Lannett and Genus’s battle parses the distinction between NMEs and NCEs and the meaning of US Hatch-Waxman exclusivity.
Lannett Co. Inc. is working toward a new drug application resubmission this year for Numbrino, its topical cocaine solution, despite the efforts of Genus Life Sciences, which received the first US NDA approval of cocaine for its topical Goprelto.
Cocaine, of course, is a very old and infamous drug, but it has decades of specialty use as a topical nasal anesthetic. As a drug on the market before the 1938 Food, Drug & Cosmetics Act, it has been sold under a “grandfathering” approach
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
