Month: November 2018

Biosimilars Biotech

Celltrion’s Truxima (rituximab-abbs) Receives FDA’s Approval for Three on-Hodgkin’s Lymphoma

Shots: The approval is based on non-inferiority data demonstrating biosimilarity in pharmacology, immunogenicity, clinical efficacy with safety, potency and purity when compared to reference medicine (rituxan) Truxima is a mAb, indicated and approved in three indications i.e. r/r, low-grade or follicular, CD20-positive, B-cell NHL, 1L patients with CD20-positive B-cell NHL and 1L Non-progressing low-grade CD20-positive […]Read More


Q BioMed Acquires Rights of Metastron from GE Healthcare

Shots: • GE Healthcare to receive upfront, milestone and single digit royalties for 15 yrs and Q BioMed to get rights of Metastron, in 22 approved countries• The acquisition of Metastron will support as a non-opioid therapy to treat debilitating pain associated with skeletal cancer metastases and is expected to expand the scope of drug• […]Read More


Merck’s Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) &

Shots: The approval is based on the results of P-III DRIVE-AHEAD and DRIVE-FORWARD trial assessing Delstrigo vs efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) & Pifeltro vs darunavir + ritonavir (DRV+r) + FTC/TDF or abacavir (ABC)/3TC respectively for a duration of 48/96 wks. DRIVE-AHEAD and DRIVE-FORWARD results: suppression of HIV-1 RNA @ 48 wks. (84%, 83% […]Read More


Genentech Acquires Jecure Therapeutics for its Preclinical Stage NLRP3 inhibitors

Shots: Genentech to acquire Jecure, in all stock transaction for the portfolio of preclinical NLRP3 inhibitors The acquisition is focus to develop therapies using Jecure’s NLRP3 inhibitors for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis NLRP3 – Nucleotide-binding oligomerization (NOD)-like Receptor Family Pyrin Domain Containing Protein3, investigated for the treatment of autoimmune and […]Read More


Mesa Biotech’s Accula RSV Test Receives FDA’s 510(K) Clearance and

Shots: Accula RSV is second POC (point-of-care) test, to receive FDA’s 510(K) & CLIA Waiver and used additionally with nasal swab collection with disposable test cassettes The Accula RSV (respiratory syncytial virus) test is performed for detection of respiratory tract infections like bronchiolitis & pneumonia in adults and children In 2017, Sekisui Diagnostics collaborated with […]Read More