Improving safety and efficacy coupled with drug industry desire for “stronger” patents will drive growth of the biologics sector over the next five years, according to new research.
Imclone has closed the manufacturing facility in Branchburg, New Jersey where it produces the cancer drug Erbitux, according to reports in the US media.
SAFC Pharma has added extra viral and biologics capacity at its California plant in a $12m project that allows it to take projects from the lab to commercial scale.
Basel-headquartered Roche has paid fellow Swiss firm Lonza $290m (€203m) for its Singapore biologics plant in a bid to secure long-term manufacturing capacity for biotech cancer drugs.
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.
US biotechnology group OSI Pharmaceuticals will move HQ to a facility in Greenburgh, New York due, according to observers, to the high cost of land at its current base in Long Island.
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.
in-Pharmatechnologist's Nick Taylor looks back on BIO 2009, an event at which uncertainty about the development of the biotechnology industry’s future shape dominated proceedings.
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.
Massachusetts Biotechnology Council’s (MBC) 2015 strategic plan has outlined the difficulties the state faces in attracting biomanufacturing and called for increased focus on R&D.
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...
Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.
Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.
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.
Biotech bodies from around the globe have been calling on their respective governments to provide stimulus packages to compensate for the current difficulties in obtaining credit.
Irish drugmaker Elan, which recently dropped plans to sell its Elan Drug Technologies operation, has announced job cuts and the closure of offices in a bid to save cash.
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.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
Abraxis has licensed rights to use ProMetic’s protein technology in the development of four new biopharmaceuticals that it hopes will generate around $600m (€422.5m) in US sales.
An increase in the sale of vaccines such as Quinvaxem and Epaxal, helped Dutch drugmaker Crucell reduce its loss some 56 per cent to €7.9m ($12.5m) in the second quarter.
Lonza is to co-develop and manufacture Novartis' biological pipeline as part of a long term strategic partnership that has been struck between the companies.
Invitrogen plans to cement its place as one of the world's largest
suppliers of analysis tools and reagents for the life science and
pharmaceutical industries by acquiring Applied Biosystems (ABI).
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
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.
The critical role transgenic animals could play in the future of
biopharmaceutical production has been tackled by a task force in a
new report out this week.
The European Union's (EU) member states must take their
responsibilities to implement the biotech policy proposed by the
European Commission (EC), said EuropaBio, the EU industry body.
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.
The French Parliament has adopted legislation which prevents
biosimilar medicinal products from being classed as generics and
bans the automatic substitution of one biological medicine for
another.
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
into biopharmaceuticals.
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...
Swiss chemicals firm and contract manufacturer Lonza has announced
18 per cent rise in net profit in 2006 rising to CHF 222m (€137.4),
fuelled by its strategic move into biopharmaceuticals.
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.
MedImmune has embarked on an expansion of its biologics
manufacturing facility in Frederick, Maryland, to ramp up its cell
culture production capacity, as several of its monoclonal
antibodies (MAbs) approach commercialisation.
The European Union (EU) has been criticised for being more
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
As the bio-outsourcing market hits boom time, the number of
contract biomanufacturing organisations (CBMOs) that specialise in
the production of biopharma products, is rapidly expanding.
