BioCentury | Mar 26, 2021
Regulation

CHMP backs GSK’s lupus drug for kidney complication, J&J’s oral MS therapy

GSK’s Benlysta and J&J’s Ponvory are two of the latest therapies to win support from EMA’s CHMP, which did not issue any negative recommendations in March. The agency recommended a label extension for Benlysta belimumab to treat active lupus...
BioCentury | Mar 25, 2021
Regulation

March 24 Quick Takes: A first for Twist, Biotia and a refusal-to-file letter for Novo; plus Novartis’ radioligand, Zealand, four Japan approvals and more

...of semaglutide to treat Type II diabetes. The agency requested additional information relating to the GLP-1...
...inhibitor had potent antiviral activity.TARGETSPD-1 (PDCD1) (CD279) - Programmed cell death 1 FGFR - Fibroblast growth factor receptorGLP-1Glucagon-like peptide-1 NTRK...
BioCentury | Mar 5, 2021
Product Development

Lilly’s tirzepatide more potent than Novo’s semaglutide, but higher discontinuation: Data Byte

...initiating rescue therapy for persistent severe hyperglycemia. TARGETSGIP - Gastric inhibitory protein GLP-1R (GLP1R) - Glucagon-like peptide-1...
...LY3298176) Ozempic (Brand), NN9535 (Compound #), subcutaneous semaglutide (Informal) Eli Lilly and Co. Novo Nordisk A/S Gastric inhibitory protein (GIP) Glucagon-like peptide-1...
BioCentury | Feb 18, 2021
Regulation

Feb. 18 Quick Takes: Label expansion for Entresto; plus Amgen, Sesen, BeiGene, Cortexyme and more

...and 40 weeks, respectively. Data from the Phase III SURPASS-2 trial comparing the GIP and GLP-1...
BioCentury | Dec 17, 2020
Product Development

Two non-amyloid therapies for Alzheimer’s advance to late-stage trials

...Alzheimer’s disease. The biological rationale for testing a GLP-1...
...becomes less sensitive to insulin in Alzheimer's and GLP-1...
BioCentury | Dec 12, 2020
Product Development

Dec. 11 Quick Takes: AZ to run combo trial with Sputnik; plus Phase III hits for Lilly, AbbVie and TG, data from Immutep, NVS, Mycovia, Sarepta and Greenwich

...the Phase III SURPASS-1 trial to treat adults with Type II diabetes. The co-agonist of GLP-1...
BioCentury | Dec 2, 2020
Distillery Therapeutics

Neuraly’s GLP-1R agonist NLY01 for ocular hypertension

...diabetes.GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Eperzan albiglutide, a GLP-1R agonist comprising 2 copies of modified human GLP-1...
...albumin, for Type II diabetes and has the drug in Phase II testing for heart failure.TARGET/MARKER/PATHWAY: Glucagon-like peptide-1...
...Pa.email: jacob.sterling@pennmedicine.upenn.eduCONTACT: Qi N. Cui, same affiliation as aboveemail: qi.cui@pennmedicine.upenn.edu Claire Quang NLY01 (pegylated exenatide) University of Pennsylvania Neuraly Inc. Glucagon-like peptide-1...
BioCentury | Dec 2, 2020
Regulation

Dec. 1 Quick Takes: broader label for Blueprint; plus Minerva, Biohaven-Sosei, Genetron, PegBio, drug imports

Blueprint gains broader FDA label for Gavreto FDA approved Gavreto pralsetinib from Blueprint Medicines Corp. (NASDA:BLUE) to treat advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive, radioactive iodine-refractory thyroid cancer in patients at...
BioCentury | Nov 18, 2020
Product Development

Nov. 17 Quick Takes: Phase III miss for BrainStorm’s ALS program; plus Novo, BioMarin-Deep Genomics, Lexicon, Seed-Lilly and RhoVac

...of Ozempic in the Phase IIIb SUSTAIN FORTE trial. The higher dose of the once-weekly GLP-1...
BioCentury | Nov 6, 2020
Deals

With $1.4B Emisphere buy, Novo gets delivery tech used in Rybelsus

...Danielsen told BioCentury that the pharma plans to apply the Eligen technology to more oral GLP-1...
...to $7.58 in afternoon trading Friday.Associate Editor Stephen Hansen contributed to this report.TARGETSGLP-1R (GLP1R) - Glucagon-like peptide-1...
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