Another biosimilar drug, Herceptin, is on the market. 218 drugs have been asked to reduce prices

Wuhan's new purchasing plan with volume was put forward; anstelai purchased American generic manufacturer audentes with us $3 billion; competition intensified! Another biosimilars of Herceptin are on the market; On February 2, Heilongjiang drug centralized purchase network released the notice on the implementation of price linkage of non selected drugs in the alliance area According to the catalogue, 218 drugs need to declare the lowest price in China The relevant pharmaceutical manufacturers shall declare within the prescribed time limit and ensure the authenticity and accuracy of the declared items For the enterprises that fail to declare the price reduction within the prescribed time limit, the qualification for online trading of corresponding products will be suspended (Heilongjiang medicine collection network) On February 2, Anhui food and Drug Administration issued the specific measures to promote the healthy development of drug retail (chain) enterprises, and put forward six measures for the healthy, standardized and high-quality development of drug retail (chain) enterprises Among them, Article 1 of the measures clearly points out that the legal representative and the main person in charge of the headquarters of the drug retail chain enterprise must bear legal responsibility for the drug trading activities of its stores according to law, and no longer requires that the person in charge of the stores of the chain enterprise must be a licensed pharmacist (pharmacy manager) On January 1, Wuhan issued four copies of detailed rules on drug volume purchasing: classification method of drug volume purchasing catalogue in Wuhan (Draft for comments), quality stratification method of drug volume purchasing in Wuhan (Draft for comments), quality scoring method of drug volume purchasing in Wuhan (Draft for comments), implementation of the first batch of drug volume purchasing in 2019 in Wuhan Detailed rules, for the "4 + 7" after the volume procurement mode, to create a new sample (e drug manager) In order to speed up the promotion of unified coding standards for medical insurance information business and form a national "common language" On December 2, the State Medical Insurance Bureau issued the notice on publicizing the first batch of medical consumables information in the medical consumables classification and code database of medical insurance, and more than 30000 medical consumables codes of medical insurance were published (state health insurance bureau) Japan's anstelai pharmaceutical company recently announced that it has agreed to purchase American generic manufacturer audentes therapeutics for about $3 billion in cash to strengthen its generic product portfolio for the treatment of rare neuromuscular diseases Under the deal, Astaire will pay $60 in cash for each of the audentes shares, a 110% premium to Monday's closing price (Sina Finance) Today, IFM therapeutics announced the completion of a new round of US $55.5 million financing, which will be used to establish its third subsidiary IFM Quattro and its first incubator IFM discovery IFM Quattro and IFM discovery are both committed to developing the next generation of small molecule immunotherapy for inflammatory diseases and cancer This round of financing is led by Omega funds, with Atlas venture and abingworth participating in the investment (chuangjianhui) Recently, mylan and biocon, an Indian pharmaceutical company, have successfully launched ogivri, a biosimilar drug of Herceptin in the United States It is the second biosimilar drug of Herceptin to be listed in the United States after Amgen / Erjian kanjinti Although the specific prices of 420mg and 150mg ogivri were not disclosed, mylan said it would enter the market with a "competitive discount" (Sina Medical News) On the 2nd, Seattle genetics / Astaire announced a cooperation agreement with MSD to jointly carry out the clinical trial of antibody coupled drug (ADC) enfortumab vedotin and keytruda for the first-line treatment of locally advanced or metastatic urothelial carcinoma Under the agreement, the three companies will fund the launch of a global registered phase III study, which will be led by Seattle genetics and is currently communicating with regulatory agencies on the pilot design, which is expected to start in the first half of 2020 (medicine cube) Recently, y-mabs therapeutics announced that it has launched its rolling BLA application for humanized monoclonal antibody naxitamab targeting gD2 antigen to treat patients with recurrent / refractory high-risk neuroblastoma According to the information on y-mabs's website, the application will be submitted in the first quarter of 2020, and FDA's reply is expected in October 2020 (yaomingkant) Today, Incyte announced that FDA has accepted the listing application of its FGFR inhibitor, pemigatinib, for the second-line treatment of advanced cholangiocarcinoma after FGFR2 fusion or translocation In a phase II clinical trial called light-202, pemigatinib produced a 36% response rate and a median response time of 7.5 months in this population The FDA gives pemigatinib the priority approval qualification, which is usually a priority approval channel to significantly improve the treatment of new drugs without standard therapy, which is 4 months shorter than the standard approval time (source of us and Chinese Medicine) Recently, the listing application of four new generic drugs "Acarbose Tablets" of Beijing Wansheng Pharmaceutical Co., Ltd is in the state of "being approved" (acceptance No.: cyhs1800091) It is expected to be approved in the near future after two rounds of supplementary information and on-site inspection during the review process After the application is approved according to the four new registration categories, it will be deemed to have passed the consistency evaluation (meter net) Shanghai Hyundai Pharmaceutical Co., Ltd announced Tuesday that its holding subsidiary, Sinopharm Zhijun, had received the approval document for supplementary application of cefuroxime axetil capsule (0.125g) approved and issued by the State Food and drug administration, which approved the drug to pass the consistency evaluation (Sina Medical News) On February 2, Anke Hengyi, a wholly-owned subsidiary of Anke biology, received the approval document for supplementary application for amoxicillin capsule approved and issued by the State Food and Drug Administration with the approval number of 2019b0 * * 7 After examination, amoxicillin capsule of ankehengyi passed the consistency evaluation of quality and efficacy of generic drugs At the same time, the State Food and Drug Administration agreed to change the prescription process and revise the quality standard of the drug (Sina Medical News) On February 2, "tegrilol tablets" of Nanjing Youke Pharmaceutical Co., Ltd was approved by the State Food and Drug Administration and registered as the old 6 categories (medicine cube) On March 3, Taiji Group announced that southwest pharmaceutical, a holding subsidiary, had received the notice of clinical trial of oxycodone hydrochloride sustained-release tablets approved and issued by the State Food and drug administration According to the data of minenet, in 2018, the sales volume of oxycodone in China's public medical institutions was close to 900 million yuan NAPP, the original research enterprise, had the approval documents for sustained-release tablets, injections and capsules Beijing HuaSu Pharmaceutical Co., Ltd There are approvals for oxycodone hydrochloride tablets (meter net)