation for its robotized ureteroscope. The device, currently known as Easyuretero, is the first of its type to be developed in South Korea. The next goal for Easyendo will be regulatory approval, said the MFDS. Daejeon, South Korea-based Easyendo is already working towards winning that approval. “We are now preparing to start clinical trials in South Korea, and discussing the start date and scope of the trials with MFDS,” an Easyendo spokesperson told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amra Medical, Audere, Cosara, Foldax, Linus Biotechnology, Medtronic.
Although Pfizer Inc.’s COVID-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), has yet to be authorized anywhere, the push for compulsory licensing of the drug has begun.
John Klein, the former CEO and majority shareholder of a New Jersey-based pharmaceutical company, was charged Dec. 6 with one count of wire fraud involving the alleged embezzlement of millions of dollars from the unnamed company.
Mitsubishi Tanabe Pharma Corp.'s Medicago Inc. plans to "imminently" seek Health Canada approval for its plant-based COVID-19 vaccine candidate, MT-2766, after top-line phase III results showed an overall vaccine efficacy rate of 71% against all variants of SARS-CoV-2.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cyprium, Enlivex, Gan & Lee, Octapharma, Roche, Sentynl, Theratechnologies, Vincerx.
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