Amgen and Ortho Biotech are breathing a sigh of relief after a
regulatory committee recommended not to change the label on their
blockbuster anaemia drugs when used in the kidney failure setting.
A US judge has backed Amgen's court motion, ruling that Roche's
Mircera infringes one of its composition patents. Roche is standing
firm against the allegations.
Amgen has finally put an end to weeks of rumours and speculations
by admitting its plans to slash 12-14 per cent of its workforce to
offset the recent difficulties it has been facing with the sales of
its anaemia blockbusters.
A European regulatory committee has recommended the approval of
three generic versions of Johnson & Johnson's (J&J) anaemia
blockbuster Eprex in what could lead to the market launch of new
"biosimilars" by the...
Swiss drug major Roche is facing a delay in bringing its EPO drug
Mircera (continuous erythropoietin receptor activator) to market in
the US after the Food and Drug Administration sent it an
'approvable' notice for the product.
The decision of the US Supreme Court not to hear Amgen's appeal in
a patent infringement case against Sanofi-Aventis and Shire,
involving the anaemia drug Epogen (epoetin alfa), may weaken
Amgen's position in keeping another...
Croatian pharmaceutical company Pliva has won its first European
approval for generic erythropoietin, a biologic drug used for the
treatment of low red blood cell counts, reports Phil Taylor.
Croatia's Pliva, the largest pharmaceutical company in Eastern
Europe, has teamed up with Australia's Mayne Pharma to hasten the
development of two 'generic' biologic drugs.
A subsidiary of Switzerland's Serono has filed a lawsuit alleging
that gene activation technology used in the production of
Transkaryotic Therapies' biological drugs contravenes a US patent.
The latest data on cases of antibody-mediated pure red cell aplasia
associated with Johnson & Johnson subsidiary Janssen-Cilag's
erythropoietin product Eprex/Erypo (epoetin alfa) have suggested
that measures put in place...
