The clock is running
30 NOV IN 16 DAYS
Medicare negotiated prices for 15 more drugs, effective 2028
Brand owners of the 2028 list, first cycle with Part B drugs
18 DEC IN 34 DAYS
BIOSECURE Act: first list of biotech companies of concern
Buyers of Chinese CDMO and API services, WuXi first in line
01 JAN IN 48 DAYS
Medicare negotiated prices for 15 drugs take effect
Brand owners of the 15 drugs on the 2027 list
FEB
Teva price-fixing trial
Sandoz already settled for $469M
01 FEB IN 79 DAYS
Medicare picks up to 20 drugs for 2029 price cuts
Brands on the list; generic and biosimilar filers on the same molecules
02 APR IN 139 DAYS
Section 232: Commerce reports on tariffs for generics
Generic and biosimilar importers, API exporters to the US
30 SEP IN 320 DAYS
GDUFA III and FDA user fee programs expire
ANDA filers and DMF holders, if Congress does not renew
27 NOV IN 378 DAYS
DSCSA: small pharmacy exemption ends
Pharmacies with 25 or fewer pharmacists and techs, and the wholesalers that ship to them
13 JAN IN 425 DAYS
EU HTA: joint clinical assessments start for orphan drugs
Orphan drug makers filing at EMA