p applicant Astrazeneca 
Pharmaceutical Technology
APRIL 18, 2023
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. By means of geographic reach, Amicus Therapeutics holds the top position, while F.
The Pharma Data
APRIL 28, 2023
In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. AstraZeneca and MSD will continue to work with the FDA as it completes its review of the application. 0.81; p<0.001). 0.81; p<0.001).
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The Pharma Data
APRIL 28, 2023
In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.
The Pharma Data
DECEMBER 8, 2020
Ionis and AstraZeneca are committed to bringing the best possible PCSK9 antisense treatments to patients and have been collaborating on both the subcutaneous and oral formulations. Preclinical and early clinical data give Ionis and AstraZeneca confidence that they can achieve effective oral delivery of ION449 and other ASOs.
Roots Analysis
FEBRUARY 22, 2022
Notable examples of other autoinjector-based combination products include Fasenra® Pen (AstraZeneca), Gvoke® Hypopen (Xeris Pharmaceuticals), NUCALA Autoinjector (GlaxoSmithKline), and Vyleesi Autoinjector (AMAG Pharmaceuticals® / Palatin Technologies). The generic version of EpiPen received the FDA approval in 2018.
FDA Law Blog
AUGUST 16, 2023
And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.
Drug Discovery World
NOVEMBER 9, 2023
Following this, Rebecca Croasdale-Wood, PhD, Director, Augmented Biologics Discovery & Design, Biologics Engineering, Oncology, AstraZeneca, will present: ‘Benchmarking the impact of AI biologics discovery and optimisation for pharma’. Croasdale-Wood will then participate in a keynote chat, interviewed by Miho. Filip Borgions, Ph.D,
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