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...
US biotech firm Genzyme has been given a green light by the US Food
and Drug Administration (FDA) to begin manufacturing its kidney
drug at its Waterford facility in Ireland.
Purdue Pharma is the first drug manufacturer to implement a new
software program that allows firms to order all Schedule I & II
controlled substance purchases on a single electronic form -
potentially saving up to 90 per cent...
The first revisions to the layout of drug package inserts in 25
years will come into effect as of June 30 and the Food and Drug
Administration (FDA) has released a draft technical document to
help drug manufacturers incorporate the...
While praising the benefits of radio-frequency identification
(RFID), the US Food and Drug Administration (FDA) has refrained
from demanding its implementation in new measures it unveiled to
combat counterfeit drugs, asking instead...
Lonza has been authorised by the US Food and Drug Administration
(FDA) to produce Bristol-Myers Squibb's arthritis drug Orencia
(abatacept), in what is shaping up to be a major manufacturing deal
for the Swiss company.
New legislation has given UK company Accentus the green light to
use its novel predictive crystallisation technology to discover and
market variations of patented drugs without infringing the original
patent.
New rules detailing an improved format for prescription drug labels
will be issued later this year, US Food and Drug Administration
deputy commissioner for medical and scientific affairs Scott
Gottlieb has said.
The European Medicines Agency has published updated guidelines on
the use of plastic packaging in pharmaceuticals, in a bid to help
packagers select the best and safest materials for their products.
The UK's figures on recycling waste is skewed because companies are
exporting their problem rather than increasing reprocessing rates,
the UK's second largest packaging waste compliance company claims.
French public prosecutors have expanded their criminal
investigations into alleged accounting irregularities by specialty
chemicals maker Rhodia, with a raid on the country's Ministry of
Finance.
Security printing specialist AlpVision has signed an agreement with fellow Swiss company Serolab to develop packaging that will guard against drug counterfeiting.
A high-ranking US Food and Drug Administration official has told a
Senate advisory committee that the agency needs more authority to
force drug companies to change labelling for their drugs when
safety issues arise, writes Phil Taylor.
Calling the next six months 'a critical period', the US Food and
Drug Administration's Acting Commissioner Lester Crawford has
unveiled a lengthy list of agency priorities, including continued
work on Good Manufacturing...
The European Union parallel trade in pharmaceuticals is offering
few benefits to cash-strapped national healthcare systems and may
raise the risk of medication errors and entry of counterfeit
medicines into the supply chain, according...
RFID has arrived. Long hailed as the next IT revolution for
industry, communicating labels are being forced into place by
retailers and legislators alike, leaving manufacturers racing to
implement a newborn technology steeped in unknowns,...
Swedish company Cypak has started two trials of its Intelligent
Pharmaceutical Packaging (IPP) technology, which offers an
alternative to radiofrequency identification (RFID) for tracking
the use of medicines.
Designers of child-proof packaging must always work against the
paradox that a package which is hard for a child to open can often
also be difficult for the adult patient it is intended to treat. In
fact, up to 90 per cent of adults...
3M has launched an updated version of its Integrated Packaging Tool
software that brings it into compliance with the US Food and Drug
Administration's 21 CFR Part 11 regulations on electronic
record-keeping, used to generate...
The US Food and Drug Administration is planning to hold a meeting
in June to re-examine its regulations on electronic records and
signatures, used to generate the audit trail in the food and drug
industries, to examine whether some...
The UK's recently adopted standard for child resistance in
non-recloseable pharmaceutical packaging such as blister packs
contains a serious flaw that must be addressed, according to
Stephen Wilkins, secretary of the UK's...
The US Food and Drug Administration (FDA) has created a new rule
requiring content and warning labelling for over-the-counter (OTC)
drugs that contain levels of calcium, magnesium, sodium, or
potassium that might be harmful to people...
Compared with European and US chemical companies, most domestic
Chinese chemical enterprises have remained technologically
challenged with productivity lagging behind international levels.
Companies involved in the parallel trade of pharmaceuticals have
been boosted by a court ruling which gives them the right to re-box
products shipped into the UK from another country in the European
Union.
The US Food and Drug Administration has issued a new rule that
makes it a requirement for most prescription and some
over-the-counter pharmaceutical products to carry bar codes. The
move is aimed at reducing the number of medication...
The US Food and Drug Administration issued its final report on ways
to combat pharmaceutical counterfeiting and identifies
radiofrequency identification (RFID) as a primary means of tackling
the problem.
Drug major Eli Lilly has provided a detailed response to a US
congressional committee request for details of how the firm intends
to tackle the issue of drug counterfeiting.
Monsanto and Pfizer's Pharmacia subsidiary have asked a federal
judge to either deny or postpone a request by Solutia to eliminate
liabilities to its former parent Monsanto.
A US congressional committee has asked five drug makers for advice
on the measures they are taking to combat the counterfeiting and
diversion of prescription drugs.
October has seen a rush by US biotechnology companies to list on
the stock markets, bringing to an end an Initial Public Offering
(IPO) drought lasting more than 18 months. Is Europe destined to
follow?
The world market for toxicogenomics technologies is set to grow
strongly over the next five years, but needs the catalyst of
recognition by regulatory authorities.
A new report from Datamonitor predicts the end of the
pharmaceutical industry's blockbuster product model, pointing to a
dramatic shortfall in growth rates for billion dollar-plus products
out to 2008.
A conference on batch process automation and asset management in
the pharmaceutical industry is scheduled to take place in Cork,
Ireland, on 22-23 October.
The market for cell culture products is getting a lift from
stringent regulations from the US FDA and Department of
Agriculture, restricting the importation and usage of foetal bovine
serum
Sam Waksal, the disgraced former chief executive of US
biotechnology company ImClone Systems, is due for sentencing today
and could receive a jail sentence as well as significant fines.
US pharmaceutical major Eli Lilly has earmarked a hefty £220
million (€304 million) investment over the next four years in its
UK facilities, representing the largest investment by the firm in
any European country.
As this edition of In-pharmatechnologist.com goes online, the US
Food and Drug Administration is convening the inaugural meeting of
its Advisory Committee for Pharmaceutical Science's Manufacturing
Subcommittee.
The Smart Active Labels Consortium is to present its first seminar,
titled "Smart Active Labels for Temperature Tracking: Shaping
the Future of Food/Pharmaceutical Distribution," on June 10 -
11 in Chicago, US.
