IMS Health has confirmed it is “exploring strategic alternatives” after speculation this week suggested that the market analysis group had received a number of takeover bids.
Symphony Metro Pharma Solutions and HP Solutions have created a new application that, they claim, can help drug marketeers identify activities with the greatest revenue potential.
Drug development partnering site goBalto’s addition of Latin American clinical sites to its database in a deal with Chilean CRO Clinical Trials Support (CTS) is timely given the pharma and biotech industry’s focus on emerging markets.
US drug giant Pfizer has joined the growing list of organisations seeking to boost trial recruitment via the web, teaming up with IT firm Private Access to create a website designed to “increase clinical trial awareness and participation.”
US firm Compass Pharma Services is now offering ISO class 8 certified packaging services in a bid to capture a share of the expanding high-potency drug sector.
Use of graphs and tables depicting pharmacokinetic attributes is among the recommendations made in the FDA’s latest guidance on clinical pharmacology labelling of prescription drugs.
Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
As the sophistication of counterfeit drug packaging continues to improve it is becoming harder and harder to tell real products from fake. in-PharmaTechnologist spoke with Alpvision's Roland Meylan about the company's approach to brand authentication.
The FDA is calling for all drugs to be labelled using a standardised numerical identifier (SNI) similar to the one suggested in the delayed California e-Pedigree guidelines in a bid to tighten up supply chain security.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
The European Association of Pharmaceutical Full-line Wholesalers (GIRP) says it has concerns about the anti-counterfeiting proposals contained in the European Commission's recently-released 'pharmaceutical package.'
To accompany the map detailing job losses, which can be viewed here, we have picked out the details and trends from the data, uncovering the state of US pharmaceutical employment in 2008.
The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
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.
Although Japan's pharma market sits in firm second position on the
global stage, the country's foothold is slipping as other more
innovative countries grasp for a greater presence.
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.
The US Food and Drug Administration (FDA) has defended its proposed
rule on product labelling changes made unilaterally through
"changes being effected" (CBE) supplements against
accusations from Congress, trial lawyers...
The pharmaceutical industry has lost confidence in the UK as a
place to do business to an "alarming degree" and the
situation is only set to deteriorate, reveals new research.
The generic pharmaceutical industry has given short shrift to the
latest congressional attempt to construct a viable approval pathway
for biosimilars in the US.
Pfizer has outlined a number of strategies for growing its
fledgling pipeline and lowering its cost base and is planning to
increase globalisation and accelerate growth in emerging markets as
part of this.
A proposed rule on labelling changes published by the Food and Drug
Administration (FDA) has re-ignited the reliably inflammable debate
over the role of pre-emption in US product liability cases.
'Legislative chaos' has been preventing Poland from reaching its
full potential in the increasingly competitive central Eastern
European (CEE) region, although progress is being made.
PharmaNet Development Group has reached a significant turning point
in its attempt to finally close the doors on a long period of
trouble with its Phase I clinical business.
Parexel talks to Outsourcing-Pharma about Phase I trials, touching
on trends and growth opportunities, future plans for India and
lessons learned from Tegenero.
Despite a lift of the ban on biological sample transportation out
of Russia, the country's clinical research industry is still in the
dark on the new rules to control export of such materials.
Alcan Packaging Kreuzlingen is the latest company to receive
certification for the new ISO standard for primary packaging,
becoming the first flexible packaging firm in the world to achieve
the accreditation.
The first contract research service alliance (CROSA) in China has
been formed between three leading local firms to provide a more
exhaustive range of drug development services to pharma companies.
Kendle has climbed back into the black in the first quarter of 2007
after another quarter of strong sales although pre-tax profit
remains down on 2006.
Japan is getting serious about clinical trial reform after years of
lagging behind the rest of the developed world in the availability
of drugs in the country, which ironically is the world's number two
pharma market behind the...
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.
US services provider Frontier Biosciences has announced that it has
bought a majority stake in a China-based preclinical contract
research organisation (CRO).
MDS pharma has ceased operations at its bioanalytical services
facility in Blainville, Quebec in a bid to boost profitability
after an ongoing investigation of the site by the US Food and Drug
Administration (FDA).
In the next one to two years there will be a trend towards
significant reductions in clinical outsourcing/contract research
organisation (CRO) budgets in the majority of biopharma firms,
reveals a recent industry survey.
MDS has been heavily impacted by a US Food and Drug Administration
procedural review of its bioanalytical operations, but still
managed to report quarterly earnings of C$53m (€35m).
Animal welfare group, PETA has reportedly targeted Pfizer, accusing
them of also trying to avoid US animal welfare laws by exporting
its animal testing to countries with no or poor animal welfare
standards.
The US government to pass new measures that make prosecuting
animal-rights activists who target enterprises much easier. The
move has lead critics to warn that peaceful demonstrators would be
labelled as terrorists.
A group of researchers have come together to form a coalition,
which aims to campaign for the revision directives on the
protection of animals used for scientific research.
Ground Zero Pharmaceuticals (GZP) has announced an expansion to the
services it offers enabling the expansion into more of its clients'
late-stage development programs, with the potential for creating
submissions that lead to...
Integrated exploratory protocols could be the way forward in
carrying out early phase clinical studies, which not only reduces
drug development time and cost but minimises risk of late phase
failures.
When it comes to managing an early phase research and clinical
development programme, drug companies have three choices - each
with their own pros and cons.
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.
European parliamentarians have come up with a long list of measures
that the EU needs to take to combat counterfeit drugs, yet track
and trace technologies were noticeably absent from their calls for
action.
In the first drug master file (DMF) approval of its kind, the US
Food and Drug Administration (FDA) has approved the sale of
metformin hydrochloride tablets which are produced by an Indian
company using a pharmaceutical formulation...
Spurred on by the frustration of drug manufacturers, governors from
four US states have petitioned the US Food and Drug Administration
(FDA) for clarity in their requirements for the production of
generic versions of insulin and human...