Modigene says that data from a trial of a Schering-Plough's (SP)
fertility stimulation hormone (FSH-CTP) confirms that carboxyl
terminal peptide (CTP) modification can extend the therapeutic
duration of protein drugs.
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...
Novartis has paid a US drug delivery company $10 million for an
option to an oral formulation of an injectable drug used to treat
osteoporosis that is currently the subject of litigation with Eli
Lilly.
Emisphere Technologies of the US has entered into a licensing deal
with Swiss drug major Novartis to develop an oral formulation of
recombinant growth hormone, currently administered by injection.
The Generic Pharmaceutical Association (GPhA) has urged the US Food
and Drug Administration (FDA) to move forward to accelerate the
approval of affordable generic versions of biopharmaceutical drugs.
The US Food and Drug Administration has failed to reach a decision
on approving a growth hormone (hGH) product developed by Novartis'
generics subsidiary Sandoz in what is emerging as a test case for
the development of generic...
Mark McClellan, the US Food and Drug Administration Commissioner,
has given the strongest hint to date that generic versions of
biological drugs may be approved without the need for extensive
clinical trials.