- Merck’s Keytruda “Unlimited Cancer Species” Receives Priority Review by FDA
On the 8th, Merck & Co. announced that the US FDA has accepted the company’s second application for a license for supplementary biological products of “unlimited cancer species” for the key PD-1 inhibitor Keytruda. This application seeks accelerated approval of Keytruda for the treatment of patients with unresectable or metastatic solid tumors with high tumor mutation burden. The FDA also granted priority review qualification for this application and is expected to respond by June 18 this year. (WuXi PharmaTech)
- The United States will ban the export of key medical supplies
CNN reported on the 8th that according to a draft federal regulation, US companies will be banned from exporting key medical supplies used in response to the new coronary pneumonia epidemic. The US Emergency Management Agency and Customs and Border Protection will be responsible for the implementation of the ban. The two institutions said on the 8th that they are “working together to prevent domestic middlemen, distributors and other intermediaries from transferring these important medical resources abroad.” (CCTV News)
- Paricalcitol injection meets its rivals again, three domestic companies will siege AbbVie
Recently, Chengdu Yuandong Pharmaceutical Co., Ltd.’s application for paricalcitol injection has completed the review process, and the latest status is “under approval”, which is expected to welcome good news in the near future. Paricalcitol injection was first developed and marketed by AbbVie. It was approved for import in China in 2013. Hengrui was approved for the first imitation in 2018. In December 2019, Shanxi Weiqida Guangming Pharmaceutical became the second approved Domestic enterprises.
- Ministry of Industry and Information Technology: ECOM and other high-end medical equipment domestic enterprises are still unable to produce
Chen Kelong, deputy director of the First Department of Equipment Industry of the Ministry of Industry and Information Technology, introduced at the press conference of the Joint Defense and Joint Control Mechanism of the State Council on the 8th. During the epidemic prevention process, some shortcomings and weaknesses in the development of the industry were also highlighted. Enterprises cannot produce, insufficient supply of invasive ventilators, etc., some products need to be improved, and the standard system is not yet perfect. At present, the Ministry of Industry and Information Technology is organizing experts in the fields of health care, medical equipment, etc. to thoroughly sort out the shortcomings and weaknesses of medical equipment, study and take effective measures to break through the bottlenecks of key core technologies, parts and equipment, and accelerate the completion of China’s high-end medical equipment Short board. (Economic Daily News)
- Ministry of Industry and Information Technology: China’s new coronary pneumonia-related API exports have recently grown against the trend
Cao Xuejun, deputy director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, said that there are more than 1,500 manufacturers of APIs in China, with an output of more than 3 million tons in 2019 and more than 1 million tons of exports. The production of vitamins, antibiotics, antipyretics and analgesics in China accounts for more than 60% of the global output, and some products can reach 80%. From the current point of view, in the first quarter of this year, the output of APIs is basically the same as last year. The production of APIs has fully recovered. Due to the recent difficulties in logistics and transportation, the actual export volume of APIs has decreased by about 20% compared with last year, but it is related to the treatment of new coronary pneumonia Of APIs have grown against the trend.
- The US Food and Drug Administration (FDA): FDA and the Federal Trade Commission (FTC) jointly sent a letter to Genesis II Church of Health and Healing to market dangerous chlorine dioxide products, claiming to be used for treatment, or preventing infection with the new coronavirus Warning. It was reported that after drinking chlorine dioxide products, the body had serious adverse reactions.
- BGI will assist the Serbian government in building two “Fire Eye” laboratories
On April 8, the Serbian government and BGI signed a cooperation agreement, entrusting BGI to build two “Fire Eye” virus detection laboratories in Serbia, which are located in the capital of Belgrade and the southern city of Niš. After completion, the total detection capacity will reach 3000 per day One sample will greatly improve the detection capacity of the CSFV and help the Cypriot side fight the epidemic. (Shenzhen News Network)
- China’s large-scale production of ventilator? Ministry of Industry and Information Technology: Be sober
Chen Kelong, deputy director of the Department of Equipment Industry of the Ministry of Industry and Information Technology, said on the 8th that with the supply of key parts and components, China’s invasive ventilator’s weekly production capacity is about 2200 units, which is less than one-fifth of the world’s production capacity. reality. Therefore, in the context of the epidemic, large-scale production increases through expansion and conversion are basically impossible in the short term and difficult in the long term.