Pfizer has updated the US product labeling of its inhaled insulin
treatment Exubera to include a warning of increased risk of lung
cancer among those using it.
The repercussions of Pfizer's dramatic Exubera exit are finally
filtering through to West Pharmaceutical Services, with the
company preparing to restructure its affected Tech Group
contract manufacturing unit.
Eli Lilly is remaining optimistic about its yet-to-be-approved
inhaled insulin despite the dramatic downfall of Pfizer's Exubera.
But is Exubera's fall from grace an indication of things to come
for inhaled diabetes treatments?
With yesterday's perhaps unsurprising news that Pfizer has cut its
losses and pulled out of the inhaled insulin market by dropping
Exubera and giving up on second generation devices, the world's
biggest pharma firm is in...
Pfizer revealed today that it is abandoning its once-touted
blockbuster Exubera, ending months of speculation as to whether the
fledging world-first inhalable insulin would sink or swim in the
fierce waters of pharma.
UK-based Bespak, one of the two contract manufacturers of Pfizer's
inhaled insulin Exubera, confirmed on Friday it has been approached
by a potential buyer.
An improved inhalable insulin product developed by collaborating UK
and US firms has just completed a glucose clamp study in the US,
with results suggesting that the product could pose a significant
threat to Pfizer's Exubera...
West Pharmaceutical Services have been informed to scale back
production of Exubera devices following the dismal revenues the
inhalable insulin product has generated so far this year.
Bespak, one of the two contract manufacturers of Pfizer's inhaled
insulin Exubera, has announced it will cut a "significant" number
of jobs as sales of the once-touted blockbuster are falling short
of expectations.
Eager to find a formulation that will give Pfizer's inhalation
device Exubera (insulin rDNA) a run for its money, Nastech is
initiating a Phase I study to compare Exubera to its insulin nasal
spray and to an approved injectable...
Innovata is moving forward with its dry powder pulmonary insulin
inhaler, which it claims has a formulation superior to Exubera,
gearing up for Phase II clinical trials and anticipating a new
partnership deal by the end of the year.
The Tech Group has experienced a quarter of explosive growth as it
ramps up production for the launch of Exubera - Pfizer's
newly-approved and much-anticipated needle-free insulin.
Bespak is now ramping up manufacturing of Chiesi Farmaceutici's new
dry powder inhaler (DPI), in preparation for clinical trials of the
device in patients with asthma and COPD (chronic obstructive
pulmonary disease).
The FDA is to extend its original review period for Exubera
(insulin (rDNA origin) powder for oral inhalation) by three months
to review additional technical chemistry data submitted by its
producers.
The first non-injectable insulin treatment in Europe may soon
become available after a panel of experts recommended it for
regulatory approval on Thursday.
Diabetics moved a step closer to having an alternative to
injections for their insulin therapy yesterday, after a US Food and
Drug Administration (FDA) advisory committee gave its backing to an
inhaled formulation of the drug developed...
US pharmaceutical giant Pfizer and French drugmaker Sanofi-Aventis
have filed with the US Food and Drug Administration seeking
marketing approval for Exubera, an inhaled human insulin powder,
for the treatment of diabetes.
Drug delivery company Nektar Therapeutics has bounced back from a
recent share slump after reporting encouraging new data supporting
the safety of its inhaled insulin product Exubera.
The race to develop an inhaled formulation of insulin - and provide
the first alternative to injections for the millions of people
worldwide who suffer from diabetes - is getting closer.
Shares in drug delivery company Nektar Therapeutics fell through
the floor yesterday after it was suggested that regulators in
Europe were not prepared to approve an inhaled insulin product for
diabetes based on its technology.
A new inhaled formulation of insulin that could do away with the
need for diabetics to inject themselves before meals has been filed
for approval in Europe by Aventis and Pfizer and the dossier
accepted by the European Medicines Evaluation...
There has been a steady increase in the number of diabetes-related
R&D projects in recent years, and one area of particular
interest is the pulmonary delivery of insulin, says a new report
