Huaxi Bio, a pharmaceutical speed reading agency, appointed Gao Yi as deputy general manager

February 20, 2021 / Medical Information At a Glance: Huaxi Bio appointed Gao Yi as Deputy General Manager; Pfizer submitted the latest stability data for the new crown vaccine; And Takeda Darvadstrocel Japan applied for listing... Daily fresh medicine news, speed reading society and you pay attention to! Part1 Policy Brief Liaoning Province drug production supervision and inspection defect rectification guide issued recently, in order to further implement the "four most stringent" requirements, further promote the implementation of the main responsibility of enterprises, guide and standardize enterprise supervision and inspection of defect rectification work, to achieve risk closed-loop management, prevent and resolve drug safety risks, in accordance with the People's Republic of China Drug Administration Law, the People's Republic of China Vaccine Administration Law, drug production supervision and management measures, drug production quality management norms and other laws and regulations, combined with the actual drug regulatory work
(Liaoning Provincial Drug Administration) "2020 Medical Device Registration Report" released on February 18, according to the State Council's official website, the State Drug Administration issued "2020 Medical Device Registration Report."
2020, the State Drug Administration approved the listing of 26 innovative medical device products, according to the report.
These innovative product core technologies have China's invention patent rights or invention patent applications have been disclosed by the patent administrative department of the State Council, the main working principle / mechanism of action of the product for the domestic initiative, with significant clinical application value.
(National Drug Administration) National Health Insurance Bureau: vaccination and vaccination costs borne by the medical insurance fund The financial system to give appropriate subsidies to the health insurance fund On February 20, Shi Zihai, deputy director of the State Administration of Health Insurance, said that the cost of vaccinations and vaccinations is borne by the medical insurance fund, the financial health insurance fund to give appropriate subsidies, individual residents free vaccination.
health insurance fund mainly through the use of the balance of previous years to bear, does not affect the current fund's income and expenditure, that is, will not affect the people's current medical treatment.
(Caixin) Part2 production by observation Huaxi Bio appointed Gao Yi as Deputy General Manager February 19, Huaxi Bio issued a notice that the company held the first board of directors of the 20th meeting, considered and adopted the "on the appointment of senior management of the company's bill , agreed to appoint Ms. Gao Yi as the company's deputy general manager for a term from the date of consideration and adoption of the current board of directors to the end of the term of office of the first board of directors, the board of directors authorized the general manager in accordance with the company's remuneration policy and Ms. Gao Yi's duties and contributions in the company and with reference to the industry level, to determine their remuneration.
(Huaxi Biological Announcement) Kangyuan Pharmaceuticals Deputy General Manager Wan Yanhuan resigned on the evening of February 19, Kangyuan Pharmaceuticals issued a notice that the board of directors of Jiangsu Kangyuan Pharmaceutical Co., Ltd. recently received a written resignation report from Mr. Wan Yanhuan, Deputy General Manager of the company.
Mr. Wan Yanhuan resigns as Deputy General Manager of the Company for personal reasons, Mr. Wan Yanhuan will no longer hold any position in the Company.
announced that it had raised $40 million in Round A financing.
the financing was led by Khosla Ventures, investment institutions such as Perceptive Advisors, Casdin Capital, Andreessen Horowitz, Sands Capital, and top individual venture capital investors including Jim Breyer/Breyer Capital, Rahul Mehta, former Goldman Sachs CFO and CIO R. Martin Chavez, biomedical equipment entrepreneur Shlomo Ben-Haim.
(Arterial Network) Yukun Intelligence and Abo Bio reached a strategic cooperation on February 19, Zikun Intelligence and Aibo Bio jointly announced that the two sides reached a comprehensive strategic cooperative relationship, relying on the two sides' technology platform and advantages of resources to form a joint effort to empower nucleic acid drug research and development.
to accelerate the development of infectious disease vaccines, therapeutic cancer new antigens, tumor vaccines and other drugs to meet major public health emergencies and clinical needs.
(Pharmaceutical Rubik's Cube) Part3 Drug News Pfizer BCMA-CD3 dual-specific antibody elranatamab launched a key Phase 2 trial Pfizer recently announced that the first patient has been treated with a registered Phase 2 Magnetis MM-3 study evaluating the treatment of double-specific antibody elranatamab for relapse or refractic multiple myeloma.
elranatamab is a two-specific antibody in the study that targets BCMA and CD3.
(Bio Valley) Concorde Kirin pioneered OX40 targeted single anti-KHK4083 Phase II clinical success Japan Pharmaceutical Association and Kirin recently announced that the evaluation of the antibody drug KHK4083 treatment of moderate to severe specific dermatitis adult patients phase 2 research reached the main endpoint.
KHK4083 is the first anti-OX40 all-human monoclonal antibody of its kind and is currently being developed for the treatment of autoimmune diseases, including specific dermatitis.
(Bio Valley) Hengrui Pharmaceutical Fluoropali 2 research results published recently, "Clinical Cancer Research" online full text published the full text of fluorine Pali single drug treatment BRCA1/2 mutation recurrence ovarian cancer single-arm, multi-center Phase 2 clinical results.
study was led by Professor Wu Lingying of the Oncology Hospital of the Chinese Academy of Medical Sciences and involved 26 research institutions in China.
results show that fluorozopa, which is used in patients with relapsed ovarian cancer with BRCA1/2 mutations, shows promising anti-tumor activity and acceptable safety and is expected to provide a new treatment option for this population.
(Pharma Mission) Sanofi's new factor VIII therapy has been approved by the FDA Fast Track Qualifying Noofi recently announced that the FDA has granted fast-track eligibility for the treatment of patients with type A blood type A blood.
efanesoctocog alfa is a new type of factor VIII therapy, independent of vascular haemophilia factors, which provide near-normal levels of factor activity for most of the week in a once-a-week preventive treatment.
applications for Padcev, a new ADC drug, have been jointly announced by the FDA to seattle Genetics and Astellas, and two applications for a supplemental biologics license for the antibody-coupled drug Padcev have been submitted to the FDA.
one of the phase 3 EV-301 trials aimed at transforming Padcev from accelerated approval to regular approval.
second trial, based on a critical EV-201 trial, aims to expand the current drug label to include patients with localized advanced or metastatic urethroid cancer who have been treated with a PD-1/L1 inhibitor and are not eligible for cisplatin therapy.
(Bio Valley) TCR Therapy was recognized by the FDA Breakthrough Therapy Today Immunocore announced that the FDA awarded its innovative T-cell-subject (TCR) therapy tebentafusp breakthrough therapy for the treatment of non-extinct or metastasis staphylactic melanoma adult patients who are HLA-A-02:01 positive.
, tebentafusp would be the first new treatment for metastasis staphylocosal melanoma in 40 years, according to a press release.
(Pharmaceuticals) Incyte uses priority review vouchers to submit new drug applications Incyte announced today that the FDA has accepted and will prioritize new drug applications for reedcotinie creams.
reed cocotinib cream is a topical drug of choice JAK1/JAK2 inhibitor for the treatment of adverse dermatitis, which is a type of eczema.
(Xinhua) -- Pfizer and BioNTech announced today that they have submitted new data to the FDA, demonstrating the stability of the new crown vaccine developed jointly at temperatures from -25C to -15C, which are more common in drug freezers and refrigerators.
companies are seeking to update labeling information under the emergency use authorization, which would allow the vaccine to be stored at these temperatures for a total of two weeks as an alternative or supplement to storage in ultra-low-temperature refrigerators.
(Pharmaceutical Mingkang) Johnson and Johnson single-dose new crown vaccine EU application for market, Johnson and Johnson announced that its Jansen-Cilag has submitted a conditional marketing authorization application to the EMA, seeking approval for its single dose of Jassen COVID-19 vaccine.
maa based on top-line efficacy and safety data from Phase 3 ENSEMBLE clinical trials.
a conditional marketing authorization, Johnson and Johnson must meet certain obligations, including providing additional data, within a specified period of time.
( Biogu) Takeda Darvadstrocel Japan's application for listing Takeda Pharmaceuticals recently announced that it has submitted an application to Japan's Ministry of Health, Labour and Industry to produce and sell Darvadstroce.
darvadstrocel is an allogeneic (or supply source) amplified fat stem cell suspension used to treat complex fistula in adult patients with in activityless or mildly active tube cavity CD.
(Bio Valley) Mercadong Innovative Therapy submitted clinical applications in China on February 20, the NMPA Review Center recently announced that Merca East submitted a new class of 1 drug belzutifan clinical trial applications for acceptance.
berzutifan's targeted signaling path is associated with hypoxia-inducing factors, and the study was awarded the Nobel Prize in Physiology or Medicine in 2019.
(Pharmaceutical Mission) Sun Pharmaceuticals in China to submit a new anti-cancer drug market application February 19, NMPA Drug Review Center announced that Sun Pharmaceuticals introduced phosphoric acid Soniadji capsules in China to submit a new drug listing application and CDE acceptance.
Phosphate Sonedge, an oral selective Smoothened inhibitor developed by Novaral, has been approved in the United States for the treatment of advanced substrate cell carcinoma, and Sun Pharmaceuticals announced in December 2016 that it had received a global interest in the drug from Novaral for $175 million.
(Medical Mission) New Discovery! Psychiatry drug lipeone may be able to treat stuttering recently, said Gerald A. A., professor and chairman of the Department of Psychiatry and Neuroscience at UCR School of Medicine. In an article published in Frontiers in Neuroscience entitled Investigation of Risperidone Associates With Enhanced Brain Activity in Patients Who Stutter, Dr. Maguire integrated functional neuroimaging techniques into stuttering therapy and found that lipid ketones, a drug previously earmarked for schizophrenia and bipolar disorder, may have some effect on stuttering, and that its function may be related to star cells in the brain streatum.
(Biological Exploration)