"Pharmaceutical Express" Kangmei management "blood change" drug recall management measures for comments.

October 13, 2020 / Medical Information At a Glance: Conme management "changed blood" after the state-owned company entered the administration; drug recall management measures for comments; Lilly and Johnson and Johnson announced the latest clinical results of il-23 inhibitors for the treatment of Crohn's disease; Sanofi Dupixent treatment of children with moderate severe asthma Phase III research success ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Briefing State Drug Administration: Do a good job in the construction of key varieties information traceability system Today, the State Drug Administration issued a good job in the key varieties information traceability system construction announcement, put forward by December 31, 2020, the basic realization of the national drug centralized procurement of selected varieties, narcotic drugs, psychotic drugs, blood products and other key varieties traceable.
(State Drug Administration) The State Drug Administration publicly solicited the opinions of the Measures for the Administration of Drug Recalls (Draft for Comments) Today, the General Department of the State Drug Administration publicly solicited the opinions of the Measures for the Administration of Drug Recalls (Draft for Comments), and the draft requested that drug market license holders should establish and improve the drug recall system, collect relevant information on drug safety, investigate, evaluate and recall defective drugs in a timely manner.
(State Drug Administration) The State Drug Administration issued the "National Medical Device Quality Spot Check Inspection Procedures (Draft for Comments)" in order to further strengthen the quality of medical device spot checks and inspection management, standardize the national medical device quality spot checks and inspection work, the State Drug Administration General Division today issued a public consultation "National Medical Device Quality Spot Checks and Inspection Procedures (Draft for Comments)" opinions.
(National Drug Administration) from now to 16 Heilongjiang Province inspection pharmacy October 12, Heilongjiang Province issued "on the implementation of the autumn and winter new crown pneumonia outbreak risk detection work notice", the content of the investigation is mainly 5 aspects: medical institutions infection prevention and control situation, each sentinel prevention and control situation, nucleic acid detection capacity-building situation, isolation site control situation, "two stations one" epidemic prevention and control situation.
(Heilongjiang's leading group to deal with the outbreak of new crown pneumonia) from this month, Hunan pharmacies can only increase the price of these drugs by up to 15% today, Hunan Provincial Health Insurance Bureau issued "on strengthening the participation in the national collection of medical insurance agreement retail pharmacy management notice."
the first paragraph of the Notice, "As of October 20, 2020, retail pharmacies under the health insurance agreement will be allowed to sell at a rate of not more than 15% on top of the selected price if they participate in the national collection."
" (Hunan Provincial Health Insurance Bureau) Guizhou recently released: domestic non-conformance recommended procurement of imported equipment October 12, Guizhou provincial government procurement network released "Guiyang City Fourth People's Hospital high-performance color ultrasound diagnostic equipment and other medical equipment procurement items import products public notice" shows that in whether to restrict imports or prohibit imports of products column "No."
(Guizhou Provincial Government Procurement Network) Part 2 after observing the state-owned investment into the management of Kangmei "blood change" on the evening of October 12, Kangmei Pharmaceuticals issued a notice that the board of directors on October 10, 2020 received the company's chairman and general manager Mr. Ma Xinggu for work arrangement reasons resigned as general manager of the company's report.
AGC Biologics has appointed CDMO, general manager of the Milan plant, to announce a new appointment today to kick-start the business consolidation following the acquisition of MolMed on July 31, 2020.
from now on, Luca Alberici will change his position from Chief Business Officer of MolMed to General Manager/Director of the Production Plant in Milan, Italy, to ensure that the company is able to take full advantage of and integrate the global integrated capabilities of AMC Biologics.
(The Associated Press) Part 3 Drug News Lilly and Johnson and Johnson announced the latest clinical results of IL-23 inhibitors for crohn's disease at the 28th European Digestive Disease Week Virtual Meeting, Lilly and Johnson and Johnson announced the latest results of two IL-23 inhibitors mirikizumab and Tremfya treatment of Crohn's disease Phase 2 clinical studies, respectively, continue to improve symptoms, reduce intestinal inflammation and effective induction clinical and endoscopic improvement.
(Xinhua) -- Sanofi Dupixent has reached the primary and critical secondary endpoints in a critical Phase III clinical trial for moderate to severe asthma in children aged 6-11 years, the company announced today.
Dupixent is also the only biologic agent currently shown to improve lung function in children in a randomized Phase III study.
(Pharmaceutical Rubik's Cube) Pfizer Vyndaqel and Vyndamax co-pay litigation to impact the industry's drug pricing Pfizer's two fast-growing and expensive heart drug Vyndaqel and Vyndamax, which have been the focus of attention since they were approved by the FDA in 2019.
, two drugs became the core product of a federal Medicare-paid lawsuit that could have repercussions across the industry.
(Xinhua) -- The FDA recently announced that it rejected a new drug application for IV Tramadol, an intravenous agent, because of safety concerns.
the news, Avenue's share price plunged more than 56 per cent in pre-market trading.
(Xinhua) -- For the first time in five years, innovative NASH therapy has been recognized by the FDA as a breakthrough therapy, Inventiva announced today, and the U.S. FDA has awarded the company's leading candidate drug, Lanifibranor Breakthrough Therapy, for the treatment of non-alcoholic fatty hepatitis (NASH).
is the first NASH candidate to be awarded the drug since January 2015.
(Pharmaceutical Mingkangde) Oshitini's application for listing of new adaptive diseases in China is to be included in the priority review On October 12, AstraZenecon's application for the listing of methionate occitini tablets submitted in China is to be included in the priority review for postoperative treatment of tumors in adult patients with non-small cell lung cancer with skin growth factor-sensitive mutations.
(Pharmaceutical Rubik's Cube) Gilead JAK1 inhibitor Phase 2b/3 clinical results positive Today, Gilead Sciences and Galapagos jointly announced that the oral JAK1 selective inhibitor filgotinib, jointly developed by the two sides, demonstrated long-lasting efficacy and safety in the treatment of severe active ulcerative colitis (UC) Phase 2b/3 clinical trials.
patients treated with 200 mg filgotinib achieved clinical remission at week 10 and maintained remission until week 58 compared to placebo.
(Pharmaceutical Mingkangde) Fujifilm silver amplification technology to develop highly sensitive and fast new coronavirus antigen testing kit October 12, Fujifilm announced the beginning of the development of antigen detection kit for the diagnosis of new coronavirus infection.
Fujifilm will use its unique silver amplification immunotomography method to develop antigen test kits that can detect new coronavirus quickly and sensitively using silver amplification technology used in photo development.
team led by Dr. Jennifer Doudna, one of the nobel laureates in chemistry, developed a new type of new coronavirus detection based on CRISPR-Cas13a technology without PCR.
it does not need to amplify viral RNA using RT-PCR, which directly quantifys the level of viral RNA in the sample.
test results can also be read out in environments outside the laboratory using a smartphone-based detection system.
(Pharmaceutical Minder)