2016 Licensing Pharmacokinetics 
New Drug Approvals
OCTOBER 12, 2024
2016 ; Abushakra et al., Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2018; 32(9): 849–861. [2]. Hey JA, et al.
New Drug Approvals
SEPTEMBER 29, 2024
The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). All volunteers with AD had P. gingivalis DNA fragments in their CSF at baseline. Examples Example 1. mmol, 1.00
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The Pharma Data
AUGUST 22, 2021
Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2016; 61 (1): e01020-16. About AstraZeneca.
The Pharma Data
DECEMBER 21, 2020
UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,
The Pharma Data
DECEMBER 15, 2020
Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.
Agency IQ
AUGUST 16, 2024
The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.
FDA Law Blog: Biosimilars
MAY 21, 2024
We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).
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