article thumbnail

What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

article thumbnail

PIMICOTINIB

New Drug Approvals

History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 2023) [link] ^ “Abbisko Therapeutics Announced the Entry into a Licensing Agreement for Pimicotinib (ABSK021) with Merck” [link] (Press release). 2018-11-29. [2].

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Zilucoplan

New Drug Approvals

April 2018). World Health Organization (2018). 24 September 2024. . ^ “Zilbrysq Product information” Union Register of medicinal products. 4 December 2023. Archived from the original on 11 December 2023. Retrieved 11 December 2023. Howard JF, Kaminski HJ, Nowak RJ, Wolfe GI, Benatar MG, Ricardo A, et al. doi : 10.1212/WNL.90.15_supplement.S31.006.

FDA 57
article thumbnail

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Agency IQ

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. See AgencyIQ’s full analysis of the 2018 framework, and industry response, here.]

FDA 40
article thumbnail

Orforglipron’

New Drug Approvals

then was licensed to Lilly in 2018. [1] Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] 1] It was discovered by Chugai Pharmaceutical Co. percentage points from a starting level of 8%. [1] kg), on average after 40 weeks. [1]

article thumbnail

VALILTRAMIPROSATE

New Drug Approvals

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. 2018; 32(9): 849–861. [2]. 2018 Mar;57(3):315-333. Tramiprosate was reported to inhibit Aβ42 aggregation into toxic oligomers ( Gervais et al., 2007 ; Kocis et al., 2016 ; Abushakra et al., Hey JA, et al. Clin Pharmacokinet.

article thumbnail

Elacestrant 

New Drug Approvals

Patent and Trademark Office. 2] [4] Pharmacology Pharmacodynamics Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , specifically targeting the estrogen receptor alpha (ER), which is the biological target of endogenous estrogens like estradiol. [1] 1] The elimination half-life of elacestrant is 30 to 50 hours. [1]

FDA 62