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    Home > Medical News > Medical World News > Research and development daily Pfizer Xalkori's treatment of APK-positive sALCL has been given priority by the FDA.

    Research and development daily Pfizer Xalkori's treatment of APK-positive sALCL has been given priority by the FDA.

    • Last Update: 2020-10-06
    • Source: Internet
    • Author: User
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    2020.09.24 Research and Development NEWS: Johnson and Johnson launched the global key Phase 3 clinical trial of Yang Sen's new crown pneumonia candidate vaccine; We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
    (click on the title, read the original article) Fujifilm in Japan to apply for approval of the treatment of the new crown Fujifilm, said on Wednesday, will apply for its anti-flu drug Avigan (a.g. Favipiravir, Fapiravir) in Japan for the treatment of new crown pneumonia.
    the application is based on a Phase 3 study that shows the drug can help patients with neo-coronary mild recovery more quickly.
    Tau Antibody Phase II Clinical Failure Today Roche and partner AC Immune announced their Tau Antibody semorinemab clinical failure in Phase II called TAURIEL.
    the trial recruited 457 patients with early (no or mild) Alzheimer's disease, comparing 79 weeks of semorinemab with comfort to improve cognitive function.
    test level one endpoint is the CDR-SB score, the secondary endpoint is the ADAS-Cog13 and ADCS-ADL score, resulting in semorinemab missing all these therapeutic endpoints, but the safety is good.
    Johnson and Johnson launched the Johnson and Johnson New Coronary Pneumonia Candidate Vaccine Global Key Phase 3 Clinical Trial 24, Johnson and Johnson corporation today announced the launch of its Janssen Pharmaceuticals research and development of the new Coronary Pneumonia Candidate Vaccine JNJ-78436735 in many countries large-scale critical Phase 3 trials.
    based on the results of an in-phase analysis of the phase 1/2a clinical study by Johnson and Johnson, the safety and immunogenicity shown after single-dose vaccination can support the initiating of the ENSEMBLE trial.
    Fuhong Hanyu Shudan anti-mono-drug HLX-14 initiated clinical 23, Fuhong Hanxuan HLX14 initiated Phase I clinical, adaptive disorder for women at high risk of fractures post-menopautical osteoporosis.
    (Drug Approval) Johnson and Johnson EGFR-MET combination therapy approved to carry out the Oghitinini drug-resistant NSCLC clinical trial Recently, Johnson and Johnson Amivantamab (EGFR-MET dual resistance) and Lazertinib (third generation EGFR-TKI) in China approved 2 clinical trials, respectively: 1) joint treatment of EGFR 19 exon loss or L85 8R-activated mutations in patients with local late stage or progressive NSCLC who have not been treated in the past; 2) combined medication to treat patients with EGFR 19 exon loss or L858R activation mutations, and NSCLC patients who are treated first- or second-generation TKI with first-generation or second-generation TKI or who have progressed after using third-generation TKI for first- or second-line treatment.
    Fycompa treatment of epilepsy by the European Union CHMP recommended approval to expand the application of the population of sanitation recently announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued a positive review, recommended approval of the anti-epileptic drug Fycompa to expand the applicable population: (1) as an auxiliary therapy part of the treatment of seizures The age range of patients with or without OR without secondary systemic seizures was expanded from 12 years of age and above to 4 years of age and above;
    Pfizer Xalkori's treatment of ALK-positive sALCL has been given priority review by the FDA, which has accepted and granted priority review of a new drug for the targeted cancer drug Xalkori (crizotinib, kertinib).
    the sNDA seeks approval for Xalkori's new adaptation for the treatment of patients with mesolytic lymphoma kinase (ALK) positive, recurring or refractic systemic mesozoic large cell lymphoma pediatrics.
    U.S. and Europe received better efficacy than Humira and Stelara Yossbet recently announced that the U.S. FDA and the European EMA have accepted the new anti-inflammatory drug bimekizumab biological products licensing application and marketing authorization applications, the drug used in the treatment of moderately severe plaque psoriasis adult patients.
    disease gene therapy Bluebird Bio Zynteglo has been granted priority drug eligibility by the European Union, Bluebird Bio announced that the European Medicines Agency (EMA) has granted Zynteglo priority drug eligibility for the treatment of sickle cell disease.
    ADC Therapeutics announced that it has filed a bio-product licensing application with the FDA for innovative antibody association drug (ADC) loncastuximab tesirine (Lonca), which has a recurrence/refratic diffuse large B cell lymphoma.
    Chengdu Bett Pharmaceuticals will take the "Hepatitis B God Medicine" first imitation 23, Chengdu Bett Pharmaceuticals to copy the four categories of reported fumarate propofol novowe tablets into the administrative approval stage, the product developed by Gilead, as early as November 2016 was approved by the FDA to list, 2019 global sales of $488 million.
    the current domestic market only the original research products are on sale.
    .
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