The Food and Drug Administration (FDA) have high hopes for the
fourth revision of the Prescription Drug User Fee Act (PDUFA),
which has proved its worth by cutting review times by up to 24
months since its introduction in 1992.
The French Parliament has adopted legislation which prevents
biosimilar medicinal products from being classed as generics and
bans the automatic substitution of one biological medicine for
another.
Northern Ireland-based Almac Services has recently been awarded a
potent compound safety certification by SafeBridge, confirming that
Almac is capable of handling potent compounds safely and is able to
limit exposure using closed...
GlaxoSmithKline (GSK) has decided to consolidate all its human
resources business process outsourcing (BPO) services under the one
umbrella in a contract valued at $171m (€131m).
A new international agreement will eliminate customs duties on
pharmaceuticals and chemical intermediates traded between the major
nations dealing in the industry. The move is set to save EU
pharmaceutical companies around €230m in...
Heavyweight Pfizer is the latest pharmaceutical to cut
manufacturing capacity and shut down plants as it announces the
closure and sale of active pharmaceutical ingredient (API)
facilities in Ireland.
Pharmaceutical companies manufacturing vaccines to protect against
avian flu outbreaks will be protected from product liability claims
according to new regulations announced by the US Department of
Health and Human Services (HHS).
PerkinElmer will now offer a new lab equipment relocation service
to support customers who need to move and require special care for
their testing and manufacturing equipment.
Contract manufacturer Lonza has completed its acquisition of two
Cambrex subsidiaries, research bioproducts and microbial
biopharmaceutical, in a move that is fuelled by its strategic move
into biopharmaceuticals.
This year is shaping up to be another good year for third party
logistics (3PL) services firms focused on the pharmaceutical
industry, according to Sentry.
US Food and Drug Administration (FDA) has until April 2007 to reply
to a Citizen's Petition (CP) filed by Orchid Chemicals in response
to accusations of 'evergreening' related to Wyeth's re-formulated
Zosyn (piperacillin/tazobactam),...
US Democrats spearheaded by Henry Waxman intend to re-table a
stalled piece of legislation that would allow US Food and Drug
Administration (FDA) approval of generic biodrugs, which they claim
would result in cost savings for patients...
Pharma giant AstraZeneca last week announced its intention to cut
3,000 jobs in an effort to increase productivity and reduce costs.
The company is the latest big pharma to trim its workforce as the
industry readjusts in a more challenging...
Pfizer's latest cutbacks will provide a new outsourcing opportunity
for contract manufacturing organisations (CMOs) in low-cost
destinations as the drug giant announces plans to double its amount
of drug production outsourcing.
Johnson Matthey has announced a reassuring business update ahead of
its 31 March year-end, suggesting that Adderall is the driving
force behind a recovery in its pharmaceutical materials business.
Cardinal Health is about to sell its drug manufacturing arm to an
international private investment firm, only two months after
announcing its decision to divest the segment, while its second
quarter earnings doubled as a result.
Swiss chemicals firm and contract manufacturer Lonza has announced
18 per cent rise in net profit in 2006 rising to CHF 222m (€137.4),
fuelled by its strategic move into biopharmaceuticals.
Germany's Vetter Pharma-Fertigung has announced it has obtained a
manufacturing license for its new facility which will expand its
services by adding vial filling for lyophilised (freeze-dried)
products to its portfolio, in addition...
Shipping giant DHL has bagged a lucrative contract with pharma
giant Wyeth and become the first logistics provider to be given
complete responsibility for a company's worldwide clinical trial
materials distribution.
More companies in the pharmaceutical industry than any other
industry are set to increase their reliance on information
technology (IT) and business process (BP) outsourcing this year,
new research indicates.
German fine chemicals company Saltigo is benefiting from a cash
injection from its parent company, Lanxess. The German firm is
earmarking €30m for plant modernisation at its subsidiary, and a
€10m brand new multi-purpose facility...
Pfizer has announced it will axe 10,000 jobs and close facilities
in a further effort to save on costs; the move comes in the face of
patent expiries for their biggest drugs and the failure of a
late-stage pipeline project.
Biopharmaceutical firm SciGen has invested $30m (€23.2m) in a
hepatitis B vaccine manufacturing plant in Israel, expecting to
capture up to 15 per cent of the global market during a three year
period.
More cattle-derived materials used in the production of medical
products are due to be banned in the US Food and Drug
Administration's (FDA) latest steps to protect against mad cow
disease.
A new study condemns the high prevalence of ghost writing in
pharmaceutical company-sponsored clinical trials and calls for the
controversial practice to be culled in order to improve
transparency.
Drug giants Novartis and GlaxoSmithKline (GSK) have been awarded
contracts with the US government to develop adjuvant technology for
pandemic influenza, to potentially increase the number of doses to
be distributed among US citizens.
A federal court judge has imposed a temporary injunction against
the US Food and Drug Administration (FDA) over the organisation's
drug 'pedigree' requirements, on the basis that the regulations
leave sections of the...
Giant drug manufacturer Eli Lilly last week announced a reshuffle
in its global manufacturing operations to reflect the company's
focus on its current product portfolio and drug pipeline.
A new report out this week suggests the pharma industry is losing
the trust of its key stakeholders. The report, compiled by
PricewaterhouseCoopers (PwC), concludes that the growing decline in
the pharmaceutical industry's reputation...
Although US spending on healthcare rose by 6.9 per cent in 2005,
taking it to almost $2 trillion (€1.5 trillion), it's the smallest
increase since 1999, down from 7.2 per cent in 2004 and 8.1 per
cent in 2003.
New US legislation governing the security of chemical production
plants will come into force on 4 April 2007, with non-compliers
risking daily fines or plant shutdown.
Merck KGaA last week confirmed that it is considering selling off
its generics division, prompting mass speculation over potential
buyers within the industry.
Drug maker Merck & Co has entered an expansion phase, to boost
global manufacturing capacity for vaccines, adding $100 million to
its facilities in Durham.
German packaging firm Gerresheimer has acquired Wilden, the
European market leader for medical drug-delivery plastic systems,
in a move that will show worldwide presence through targeted
acquisitions.
India's Dishman Pharmaceuticals & Chemicals is planning to snap
up biotech and nanotech contract research organisation (CRO)
companies in Europe and in the US within drug conjugates to expand
their biologics capability.
Giant drug maker Eli Lilly has confirmed that it will be closing
its manufacturing facility in Basingstoke, England, resulting in
$85m to $95m in restructuring costs for the company.
Pfizer has entered a capacity expansion phase, to meet requirements
of global manufacturing of Genotropin (somatropin), a top-selling
human growth hormone.
NNE and Fresenius ProServe yesterday announced they had reached an
agreement by which NNE will acquire Fresenius' subsidiary,
engineering company Pharmaplan GmbH.
