"Pharmaceutical Speed Reading Society" Pharmaceutical Province's latest collection of documents Roche SMA therapy long-term efficacy is positive.

September 29, 2020 / Medical Information At a Glance: Company Director Wen Zhongyi applied for resignation; Junshi BioPD-1 Monoantigen Phase 3 clinically reached the end of major research; Jetbellin Haegarda Enlargement Adaptive Disease was approved by the FDA; And Kontai Biovirus Inactivated Vaccine (Vero Cell) was approved for clinical trials... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief Issued by the State Drug Administration: "Requirements for the Registration classification and Declaration of Chinese Medicine Information" on the 28th, the State Drug Administration issued the "Requirements for the Classification and Declaration of Chinese Medicine Registration Information" notice.
requirements, it is clear that the ancient classical prescription of Traditional Chinese medicine compound preparation two types of cases should be prepared using traditional technology, the use of traditional drug methods, the main function of traditional Chinese medicine terms.
drug approval number in a special format: the national drug quasi-word C plus four-bit year number and four-bit sequence number.
For Chinese medicine compound preparations managed according to the ancient classic prescription catalogue, the registered applicant, after completing the pharmaceutical and non-clinical safety research, directly put forward a one-time application for the listing license of the ancient classic prescription Chinese medicine compound preparation, the P.O.A. will no longer review and issue the unified standard of "classic prescription material benchmark".
(State Drug Administration) Pharmaceutical Province issued the latest collection document Sichuan Provincial Health Insurance Bureau issued on the 28th on the "Sichuan Province pharmaceutical institutions centralized procurement implementation plan (draft for comments)" announcement.
It is mentioned that we should adhere to the direction of centralized drug procurement, implement a platform, up-down linkage, classified procurement, dynamic adjustment, ensure the quality and supply of drugs, reduce the burden of drug costs for the masses, and build a new mechanism for centralized drug procurement.
(Sichuan Provincial Health Insurance Bureau) Part 2 by observation of Xinlitai: the company's director Wen Zhongyi applied to resign XinLitai issued a notice that recently received the company's director Mr. Wen Zhongyi submitted a written resignation report, for personal reasons, he applied to resign as a director of the company.
Mr. Wen Zhongyi will not hold any position in the Company after his resignation takes effect.
(Xinlitai Announcement) Part 3 Pharmaceutical Information Junshi BioPD-1 Single Anti-Phase 3 Clinical End of Major Study 28, Junshi Bio announced that the company's independent research and development of anti-PD-1 monoantigen monoantigenic chemotherapy treatment relapsed or metastatic nasopharyngeal cancer randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical study in the in-phase analysis, by the independent monitoring data committee determined to reach the primary research endpoint.
Plans to submit a listing application to the State Drug Administration and the drug regulatory departments of relevant countries in the near future.
(Pharmaceutical Mingkangde) Roche oral SMA therapy with positive long-term efficacy Roche's gene Tek announced that its innovative spinal muscular dystrophy (SMA) therapy Evrysdi, in the treatment of symptomatic SMA infants (age 2-7 months) in the FIREFISH study, obtained positive 2 years of trial results.
infants receiving the treatment dose Evrysdi, 80.9% of patients continued to improve their symptoms and reached exercise milestones.
Evrysdi was approved by the FDA in August to become the first oral therapy to treat SMA patients.
(Drug Mingkangde) Sarepta announced positive clinical results for gene therapy SRP-9001 and SRP-9003 positive data Sarepta recently announced 2 gene therapy SRP-9001 and SRP-9003.
SRP-9001 is a gene therapy for Duchy muscular dystrophy, and over a 2-year period, all patients were well resistant to SRP-9001.
all adverse events are mild or moderate and occur within 90 days of treatment.
no serious adverse events or signs of complement activation.
SRP-9003 is a gene therapy for the treatment of muscular dystrophy type 2E, the results showed that after infusion of SRP-9003 in two dose groups, effective transductivity of skeletal muscle and expression of β-myosin were observed, and creatinase was significantly reduced during 90 days of treatment.
(Xinhua) -- Pfizer XELJANZ has been approved as the fourth adaptive disorder in the United States on the 28th, Pfizer announced that the U.S. FDA has approved XELJANZ® for the treatment of active multi-joint disease in adolescents with idiopathic arthritis 2 years of age and older.
has previously been approved in the United States for three types of adaptive disorders: moderate to severe active RA patients after failure to use methotrexate; adult patients with active psoriasis arthritis after failure to use anti-rheumatoid drugs; and adult patients with moderate to severe active colitis after failure with tumor necrosis agent inhibitors.
(Xinhua) -- The U.S. FDA has granted Abelvielezanumab orphan drug and fast-track qualification AbbVie the right to a fast-track drug, a treatment for patients with spinal cord injury, the FDA announced.
elezanumab is a human immunoglobulin G1 monoclonal antibody that selectively binds to the repulsive guide molecule A.
(Bio Valley) Jetblyn Haegarda Enlarged Adaptive Disorders approved by the FDA JetBelin recently announced that the FDA has approved Haegarda Enlarged Adaptation as a conventional preventive treatment for the prevention of hereditary angioedema (HAE) episodes in patients 6 years of age and older.
Haegarda reduces HAE seizures by 95%, making the drug the first and only off-skin treatment for patients 6 years and older to prevent HAE seizures.
addition to expanding pediatric adaptations, the updated label includes clinical safety data on the use of Haegarda by pregnant women.
(Bio Valley) The European Union has approved a new non-opioid dual-acting painkiller, Zynrelef, and Heron announced recently that the European Commission has approved Zynrelef for the treatment of postoperative pain caused by small and medium-sized surgical wounds in adults.
Zynrelef is a new, non-opioid painkiller, a dual-acting, fixed-dose combination of local anaesthetic bubikain and low-dose nonsteroidal anti-inflammatory drug meloxicon, designed to treat pain and inflammation after a single dose at the surgical site.
(Bio Valley) Kantai Bio-New Coronavirus Inactivated Vaccine (Vero Cell) approved clinical trials Kantai Bio issued a notice, recently received the State Drug Administration issued a drug clinical trial approval.
: After review and review by a special expert group, the new coronavirus inactivated vaccine (Vero cells) was approved for clinical trials, and the adaptation was used to prevent new coronavirus pneumonia caused by SARS-CoV-2 infection.
(Kantai Biological Announcement) Luo Xin obtained acetic acid abitor tablets listing application acceptance notice 28, Luoxin Pharmaceuticals issued a notice that subsidiary Shanghai Luoxin as MSN LABORATORIES PRIVATELIMITED in China registered agency to declare the listing application of acetic acid abphetron tablets received the State Drug Administration issued a "receiving notice."
announcement shows that acetic acid a bittron tablets are the first overseas-listed drug applications introduced by Luoxin Pharmaceuticals through international cooperation to list projects in China, compared with the local imitation development, with a short market cycle, low cost and other advantages.
(Rohin Pharmaceuticals Announcement) Heyikang Pharmaceuticals benzoic acid left ammonia chloride tablets will be approved before the day, Hebei Ren Heyikang Pharmaceuticals to imitate the 4 categories of submitted benzoic acid left ammonia chloride tablets market applications into the administrative approval stage, will be approved in recent days.
Benzene sulfonate L-Achloride is a calcium ion antagonist-type antitrophic drug, for benzodiacycline chlorine-leveling L-spinner, retaining the anti-hypertension effect at the same time can reduce edema and other side effects.
(Mienet)