Janssen Halts Phase 3 Development of First-in-Class Influenza Drug Pimodivir Due to Lack of Efficacy
Takeda
Biopharmaceutical Manufacturer
【R&D NEWS 2020.09.03】Novartis reports positive results from pivotal Phase 3 trial of semi-annual injectable lipid-lowering therapy for atherosclerosis; Lilly initiates Phase 3 clinical trial of RET-targeted drug Selpercatinib; “Third-generation” Epclusa approved by EU for children aged ≥6 years and weighing ≥17 kg...
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[Drug Development]
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that it has made the strategic decision to discontinue the development of pimodivir, an oral antiviral drug for the treatment of influenza A virus infection. This decision was based on the results of a pre-planned interim analysis of the Phase 3 trial of pimodivir in hospitalized patients with influenza A. The analysis indicated that pimodivir combined with standard of care (SOC) is unlikely to demonstrate additional benefit compared to SOC alone in hospitalized patients with influenza A.
Novartis recently announced the results of a post hoc analysis of pooled data from two pivotal Phase 3 clinical trials evaluating Inclisiran, its first-in-class cholesterol-lowering drug, for the treatment of hyperlipidemia in adults. The analysis showed that among patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalents who were followed for more than 17 months, Inclisiran demonstrated highly consistent LDL-C lowering effects across individual patients after an initial two-dose regimen (with the second dose administered three months after the first), followed by maintenance therapy via subcutaneous injection every six months. Meanwhile, its safety and tolerability profile was similar to that of placebo.
Novartis Releases Key Study Results of Tabrecta for NSCLC Patients with METex14 Mutations
On the 2nd, The New England Journal of Medicine published the positive results of Novartis’ pivotal Phase 2 clinical study GEOMETRY mono-1 for Tabrecta (capmatinib, formerly INC280). The data showed that Tabrecta demonstrated a favorable overall response rate and duration of response in adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping (METex14) mutations.
Lilly’s RET-Targeted Drug Selpercatinib Initiates Phase III Clinical Trial
On the 1st, Eli Lilly’s new drug Selpercatinib (also known as LOXO-292) initiated Phase III clinical trials for the treatment of RET-mutant medullary thyroid cancer.
Afatinib Plus Osimertinib Sequential First-Line Therapy Achieves Overall Survival of 37.6 Months
Boehringer Ingelheim recently announced the final analysis of the GioTag study in lung cancer. The results showed that in patients with Del19/L858R epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) who developed the common acquired resistance mutation T790M, the median overall survival for first-line treatment with Gilotrif (afatinib) followed by Tagrisso (osimertinib) reached 37.6 months.
[Drug Approval]
“Epclusa” Approved by the EU for Children Aged ≥6 Years and Weighing ≥17 kg
Gilead’s Hepatitis C Drug Epclusa (Chinese Brand Name: Bingtongsha; Generic Name: Sofosbuvir/Velpatasvir, 400 mg/100 mg Tablets) Recently Announced That the European Commission Has Approved an Expansion of Epclusa’s Marketing Authorization for the Treatment of Pediatric Patients Aged ≥6 Years and Weighing ≥17 kg with Chronic Hepatitis C, Regardless of HCV Genotype or Severity of Liver Disease.
Roche’s COVID-19 Antigen Test Product Launched in Europe
Roche recently announced that it will launch its novel coronavirus rapid antigen test product, the SARS-CoV-2 Rapid Antigen Test, in markets accepting the CE mark by late September. Additionally, the company plans to apply for Emergency Use Authorization from the U.S. FDA.
Takeda Entyvio Subcutaneous Formulation US Project Update
Takeda recently announced the latest progress in the U.S. development program for Entyvio® (vedolizumab, vedolizumab for injection), a gut-selective biologic agent administered via subcutaneous injection.
Four Innovative Drugs Approved in China from Innovent, Sanofi, AstraZeneca, and Nuai Pharmaceutical
On the 3rd, according to the NMPA drug approval announcement, four innovative drugs were approved for marketing in China: Innovent Biologics’ adalimumab injection, AstraZeneca’s ticagrelor dispersible tablets, Sanofi’s insulin glargine injection, and Nuoa Pharmaceutical’s idursulfase beta injection.
AstraZeneca’s “Ticagrelor Dispersible Tablets” Are About to Be Approved in China
Recently, AstraZeneca's application for the market approval of ticagrelor dispersible tablets in China has entered the "under review" stage, with expectations for imminent approval and launch in the Chinese market.
CDE Announces Two New Breakthrough Therapy Drugs
On the 3rd, the CDE official website publicly disclosed information on two drugs proposed for breakthrough therapy designation: YY-20394 tablets (linperlisib) from Shanghai Yingli Pharmaceutical and the concentrated solution for injection of plinabulin from Dalian Wanchun Borealis Pharmaceuticals.
On the 2nd, Hengrui Medicine submitted a new indication marketing application for its PD-1 inhibitor camrelizumab, which is proposed to be included in the priority review and approval procedure under the category "(5) Drugs eligible for conditional approval." According to Hengrui Medicine's announcement released on August 13, the new indication is for camrelizumab in combination with cisplatin and gemcitabine as first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma.
Canary Biopharma’s Imported “Idursulfase Beta Injection” Is Set for Approval in China
On the 28th, the new drug application for idursulfase beta injection (Hunterase), submitted by Canhelp Biologics for the treatment of Hunter syndrome, entered the “under review” phase, with expectations for imminent approval and market launch in China.
Baili Pharmaceutical’s Another Investigational Anti-Cancer Drug Approved for Clinical Trials
CDE’s Latest Announcement: Baili Pharmaceutical’s Class 1 Novel Drug GNC-038, a Quadruple-Specific Antibody Injection, Receives Implied Clinical Trial Approval for the Indication of “Intended for the Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma, Relapsed or Refractory Acute Lymphoblastic Leukemia, and Refractory or Metastatic Solid Tumors.”
China Biopharmaceuticals Submits IND Application for ROCK2 Inhibitor
On the 2nd, China Biopharmaceutical announced that its independently developed innovative anti-fibrotic drug TDI01 has submitted a clinical trial application to the CDE and has been accepted.
Qilu Pharmaceutical's "Afatinib Maleate Tablets" Approved for Market Launch
On the 3rd, Qilu Pharmaceutical’s new Class 4 generic drug, afatinib maleate tablets, received approval for market launch from the National Medical Products Administration (NMPA), making it the second company in China to have this product approved, following Hansoh.
Chia Tai Tianqing’s “Saxagliptin” Is Set for Approval
On the 2nd, the marketing application for saxagliptin tablets, a Class 4 generic drug submitted by Chia Tai Tianqing, entered the administrative approval phase. It is expected to be approved in the near future, making Chia Tai Tianqing the second company in China, after Aosaikang, to obtain marketing approval for this product.
[R&D Collaboration]
Lyell and Orca Bio Partner to Develop Cell Therapies for Solid Tumors
Orca Bio and Lyell Immunopharma Announce Research Collaboration to Develop Next-Generation T Cell Therapies for Solid TumorsOrca Bio and Lyell Immunopharma today announced that they have entered into a research collaboration to combine Orca Bio’s precisely purified T cell technology with Lyell’s scientific expertise in T cell biology, aiming to develop next-generation T cell therapies for the treatment of solid tumors.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.