A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
Simple preclinical experiments should be able to predict whether immunotherapeutic medicines are safe to advance to preclinical testing in humans and avoid the Northwick Park trial that left six healthy volunteers hospitalised.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
Aptuit presented a seminar at this year’s AAPS explaining how it had implemented its INDiGO programme, which takes an API to IND in 26 weeks, and how it can benefit clients.
The proportion of women in clinical trials has become more representative, although there are still areas for improvement, according to research by the FDA.
Increasing bureaucracy in clinical research in the UK is posing a threat to the industry, according to a report published in the British Medical Journal.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
Pharmaceutical Profiles of the UK has completed a groundbreaking study that bundles together a number of tests used to decide whether a drug development candidate is worth pursuing into a single clinical trial.
After months of deliberations, a court in Iowa has opted to fine contract manufacturing company Cambrex $6,000 for safety violations after an explosion at its facility in Charles City.
Indian pharmaceutical companies are making their first forays in the biotechnology arena, helping the market expand from a standing start at the beginning of the decade to reach a value of $2bn in 2006-7, according to a recent report from KPMG.
Germany-based Diapharm has launched a service allowing pharmaceutical manufacturers to perform joint third-party audits of active pharmaceutical ingredients (APIs).
Active pharmaceutical ingredient specialist Calyx Chemicals and Pharmaceuticals is planning an acquisition within the next two years, probably in the US or Europe, according to chief executive Smitesh Shah.
Outsourcing-Pharma.com presents its latest round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.
India’s contract manufacturing market is expected to rocket forward over the next couple of years to reach a value of $2.46bn in 2010, according to a just-released report from KPMG.
The outsourcing of Phase I trials to India may be allowed by 2009-10 after the Central Drugs Standard Control Organisation (CDSCO) said it is considering changing its stance.
Canada’s Patheon put in another quarter of robust revenues growth in its third quarter, which coupled with cost-reduction measures helped the firm trim its net loss to $14.7m, down 75 per cent on a year ago.
Contrary to fears, the European Union’s Clinical Trials Directive has not had an inhibitory effect on the number of studies carried out by publicly-funded researchers, at least in Denmark.
Canada’s PharmEng International almost tripled its turnover in the second quarter, as its acquisition of a Pfizer manufacturing facility at the end of 2007 transformed sales at contract manufacturing facility Keata Pharma.
Venus Remedies’ oncology facility has received EMEA GMP accreditation, making it one of very few Indian contract manufacturers licensed to make cancer treatments for the European market.
Outsourcing-Pharma.com presents its periodic round-up of personnel changes in the pharmaceutical outsourcing arena, with senior appointments at Bristol-Myers Squibb, Parexel and GVK Bio, amongst others.
Pharmaceutical companies in the developed world have already
shifted substantial manufacturing and clinical trial work to
emerging economies such as China and India, but a new study suggest
they are increasingly counting on these...
Visiongain's third annual conference on Pharmaceutical
Anti-counterfeiting Strategies kicks off next week, covering many
aspects of the problem from technological deterrents, regulatory
developments in the EU and US and the implications...
The new European Chemicals Agency (ECHA) opened its doors in
Helsinki this week, with questions raised immediately about its
ability to handle the thousands of registration requests required
under the controversial REACH legislation.
Canadian contract manufacturer and consultancy firm PharmEng
International has published its 2007 accounts, and says it remains
firmly focused on getting into the black in 2008.
IT infrastructure and business process services firm Cognizant has
announced an alliance with CTC Laboratory Systems that aims to
assist Japanese pharmaceutical firms in enhancing efficiencies in
drug discovery and development.
The US Food and Drug Administration (FDA) has revealed it will be
operating on the ground in China imminently, while the Drug
Information Association (DIA) has just planted itself in Asia's
other pharma don, India.
Overall, 2007 was another stellar year for contract service
providers, particularly those at the early-stage end of
development, although companies are advised to watch out for a
tougher environment ahead.
Steven Liberty, senior vice president of operations for Patheon's
North American businesses spoke at Interphex on the strategies
contract manufacturing organisations (CMOs) can use to obtain a
competitive advantage.
An investigation in the aftermath of a fire and explosion at one of
Cambrex' US plants last year has found the firm in breach of
several safety regulations and the company will be fined
accordingly.
More details have emerged over the US Food and Drug
Administration's (FDA's) failure to vet the Chinese manufacturing
plant implicated in the Baxter heparin scare - the agency mistook
it for an already-inspected plant, it...
Questions are hanging over the role of a Chinese manufacturing
facility in the Baxter heparin scare after it has emerged that the
US Food and Drug Administration (FDA) has never inspected the
facility.
Four of India's biggest vaccine manufacturers have had their
licenses suspended by the Indian government after failing to meet
good manufacturing practise (GMP) requirements, according to local
media reports.
Eli Lilly has released a statement strongly objecting to
implications made in a New York Times article that it has
suppressed results of negative clinical trials.
Product recalls in the UK due to health and safety concerns have
shot up to their highest level, with the rise in outsourcing to
China finger pointed for much of the blame.
The first steps in tightening the safety controls on the
pharmaceutical ingredients imported to the US from China have been
taken following months of negotiations between the regulatory
bodies of the two countries.
Bristol-Myers Squibb (BMS) has finally detailed its plans to trim
the fat and save cash, months after first revealing that big
changes would be on the cards.
Pfizer's revelation this week that it plans to slice jobs in Puerto
Rico is the latest in a string of blows for this popular offshore
manufacturing location.
As of next year Chinese pharmaceutical manufacturers will face a
tougher time gaining good manufacturing practice (GMP)
certification after the country's regulator signalled new and
stricter standards were on the way.
A new report highlights a number of worrying trends emerging in
regard to the increasing number of fake pharmaceuticals
infiltrating supply chains around the globe.
Discovery Laboratories could see the end of its struggle to launch
its Surfaxin (lucinactant) drug on the US market as it has finally
resolved the manufacturing issues that have plagued the product for
months.
The US Food and Drug Administration (FDA) is following the growing
pharma industry trend by embracing outsourcing as part of a
cost-saving drive - a move that is attracting strong opposition.
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...