A next-generation insomnia drug has been put to bed after its
developers decided the risk of using the drug outweighed its
potential benefit to millions of insomnia sufferers.
Artel is sending three of their employees to the most extreme
environments in the US to demonstrate the impact of environmental
conditions on pipetted volumes.
More analysis of a drug's target and mode of action in the
preclinic has been called for in the draft guidelines for
first-in-man trials published by the European Medicines Agency
(EMEA).
GlaxoSmithKline (GSK) has announced plans to outsource all its data
management and medical trial and regulatory reporting functions to
India in a deal said to be worth over £10m (€14.7m).
The FDA is giving contract research organisations (CROs) the chance
to take part in a pilot designed to test the viability of
electronic case report forms (eCRF).
Antisense drug developers received a boost today with the news that
Isis Pharmaceuticals' cholesterol lowering drug is showing good
results in clinical trials.
Outsourcing is key for pharma companies and medical device
manufacturers keen to develop and produce "combination products" -
medical devices embedded with a pharma component - according to an
industry player.
The pan-European drug regulator, the European Medicines Agency
(EMEA), has adopted a draft guideline for first-in-man clinical
studies for potential high-risk drugs in a bid to prevent a repeat
of last year's TGN1412 drug trial...
Suggestions that Pfizer's scrapped cholesterol drug could actually
make coronary artery disease worse could set hearts racing among
others developing drugs in the same class.
The US Food and Drug Administration (FDA) has tackled escalating
concerns about the independence of its advisory committees by
proposing more stringent criteria for avoiding potential conflicts
of interest when considering potential...
Major chemical manufacturer Dow has struck a deal with long-term
partner Colorcon forming an alliance to offer a unified package for
the development and production of drug ingredients and products.
The demand for international assistance in recruitment processes
from pharmaceutical companies is set to boom in the next 12 months,
according to an industry player.
Contract research organisation (CRO) Charles River Laboratories has
announced it will establish a presence in China by signing a joint
venture deal with Shanghai BioExplorer, a Chinese preclinical
services provider.
French chemicals company Rhodia has decided to shut down a local
production site for its Rhodia Organics business, citing
competitive pressures in the market for pharmaceutical and
agrochemical intermediates.
Novartis and Bayer Schering Pharma have come to an agreement
regarding the production of multiple sclerosis (MS) drug Betaseron
(interferon beta-1b), with Novartis planning to bring out its own
version in 2009 and Bayer paying around...
UK drug delivery and orthopaedic devices company The Medical House
(TMH) is entering the second phase of a development project for a
European defence agency involving its AutoSafety Injector (ASI)
disposable autoinjector technology...
A Brazilian firm has signed a licensing deal to take advantage of a
biopharmaceutical manufacturing technology which will allow the
company to locally manufacture complex biopharmaceuticals destined
for the South American market.
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.
Indian biotech firm Biocon is planning to boost its contract
research business as global pharma companies are increasingly
looking to outsource R&D to India, according to media reports.
A new wave of drugs designed to treat rare brain disorders, which
are caused when proteins don't fold correctly, are showing
promising results in trials, according to their developer.
Both Agilent and Applied Biosystems (ABI) have announced new
facilities in Asia and are looking to gain from the increasing
pharmaceutical industry presence in the region.
The seventh 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.
Discovery Laboratories has announced that a shareholder lawsuit
filed against the company was dismissed by a Pennsylvania court,
marking the end of its two-year manufacturing nightmare.
A novel method of delivering a hydrophobic (water-insoluble) drug,
in which the compound effectively acts as its own carrier, has
shown comparable efficacy both in vitro and in
vivo to the same drug formulated in a conventional delivery...
ActivX has launched a new profiling platform, which the company
claims allows the functional analysis of twice the number of
protein kinases than competing systems.
Sanofi-Aventis is gearing up for the European roll-out of a new
disposable insulin pen designed to address a broader spectrum of
patient needs than currently available injection devices.
PharmaNet has been told by the US Securities and Exchange
Commission (SEC) that it will now be the subject of a formal
investigation as it continues to be haunted by the early phase unit
it used to own in Miami.
The European Parliament has backed proposed legislation to impose
hefty fines and penalties on criminals taking part in piracy and
counterfeiting activities.
The purchase of Canada's Allied Research International (ARI) has
given Cetero Research a boost to its early-phase clinical services
and geographic reach in Canada.
GlaxoSmithKline (GSK) has today opened a new medicinal chemistry
laboratory in Singapore and plans to double the number of
researchers hired at the site to 60.
An innovative new platform technology with a myriad of applications
has been developed by a UK firm, and promises to be a novel arrow
in the quiver of the pharma industry in its attempts to shoot down
drug counterfeiters.
Albany Molecular Research, Ranbaxy Laboratories, IBS Pharma, PhRMA
and Globalpharma have all had people on the move in the world of
pharmaceutical manufacturing.
Scientists hope to harness the power of Sony's new PlayStation 3
games console to conduct research on protein folding and associated
diseases such as Alzheimer's and cancer.
Packaging technology firm Bradman Lake is selling off recently
acquired brands Albro, Dico and Gravfil only months after investing
in a new multi-million pound manufacturing facility.
The mayor of a US city where Covance is planning to build a
controversial new preclinical testing facility met last week with
the Food and Drug Administration (FDA) and government officials to
discuss the animal testing issues surrounding...
A novel drug designed to prevent coronary heart disease has failed
a pivotal clinical trial although the developers are hopeful the
drug might still win approval.
GlaxoSmithKline's (GSK) new breast cancer drug has been given the
all clear to be used in the US, with the company expecting European
approval to follow later this year.
Eli Lilly & Co has withdrawn its European approval application
for Arxxant (ruboxistaurin), a potential blockbuster drug to treat
blindness caused by diabetes.
A new piece of equipment could enable scientists to study changes
in protein structure, including those necessary to cancer tumour
growth, both faster and more accurately, according to its
developers.
