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 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...
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
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
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...
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.