Blog
RSS FeedPosted by Michael Wonder on 28 Feb 2022
JW Therapeutics announces NMPA acceptance of the supplemental new drug application for Carteyva in patients with relapsed or refractory follicular lymphoma
27 February 2022 - JW Therapeutics announced that the National Medical Products Administration of China accepted the supplemental new drug ...
Posted by Michael Wonder on 12 Feb 2022
China approves use of Pfizer's COVID drug Paxlovid
12 February 2022 - China's medical products regulator said on Saturday it has given conditional approval for Pfizer's COVID-19 drug ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...
Posted by Michael Wonder on 06 Feb 2022
Importing oncology trials from China: a bridge over troubled waters?
4 February 2022 - On 10 February 2022, the US FDA's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a ...
Posted by Michael Wonder on 31 Jan 2022
Trevena announces submission of new drug application in China for Olinvyk by its partner Jiangsu Nhwa Pharmaceutical
27 January 2022 - Submission supported by data from a Phase 3 bridging study of oliceridine injection compared to intravenous morphine, ...
Posted by Michael Wonder on 30 Jan 2022
BeiGene announces acceptance of supplemental new drug application in China for Brukinsa (zanubrutinib) in chronic lymphocytic leukaemia with breakthrough therapy designation
28 January 2022 - Brukinsa was granted its first breakthrough therapy designation in China with this application. ...
Posted by Michael Wonder on 19 Jan 2022
CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration
17 January 2022 - Priority review expected to be granted. ...
Posted by Michael Wonder on 16 Jan 2022
Basilea announces approval of antifungal Cresemba (isavuconazole) for invasive aspergillosis in China
13 January 2022 - Second approved indication after invasive mucormycosis in December 2021. ...
Posted by Michael Wonder on 27 Dec 2021
Ligand’s Partner CStone Pharmaceuticals receives approval in China for sugemalimab (Cejemly) for the first-line treatment of advanced non-small-cell lung cancer in combination with chemotherapy
22 December 2021 - Sugemalimab was discovered using the OmniAb platform. ...
Posted by Michael Wonder on 18 Dec 2021
Chinese official a ‘hero’ after forcing US drug maker Biogen to cut cost of treatment for spinal disease with ‘gentle but firm’ approach
6 December 2021 - US pharmaceutical company reduces the price of a drug for a rare spinal disease after seven rounds ...
Posted by Michael Wonder on 14 Dec 2021
New hope offered to rare disease patients
14 December 2021 - Early this month, the world's first therapy to treat spinal muscular atrophy, a rare genetic disorder ...
Posted by Michael Wonder on 11 Dec 2021
Junshi Biosciences announces NMPA accepted supplemental new drug application for toripalimab in combination with chemotherapy as first-line treatment of advanced NSCLC
10 December 2021 - Sixth indication for toripalimab submitted in China. ...
Posted by Michael Wonder on 09 Dec 2021
Henlius' fourth biologic bevacizumab biosimilar approved by National Medical Products Administration
3 December 2021 - Shanghai Henlius Biotech announced that bevacizumab biosimilar, developed and manufactured by Henlius independently, has been approved by ...
Posted by Michael Wonder on 09 Dec 2021
InnoCare announces inclusion of orelabrutinib in China National Reimbursement Drug List
2 December 2021 - InnoCare Pharma announced today that its BTK inhibitor orelabrutinib has been included in the updated National Reimbursement ...
Posted by Michael Wonder on 09 Dec 2021
Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA as first COVID-19 neutralising antibody combination therapy in China
8 December 2021 - The approval marks the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomised, double-blind ...