Panellists serving on the FDA's advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.
US Senator Sherrod Brown has fired off another broadside in his probe into pharmaceutical outsourcing, this time sending a request to Merck & Co “for further information on its heavy reliance on global outsourcing for the manufacture of pharmaceutical...
Like many of its peers in the contract clinical research sector, data management specialist Phase Forward put in another bumper financial performance in the second quarter headed by a 30 per cent hike in revenues to $41m.
ClinPhone's shareholders have now approved the acquisition of the company by Parexel after rival Quintiles withdrew from the race to buy the eClinical technology company.
Brookwood Pharmaceuticals, a subsidiary of SurModics, has acquired the exclusive rights to all pharmaceutical applications of PharmaSol’s nanostructured lipid carrier (NLC) technology.
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...
Acquisitive Indian contract research organisation Veeda has added
another company to its portfolio, buying International Oncology
Network (ION) of the US.
A service provider called Binto is filling a much needed vacuum in the clinical trial industry in terms of patient tracking, eliminating the need for big pharmaceutical firms to resort to methods such as hiring private investigators to track down "lost"...
UK-based Sinclair Pharmaceuticals has entered into a manufacturing
and distribution agreement with Wockhardt, an Indian pharmaceutical
and biotech company.
European pharmaceutical manufacturers stepped up calls for a
blanket ban on repackaging of pharmaceuticals last week, suggesting
that this would be the single most effective way to seal the supply
chain for counterfeiting drugs.
A US senator has asked the Food and Drug Administration (FDA) for a
probe into outsourcing of production for pharmaceuticals, as well
as ways to make drugmakers accountable for products which fail to
meet quality standards.
The US Food and Drug Administration has declared the country's
previously-tainted heparin supply to be "safe" due to
stronger testing and controls that are now in place. Meanwhile,
China continues to distance itself...
China is on course to having its own version of the International
Pharmaceutical Excipients Council - joining its fellow
organisations in Europe, the Americas and Japan.
The healthcare logistics industry is currently experiencing a shift
toward globalisation, supply chain simplification and delivery
specialisation, says an industry expert.
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.
The US Food and Drug Administration (FDA) believes that the
contamination of Baxter's blood thinner heparin, which has been
linked to 62 deaths in the US, may have been due to the deliberate
replacement of some ingredients with...
At present India appears to be beating China in the race for Asia's
top clinical spot, according to new figures published by india´s
Planning Commission.
Despite all the hype over clinical trial offshoring, the US still
dwarfs the scene, with emerging countries as yet only a blip on the
radar, a unique new study reveals.
The pharmacopoeias of the US and China will work more closely
together in future in a bid to improve the quality of medicines
available in both countries.
Three of India´s large pharmaceutical manufacturers, Dr Reddy's,
Ranbaxy Laboratories and Shilpa Medicare have just announced new
merger and acquisition (M&A) deals.
Pharmaceutical manufacturers, distributors and retailers alike have
welcomed a unanimous vote by the California State Board of Pharmacy
to delay for another two years the implementation of electronic
pedigree requirements for tracking...
The globalisation of the supply chain increasingly challenges the
US Food and Drug Administration's ability to ensure the quality of
pharmaceuticals on the US market, acknowledges the acting director
of the agency's Center...
Novartis has lent impetus to the growing trend towards
philanthropic R&D in the pharmaceutical industry by opening a
new research institute in Siena, Italy "with a non-profit
mission to exclusively focus on the development...
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.
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.
As eClinical gathers momentum, Outsourcing-Pharma.com spoke to two
contract research organisations (CROs), Icon and Parexel, to get
their views on the present and future of these emerging
technologies.
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.
This week two sets of contract research organisations (CROs) have
announced plans to link arms in order to spread their reach further
into this increasingly globalised marketplace.
Two major bioscience industry trade associations have called for
changes to be made to the European clinical trials directive in
order to bring about "harmonisation, transparency and consistency"
in this area across the...
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has signalled it will
soon allow a new "adaptive" approach to clinical trials in order to
streamline drug testing and speed drugs to market.
Outsourcing-Pharma focus on: cutting the cost of clinical trials
As pharma companies flock towards Eastern Europe and India in a bid
to cut direct clinical trial costs, does outsourcing actually
translate into real world cost-savings?
