Durata Files Dalbavancin NDA

reviewed, and said multiple times is approvable,” Edick
you’re
you’regoing
goingto
toget
getit,”
it,”and
andthe
theFDA
FDAprovided
providedguidelines,
guidelines,he
he
TM
said.
said.
said
saidFriday.
Friday.“What
“Whatwe
wesent
sentyesterday
yesterdayisisbased
basedon
onwhat
whatour
our
In
2009,
New
York-based
Pfizer
Inc.
–
having
In 2009, New York-based Pfizer Inc. – having
discussion
discussionwith
withthe
theFDA
FDAhas
hasalready
alreadybeen.”
been.”
acquired
dalbavancin
acquired
dalbavancinas
aspart
partof
ofthe
thebuyout
buyoutof
ofVicuron
Vicuron
The
from
TheNDA
NDApackage
packageincludes
includesthe
thefull
fulldataset
dataset
from
MC
onday
B
I
O
T
E
C
H
’
S
M
O
S
T
R
E
S
P
E
T
E
D
N
E
W
S
S
O
U
R
C
E
F
O
R
M
O
R
E
T
H
A
N
2
0
Y EYAEthree
R
Pharmaceuticals
Inc.
in
2005,
and
having
collected
Pharmaceuticals
Inc.
in
2005,
and
having
collected
three
Durata’s
positive
results
B I O T development
E
C H ’ S Mprogram,
O S T Rincluding
E S P SEepteMber
C
TED
N
E
W
S
S
O
U
R
C
E
F
O
R
M
O
R
E
T
H
A
N
2
0
ASR S
Durata’s
development
program,
including
positive
results
30, 2013
“approvable”
letters
from
the
FDA,
but
no
approval
–
“approvable” letters from the FDA, but no approval –
from
fromtwo
twoPhase
PhaseIII
IIItrials
trials–– Discover
Discover11and
andDiscover
Discover2,
2,
TM
’ S M Oconducted
SBTI ORTEES
PHE’ C
Tspecial
EO
D Sprotocol
N
WESS
SE
OC
U TRECwith
R SMS
O
Eout
HEAdrug
N Ointo
2into
Y
EA
ST
spun
the
Durata,
Chicago.
spun
out
the
drug
Durata,
of
Chicago.
Regulatory
C
S
M
T ER
P
DE NF
EOW
ORUTM
RTC
F
R0 M
O
RR
Eof
H A N Regulatory
20 YEARS
under
aaspecial
assessment
the
conducted
under
protocol
assessment
with
the
guidelines,
which
had
been
shifting
Long
Time
Coming
guidelines, which had been shiftingin
inthe
theU.S.,
U.S.,settled
settledat
at Lilly’s
FDA
FDA––as
aswell
wellas
asaaprevious
previousPhase
PhaseIII
IIIstudy,
study,known
knownas
asVERVERTM F O R M O R E last,
O S T R009.
E
S
P
E
C
T
E
D
N
E
W
S
S
O
U
R
C
E
T
H
A
N
2
0
Y
E
A
R
S
and
developers
of
antibiotics
saw
the
way
forward.
TM
Bonday
I O T E C H ’ S M O S T R E S P E C T E D N E W S Slast,
O Uand
R Cdevelopers
E F O R ofMantibiotics
O R E T saw
H AV
NoluMe
2 024forward.
Y, nEo.A187
R S Inves
the
way
M
009.
Monday
(See
23,
2009.)
VoluMe
24 , no. 187
(SeeBioWorld
BioWorldToday,
Today,June
June17,
17,2005,
2005,and
andDec.
Dec.
23,
2009.)
Dalbavancin,
semisynthetic
SepteMber
30, 2013aasecond-generation,
Dalbavancin,
second-generation,
semisynthetic
page 1 of 10 Cans
TM
SepteMber 30, 2013
TM approvable
“The
clinical
page
1 of 10
“The
approvableletters
lettershad
hadnothing
nothingto
todo
dowith
with
clinical
lipoglycopeptide,
which
lipoglycopeptide,
whichconsists
consistsof
oflipophilic
lipophilicside-chains
side-chains
Monday
V
oluMe 24 , no. 187
V
oluMe
24
,
n
efficacy
or
safety,
and
I
think
that’s
a
big
reason
why
efficacy or safety, and I think that’s a big reason why o. 187By Shan
attached
to
has
attached
toglycopeptides,
glycopeptides,
hasbeen
beendesignated
designatedaaqualified
qualified
3
SLong
epteMber
30,
2013
page
1 ofis10aArm
Time
Coming
By Randy Osborne everybody
pagebe
1 of
Lilly’s
VC
has
‘Look,
this
that
on
everybody
hassaid,
said,
this
is adrug
drug
thatshould
should
be
on10Staff Wr
infectious
disease
product
Time
Coming
infectious
disease
productby
bythe
theFDA,
FDA,which
whichmeans
means
VC
Arm
VoluMe
24 , Lilly’s
n‘Look,
o. 187
MLong
onday
SHA
Staff Writer
VoluMethe
24process
,process
no. 187
the
said.
“We
go
Invests
into
themarket,’”
market,’”Edick
Edick
said.
“Wehad
had
toChina’s
gothrough
through
the
p
age
1
of 10
S
epteMber 30, 2013
Invests
in
China’s
arm
of E
The
antibiotic
dalbavancin’s
long
road
to
approval
seems
likely
to
end
near
age 5
1 of
ming MLong
onday,Time
SepteMber
30, 2013
bioWorld
™of
today
ppage
of 10
10
doing
other
studies,
on
the
Lilly’s
VCthese
Arm
of
doing
these
other
studies,based
based
on
thenew
newguidance,
guidance,
Coming
Cansino
Biotech
Lilly’s
VC
Arm
in
a
sma
the end of next May, now
that
Durata
Therapeutics
Inc.
has
submitted
the
new
Biotech
and
the
FDA
is,
that’s
reasonable.”
andthat’s
that’s
where
the
FDA
is,and
andEllis
that’s
reasonable.”
ByCansino
Shannon
Invests
inwhere
China’s
Invests
in
China’s
compan
drug
application
(NDA)
for
the
drug
targeting
acute
bacterial
skin
and skinawaiting
By
Shannon
Ellis
Another
reason
“people
have
been
anxiously
Lilly’s
VC
Arm
Long
Time
Coming
Anotherofreason
“people
have
been
anxiously
awaiting
Trials
Staff
Writer
Lilly’s
VC
Arm
By
Randy
Osborne
the
quality
clinical
trials
in
China.
Strengthening
the
Cansino
Biotech
structure
infections
caused
by
gram-positive
microorganisms,
including
the
Cansino
Biotech
Staff
Writer
By
Randy
Osborne
this
particular
ithas
for
the
patients
Continued
from page 1
this
particular
drugis
iswhat
what
itwill
will
do
forventure
theway
way
patients push for
Invests
inMRSA:
China’s
SHANGHAI
–do
The
capital
Staff
Writer
monitoring
of drug
clinical
trials
become
increasingly
Invests
in
China’s
By
Shannon
Ellis
third-gen
hospital
scourge
known
as
methicillin-resistant
Staphylococcus
aureus.
By
Ellis
SHANGHAI
–Co.
The
venture
capital
Staff
Writer
are
treated,”
said.
“We’re
about
skin
are
treated,”
he
said.
“We’re
only
talking
about
skin
arm
ofShannon
Elionly
Lilly
and
plans
to
invest
The
antibiotic
dalbavancin’s
long
to approval
seems
likely
to
end
urgent
asnear
thehe
market
grows
andtalking
more
companies
carry out vaccine.
growing
number of
trials done in
theroad
country.
Cansino
Biotech
Staff
Writer
orne
“We
wouldn’t
anticipate
that,
within
the
first
60
days,
[the
FDA]
would
find
Cansino
Biotech
Staff
Writer
By Randy
Osborne
arm
of
Eli
Lilly
and
Co.
plans
to
invest
The
antibiotic
dalbavancin’s
longTherapeutics
road to approval
seems
likely
to
end
near
infections
because
the
path
to
market.
drug
because
that’s
the
path
tothe
the
market.
This
inthat’s
a small
but
rapidly
growing
end
next
May,
nowfor
that
Durata
Inc.
has
submitted
the
new
trials
here
to
getventure
access
to
the
market.
The
sheerbiotech
quantity
Mthe
onday
, Sof
epteMber
30,
2013
io
World
™SHANGHAI
tinfections
oday
pThis
age 3drug
of 10
The
Chinese
Center
Drug
Evaluations
(CDE),
abwould
By
Shannon
Ellis
–new
The
capital
Tian
anything
that
cause
them
to
not
accept
the
filing,”
said
Durata
CEO
Paul
By
Shannon
Ellis
SHANGHAI
–
The
venture
capital
Staff
Writer
in
a
small
but
rapidly
growing
biotech
the
end
of
next
May,
now
that
Durata
Therapeutics
Inc.
has
submitted
the
will
be
very
effective,
we
believe,
in
osteomyelitis,
and
will
be
very
effective,
we
believe,
in
osteomyelitis,
and
company
with
a
strong
pipeline
to
drug
application
(NDA)
forFood
the drug
targeting
acute bacterial
skin
and
skin
of
trials
has
passed
the
ability
of
authorities
to
effectively
department
of
the
China
and
Drug
Administration
Staff
Writer
arm
of
Eli
Lilly
and
Co.
plans
to
invest
tic dalbavancin’s
long
road
to
approval
seems
likely
to
end
near
Co.
Ltd.
w
Edick.
Staff
Writer
By
Randy
Osborne
arm
of
Eli with
Lilly
and
Co. plans
to things.”
invest
The
antibiotic
dalbavancin’s
long
road tomicroorganisms,
approval
seemsskin
likely
to skin
end
near
company
adevelopment
strong
pipeline
drug
application
(NDA)
for the
drug
targeting
acute bacterial
and
pneumonia,
diabetic
foot
ulcers
and
various
other
pneumonia,
diabetic
foot
ulcers
and
various
other
push
forward
the
ato
structure
infections
caused
by
gram-positive
including
the
supervise
because
the
number
of
officials
has
notofthings.”
grown
(CFDA),
announced
on Sept.
17has
thatsubmitted
all clinical
trials
SHANGHAI
–
The
venture
capital
in
a
small
but
rapidly
growing
biotech
May, nowDurata
that
Durata
Therapeutics
Inc.
the
new
expedited
review
of
six
months
or
less,
once
the
NDA
is
Lilly
Asia
In
early
July,
the
company
met
with
regulators
to
nail
down
the
details
of
– The
venture
capital
Staff
Writer
in a SHANGHAI
small
but
rapidly
growing
biotech
the
end
of
next May,
nowasthat
Therapeutics
Inc.
has submitted
the
new
push
forward
the
development
of a
structure
infections
caused
byDurata
gram-positive
microorganisms,
including
But
in
skin
infections
3drugs.
patients
are
But
inthe
skindemand
infections
alone,
3million
million
patients
are
whooping
cough
hospital
scourge
known
MRSA:
methicillin-resistant
Staphylococcus
aureus.
alongside
the
foralone,
more
conducted
inapproval
China
now
have
to be
registered
on anarm
online
of Eli
Lilly
and
Co.
tothird-generation
invest
long
road
to
likely
to
end
near
Continued
from
page
1 seems
company
with
aplans
strong
pipeline
to
navancin’s
(NDA) for
the
drug
targeting
acute
bacterial
skin
and
skin
accepted.
arm
of
Eli
Lilly
and
Co.
plans
to
invest
The
antibiotic
dalbavancin’s
long
road
to
approval
seems
likely
to
end
near
company
with
a
strong
pipeline
drug
application
(NDA)
for
the
drug
targeting
acute
bacterial
skin
and
skin
third-generation
whooping
cough
hospital
scourge
known
as
MRSA:
methicillin-resistant
Staphylococcus
aureus.
admitted
to
hospitals
every
year.
“We
estimate
that
a
third
vaccine.
admitted
to hospitals
every year.
“We estimate
thatPage
ato
third
“We
wouldn’t
anticipate
that, withinthe
the
first include
60 days,
[the FDA]
would
find
See
Durata,
3
The industry
as
a whole
may
benefit
through
platform
at www.chinadrugtrials.org.cn.
Those
in a has
small
but
rapidly
growing
biotech
w that
Durata
Therapeutics
Inc.
hasthat
submitted
new
push
forward
the
development
ofalso
aFDA
ons
caused
by
gram-positive
microorganisms,
including
the
“You
have
a
drug
that
the
already
had
completely
in
a
small
but
rapidly
growing
biotech
the
end
of
next
May,
now
Durata
Therapeutics
Inc.
submitted
the
new
push
forward
the
development
of
a
structure
infections
caused
by
gram-positive
microorganisms,
including
the
vaccine.
“here’s
all
the
stuff
you’re
going
to
get,
and
here’s
how
“We
wouldn’t
anticipate
that,
within
the
first
60
days,
[the
FDA]
would
find
of
them
are
only
in
the
hospital
to
get
the
[intravenous
Tianjin
Cansino
Biotechnology
anything
that
would
cause
them
to
not
accept
the
filing,”
said
Durata
CEO
Paul
of
them
are
only
in
the
hospital
to
get
the
[intravenous
more
open
competition.
Companies
will
be
able
to
monitor
bioequivalence
studies,
pharmacokinetic
(PK)
studies
and
company
with
a strong
pipeline
to cough
the drug
targeting
acute
bacterial
skin
and
skin
third-generation
whooping
efor
known
as
MRSA:
methicillin-resistant
Staphylococcus
aureus.
reviewed,
and
saidCo.
multiple
times
approvable,”
Edick
company
with
afinancial
strong
pipeline
to
drug
application
(NDA)
for
the
drug
targeting
acute
bacterial
skin
and
skin
third-generation
whooping
cough
hospital
scourge
known
asthe
MRSA:
Staphylococcus
aureus.
Tianjin
Cansino
Biotechnology
you’re
going
towould
get
it,”cause
and
FDA
provided
guidelines,
he
anything
them
tomethicillin-resistant
not
accept
the filing,”
said
Durata
CEO
Paul
antibiotic]
therapy,”
Edick
told
BioWorld
“Incredibly
Ltd.
will
get
ais
boost
from
Edick.
antibiotic]
therapy,”
Edick
told
BioWorld
Today.
“Incredibly
the
progress
of their
competition
and,
inToday.
some
cases,
Phase
I, within
II,that
III and
IVfirst
studies.
push
forward
the
development
of
a
used
by gram-positive
microorganisms,
including
the
vaccine.
’t anticipate
that,
the
60
days,
[the
FDA]
would
find
said.
push
forward
the
development
of
ain
FINANCINGS
N
structure
infections
caused
by
gram-positive
microorganisms,
including
the
vaccine.
ASIA
“We
wouldn’t
anticipate
that,
within
the first
60
days,
[the FDA]
would
find
Co.
Ltd.
will
get
a
financial
boost
from
said
Friday.
“What
we
sent yesterday
is based
on
what
our
Edick.
flexible”
dalbavancin,
on
the
other
hand,
can
be
given
in
Lilly
Asia
Ventures,
the
Shanghai-based
In
early
July,
the
company
met
with
regulators
to
nail
down
the
details
of
flexible”
dalbavancin,
onof
the
othertrials,
hand,particularly
can be given
avoidwhooping
wasteful
overlaps
similar
in
the
Including
information
on thesaid
accessible
website
could
third-generation
cough
n
as MRSA:
methicillin-resistant
Staphylococcus
aureus.
Tianjin
Cansino
Biotechnology
ould
cause
them
to
not
accept
the
filing,”
Durata
CEO
In
2009,
New
York-based
Pfizer
Inc.
–
having
third-generation
whooping
cough
hospital
scourge
known
as
MRSA:
Staphylococcus
aureus.
Tianjin
Cansino
Biotechnology
anything
that
would
cause
them
tomethicillin-resistant
not
accept
thePaul
filing,”
said
Durata
CEO
Paul
Lilly
Asia
Ventures,
the
Shanghai-based
discussion
with
the
FDA
has
already
been.”
In
early
July,
the
company
met
with
regulators
to
nail
down
the
details
of
the
emergency
room,
an
outpatient
clinic
or
ambulatory
emergency
an outpatient clinic
or ambulatory
generics
space.
allow
for greater
public
andFollowing
closer
monitoring
vaccine.
Cansino,
Page
4 Rebio
Durata,
Page
3room,
WHO
Examples
pate that,Edick.
within
first 60
days,supervision
[thethat,
FDA]
would
find
Co.See
Ltd.
will
get
aatfinancial
boost
from
acquired
dalbavancin
asLtd.
part
ofchanging
the
ofburden,
Vicuron
Inotek
Vision
for
vaccine.
“We the
wouldn’t
anticipate
within
the
first
60U.S.,
days,
[the
FDA]
would
find
Co.
will
get buyout
aSee
financial
boost
from
The
NDA
package
includes
the
full
dataset
from
center,
and
two
doses
––thus
the
center,
and
at
two
doses
thus
changing
the
burden,
But
the
biggest
overall
winners
should
be
patients
and4
of
trials
by
regulators,
including
the
CFDA.
See
Cansino,
Page
See
Durata,
Page
3
Tianjin
Cansino
Biotechnology
use
to
not
accept
the
filing,”
said
Durata
CEO
Paul
Lilly
Asia
Ventures,
the
Shanghai-based
the them
company
met
with
regulators
to
nail
down
the
details
of
Pharmaceuticals
Inc.
in
2005,
and
having
collected
three
Online
Platform
for
Tianjin
Cansino
Biotechnology
anything
that
would
cause
them
towith
not accept
the filing,”
Durata
CEO
Paul
Lilly
Asia
Ventures,
the
Shanghai-basedPione
In early
July,
the company
met
regulators
to nail said
down
the
details
ofcost
Durata’s
program,
including
positive
results
location
and
of
Glaucoma
Supported
location
and
cost
oftreatment.
treatment.
patient
groups,
typically
weak in China
due to laws that
The development
website is “a good
indicator
that the
government
Co. Ltd. will “approvable”
get
a financial
boost
from
letters
from
the
FDA,
but
no
approval
–very
Co.
Ltd.
will
get
a
financial
boost
from
Edick.two Phase
from
III
trials
–
Discover
1
and
Discover
2,
What’s
more,
among
skin
infection
patients,
“a“avery
FINANCINGS
NEWCO
NEWS
Trials
to
Improve
ASIA
See
Cansino,
Page
4
See
Durata,
Page
3
What’s
more,3By
among
skin
infection
patients,
$28M
in
Financing
hinder
the Shanghai-based
development
of
civil
society.
Those
groups
now4Resto
See
Cansino,
Page
See
Durata,
Page
is with
trying
to make the
clinical
trial
process
more
open
to Asia Ventures,
Lilly
the
mpany met
regulators
to
nail
down
the
details
of
spun
out
the
drug
into
Durata,
of
Chicago.
Regulatory
Lilly
Asia
Ventures,
the
Shanghai-based
In earlyunder
July,
the
company
met with
regulators
to the
nail down large
the
details
of
conducted
a
special
protocol
assessment
with
percentage,
depending
on
the
day
you
look
at,
65
FINANCINGS
NEWCO
NEWS
ASIA
large
percentage,
depending
on Shaffer
the daythat
youhas
look
at, 65
Catherine
willChina
have
greater By
access
to information
long
been By Mari
Transparency
in
the
public,
and
have
the
public
supervise
trials
in
real
Following
U.S.,
WHO
Examples
guidelines,
which
had
been
in
the U.S.,which
settled
at
Inotek
Vision
for
Rebiotix
Seeking
to
FDA
– as
well
asWu,
a previous
Phase
study,
VERpercent
to
percent
of
them
have
cellulitis,
has
See
Cansino,
Page
4 shifting
SeeIII
Durata,
Page
3 asR&D,
percent
to70
70
percent
of
them
have
cellulitis,
which
has
Writer
outDurata,
of their
reach.
The
government’s
stated
intention
is to 4Staff Wr
By
Shannon
Ellis
See Cansino,
Page
Page
3Staff
time,”
said
Yan
principal
consultant
at known
Modular
an See
FINANCINGS
NEWCO
NEWS
Following
U.S.,
WHO
Examples
last,
and
developers
of
antibiotics
saw
the
way
forward.
IA
Online
Platform
for
FINANCINGS
NEWS
Inotek
Vision
for
Seeking
todon’t
009.
aa
high
of
MRSA,”
Edick
said.
“Hospitals
Glaucoma
Supported
Pioneer
highpercentage
percentage
ofRebiotix
MRSA,”
Edick
said.
“Hospitals
don’t the
InotekNEWCO
Pharmaceuticals
Corp.,
Rebi
improve
the standardization
ofMicrobiota
trials
and
better
protect
Staff
Writer
internationalASIA
information and consulting
firm
that focuses
(See
BioWorld
Today,
June
17,
2005,
and
Dec.
23,
2009.)
Dalbavancin,
a
second-generation,
semisynthetic
Online
Platform
for
want
to
admit
those
patients
if
they
don’t
have
to,
Trials
to
Improve
want
to
admit
those
patients
if Mass.,
they
don’t
have
to,abecause
because
Glaucoma
Supported
Pioneer
Microbiota
rights
and
interests
of
test
subjects.
That
follows
trend
of
Lexington,
plans
to
apply
concept
Following
calls
to
improve
By
$28M
in
Financing
Restoration
on
drug
and
device
development
and
has
extensive
WHO Examples
FINANCINGS
NEWCO
NEWS
Inotek
Vision
forInotek
Rebiotix
Seeking
toMRSA
Following U.S.,
WHO
Examples
“The
approvable
letters
hadproblem.”
nothing
to do with
Vision
for
Rebiotix
Seeking
toclinical
FINANCINGS
NEWCO
NEWS
ASIA
lipoglycopeptide,
which
consists
of lipophilic
side-chains
you’re
just
adding
to
the
you’re
just
adding
toRestoration
theMRSA
problem.”
Trials
toworking
Improve
that
various
government
departments
infrom
Chinaa have
taken than two
$21
million
in proceeds
supervision
overShaffer
clinical
trials,
China
By
Catherine
By
Marie
Powers
Transparency
in
China
experience
with
multinational
companies
on
By
$28M
in
Financing
atform
for
oWorld™ attached
tOnline
oday
p
age
3
of
10
efficacy
or
safety,
and
I
think
that’s
a
big
reason
why
Glaucoma
Supported
Pioneer
Microbiota
Platform
for
toanswers
glycopeptides,
has
been
designated
a qualified
Medicare
data
suggest
that
“hospitals
that
are
treating
Glaucoma
Supported
Pioneer
Microbiota
Medicare
data
suggest
that
“hospitals
that
are
treating
up
of
sharing
supervisory
tasks
of
various
functions
with
venture
financing
and
$7
million
in
for gastr
has
launched
a
new
online
registration
Staff
Writer
Staff
Writer
ExamplesFollowing
Fast
for
unobstructed
By
Shannon
Ellis
clinical
trials
in
China.
Based
in
Shanghai,
Modular
R&D
has
Fast
answers
for
unobstructed
By
Catherine
Shaffer
By
Marie
Powers
Transparency
in by
China
Inotek
Vision
for
Rebiotix
Seeking
to
U.S., WHO
Examples
everybody
hasin
said,
‘Look,
thiswith
is a generic
drug
that
should
be on
Inotek
Vision
for
Rebiotix
Seeking
to
mprove
infectious
disease
product
the
FDA,
which
means
these
patients
the
hospital
drugs,
are
By
$28M
in
Financing
Restoration
Trials
to
Improve
these
patients
in
the
hospital
with
generic
drugs,
are
an
increasingly
vigilant
and
interested
population.
venture
debt
financing
to
advance
recurring
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
from
platform
that
should
help
improve
Staff
Writer
a
number
of
specialized
databases
on
drug
development
By
$28M
in
Financing
Restoration
Staff
Writer
Staff
Writer
By Shannon
Ellis
m forin
the
market,’”
Edick
said.
“We
had
toMicrobiota
gobe
through
the
process
Glaucoma
Supported
Pioneer
Microbiota
Online
Platform
for
paths
to
market.
losing
money”
on
people
who
might
triaged
and
given
Glaucoma
Supported
Pioneer
paths
to
market.
expedited
review
ofto
six
months
or
less, once
the
NDA
isMass.,
By
Catherine
Shaffer
By
Marie
Powers
losing
money”
on
people
who
might
be
triaged
and
given
ency
China
The
U.S.
National
Institutes
of
Health
(NIH)
set
up
of
Lexington,
plans
to
apply
concept
to
clinical
application
in
less
its
A1
subtype
adenosine
mimetic
for
(CDI), us
Following
calls
improve
transparency
and
the
quality
of
the
in
China.
By
Catherine
Shaffer
By
Marie
Powers
Transparency
in
China
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
from
Staff Writer
of
doing these
other studies,
based
on
the
new guidance,
ove
dalbavancin
without
aahospital
stay,
he
said.
By
$28M
in
Financing
Restoration
accepted.
Trials
to
Improve
Staff
Writer
Staff
Writer
dalbavancin
without
hospital
stay,
he
said.
lis
$21
million
in
proceeds
from
a
than
two
years
in
pursuit
of
treatment
its
clinical
trial
registry
(at
clinicaltrials.gov)
in
2000.
supervision
over
clinical
trials,
China
By
$28M
in
Financing
Restoration
“The
increased
transparency
is
a
measure
to
improve
Staff
Writer
Staff
Writer
By
Shannon
Ellis
of
Lexington,
Mass.,
plans
to
apply
concept
to
clinical
application
in
less
Following calls to improve
See
Trials,
Page
5 the
See Inotek,
Page 6 – the col
and
that’s
where
FDA from
is,
and
that’s
reasonable.”
Ensure
drug
approval
processes
“A
lot
of
them
present
at
the
emergency
department,”
Bycontrol,
Catherine
Shaffer
By
Marie
Powers
in China
“You
have
ayour
drugonline
that
the
FDAthe
already
had
completely
Ensure
your
drug
approval
processes
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
“A
lot
of
them
present
at
the
emergency
department,”
venture
financing
and
$7
million
in
for
gastrointestinal
diseases,
such
asthe human m
has
launched
new
registration
According
to
Wu,
the
Chinese
version
largely
follows
By
Catherine
Shaffer
By
Marie
Powers
trial
quality
on
par
with
more
developed
Transparency
in
China
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
from
Staff
Writer
$21
million
in
proceeds
from
a
than
two
years
in
pursuit
of
treatment
supervision over clinical trials, China
Another
reason
“people
have
been
anxiously
awaiting
Edick
noted.
“If
you
can
catch
them
there,
and
give
them
Staff
Writer
Staff
Writer
reviewed,
andcountries,”
said
multiple
times
is approvable,”
Edick
of
Lexington,
Mass.,
plans
to
apply
concept
to
clinical
application
in
less
Edick
noted.
“If
you
can
catch
them
there,
and
give
them
venture
debt
financing
to
advance
recurring
Clostridium
difficile
infection
alls
platform
that
should
help
improve
U.S.
one
but
requires
more
compulsory
data
and
will
in
turnapprove
, heto improve
clinical
trial
Wu
said.
Staff
Writer
Staff
Writer
By
Shannon
Ellis
of
Lexington,
Mass.,
plans
to
apply
concept
to
clinical
application
in
less
Following
calls
to
improve
venture
financing
and
$7
million
in
for
gastrointestinal
diseases,
such
as
hasrun
launched
a new online
registration
smoothly
and
accelerate
your
BENCH PRESS
THE
BIOWORLD
run
smoothly
and
accelerate
your
this
particular
drug
isthey’ve
what
itgot
will
do
forBIOME
the
way
patients
their
first
treatment,
seven
days
of
drug
on
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
from
its
A1
subtype
adenosine
mimetic
for
(CDI),
using
the
human
microbiome
$21
million
in
proceeds
from
a
than
two
years
in
pursuit
of
treatment
their
first
treatment,
they’ve
got
seven
days
of
drug
on
transparency
and
the
quality
of
the
r clinicalsaid.
trials,
China
be
a
richer
resource.
For
example,
the
principal
investigator
compan
our
The
existing
process
trial
registration
will
be
migrated
Inotek
Pharmaceuticals
Corp.,
Rebiotix
Inc.
has
sprinted
from
Staff
Writer
$21
million
in
proceeds
from
a
than
two
years
in
pursuit
of
treatment
supervision
over
clinical
trials,
China
venture
debt
financing
to
advance
recurring
Clostridium
difficile
infection
platform that should help improve
are
treated,”
he
said.
“We’re
only
talking
about
skin come
board.
Aapply
lot
of
physicians
will
probably
have
them
of Lexington,
Mass.,
plans
to apply
concept
to
clinical
application
inthe
less
mprove
In
2009,
New
York-based
Pfizer
Inc.
–Cortellis™
having
–
collective
genomes
of
the
venture
financing
and
$7
million
in
for
gastrointestinal
diseases,
such
as
board.
A
lot
of
physicians
will
probably
have
them
come
new
online
registration
regulatory
decisions
with
and
hospital
details
are
mandatory
on
the
Chinese
site.
applicati
onto
the
online
platform
and
companies
will
be
expected
of
Lexington,
Mass.,
plans
to
concept
to
clinical
application
in
less
regulatory
decisions
with
Cortellis™
Following
calls
to
improve
venture
financing
and
$7
million
in
for
gastrointestinal
diseases,
such
as
•
Immunity
Ignores
IPS
has
launched
a
new
online
registration
Nongenetic
Data
Yield
Risk
Genes
See
Trials,
Page
5
See
Inotek,
Page
6
its
A1
subtype
adenosine
mimetic
for
(CDI),
using
the
human
microbiome
transparency and the quality of the
infections
because
that’s
the
path
to the
market.
This
drug
back
in
or
days,
just
to
check
the
wound
and
$21over
million
in
from
a•
than
two
years
inadvance
pursuit
ofthree
treatment
alould
trials,
China
acquired
asproceeds
part
offinancing
the
buyout
of million
Vicuron
human
microbiota.
In
July,
the
FDA
venture
debt
to$21
advance
recurring
Clostridium
difficile
infection
back
in
two
or
three
days,
just
to
check
the
wound
and
help
improve
China’s
site
will
undergo
aClostridium
one-year
trial
period
where (microbi
to
take adalbavancin
number
of steps.
in financing
proceeds
from
atwo
than
two
years
in
pursuit
treatment
supervision
clinical
trials,
China
venture
debt
to
recurring
difficile
infection
NCoR’s
Encore
Is
Antiplatform
that
should
help
improve
–
the
collective
genomes
of
the
Complex
Diseases
Can
will
besure
very
effective,
we
believe,
inget
osteomyelitis,
and
Regulatory
Intelligence.
See
Trials,
Page
5 collected
See
Inotek,
Page
6such
Regulatory
Intelligence.
make
they’re
doing
OK.
They
their
second
dose
venture
financing
and
$7
million
inA1 within
forone
gastrointestinal
diseases,
as
line
registration
approved
the
Roseville,
Minn.-based
Pharmaceuticals
Inc.
in
2005,
and
having
three
its
A1
subtype
mimetic
for
(CDI),
using
the
human
microbiome
make
sure
they’re
doing
OK.
They
get
their
second
dose
nd
quality
of
the
the
CDE
will
make
adjustments
and
changes
tothe
what
isasaa PUNCH C
Pre-registration
ofquality
trials
must
be
uploaded
ltsthe
venture
financing
and
$7
million
in
for
gastrointestinal
diseases,
such
has
launched
aand
new
online
registration
its
subtype
adenosine
mimetic
for
(CDI),
using
the
human
microbiome
inflammatory
transparency
the
ofadenosine
the
human
microbiota.
In
July,
FDA
BENCH
PRESS
THE
BIOWORLD
BIOME
pneumonia,
diabetic
foot
ulcers
and
various
other
things.”
Start
in
Mendelian
Genes
week
[after
the
first],
and
they’re
good
to
go.”
venture
debt
financing
to
advance
recurring
Clostridium
difficile
infection
company’s
investigational
new
drug
elp improve
“approvable”
letters
from
the
FDA,
but
no
approval
–
–
the
collective
genomes
of
the
week
[after
the n
first],
they’re
good
to go.”
posted
online.
Whil
month
of
approval,
and
the
trial will beSee
given
a registration
debt 6financing
to Inotek,
advance
recurring
Clostridium
difficile
infection
that
help
improve
– and
the alone,
collective
genomes
of the
A
New
Approach
to Batten
approved
the
Roseville,
Minn.-based
Seeplatform
Trials, BENCH
Page
5should
Inotek,
Page
See
Trials,
Page
5• venture
See
Page
6July,
But
in skin
infections
3lead
million
patients
are the
PRESS
THE BIOWORLD
BIOME
By
Anette
Breindl
Analyst
Adnan
Butt,
RBC
Capital
Markets,
called
application
for
candidate
RBX2660
its A1
subtype
adenosine
mimetic
for
(CDI),
using
the
human
microbiome
uality
of spun
the
out the
drug
into
Durata,
ofthe
Chicago.
Regulatory
• Immunity
Ignores
IPS
human
microbiota.
In
theof
FDA
Analyst
Adnan
Butt,
of
RBC
Capital
Markets,
called
the Lee Jone
Data
Yield
Risk
Genes
number.
The
CDE
is adamant
that
no
trialNongenetic
subjects
are
toadenosine
e
its
A1 subtype
mimetic
for
(CDI),
using
the human
microbiome
transparency
and
the
quality
of
human
microbiota.
In
July,
the
FDA
Disease
company’s
investigational
new
drug
admitted
to profile
hospitals
every
year.
“We estimate
that
aIIthird
Science
Editor
(microbiota
suspension).
Phase
Durata
risk-reward
of
Durata
“favorable,
as
even
aaniche
–Brain
the
collective
genomes
of the
which
had
been submission
shifting
in the
U.S.,
settled
atDiseases
•
NCoR’s
Encore
Is Antiapproved
the
Roseville,
Minn.-based
risk-reward
profile
of
Durata
“favorable,
asIts
even
niche
device in
be
enlisted
until
the
initial
is
completed
online.
R- Trials,guidelines,
–application
the
collective
genomes
of
the
approved
the
Minn.-based
ee
Page
5 BENCH
See
Inotek,
Page
6BIOWORLD
•Complex
Anorexia
Pathway?
Can
forRoseville,
lead
candidate
RBX2660
PRESS
THE
BIOWORLD
BIOME
•
Immunity
Ignores
IPS
Nongenetic
Data
Yield
Risk
Genes
See
Trials,
Page
5
See
Inotek,
Page
6
of
them
are
only
in
the
hospital
to
get
the
[intravenous
PRESS
THE
BIOME
Continued
from
page
3
Figuring
out
the
contribution
of
CD
study
is already
under
way.
market
share
beat
Street
expectations
and
lead
to
human
microbiota.
In
July,could
the PUNCH
FDA
last,inflammatory
and
developers
of antibiotics
sawbe
the
wayOunce
forward.
company’s
new
drug
marketinvestigational
share
could
beat
Street
expectations
and
lead
to
in-reside
Timely
clinical
trial
updates
must
made
to
the
human
microbiota.
In
July,
the
FDA
company’s
investigational
new
drug
•
An
of
Resistance
(microbiota
suspension).
Its
Phase
II
• NCoR’s Encore Is AntiStart
inapproved
Mendelian
Genes
antibiotic]
therapy,”
Edick
told
BioWorld
Today. and
“Incredibly
Complex
Diseases
Can
While
Rebiotix
president
CEO
any
gene
to
complex
disorders
isRBX2660
a
the
Roseville,
Minn.-based
• ABioWorld
Newon
Approach
to
Batten
Today,
June
17,
2005,
and
Dec.
23,
2009.)
application
for
lead
candidate
RBX2660
significant
upside.
Minneso
website
a
regular
basis
depending
on
the
published
ores IPS (See
approved
the
Roseville,
Minn.-based
Nongenetic
Data
Yield
Risk
Genes
application
for
lead
candidate
Prevention
THE
BIOWORLD
BIOME
See
Durata,
Page
5
PUNCH
CD
study
is
already
under
way.
• inflammatory
Immunity
Ignores
IPS
Nongenetic
Data Yield
Risk dalbavancin,
Genesnew
Seedone
Durata,
Page
By
Anette
Breindl
PRESS
THE
BIOWORLD
BIOME
flexible”
on
the aother
hand,
can
be given
in 5
Lee
Jones,
veteran
of which
the
medical
murky
fishing
expedition,
in drug
company’s
investigational
drug
Disease
“TheBENCH
approvable
letters had for
nothing
toStart
do
with
clinical
(microbiota
suspension).
Its
Phase
II
in
Mendelian
Genes
Durata
“owns
dalbavancin
outright,
means
the
regulations
and
the
“Guidelines
Completing
Registration
approac
e Is Anti- •
ns
company’s
investigational
new
(microbiota
suspension).
Its
Phase
II
•
Alzheimer’s
Antibodies
While
Rebiotix
president
and
CEO
NCoR’s
EncoreComplex
Is to
AntiScience
EditorDiseases
Can
A
New Approach
Batten Diseases
theCD
emergency
room,
an
outpatient
clinic
or ambulatory
Complex
Can
device
industry,
was
serving
as CEOwaters
muddied
by
the
interaction
• Anorexia
BrainTrials.”
Pathway?
application
for
lead
candidate
RBX2660
efficacy
orClinical
safety,
and
I Data
think
that’s
a big•
reason
why
PUNCH
study
is
already
under
way.
By
Anette
Breindl
opportunity
for
partnering
or
selling
dalbavancin
directly
Nongenetic
Yield
Risk
Genes
for
Drug
Failure
to
follow
the
guidelines
who wer
ySfied
application
for
lead
candidate
RBX2660
PUNCH
CD
study
is
already
under
way.
Mucus
Protection
•
Immunity
Ignores
IPS
Lee
Jones,
a
veteran
of
the
medical
inflammatory Start in Mendelian
Nongenetic
Data
Riskand
Genes
Figuring
out
the Yield
contribution
ofat twoof
center,
doses
– thus
changing
the
burden,
Genes
in-residence
at
the University
of
theCanada,
gene
in
question
with
other
• Disease
An Ounce
ofTo
Resistance
subscribe,
please
call
Customer
Service
at
(800)
outside
the
U.S.
and
call
(770)
810-3144.
(microbiota
suspension).
Its
Phase
IICanada,
Start
in
Genes
everybody
has
said,
‘Look,
this
is
drug
that
should
beMendelian
on
To
subscribe,
please
callaBtrial
Bio
ioW
World
orld
Customer
Service
at
(800)477-6307;
477-6307;
outside
the
U.S.
and
call
(770)
810-3144.
While
Rebiotix
president
and
CEO
tiScience
Editor
also
exists,”
Butt
wrote
in
a
research
report.
“At
branded
could
result
in
the
original
clinical
approval
being
transpla
ach to Batten
(microbiota
suspension).
Its
Phase
II
While
Rebiotix
president
and
CEO
•
And
Mucosal
Immunity
•
NCoR’s
Encore
Is
AntiComplex
Diseases
Can
device
industry,
was
serving
as
CEOA New Approach
to
Batten
any
gene
to complex
disorders
is
aVisit
Anorexia
BrainBy
Pathway?
location
and
cost
of
treatment.
Complex
Diseases
Can
Copyright
2013
Reuters.
Reproduction
isisstrictly
prohibited.
Visit
our
web
site
at
Minnesota
Venture
Center,
she
was
Anette
Breindl
Copyright
2013Thomson
Thomson
Reuters.
Reproduction
strictly
prohibited.
our
web
site
atwww.bioworld.com
www.bioworld.com
genes
and
environmental
influences.
Prevention
PUNCH
CD
study
is
already
under
way.
By
Anette
Breindl
the
market,’” Edick
said.
“We©©had
to
go through
the
process
Lee
Jones,
a
veteran
of
the
medical
Figuring
out
the
contribution
of
drug
pricing,
this
could
represent
a
$3
billion
market
voided.
of work
PUNCH
CD
study
is
already
under
way.
Lee
Jones,
a
veteran
of
the
medical
•
Biomarker
Expansion
Fails
inflammatory
in-residence
at
the
University
of
Disease
murky fishing expedition, done
in more, among
•
Ounce
ofAntibodies
Resistance
Start
instudies,
Mendelian
Genes
What’s
skin
infection
patients,
“a very
approached
bygoing
university
researchers
Science
Editor
• An
Alzheimer’s
Start
in
Mendelian
Genes
While
Rebiotix
president
and
CEO
Science
Editor
of
these
other
based
on the
new
guidance,
device
industry,
was
serving
as
CEOBatten
any
gene
to
complex
disorders
is
a
opportunity.
Even
a
small
share
to
Durata
could
have
In
steps,
the
online
database
already
is
being
n Pathway?
While
Rebiotix
president
and
CEO
device
industry,
was
serving
as
CEOSee
Attachment
See
Genes,
Page
8
•doing
A
New
Approach
to
Batten
Minnesota
Venture
Center,
she
was
waters
muddied
by
the
interaction
Anorexia
Brain
Pathway?
Anette
Breindl
large
percentage,
depending
on the day work
you look
at, 65
whoimpact
were
on fecal
Figuring
out
the some
contribution
of
• Prevention
Mucus
Protection
By
Anette
Breindl
Lee
Jones,
veteran
of in
the
medical
Figuring
out
theacontribution
ofpositive
and
that’s By
where
the
FDA
and
that’s
reasonable.”
in-residence
at
the
University
of conducting
murky
fishing
expedition,
done
awith
significant
on
valuation.”
populated.
Asofof
Sept.
27,is,there
were
126
trials
Resistance
Lee
Jones,
a veteran
of the researchers
medical
in-residence
at– the
University
ofhas
Disease
of
the
gene
in
question
other
approached
by
university
An
Ounce
Resistance
•
Alzheimer’s
Antibodies
Science
Editor
transplants
(FT)
the
“first
generation”
percent
to
70
percent
of
them
have
cellulitis,
which
To
subscribe,
please
call
bis
ioWa
orld™as
Customer
Service
at (800) 477-6307; outside
the U.S. and Canad
any
gene to
complex
disorders
is
aEditor
• And
Mucosal
Immunity
Science
device
industry,
was
serving
CEOany
gene
to
complex
disorders
Another
reason
“people
have
been
anxiously
awaiting
Minnesota
Venture
Center,
she
was
way?
waters
muddied
by
the
interaction
The
company
plans
to
hire
about
140
customer-facing
already
registered
online,
but
that’s
out
of
7,468
approved
device
industry,
was
serving
as
CEOMinnesota
Venture
Center,
she
was
genes
and
environmental
influences.
•
Anorexia
Brain
Pathway?
who
were
conducting
work
on
fecal
Prevention
Mucus
Protection
Copyright
© 2013
Thomson Reuters.
Reproduction
issaid.
strictly
prohibited.
our web site at ww
Figuring
out
the
contribution
of Figuring
of work
in Edick
the microbiome,
she Visit
a
high
percentage
MRSA,”
“Hospitals
don’t
murky
fishing
expedition,
done
in
•
Biomarker
Expansion
Fails
out
the
contribution
of
in-residence
at
the
University
of
murky
fishing
expedition,
done
in
this
particular
drug
is
what
it
will
do
for
the
way
patients
approached
by
university
researchers
nce
of the gene in questionprofessionals,
with other including
100 salespeople,
10
medical
trials
that
willofhave
to be included.
Antibodies•
in-residence
at the
University
of
approached
by
university
researchers
An
Ounce
Resistance
transplants
(FT)
–
the
“first
generation”
Alzheimer’s
Antibodies
And
Mucosal
Immunity
any
gene
to
complex
disorders
is
a
want
to
admit
those
patients
if
they
don’t
have
to,
because
See
Attachment
See
Genes,
Page
See
Rebiotix,
Page 7
waters
muddied
by theabout
any
gene
toenvironmental
complex
disorders
is a 8she
Minnesota
Venture
Center,
was
waters
muddied
by the
interaction
are Prevention
treated,”
he said.
“We’re
only
talking
skin
who
were
conducting
work
onwere
fecal
genes
and
influences.
science
liaisons,
10
regional
directors
and
the
rest
The creation
of the
database
marks
ainteraction
substantial
tion
Minnesota
Venture
Center,
she
was
who
work
oncovering
fecal
of
work
in conducting
the
microbiome,
she
Mucus
Protection
• Biomarker
Expansion
Failsin question
murky
fishing
expedition,
done
in
you’re
just
adding
to
the
MRSA
problem.”
of
the
gene
with
other
murky
fishing
expedition,
done
in
approached
by
university
researchers
of
the
gene
in
question
with
other
infections
because
that’s
the
path
to
the
market.
This
drug
transplants
(FT)
–
the
“first
generation”
ies
reimbursement
and
hospital
discharges.
Butt
expects
a
improvement
to
the
past
system,
Wu
said,
adding
that
To
subscribe,
please
call
b
io
W
orld
™ Customer
Service
at
(800)
477-6307;
outside
the
U.S.
and
Canada,
call
(770)
810-3144.
Immunity•
approached
by
university
researchers
transplants
(FT)
–
the
“first
generation”
Alzheimer’s
Antibodies
And Mucosal
Immunity
See©
Attachment
See
Genes,
Page
8 suggest
Seethat
Rebiotix,
Page 7
waters
muddied
by
theThomson
interaction
Medicare
data
that
“hospitals
are treating
genes
environmental
influences.
Copyright
2013
Reuters.
Reproduction
is strictly
prohibited.
Visit
our
web
site at
www.bioworld.com
waters
muddied
bywork
the
interaction
who
were
conducting
work
on
fecal
genes
and
environmental
influences.
Fast
answers
for
unobstructed
be very
effective,
weand
believe,
in
osteomyelitis,
and
of
in
the
microbiome,
she
partnering
deal
outside
the
U.S.
regulators
will
be
among
the
biggest
beneficiaries.
pansion will
Fails
who
were
conducting
work
on
fecal
of
work
in
the
microbiome,
she
•
Mucus
Protection
Biomarker
Expansion
Fails
of diabetic
the
genefoot
in question
with
other
these
patients
in
the
hospital
with
generic
drugs,
are
of
the gene
in8atquestion
with
other
transplants
(FT)
–Durata’s
the
“firststock
generation”
Toitsubscribe,
please
call
bioW
orld
™ Customer
Service
(800) 477-6307;
outside
the
U.S.
and
Canada,
call(FT)
(770)
810-3144.
pneumonia,
ulcers
and
various
other
things.”
(NASDAQ:DRTX)
closed
Friday
at $9.
10, 7
ity
In the
past,
has been
difficult
for
authorities
to
See
See
Genes,
Page
See
Rebiotix,
Page
7
transplants
– the
“first
generation”
• Attachment
And
Mucosal
Immunity
See
Attachment
See
Genes,
Page
8
See
Rebiotix,
Page
paths
to
market.
genes
and
environmental
influences.
losing
money”
on
people
who
might
be
triaged
and
given
Copyright
© 20133Thomson
Reuters.
Reproduction
is strictly
prohibited.
Visit
our
web site at www.bioworld.com
genes
and
environmental
influences.
of
work
in
the
microbiome,
she
But
in
skin
infections
alone,
million
patients
are
up
21
cents.
n
n Fails •
monitor
the progress
of Fails
clinical trials after they were
of work in the microbiome, she
Biomarker
Expansion
subscribe, please
call bioWorld
™ Customer
Service
at (800)
477-6307;
outside
the U.S.
and Canada,
call outside
(770)without
810-3144.
dalbavancin
a hospital
stay,
he810-3144.
said.
To
subscribe,
please
call
bio
World
™ Customer
Service
at (800)
477-6307;
the U.S. and
Canada,
(770)
admitted
toin
hospitals
every
year.
“We
estimate
that
a third
See
Attachment
See
Genes,
Page
8
See
Rebiotix,
Page
7 call
approved,
large
part
due
to
the
infrequent
contact
See
Attachment
See
Genes,
Page
8
See Rebiotix,
Page 7
Copyright © Ensure
2013 Thomsonyour
Reuters.
Reproduction
is strictly prohibited.
Visit our web
site at www.bioworld.com
drug
processes
Copyright
©approval
2013 Thomson
Reuters.
Reproduction
is strictly
prohibited.
Visit
our web
site at at
www.bioworld.com
“A
lot
of
them
present
the
emergency
department,”
ofbetween
them are
only in theand
hospital
to get
the [intravenous
authorities
sponsors
during
the progress of a
e, please call bioWorld™ Customer
Service atplease
(800) call
477-6307;
the U.S.
and Canada,
(770)noted.
810-3144.
Edick
“Ifthe
you
catchisthem
there,
and give them
To subscribe,
bioWorldoutside
™ Customer
Service
at (800)call
477-6307;
outside
U.S.can
and Canada,
call
(770)
810-3144.
antibiotic] therapy,”
Edick told BioWorld
Today.
“Incredibly
BioWorld
on
Twitter!
Durata Files Dalbavancin NDA;
Approval Could Occur by May
Durata Files
Durata
Files Dalbavancin
Dalbavancin NDA;
NDA;
Approval
Could
Occur
by
May
Approval
Could
Occur by NDA;
May
Files Dalbavancin
NDA;
Durata Files
Dalbavancin
alDalbavancin
Could
Occur
byDalbavancin
May
Approval
Could
Occur by NDA;
May
s
NDA;
Durata
Files
ould Occur
by May
Approval
Could Occur by May
CLEARLY
CORTELLIS
CLEARLY
CORTELLIS