Pharmaceutical manufacturer Zentiva has signed a deal acquiring 75
per cent of Turkish Eczacibasi's generic pharmaceuticals business
for €460m, making it the third largest generics company in the
country.
UK firms Melbourn Scientific and Copley Scientific have agreed to
collaborate on developing novel methods of testing the force of
nasal sprays and metered-dose inhalers (MDIs).
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.
A bill unveiled by US senators yesterday would clear the way for
the Food and Drug Administration (FDA) to approve low cost, generic
versions of biotech medicines. There is currently no statutory
pathway allowing such generic copies...
Italian contract manufacturer Procos has just opened a US office -
a move that will allow the company to offer custom synthesis
services directly to its US customers.
A new partnership between India's Reliance Life Sciences (RLS) and
Ireland's GeneMedix will provide new contract opportunities for
European contract bio-manufacturers.
US-based drug delivery firm, BioDelivery Sciences International
(BDSI), has asked for approval to start clinical trials of a soya
bean-based delivery technology that would lead to the first oral
version of amphotericin B, a widely-used...
Major pharmaceutical player GlaxoSmithKline (GSK) has begun
construction of a €23m facility in County Waterford, Ireland. The
new facility is already under construction at the company's
consumer healthcare manufacturing site...
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...
The US Food and Drug Administration has accepted two Celsis drug
master files (DMFs) that could increase the adoption of its rapid
microbiological detection technology among pharmaceutical
manufacturers.
India's drug manufacturing industry is tipped to grow 10 per cent
over the next three years as more pharma firms shift operations
there to cut costs, says a research report.
Despite the many challenges facing the pharmaceutical industry,
drug developers should be optimistic, according to a report from
the Tufts Center for the Study of Drug Development (CSDD).
The pharmaceutical industry's first fully portable drug
anti-counterfeiting device will be presented in Baltimore later
this month at IFPAC, the International Forum on Process Analytical
Chemistry.
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).
The US Senate has confirmed Andrew von Eschenbach as the official
Commissioner of the Food and Drug Administration (FDA) after months
of delay due to complaints about the regulator's oversight.
The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.
Fewer first cycle new drug approvals by the US Food and Drug
Administration (FDA) could be the first evidence of a toughening
regulatory environment, according to new research.
The Food and Drug Administration are set to introduce a series of
measures that will accelerate the review process for generic drugs,
placing a priority on therapies that would address a public health
emergency or nationwide shortage.
The US Food and Drug Administration (FDA) has come under scrutiny
after an independent report urged the regulator to implement large
reforms to ensure the safety of new prescription drugs.
Following numerous manufacturing failures, Discovery Laboratories
believes it has resolved the stability issues that have plagued
Surfaxin, its experimental respiratory treatment for infants, and
is now seeking a meeting with the...
After selling a manufacturing plant in Texas to Cardinal Health two
years ago, Adams Respiratory Therapeutics has reacquired the
facility in order to produce its expectorant Mucinex (guaifenesin
extended-release), responding to a...
The battle for the acquisition that will form the world's third
biggest generic drugmaker has intensified, with Iceland's Actavis
making a new offer for Croatian drug manufacturer Pliva that
surpasses that of US pharmaceutical...
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...
The US Food and Drug Administration (FDA) has turned down Nastech's
generic version of the nasal spray Miacalcin for the treatment of
osteoporosis because of the possibility of an interaction with a
preservative used in the formulation,...
Biotechnology firm Alexion has acquired a Dow biomanufacturing
facility in Rhode Island as it gears up for the commercialisation
of its blood disorder drug Soliris, yet the move does not signal
the end of the company's contract...
Discovery Laboratories is claiming progress in its struggle to
correct manufacturing problems related to Surfaxin, its
experimental respiratory treatment for infants, yet the goal of
overcoming the process validation issues that prevent...
Vintage Pharmaceuticals, a generic drugmaker with plants in North
Carolina and Alabama, has pleaded guilty to 19 felony counts of
producing adulterated drugs and introducing them into interstate
commerce.
Testing services and contract manufacturing firm Microtest has
announced it will invest $7.5m (€6m) in new facilities to expand
its offering of pharmaceutical and virology testing services and
fill/finish production capacity.
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...
Fine chemicals company Hovione has passed an inspection by the US
Food and Drug Administration (FDA) at its active pharmaceutical
ingredient (API) manufacturing site in Loures, Portugal, as it
tries to conform with ever-stricter standards.
German biopharma firm Sandoz has won a landmark first-of its-kind
biosimilar drug approval in the US after a long battle with the US
Food and Drug Administration (FDA). The decision could open the
floodgates for generics manufacturers...
Canadian contract manufacturer Patheon saw pre-tax profits remain
idle in the second quarter of 2006, leaving it struggling to find
ways to boost profitability.
RSSL Pharma Training has established three new courses to help UK
pharmaceutical and medical device manufacturers prepare themselves
for a plant inspection by the US Food and Drug Administration
(FDA).
Software provider Pharsight, has been awarded a patent on its
graphical method for creating drug models, in a technique that
supports more intuitive PK/PD modelling and higher modelling
productivity.
Italian packaging and processing machinery company IMA Group has
booked more than 1,100 square metres of space at this year's
Achema, determined to push its products ranging from solid dose
processing to labelling and tube filling.
Drug companies are leaning more heavily on contract research
organisations (CROs) to save costs in getting new drugs to market.
And it is paying off, with added benefits. Companies who rely on
CROs are also completing clinical trials...
Actavis Group has announced the company has acquired the human
generics business of Alpharma, making the international generic
pharmaceuticals company one of the five largest companies in
generic pharmaceuticals worldwide in terms...
Cook Pharmica will be the first contract manufacturer to offer live
webcam services, an innovation that will enable both customers and
regulatory agencies to view production as it occurs.
US consumers could have saved $20 billion (€16.6 billion) in 2004
and even more could be saved in future years by using more generic
drugs, according to a new report by Express Scripts.
Bangledeshi's Beximco Pharmaceuticals has announced that the
company has raised $21 million after it successfully completed an
institutional placing of global depositary receipts (GDRs).
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 US Food and Drug Administration (FDA) has found itself once
again without a permanent Commissioner after the current incumbent
- Lester Crawford - resigned after 18 months in the post.
Eisai has become the first Japanese drugmaker to set up a dedicated
subsidiary in India in order to tap into local expertise in
manufacturing and research, according to local press reports.
Sandoz, the generic drug unit of Swiss pharmaceutical group
Novartis, has filed a law suit against the US Food and Drug
Administration (FDA) alleging that the agency is dragging its feet
in a review of a 'biogeneric' drug...
A US think tank, The Centre for Medicines in the Public Interest,
has released a new report projecting counterfeit drug sales to
reach $75 billion in 2010, a 92 per cent increase from 2005.
Quicker review times by the US Food and Drug Administration has not
increased the number of prescription drugs withdrawn for safety
reasons in the country, according to the Tufts Centre for the Study
of Drug Development.
India's Bilcare Ltd, a research-based pharmaceutical packaging
solutions company, has acquired ProClinical of the US in a deal the
company says takes it 'closer to achieving its vision of becoming
the world leader in the...
Troubled generic drug manufacturer Able Laboratories has conceded
defeat in its bid to get products back onto the market and elected
to sell off the assets of the business.
Lester Crawford was confirmed yesterday as the new Commissioner of
the US Food and Drug Administration, having already served for more
than a year in the post.
US pharmaceutical company Upsher-Smith Laboratories has been forced
into staffing cuts and a restructuring exercise by delays in the US
Food and Drug Administration's review of its nasal calcitonin
product for osteoporosis.
