Research and development daily plus code multiple sclerosis! Roche initiated three clinical trial studies

2020.09.10 Research and Development NEWS: Pfizer/BioNTech announces preclinical results of the new crown vaccine BNT162b2; BioMarin's type C sodium peptide similar vosoritide plus significant rapid annualization growth; and Mercedon 15-price pneumonia vaccine reaches critical clinical endpoint... 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) "Drug Research and Development" plus code multiple sclerosis! Roche launched three clinical trial studies on Monday, and Roche's Genentech announced three clinical trial programs, including an innovative Phase 3 trial program for the research drug fenebrutinib to treat multiple sclerosis, a high-dose Phase 3 trial program for Ocrelizumab (Ocrelizumab) and a unique trial program for Ocrevus to treat African-Americans, Hispanics and Latinos with MS.
/BioNTech announces the preclinical results of the new crown vaccine BNT162b2 Today, Pfizer and BioNTech announced preliminary results of the candidate new crown vaccine BNT162b2 in mouse and non-human primate models.
BNT162b2 is a nucleoside modified mRNA vaccine.
clinical studies showed that BNT162b2 was able to successfully protect against lung infections from the new coronavirus in a 55-day-after-vaccination trial in a rhesus monkey model.
the successful phase III of
strong refractic acid transporter odevixibat III, Albireo Pharma announced positive results in a global Phase 3 PDFIC-1 clinical study evaluating odevixibat therapy for in-patient familial liver bile siltation.
results showed that the study reached two main endpoints: odevixibat significantly reduced bile acid response (SBA, p-0.003), significantly improved skin itching (p-0.004), and had a single-digit diarrhea rate compared to placebo.
BioMarin's type C lysolptide similar to vosoritide plus significant fast-growing BioMarin recently announced that detailed results of a randomized double-blind placebo-controlled Phase 3 trial evaluating vosoritide (Vosoliptide, BMN111) for the treatment of cartilage dysplia in children aged 5-18 years have been published in The Lancet.
this study provides the first strong evidence for accurate treatment of cartilage dysplia: vosoritide has the potential to fundamentally change the clinical management, growth trajectory and treatment recommendations of affected children.
15-price pneumonia vaccine reached a critical clinical endpoint Mercedon announced today that the company developed the research-based 15-price pneumococcal binding vaccine V114, in two Phase 3 clinical trials reached the main immunogenic endpoint.
key clinical trials conducted by
in healthy adults over the age of 50 showed that V114 met the non-poor performance standard for the 13 serotypes targeted by the two vaccines compared to the 13-price pneumococcal binding vaccine (PCV13) that was already on the market.
V114 meets the best efficiency standards for the two serotypes 22F and 33F for V114 (non-PCV13).
plans to file a regulatory application with the FDA by the end of the year.
Caplyta's complementary treatment for biphasic depression Phase 3 clinically significantly improved depressive symptoms Recently, Intra-Cellular Therapies published positive top-line results from a Phase III clinical trial that evaluated Capallyta as an auxiliary therapy for lithium salts or valproates for the treatment of severe depressive episodes associated with biphasic type I or bisphasy type II disorder.
results showed that lumateperone 42 mg per day significantly improved depressive symptoms compared to placebo, with statistically significant results at both the primary and critical secondary endpoints.
Shanghai Pharmaceutical Injection LT3001 will soon start phase I clinical trials 10, Shanghai Pharmaceuticals announced that the company's "injection LT3001" recently obtained the Approval Notice for Drug Clinical Trials approved by the State Drug Administration, and will soon start Phase I clinical trials.
Drug Approval: Roche 2 new drugs approved clinically in China: CD3/CD20 dual resistance, C5 single resistance 9, Roche 2 new drugs approved clinically in China, respectively, CD3/CD20 dual anti-RO7082859 (diffuse large B cell lymphoma) and C5 single resistance RO7112689 (burst sleep hemoglobin patients).
JunshiTripley single anti-injection for the treatment of nasopharyngeal cancer was recognized by the FDA breakthrough therapy on the 10th, Junshi Bio issued a notice that recently, the company's products Ripley single anti-injection for the treatment of nasopharyngeal cancer to obtain FDA breakthrough therapy It was determined that Ripley monoantigen became the first domestic anti-PD-1 monoantigen to be recognized by FDA breakthrough therapy, which is another important registration progress after Terripley single anti-treatment nasopharyngeal cancer was recognized by FDA orphan drug in May 2020.
Vantai bio-new crown testing products by the FDA emergency use authorization and India's Ministry of Health import license 10, Vantai Bio issued a notice that the company's new coronavirus (2019-nCoV) nucleic acid testing kit (PCR-fluorescent probe method) recently obtained the FDA issued emergency use authorization.
Zebutinib's new drug listing application was accepted by the Canadian Drug Administration and included in the priority review 9, Baiji Shenzhou announced that the Canadian Drug Administration has accepted the new drug market application for the treatment of patients with Fahrenheit globulinemia (WM®) and included it in the priority review.
Her2 dual-specific antibody clinical declaration introduced by Baiji Shenzhou was accepted by CDE today, Baiji Shenzhou introduced from Zymeworks company at the end of 2018 targeted HER2 dual-specific antibody zandatamab declared a clinical application in China, and today was accepted by CDE.
Research and Development Cooperation: Goliath Pharmaceuticals Co., Ltd. and Galaxy Pharmaceuticals Co., Ltd. and Galaxy Pharmaceuticals Ltd. jointly announced the joint ASC41 (THR-terracites) and Aramchol (SCD 1 inhibitors) have teamed up to develop their own pipelines for the treatment of non-alcoholic fatty hepatitis (Non-alcoholic Steatohepatitis, NASH).
Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Geli Pharmaceutical Co., Ltd.
details of the partnership were not disclosed.