The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.
US drugmaker Adventrx Pharmaceuticals is reducing its workforce to just 14 employees in a bid to preserve cash and refocus efforts on bioequivalence programmes for its lead candidates.
Two manufacturers launched their docetaxel products at CPhI last
week, each trying to stake their claim in the market in
anticipation of patent expiries on Sanofi-Aventis' Taxotere
(docetaxel) towards the end of the year.
Bioxel Pharma is the latest company to submit a Drug Master File
(DMF) to the US Food and Drug Administration (FDA) for docetaxel in
the lead up to the patent expiring on Sanofi-Aventis' version of
the cytotoxic chemical at the...
Active pharmaceutical ingredient (API) specialist ScinoPharm has
been assigned a drug master file (DMF) number for its anti-cancer
ingredient docetaxel, the first such designation for the API in the
US.
Canadian pharma manufacturer Bioxel has announced the filing of a
second international patent application to secure the synthesis of
paclitaxel and decetaxel - two taxane-based drugs effective against
cancer.
Canadian firm Bioxel has manufactured the first industrial-scale
current good manufacturing practice (cGMP) batch of its key
intermediate for docetaxel, the active pharmaceutical ingredient
(API) of Sanofi-Aventis's blockbuster...
