Pfizer’s new $214.8 million (€150m) biotechnology facility in Strangnas, Sweden was inaugurated yesterday, securing the country’s future in the company’s manufacturing network according to global manufacturing president Natale Ricciardi.
Novartis and Jubilant Organosys are among several companies forced to recall generic drugs after manufacturing operations at their shared CMO, India’s MJ Biopharm, were found to be in breach of GMP guidelines.
HEM Pierre Vimont, Ambassador of France to the US, was at BIO 2009 talking about the measures his nation have taken to attract biotechs, including the introduction of the "most favourable R&D tax in Europe".
Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings greater use of generics could provide.
Faced with a tougher operating environment, Irish drugmaker Elan has decided to slash staff numbers by 230 – or around 14 per cent of its total workforce – shelve the construction of a new biologics manufacturing facility and shutter fill-and-finish capacity...
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman...
Positive noises from an FDA panel on GTC Biotherapeutics’ recombinant antithrombin ATryn may further the use of transgenic animals for drug production but should the manufacturing process rather than the drug’s safety be our prime concern?
The completion of trial batches of Siga Technologies’ smallpox treatment ST-246 could not have been better timed following as it does the recomendation that the Obama government raise the threat of bio-terror up its list of concerns.
The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
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...
At a time when single-use manufacturing equipment is riding on a
surge of popularity, in-PharmaTechnologist.com talks to Vijay Singh
of GE Healthcare's newly acquired Wave Biotech unit about the
impact disposables will have on...
The apparent inability of current analytical techniques to fully
characterise complex biological drugs still stands in the way of
easy approval pathways for 'biogenerics' or copies of off-patent
brand name biologics.
A potential new law mandating the running of clinical trials before
a "generic" biologic drug approval may seem like a potential
goldmine for contract research organisations (CROs), however, this
vision is premature.
Contract manufacturer Lonza has completed its acquisition of two
Cambrex subsidiaries, research bioproducts and microbial
biopharmaceutical, in a move that is fuelled by its strategic move
US Democrats spearheaded by Henry Waxman intend to re-table a
stalled piece of legislation that would allow US Food and Drug
Administration (FDA) approval of generic biodrugs, which they claim
would result in cost savings for patients...
India's Dishman Pharmaceuticals & Chemicals is planning to snap
up biotech and nanotech contract research organisation (CRO)
companies in Europe and in the US within drug conjugates to expand
their biologics capability.
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.