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.
Representatives of the pharmaceutical and biotechnology industries
presented strong opposition to the concept of biogenerics at a
recent meeting convened by the US Food and Drug Administration. As
expected, their argument centred...
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.
US chemical company Aceto has reported a healthy rise in sales and
operating income in the year ended 30 June, helped by its recent
entry into the market for biopharmaceuticals.
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...
Dutch drug delivery company OctoPlus has licensed two
biodegradeable polymers to SurModics that can be used to coat
medical devices and deliver drugs into the surrounding tissues.
Dutch drug delivery company OctoPlus will undergo a significant
change in 2004 as it completes its transformation from a
formulation services company to one firmly planted in drug
development.
The US Biotechnology Industry Organisation has come out in support
of European legislation that it says will require extensive tests
to be conducted on so-called 'biosimilar' versions of biological
drugs.
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.
Danish chemical group Novo Nordisk will likely deliver a
'lacklustre' set of results for the first nine months of the year
but strong enough to put the company on track to deliver its
guidance of 'low single-digit EBIT...
Biotechnology company Biovitrum has established a new business
unit, Biovitrum Biopharmaceuticals, to strengthen its position as a
supplier of process development and contract manufacture of
recombinant proteins. The move follows...
Juvantia Pharma identifies small-molecule inhibitors of two forms
of the somatostatin receptor - subtypes 1 and 4 - with potential in
a wide range of disease indications.
Akzo Nobel's Diosynth unit has signed a multi-year contract to
manufacture and supply the active pharmaceutical ingredient for
Pfizer's growth hormone receptor antagonist Somavert. The value of
the agreement was not disclosed,...
US pharmaceutical major Eli Lilly has earmarked a hefty £220
million (€304 million) investment over the next four years in its
UK facilities, representing the largest investment by the firm in
any European country.
