Lilly's Insulin Glargine Biosimilar Basaglar Meets Primary Endpoint in Phase 3 Trial for Chinese Adults with Type 2 Diabetes
Eli Lilly
Global Pharmaceutical R&D and Production Company
[2020.06.05 R&D NEWS]Novartis Releases Long-Term Data on Cosentyx for Axial Spondyloarthritis; Pfizer Announces Complete Phase 3 Clinical Results for Oral JAK1 Inhibitor, Showing Significant Relief of Dermatitis Symptoms; Positive Clinical Results Reported for GPC3-Targeted CAR-T Therapy in Advanced Liver Cancer; FDA Grants Priority Review to Novel GD2-Targeting Antibody Danyelza for Neuroblastoma Treatment...
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[Pharmaceutical R&D]
Novartis Releases Long-Term Data on Cosentyx for the Treatment of Axial Spondyloarthritis
On the 4th, Novartis announced positive results from the 52-week Phase III PREVENT clinical trial, with data demonstrating substantial and sustained benefits of Cosentyx (secukinumab) in patients with axial spondyloarthritis (axSpA).
On June 5, Eli Lilly announced that the 24-week Phase III clinical study (14L-GH-ABET), which compared the efficacy and safety of the long-acting basal insulin analog Basaglar® (insulin glargine) with Lantus® (insulin glargine) in adult patients with type 2 diabetes in China, had met its primary endpoint.
AbbVie Updates Long-Term Phase 3 Clinical Data on Rinvoq for the Treatment of RA
AbbVie Recently Announced New Long-Term Results of Oral JAK Inhibitor Rinvoq (upadacitinib) for the Treatment of Rheumatoid Arthritis (RA): The Safety Profile of Rinvoq Monotherapy and Rinvoq in Combination with MTX Was Consistent with That Observed in the Previously Reported Pooled Phase III Safety Analysis in RA, with No New Safety Risks Identified.
Treatment of RA: Gilead Releases 52-Week Data from Two Phase 3 Clinical Trials of Filgotinib
Recently, Gilead Sciences and Galapagos jointly announced the Week 52 data from two Phase III clinical trials, FINCH 1 and FINCH 3, evaluating filgotinib for the treatment of moderately to severely active rheumatoid arthritis (RA). The results demonstrated that after 52 weeks of treatment, filgotinib exhibited sustained efficacy and a consistent safety profile in patients with RA.
Pfizer announced today that the full results of the second pivotal Phase 3 clinical trial of abrocitinib, a JAK1 inhibitor developed by the company for the treatment of atopic dermatitis, have been published in JAMA Dermatology. Abrocitinib is an investigational oral JAK1 inhibitor administered once daily for use in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). Consistent with the first Phase 3 monotherapy study, both doses of abrocitinib met all co-primary endpoints and key secondary endpoints, and were well tolerated.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced new data from two Phase III clinical studies at the 2020 European Alliance of Associations for Rheumatology (EULAR) e-Congress. These two studies evaluated the efficacy and safety of Tremfya in adult patients with active psoriatic arthritis (PsA). The new data showed that at Week 52 of treatment, Tremfya demonstrated improvements across multiple clinical outcomes, including joint symptoms, skin symptoms, soft tissue inflammation, physical function, and reduction in radiographic progression.
Good News from Clinical Results of CAR-T Therapy Targeting GPC3 for Advanced Liver Cancer
Recently, Clinical Cancer Research published online the results of a Phase I clinical study on CAR-T cell therapy for advanced hepatocellular carcinoma. This represents the first globally reported clinical outcome of CAR-T cell therapy targeting GPC3 in solid tumors, demonstrating the potential of CAR-T therapy for clinical application in hepatocellular carcinoma.
[Drug Approval]
Recently, Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Danyelza in the treatment of relapsed/refractory high-risk neuroblastoma and granted it Priority Review, with a target action date set for November 30, 2020.
MSD’s Innovative Antibiotic for Hospital-Acquired Pneumonia Approved by FDA
Today, the U.S. FDA announced the approval of an expanded indication for Recarbrio, an innovative antibiotic developed by Merck & Co., for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older.
World’s First Siderophore Cephalosporin! Fetroja Receives FDA Priority Review for NP Treatment
Japanese pharmaceutical company Shionogi recently announced that the U.S. FDA has accepted the supplemental new drug application (sNDA) for the novel antibacterial agent Fetroja and granted it priority review, with a Prescription Drug User Fee Act (PDUFA) target action date set for September 27, 2020. The sNDA seeks approval for a new indication of Fetroja for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). HABP and VABP are sometimes also referred to as nosocomial pneumonia (NP).
China’s First Generic! Chia Tai Tianqing’s Emtricitabine and Tenofovir Disoproxil Tablets Approved
On the 5th, the marketing application for the Category 4 generic drug Emtricitabine and Tenofovir Disoproxil Fumarate Tablets submitted by Chia Tai Tianqing was approved by the National Medical Products Administration (NMPA), making it the first generic version in China and deemed to have passed the consistency evaluation.
Chia Tai Tianqing’s “Lurasidone Hydrochloride Tablets” Submitted for Marketing Approval
Today, Chia Tai Tianqing’s marketing application for lurasidone hydrochloride tablets, submitted under the new Class 4 category, has been accepted by the Center for Drug Evaluation (CDE). This makes Chia Tai Tianqing the third domestic manufacturer to file a marketing application for this generic drug, following Hisun Pharmaceutical and Hansoh Pharmaceutical.
On the 5th, Luye Pharma's marketing application for Rivastigmine Transdermal Patches, submitted under Category 5.2 (application for domestic marketing of generic drugs already marketed overseas), was approved by the National Medical Products Administration.
Hansoh Pharmaceutical’s “Afatinib Maleate Tablets” First Generic Approved
Today, Hansoh Pharmaceutical’s marketing application for its Class 4 generic drug, afatinib maleate tablets, was approved by the National Medical Products Administration (NMPA), making it the first generic version of this drug in China.
Hec Pharm’s “Recombinant Human Insulin Injection” Approved for Market Launch
On the 5th, HEC Pharm’s recombinant human insulin injection received approval from the National Medical Products Administration (NMPA) for marketing, indicated for the treatment of diabetes. This marks the first insulin product approved for market launch by HEC Pharm.
Hisun Pharmaceutical’s Two Generic Drugs Approved
On the 5th, two new Class 4 generic drugs from Hisun Pharmaceutical (Quetiapine Fumarate Extended-Release Tablets and Donepezil Hydrochloride Orally Disintegrating Tablets) were approved for marketing by the National Medical Products Administration and are deemed to have passed the consistency evaluation. Among them, Quetiapine Fumarate Extended-Release Tablets is the second product in China to pass the consistency evaluation, while Donepezil Hydrochloride Orally Disintegrating Tablets is the first in China.
FibroGen’s Pamrevlumab Clinical Trial Application in China Accepted for Review
On the 4th, FibroGen’s Investigational New Drug (IND) application for Pamrevlumab in China was accepted by the Center for Drug Evaluation (CDE). Pamrevlumab is a first-in-class novel drug developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF).
On the 4th, Chipscreen Biosciences’ Class 1 new drug, CS12192 capsules, received approval for clinical trials for the treatment of rheumatoid arthritis. This is Chipscreen Biosciences’ first candidate drug in the field of autoimmune disease therapy.
[R&D Collaboration]
AstraZeneca and Accent Partner to Develop Therapies Targeting RNA-Modifying Proteins
On the 4th, AstraZeneca announced a collaboration with Accent Therapeutics to develop and commercialize transformative therapies targeting RNA-modifying proteins (RMPs).
*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.