Blog
RSS FeedPosted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC ...
Posted by Michael Wonder on 01 Nov 2023
CStone announces NMPA approval of sugemalimab for patients with relapsed or refractory extranodal NK/T-cell lymphoma, the first anti-PD-1/PD-L1 mAb approved for this indication
31 October 2023 - Sugemalimab is the world’s first anti-PD-1/PD-L1 monoclonal antibody approved for relapsed or refractory extranodal NK/T-cell lymphoma indication. ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 02 May 2022
U.S. FDA declines to approve two more China tested drugs
2 May 2022 - The U.S. FDA declined to approve two China tested cancer treatments on Monday, raising concerns over ...
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 15 Nov 2021
Competing with, and learning from, China in the global pharmaceutical innovation race
15 November 2021 - President Joe Biden has promoted investment in technology based industries, including the life sciences, as a strategic ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...
Posted by Michael Wonder on 18 May 2020
The coronavirus exposed the US' reliance on India for generic drugs. But that supply chain is ultimately controlled by China
17 May 2020 - Sarah Thebarge, a 41-year-old physician assistant living in San Francisco, takes a pill every day to ...
Posted by Michael Wonder on 25 Apr 2020
Maker of drug touted as coronavirus cure accuses China of gouging
24 April 2020 - Hydroxychloroquine controversially pushed by Trump as COVID-19 remedy. ...
Posted by Michael Wonder on 16 Mar 2020
Chinese official warns against U.S. effort to limit foreign medicine supplies
17 March 2020 - A Chinese official on Monday warned that a push by the White House to reduce U.S. ...
Posted by Michael Wonder on 12 Mar 2020
Coronavirus spurs U.S. efforts to end China’s chokehold on drugs
11 March 2020 - The Trump administration says the U.S. is too dependent on China for vital drugs. But it’s unclear ...
Posted by Michael Wonder on 29 Oct 2019
In generic drug plants in China and India, data falsification is still a problem
29 October 2019 - As the generic drug industry faces allegations of data manipulation, headlines about carcinogen-tainted blood pressure medicine, ...
Posted by Michael Wonder on 26 Oct 2019
Dialogue with Chinese authorities on medicine regulation
25 October 2019 - The Deputy Commissioner of the Chinese National Medical Product Administration, Dr Chen Shifei, visited EMA on ...
Posted by Michael Wonder on 14 Sep 2019
U.S. officials worried about Chinese control of American drug supply
13 September 2019 - "Basically we've outsourced our entire industry to China," retired Brig. Gen. John Adams told NBC News. "That ...