-
FDA approves expanded use of Saphris
WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.
Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.
-
GSK inks deal with Lonza, announces CFO's exit
LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.
Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.