pharmaphorum
NOVEMBER 18, 2022
At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. The post Provention finally gets FDA nod for type 1 diabetes drug teplizumab appeared first on.
pharmaphorum
MARCH 21, 2022
Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Provention is seeking approval of teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals, hoping the drug can become the first disease-modifying therapy in these patients.
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pharmaphorum
DECEMBER 10, 2020
Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase 3 trial readout. More than half (51.7%) of participants in the treatment arm achieved an A1C less than 5.7% – the level seen in people without diabetes.
pharmaphorum
MAY 21, 2021
Eli Lilly has scored five out of five with its phase 3 trials of type 2 diabetes candidate tirzepatide, setting up regulatory filings for a drug that the drugmaker thinks could be the lynchpin of its franchise in the coming years. . Treatment with Lilly’s drug also resulted in a 11.7
Pharmafile
JANUARY 25, 2023
Lilly’s expansion is set to include the addition of further parenteral filling, device assembly and packaging capacity in order to meet the growing demand for the company’s incretin-based diabetes treatments and medications. The facility is expected to become operational in 2027 and will create over 100 new jobs for manufacturing personnel.
European Pharmaceutical Review
NOVEMBER 20, 2023
Supporting European parenteral manufacture and supply Alongside expanding the company’s global parenteral product and device manufacturing network, the new facility will support the higher demand for Eli Lilly’s medicines, including its diabetes and obesity portfolio.
Big Molecule Watch
DECEMBER 28, 2023
The patents-at-issue are directed to formulations and dosing regimens for aflibercept, an anti-VEGF treatment for retinal disorders including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The ’865 patent, which the court found to be valid and infringed, is expected to expire in June 2027.
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