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.
In-PharmaTechnologist.com and Outsourcing-Pharma.com journalist
Kirsty Barnes has received the honour of being announced among the
place winners of the 2006 Awards for Excellence in Health Care
Journalism (AHCJ).
A twist on an existing security technology will use enhanced mobile
phones to help establish the authenticity of pharmaceutical
products in developing countries.
Legal action could begin today against Parexel if the firm does not
come up with "an adequate proposal" to compensate the victims of
last years drug trial disaster in Northwick Park, London.
Novel needle-free injections that don't cause the pain and bruising
common with existing needle-free devices have been developed by a
team in California.
A new report has been released this week calling for reforms in
first-in-man clinical trials in the wake of the TGN1412 drug trial
disaster in London last year.
With a new drug on the market and its Massachusetts plant at
capacity, British drug maker Shire is actively looking to buy more
biomanufacturing space in the US.
Drugs containing pseudoephedrine and ephedrine could soon be
reclassified as prescription-only the UK, in proposals drawn up
last week by the Medicines and Healthcare Products Regulatory
Agency (MHRA).
US services provider Frontier Biosciences has announced that it has
bought a majority stake in a China-based preclinical contract
research organisation (CRO).
UK drug goliath GlaxoSmithKline (GSK) is ramping up drug production
at its Polish site as it prepares to more than double the number of
markets the plant will supply.
The second generation of a new class of HIV drugs have entered
clinical trials and could prove more difficult for HIV to develop
resistance to, according to developers Panacos.
In-PharmaTechnologist takes an indepth look at the new radio
frequency identification (RFID) technology that will soon
revolutionise pharmaceutical supply chain management.
GlaxoSmithKline (GSK) has denied allegations that some of its
vaccines have been tested illegally and against good clinical
practice (GCP) in children in Russia.
The sixth in a series of periodic roundups of drugs that have moved
from preclinical research into clinical testing via the
announcement of a Phase I trial or an application for a trial to
industry regulators.
Pharmaceutical manufacturer Zentiva has signed a deal acquiring 75
per cent of Turkish Eczacibasi's generic pharmaceuticals business
for €460m, making it the third largest generics company in the
country.
GlaxoSmithKline (GSK) has stopped development of several drugs,
leaving some industry experts to wonder if the company's cap on
research spending is stifling drug development.
A new rapidly dissolving oral strip for ondansetron, the active
ingredient in GSK's anti-emetic drug Zofran, has been developed in
a Swiss-German collaboration.
Canadian contract manufacturer Patheon has announced a $150m
(€114m) investment by a private equity firm - a move the company
sees as the best viable option to end its financial misery.
A highly-acquisitive and research-intensive year has left drug
discovery services provider Galapagos further in the red at the end
of its 2006 financial year, although sales soared.
PDL BioPharma, Synexus, Kendle, PharmaNet Development Group, MDS,
Chiltern International and Laureate Pharma have all had people on
the move in the world of pharmaceutical outsourcing.
The implantable/injectable drug delivery market generated record
revenues of $9.8bn (€7.4bn) worldwide in 2006 but is set to
continue growing, driven by growing demand for novel drug delivery
technologies.
Food and Drug Administration (FDA) staffing and timetabling
problems have delayed the re-inspection of Wyeth's Puerto Rico
site, the company said this week.