Some Lawyers Celebrate Underwhelming Career Milestones – Above the Law

I
do
not
check
LinkedIn
too
much
these
days.
Although
I
used
to
think
that
LinkedIn
was
a
solid
way
to
develop
new
business,
more
often
than
not,
LinkedIn
is
mostly
a
means
for
people
to
spam
my
inbox
and
post
career
accomplishments
for
the
affirmation
of
people
users
might
not
even
know.
One
interesting
phenomenon
I
often
see
on
LinkedIn
is
that
numerous
lawyers
post
about
purported
accomplishments
that
do
not
require
any
kind
of
recognition
or
skill,
seemingly
in
order
to
generate
content
for
people
to
see
and
like
on
the
platform.
I
understand
the
need
for
people
to
generate
content
on
such
platforms
as
LinkedIn
to
get
noticed,
but
I’m
not
sure
why
users
announce
certain
underwhelming
career
updates.

One
supposed
career
accomplishment
I
see
lawyers
post
all
the
time
is
when
they
are
admitted
to
a
new
state
or
federal
bar.
Of
course,
it
makes
sense
for
lawyers
to
want
to
advertise
to
others
that
they
are
now
licensed
to
practice
law
in
a
new
jurisdiction
in
case
contacts
have
referrals
in
that
state.
However,
some
lawyers
seem
to
suggest
that
becoming
admitted
to
a
new
bar
requires
some
kind
of
recognition
or
skill.
Indeed,
I
often
see
people
posting
about
how
proud
they
are
to
be
admitted
to
the
bar
of
the
Supreme
Court
of
the
United
States
even
though
the
requirements
to
have
this
status
are
relatively
minimal.
If
attorneys
need
to
pass
the
bar
exam
again
to
be
admitted
to
a
new
state
bar,
I
think
that
the
admission
is
an
accomplishment
since
it
is
genuinely
difficult
for
someone
to
take
time
out
of
their
career
to
study
and
pass
a
bar
exam.

However,
most
states
and
federal
bars
have
reciprocity
that
allows
lawyers
admitted
in
other
jurisdictions
to
gain
reciprocal
admission
in
the
desired
area.
All
the
lawyer
must
do
is
fill
out
the
necessary
paperwork,
pay
related
fees,
and
not
run
into
character
and
fitness
problems.
Meeting
this
low
threshold
is
not
much
of
an
accomplishment.
Sure,
it
can
be
a
pain
to
assemble
all
of
the
certificates
of
good
standing,
reference
letters,
and
other
accompanying
documents
to
apply
for
such
admission.
However,
pretty
much
any
lawyer
can
submit
such
paperwork
to
be
admitted
in
a
different
jurisdiction,
so
lawyers
should
not
post
about
reciprocal
admission
as
if
it
is
a
big
accomplishment.

Lawyers
also
post
incessantly
about

chintzy
awards

that
they
were
given
and
how
the
award
proves
that
they
are
at
the
top
of
their
fields
and
have
achieved
lofty
accomplishments.
Regrettably,
many
lawyer
achievement
awards
are
not
something
to
celebrate.
Pretty
much
any
lawyer
can
usually
either
apply
or
pay
to
be
granted
such
awards,
and
most
of
these
awards
do
not
come
with
a
rigorous
selection
methodology.

Companies
make
money
selling
plaques
and
other
hardware
showcasing
that
the
lawyer
has
won
a
supposedly
prestigious
award,
and
ad
space
is
sold
in
publications
that
print
the
names
of
people
given
the
award.
The
lawyer
awards
industry
serves
the
egos
of
lawyers,
and
makes
the
public
think
that
lawyers
are
accomplished,
when
in
reality
most
lawyer
awards
are
not
a
reflection
of
the
lawyer’s
skill,
but
perhaps
on
the
size
of
the
lawyers
ego.
Some
lawyer
awards
are
true
accomplishments,
but
these
are
far
outweighed
by
the
superficial
awards
that
people
often
post
about
on
LinkedIn
and
elsewhere.

It
is
difficult
for
lawyers
to
distinguish
themselves
in
the
legal
marketplace,
and
they
may
struggle
sometimes
to
produce
content
for
social
media
in
order
to
get
their
names
in
front
of
more
people.
However,
lawyers
should
consider
highlighting
genuine
victories
and
accomplishments
rather
than
posting
about
hollow
career
milestones.




Rothman Larger HeadshotJordan
Rothman
is
a
partner
of




The
Rothman
Law
Firm
,
a
full-service
New
York
and
New
Jersey
law
firm.
He
is
also
the
founder
of




Student
Debt
Diaries
,
a
website
discussing
how
he
paid
off
his
student
loans.
You
can
reach
Jordan
through
email
at





[email protected]
.

Biglaw Mergers Expected To Continue Apace In 2025, Even As Law Firms Grow ‘Pickier’ – Above the Law



Ed.
note
:
Welcome
to
our
daily
feature,

Quote
of
the
Day
.


It
does
reduce
the
number
of
completed
mergers
we
see,
because
firms
are
pickier,
and
they
should
be.
They’re
looking
for
this
type
of
business
case
and
strategic
rationale.
Of
course
that
differs
from
a
defensive
merger,
where
they
have
fewer
choices
available,
and
they
are
backed
into
a
corner.




Kristin
Stark,
a
principal
at
Fairfax
Associates,
in
comments
given
to
the

American
Lawyer
,
on
why
most
law
firm
merger
talks
are
seen
as
offensive
right
now
among
Biglaw
firms,
especially
considering
the
fact
that
the
legal
sector
is
performing
incredibly
well.
Fifty
law
firm
mergers
took
place
in
2024,
and
at
least
12
mergers
have
been
announced
for
2025
already.
“We
expect
to
see
at
least
the
same
number
of
mergers
in
2025
as
in
2024,
with
the
possibility
for
more
if
deals
currently
under
consideration
cross[]
the
finish
line,”
Fairfax
noted
in
its
year-end
merger
report.



Staci ZaretskyStaci
Zaretsky
 is
a
senior
editor
at
Above
the
Law,
where
she’s
worked
since
2011.
She’d
love
to
hear
from
you,
so
please
feel
free
to

email

her
with
any
tips,
questions,
comments,
or
critiques.
You
can
follow
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and Threads, or
connect
with
her
on LinkedIn.

Clarence Thomas Avoids DOJ Referral Evoking George Costanza Defense – Above the Law

There’s
an
episode
of
Seinfeld
where
George
has
sex
with
a
cleaning
lady
on
his
office
desk
and
when
confronted
responds,
“Was
that
wrong?
Should
I
have
not
done
that?”
But,
since
Seinfeld
more
closely
tracks
a
universe
where
actions
have
logical
consequences,
George
got
fired
and
Clarence
Thomas
gets
to
plead
ignorance
about
a
nearly
five-decade-old
law.

Thomas,
who
has

forgotten
more
vacations
than
you’ll
ever
know
,
has
been
the
subject
of
a
Senate
Judiciary
inquiry
ever
since

ProPublica
first
identified

around
half
a
million
in
luxury
travel
and
gifts
without
disclosing
any
of
it
as
legally
required
by
the
Ethics
in
Government
Act
of
1978.
Along
the
way,
we’ve
learned
about

free
tuition
,

free
housing
,
and

an
RV

(which
might
also
have
been
free).
The
legislators
wrote
the
Judicial
Conference
asking
the
Article
III
institution
to
do
its
job
under
the
statute
and
refer
Thomas
to
the
Department
of
Justice.
Almost
two
years
after
the
fact,
the
Conference
has
decided
to
do
nothing
instead.

In

a
letter

from
the
Judicial
Conference
to
Senator
Sheldon
Whitehouse,
Secretary
of
the
Judicial
Conference
Judge
Robert
Conrad
said
that
they’d
decided
against
doing
anything
because
Thomas
was
probably
just
confused
about
how
to
read
the
plain
meaning
of
a
law.
A
plausible
excuse
based
upon
his
jurisprudence
generally,
but
highly
suspect
here.

In
March
and
April
2023,
the
Financial
Disclosure
Committee,
with
the
approval
of
the
Judicial
Conference,
issued
guidance
that
the
personal
hospitality
gift
reporting
exemption
applies
only
to
food,
lodging,
or
entertainment.
The
exemption,
it
explained,
does
not
apply
to
gifts
of
“transportation
that
substitute[]
for
commercial
transportation,”
gifts
“extended
for
a
business
purpose,”
or
gifts
“extended
at
a
commercial
property,
e.g.,
a
resort
or
restaurant,
or
at
a
property
that
is
regularly
rented
out
to
others
for
a
business
purpose.”
The
Financial
Disclosure
Committee,
generally
speaking,
does
not
apply
new
guidance
retroactively
to
previously
filed
reports.

This
is
the
“I
didn’t
hear
anyone
say
‘Simon
Says’”
of
excuses.

The
problem
with
“not
apply[ing]
new
guidance
retroactively,”
is
that
presumes
there’s
something
“new”
about
the
guidance.
No
one
was
actually
confused
over
the
scope
of
this
exception
before
this.
No
one
thought
an
exception
for
crashing
on
your
college
roommate’s
couch
was
the
same
as
“having
a
billionaire
give
your
mom
a
house
rent
free.”
Elena
Kagan
thought

a
fucking
bagel
basket
from
her
high
school
classmates

put
her
in
breach
of
this
law!
Everyone
knew!

More
to
the
point,
when
some
of
the
allegations
in
this
matter
include

auto
loan
forgiveness
shenanigans

and

off-the-books
payments
,
there’s
more
than
a
little
to
suggest
that

Thomas

knew.
At
least
enough
suggestion
that
the
case
would
benefit
from
a
DOJ
inquiry.

“Not
only
do
presidents
have
absolute
immunity
from
prosecution
for
violating
the
law,
but
now
Supreme
Court
justices
enjoy
immunity
for
law-breaking,
as
well,”
explained
Fix
the
Court’s
Gabe
Roth.
“That
is
as
shameful
as
it
is
contrary
to
the
plain-text
reading
of
the
financial
disclosure
law,
which
sets
clear
guidelines
about
the
types
of
gifts
that
need
to
be
reported

which
Justice
Thomas
has
obviously
and
frequently
violated
over
the
years

and
includes
real
consequences
for
violations.”

Alas,
the
Conference
explained
that
Thomas
has
made
some
changes
so
everyone
should
just
chill.

Justice
Thomas
has
filed
amended
financial
disclosure
statements
that
address
several
issues
identified
in
your
letter.

“Several”
is
conspicuously
not
“all.”

Which
may
sound
like
nitpicking,
but
lawyers

especially
judges

aren’t
casual
with
words
like
these.
When
he
says,
“several”
he
means
“not
all”
and
it
would
be
interesting
to
get
more
clarity
on
just
what
it
doesn’t
include.

But
even
if
the
Conference
hadn’t
found
a
way
to
excuse
Thomas
as
confused,
the
letter
suggests
they
might
have
tried
to
avoid
their
legal
obligations
the
old
fashioned
way
by
declaring
the
Supreme
Court
exempt
from
any
consequences:

First,
the
Judicial
Conference
has
never
taken
a
position
on
whether
its
referral
authority
under
5
U.S.C.
§
13106(b)—to
refer
judges
to
the
Attorney
General
for
investigation
into
whether
they
have
“willfully”
violated
their
reporting
obligations—applies
to
Justices
of
the
Supreme
Court
of
the
United
States.
The
question,
to
be
clear,
is
not
whether
the
Ethics
in
Government
Act
applies
to
the
Justices
of
the
Court.
It
is
whether
the
Judicial
Conference’s
referral
authority
applies
to
the
Justices.
There
is
reason
to
doubt
that
the
Conference
has
any
such
authority.
Because
the
Judicial
Conference
does
not
superintend
the
Supreme
Court
and
because
any
effort
to
grant
the
Conference
such
authority
would
raise
serious
constitutional
questions,
one
would
expect
Congress
at
a
minimum
to
state
any
such
directive
clearly.

Not
to
get
all
originalist,
but
this
is
hogwash.
Roth
explains, “The
Conference
writing
the
justices
out
of
much
of
the
disclosure
law
is
also
ahistorical,
as
the
law
was
drafted
shortly
after
two
justices
were
found
to
have
accepted
outside

and
arguably
unethical

income.

But,
as
Chief
Justice
Roberts
explained
earlier
this
week,

it’s
wrong
to
point
out
that
your
judicial
emperor
wears
no
clothes
.


(Letter
on
the
next
page…)


Earlier
Clarence
Thomas
Has
Forgotten
More
Vacations
Than
You’ll
Ever
Know


Senators
Beg
Merrick
Garland
To
Do
His
Job
And
Investigate
Clarence
Thomas


If
You’ve
Appreciated
The
Service
You’ve
Received,
Consider
Tipping
Your
Supreme
Court
Justices!


Clarence
Thomas
Took
EVEN
MORE
Free
Trips
On
Private
Planes
That
He’s
Still
Not
Disclosed!




HeadshotJoe
Patrice
 is
a
senior
editor
at
Above
the
Law
and
co-host
of

Thinking
Like
A
Lawyer
.
Feel
free
to email
any
tips,
questions,
or
comments.
Follow
him
on Twitter or

Bluesky

if
you’re
interested
in
law,
politics,
and
a
healthy
dose
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college
sports
news.
Joe
also
serves
as
a

Managing
Director
at
RPN
Executive
Search
.

Modernizing Legal Workflows: The Role Of AI, Automation, And Strategic Partnerships – Above the Law



Ed.
note:
 This
article
first
appeared
in
an
ILTA
publication.
For
more, visit
our
ILTA
on
ATL
channel
here. 


As
law
firms
transition
from
exploring
artificial
intelligence
(AI)
to
fully
adopting and
implementing
emerging
technologies,
developing
a
deep
understanding
of
data
and
processes
is
imperative.


Buchanan
Ingersoll
&
Rooney
PC
recognized
the
value
of
partnering
with
industry
experts,
like
NetDocuments
and
3545
Consulting,
to
integrate
AI-powered
tools
into
the
firm’s
day-to-day
operations.


Through
this
collaborative
process,
Buchanan
implemented
NetDocuments’
PatternBuilder
and
App
Builder
(powered
by
PatternBuilder
MAX)
to
integrate
advanced
document
automation
and
AI
capabilities
to
streamline
processes
and
create measurable
efficiency
improvements.
 


Turning
Ambition
into
Action
  


In
2023,
Buchanan
Ingersoll
&
Rooney
PC
faced
the
challenge
of
staying
ahead
in
a
rapidly
evolving
legal
industry.
Recognizing
the
increasing
importance
of
AI,
automation,
and
data
analytics,
the
firm
launched
a
bold
five-year
strategic
plan
to
transform
its
operations
and
better
serve
client
needs.
This
plan
aimed
to
align
cutting-edge
technologies
with
the
firm’s
workflows,
ensuring
seamless
integration
into
daily
practice. 


Scott
Angelo,
the
firm’s
Chief
Information
Officer,
emphasized
the
importance
of
a
holistic
approach:
“We
felt
that
it
was
very
important
to
build
out
centers
of
excellence
that
covered
all
three
areas
[AI,
automation,
data
&
analytics].
Because
we
realized
that
in
order
to
come
up
with
comprehensive
solutions,
we
were
going
to
have
to
use

two
to
three
of
those
working
together
to
provide
the
best
solution
possible.” 


Angelo
added,
“We
really
doubled
down
on
AI
because
it
was
just
so
new

not
just
to
the
legal
industry,
but
to
the
world.”
Under
his
leadership,
Buchanan’s
efforts
to
embrace
AI
have
garnered
significant
attention,
earning
the
firm
recognition
as
one
of
the
“Best
of
the
Best
for
Generative
AI”
in
the
2024
BTI
“Leading
Edge
Law
Firms”
survey. 


This
acknowledgment
reflects
more
than
ambition;
it
highlights
the
firm’s
ability
to
translate
innovative
ideas
into
actionable
results.
By
focusing
on
collaboration
and
leveraging
technology
to
address
client
demands,
Buchanan
has
set
a
benchmark
for
what
is
possible
in
legal
technology
innovation. 


The


NetDocuments
App
Builder


quickly
became
integral
to
the
firm’s
strategy,
enabling
them
to
automate
complex
legal
workflows
with
AI.
By
generating
documents,
extracting
data,
and
streamlining
legal
processes,
the
tool
delivered
immediate
efficiency
gains
and
allowed
the
firm
to
focus
on
higher-value
work.
  


A
key
advantage
of
the
App
Builder
and
PatternBuilder
lies
in
their
secure
operation
within
the
firm’s
existing
NetDocuments
environment.
This
integration
ensures
that
all
workflows
and
data
comply
with
the
robust
security
standards
already
established
in
the
document
management
system.
Leveraging
this
trusted
infrastructure,
firms
like
Buchanan
can
confidently
explore
AI-driven
automation
without
risking
sensitive
client
or
case
information. 


App
Builder
offers
an
approachable
starting
point
for
firms
new
to
AI.
Its
low-code
interface
and
integration
with
familiar
platforms
reduce
the
learning
curve,
making
the
transition
to
AI
and
automation
more
accessible.
Its
unique
combination
of
security,
usability, and
seamless
integration
positions
App
Builder
as
an
ideal
tool
for
incorporating
AI-driven
technology
into
legal
operations.
  


To
ensure
they
fully
utilized
App
Builder’s
capabilities,
Buchanan
partnered
with
3545
Consulting,
a
firm
known
for
its
expertise
in
legal
technology,
to
bridge
the
gap
between
vision
and
execution.
Together,
the
team
set
out
to
modernize
workflows,
reduce
inefficiencies,
and
ultimately
enhance
client
service

all
while
maintaining
the
highest
data
security
standards. 


Time
Savings
and
Consistent
Work
Product
  


Buchanan’s
journey
started
with
a
focus
on
small,
high-impact
initiatives.
Collaborating
with
3545
Consulting,
they
identified
key
use
cases
where
AI
and
automation
could
deliver
immediate
value,
utilizing
NetDocuments’
App
Builder.
One
of
the
first
successes
was
using
the


Summarize
app
,
which
automated
the
process
of
summarizing
legal
documents.
This
tool
quickly
became
a
favorite
among
the
firm’s
attorneys,
saving
hours
of
manual
work.
  


Buchanan
shifted
from
built-in
apps
to
customizing
a
Litigation
Master
Caption
File
app
that
automates
the
creation
of
master
caption
files
for
litigation
matters.
The
app
leverages
AI
to
extract
caption
data
points
from
an
initial
court
filing
and
automation
to
generate
a
master
caption
file
with
jurisdiction-specific
formatting.
The
master
caption
file
can
then
be
used
as
the
starting
point
for
all
court
filings,
ensuring
consistency,
accuracy,
and
proper
formatting,
all
while
streamlining
the
drafting
process.
  


Outcomes:
   


  • 1500+
    practice
    assistant
    and
    paralegal
    hours
    saved
    annually
    (approx.
    $80,000
    value)
      

  • Risk
    avoidance
    and
    reputational
    benefit
    via
    accurate,
    consistent
    automation
      

  • Improved
    consistency
    for
    10,000+
    court
    filings
    annually
      


Buchanan
also
created
a
Durable
Power
of
Attorney
App
to
streamline
the
drafting
process
for
durable
powers
of
attorney.
The
app
guides
users
through
client-specific
questions,
such
as
selecting
appointees,
defining
their
powers,
and
determining
whether
the
document
should
take
effect
immediately
or
upon
incapacity.
By
automating
this
process,
the
app
reduces
drafting
time
from
hours
to
minutes,


enabling
attorneys
to
focus
on
each
case’s
unique
complexities.
   


Ensuring
that
measurements
were
in
place
to
access
each
app’s
value
was
critical
to
Buchanan’s
approach.
The
firm
worked
with
3545
Consulting
to
develop
a
simple
yet
effective
solution:
by
integrating
a
counter
in
each
app’s
data
table,
the
firm
could
track
the
app’s
usage.
This
tracking
system
allowed
them
to
quantify
the
time
savings
and
other
benefits
generated
by
each
app.
   


For
example,
one
app
saved
the
firm
five
hours
of
attorney
time
each
time
it
ran.


Its
utilization
increased
productivity
and
improved
the
consistency
and
quality
of
the
final
documents.
Other
apps
provide
less
tangible
benefits,
such
as
reducing
errors
and
ensuring
compliance
with
standard
formats
across
all
outputs.
  


It
is
also
easier
for
attorneys
to
adopt
since
the
apps
are
built
within
the
familiar
NetDocuments
platform.
Attorneys’
familiarity
with
the
existing
platform
reduced
the
learning
curve,
making
AI
and
automation
feel
less
intimidating
and
encouraging
greater
adoption
across
the
firm’s
practice
areas.
  


Turning
Use
Cases
into
Working
Apps
     


Buchanan’s
success
was
not
an
accident

it
stemmed
from
a
well-defined
process
critical
to
the
success
of
implementation
and
execution.
The
collective
team
followed
these
essential
steps
for
app
development:
  


  1. Identify
    and
    Prioritize
    Use
    Cases:


    Workshop
    with
    attorneys
    and
    staff
    to
    identify
    tasks
    ripe
    for
    automation,
    such
    as
    repetitive
    document
    drafting.
    “We
    started
    with
    smaller
    groups
    to
    get
    quick
    wins
    and
    build
    excitement,”
    said
    Jared
    Gullbergh,
    Director
    of
    Practice
    Solutions
    and
    IG
    at
    Buchanan.
       

  2. Define
    App
    Requirements:


    Collaboratively
    create
    clear
    goals
    and
    workflows.
    PatternBuilder’s
    low-code
    interface
    allowed
    for
    quick
    iterations
    and
    user
    involvement.

  3. Leverage
    Pre-Built
    Studio
    Apps
    and
    Templates:


    Customize
    templates
    to
    match
    the
    firm’s
    needs.
    This
    step
    reduced
    development
    time
    and
    increased
    overall
    value.

  4. Incorporate
    AI
    and
    Automation:


    Design
    apps
    to
    output
    consistent,
    high-quality
    documents
    by
    combining
    AI-driven
    data
    extraction
    with
    automation.

  5. Test
    and
    Iterate:


    Involve
    end
    users
    early
    to
    refine
    solutions.

  6. Deploy
    and
    Train:


    To
    foster
    adoption,
    create
    training
    sessions
    for
    end
    users
    to
    ensure
    they
    understand
    the
    apps’
    value
    and
    functionality.

  7. Measure
    Success:


    Track
    usage
    and
    time
    savings
    to
    quantify
    impact
    and
    identify
    additional
    opportunities
    for
    improvement.
      


“The
apps
available
in
ndMAX
make
it
easy
to
iterate,”
Gullbergh
noted.
“We
can
adapt
quickly
to
meet
new
needs,
which
is
critical
in
a
fast-changing
environment.”
  


Building
a
Long-Term
Strategy
Through
Collaborative
Thought
Leadership


Buchanan
Ingersoll
&
Rooney’s
thoughtful,
collaborative
approach
to
AI
can
deliver
lasting
results.
  


“We’ve
only
scratched
the
surface
of
what’s
possible,”
said
Gullbergh.
“With
NetDocuments’
AI
capabilities,
we’re
not
just
keeping
up

we’re
leading.”
 


Beyond
the
immediate
wins,
Buchanan’s
collaboration
with
NetDocuments
and
3545
Consulting
set
the
stage
for
sustained
success.
By
equipping
Buchanan’s
IT
team
to
develop
and
maintain
apps
independently,
the
firm
ensured
it
could
scale
its
automation
capabilities
while
still
having
access
to
external
support
from
3545
when
needed.
  


The
knowledge
gained
from
this
collaborative
project
is
incredibly
valuable
for
other
firms
transitioning
from
the
theoretical
ideation
phase
to
the
practical
implementation
stage
of
AI-powered
technology
deployment.
The
right
technology,
a
strategic
approach,
and
a
focus
on
measurable
outcomes
can
transform
legal
workflows.
Buchanan’s
journey
is
an
inspiring
example
of
embracing
the
future
while
prioritizing client
needs
and
upholding
firm
values. 


As
legal
technology
evolves,
the
firm’s
proactive
approach
is
a
valuable
case
study
for
other
firms
looking
to
implement
AI
and
automation.
The
lessons
learned
from
this
collaboration

such
as
the
importance
of
having
an
intelligent
DMS,
the
proper
training,
measuring
success,
and
building
internal
and
external
capacity

offer
a
roadmap
for
firms
seeking
to
modernize
their
workflows
while
delivering
value
to
their
clients.
  




Scott
Angelo
is
Buchanan
Ingersoll
&
Rooney
PC’s
Chief
Information
Officer.
He
handles
the
design,
implementation,
and
management
of
information
technology
and
risk
management
platforms.
Scott
manages
the
firm’s
IT
team
to
further
develop
technologies
to
drive
creative
solutions
for
the
firm
and
its
clients.
He
brings
more
than
30
years
of
experience
to
the
firm’s
high-performing
culture
and
efficient
client
service
through
an
innovative
digital
infrastructure.
Scott
was
recognized
by
the
Pittsburgh
Technology
Council
as
the
winner
in
the
2024
CIO
of
the
Year
Awards
and
by
The
Legal
Intelligencer
as
a
Law
Firm
Innovator
Finalist
for
the
2024
PA
Legal
Awards.  



Jared
Gullbergh
serves
as
Buchanan
Ingersoll
&
Rooney
PC’s
Director
of
Practice
Solutions
and
Information
Governance.
Jared
partners
closely
with
the
firm’s
legal
and
government
relations
practices
to
deliver
technology
and
data-driven
solutions
to
maximize
process
efficiencies,
profitability
and
to
deliver
unique
client-value.
He
also
directs
and
oversees
the
Records
and
Information
Governance
functions
of
the
firm.
Jared
brings
to
bear
more
than
19
years
of
IT
and
information
governance
experience
in
the
full-service
legal
industry.



Nancy
Griffing
is
a
seasoned
legal
technology
consultant
and
a
driving
force
at
3545
Consulting,
where
she
combines
decades
of
industry
experience
with
a
forward-thinking
approach
to
innovation.
With
a
deep
understanding
of
the
legal
sector’s
unique
challenges,
Nancy
has
become
a
thought
leader
in
the
adoption
and
integration
of
artificial
intelligence.
She
specializes
in
helping
law
firms
leverage
AI
to
enhance
existing
tools,
streamline
workflows,
and
drive
efficiency
at
scale.
As
a
Partner
at
3545
Consulting,
Nancy
empowers
firms
to
achieve
transformative
results
while
navigating
the
complexities
of
modern
legal
practice.



Michael
Owen
Hill
has
nearly
two
decades
of
experience
in
the
legal
tech
industry
in
roles
ranging
from
product
management
to
product
marketing
to
product
portfolio
strategy.
He
has
worked
with
small
firms,
corporate
legal
departments
and
the
world’s
largest
law
firms
to
advance
client
development,
legal
research
and
know-how,
financial
and
practice
management
and
legal
document
management
goals.
As
Director
of
Product
Marketing
at
NetDocuments,
Michael
focuses
on
helping
customers,
partners
and
employees
navigate
the
complexities
of
the
rapidly
evolving
legal
tech
landscape.

Law Clerks Run The Courtroom In 2024’s Lawyer Of The Year Competition – Above the Law

With
2024
in
the
rearview
mirror,
it’s
now
time
to
announce
the
winner
of
our
annual

Lawyer
of
the
Year
 competition.
The
vote
for
the
honor
was
not
a
close
one,
not
even
one
little
bit.
Our
top
candidate
took
home
more
than
50%
of
the
vote,
while
our
second-place
finisher
(perhaps
one
of
our
worthiest
contenders)
had
26%
of
the
total
tally.
In
fact,
the
new
titleholder
secured
almost
300
more
votes
than
this
year’s
silver
medalist.

Before
we
announce
which
luminary
lawyer
prevailed,
let’s
review
Above
the
Law’s
past
Lawyers
of
the
Year:

In
a
year
where
the
legitimacy
of
elections
and
the
legitimacy
of
the
winners
of
those
elections
took
hold
across
the
national
news,
it
makes
sense
that
amid
a
very
curious
voting
cycle,
the
lawyer
who
came
out
on
top
noted
in
his
self-nomination
that
he
was
“completely
unqualified”
to
win
but
that
“[f]ar
less
qualified
people
have
won
far
more
important
elections
this
year.”

In
the
end,
it
was

Ryan
Protter
,
a
recent
law
school
graduate
who
currently
serves
as
a
law
clerk
in
the
New
Jersey
Appellate
Division,
who
took
home
the
title
in
our
2024
Lawyer
of
the
Year
competition.
Referring
to
himself
on

LinkedIn

as
the
“dark
horse
candidate”
in
this
race,
voters
helped
Protter
“do
the
funniest
thing
ever,”
and
handed
him
the
LOTY
honors.
Congratulations
to
Ryan
Protter
on
achieving
the
ultimate
punchline.

Speaking
of
law
clerks,
our
silver
medalist
was

Aliza
Shatzman
,
founder
and
president
of
the Legal
Accountability
Project
.
In
what
seemed
like
a
Hurculean
task,
she
made
a
great
deal
of
progress
for
federal
law
clerks
this
year.
After
what
required
a
lot
of
blood,
sweat,
and
tears,
Shatzman
launched
the

Centralized
Clerkships
Database
,
essentially
a
“Glassdoor
for
Judges,”
a
tool
meant
to
empower
clerkship
applicants
with
much-needed
transparency
and
inside
information
from
former
clerks
about
judicial
work
environments.
Click here
to
read
some
of
her
excellent
columns
on
this
topic.
Congratulations
to
Aliza
Shatzman
on
achieving
what
many
once
considered
to
be
nigh
impossible
for
federal
law
clerks
in
the
United
States.

Congratulations
to
all
of
our
Lawyer
of
the
Year
finalists,
congratulations
to
our
2024
Lawyer
of
the
Year,
Ryan
Protter,
and
a
very
special
congratulations
to
our
runner-up,
Aliza
Shatzman.



Staci ZaretskyStaci
Zaretsky
 is
a
senior
editor
at
Above
the
Law,
where
she’s
worked
since
2011.
She’d
love
to
hear
from
you,
so
please
feel
free
to

email

her
with
any
tips,
questions,
comments,
or
critiques.
You
can
follow
her
on BlueskyX/Twitter,
and Threads, or
connect
with
her
on LinkedIn.

Mindlessly ‘Deregulating’ U.S. Telecom Contributed to The Worst Hack In U.S. History – Above the Law

For
the
better
part
of
thirty
years
telecom
giants
(and
the
consultants,
think
tanks,
and
lobbyists
paid
to
defend
them)
have
fought
against every effort
at
coherent
federal
oversight.
It
didn’t
matter
whether
it
was modest
privacy
standards
 or basic
pricing
transparency
,
the
argument
that
was
if
you
stripped
away
coherent
state
and
federal
government
oversight
of
telecom,
free
market magic
would
happen
.

Not
only
is
U.S.
broadband
uncompetitive,
patchy,
expensive,
with
bad
customer
service
as
a
result,
lax
oversight
and
privacy/security
standards
has
resulted
in
a
steady
parade
of
hacks
and
leaks,
culminating
recently
in
the worst
hacking
intrusions
the
U.S.
has
ever
seen
.
Chinese
hackers
deeply
infiltrated
nine
major
U.S.
ISPs
to
spy
on
high
profile
targets,
and
the
government
and
U.S.
telecoms
are
still
trying
to
assess
the
damage
months
later.
(Why,
it’s
almost
as
if
corruption
is
a
national
security
risk.)

Because
the
“Salt
Typhoon”
hackers
were
very
careful
about
wiping
logs
it’s
been difficult
to
assess
the
full
scale
of
the
intrusion
or
whether
intruders
are
still
in
sensitive
systems
.
Officials
believe
intruders
could
still
be
rooting
around
the
networks
of
the
nine
compromised
ISPs.
They
also
state
the
hack
was
because
telecoms
failed
to
implement
rudimentary
cybersecurity
measures
across
their
IT
infrastructure
.”

The
U.S.
reporting
on
the
hack
has
been…interesting.

The
story
has
seen
a
fraction
of
the
press
attention
reserved for
the
TikTok
moral
panic
.
And
very
few
news
outlets
are
willing
to
draw
a
direct
line
between
the
telecom
industry’s
relentless
“deregulatory”
lobbying
(read:
corruption)
and
the
intrusion,
despite
U.S.
officials
making
it
very
clear
in
statements:


“When
I
talked
with
our
U.K.
colleagues
and
I
asked,
‘do
you
believe
your
regulations
would
have
prevented
the Salt
Typhoon
 attack?’,
their
comment
to
me
was, ‘we
would
have
found
it
faster.
We
would
have
contained
it
faster,
[and]
it
wouldn’t
have
spread
as
widely
and
had
the
impact
and
been
as
undiscovered
for
as
long,’
had
those
regulations
been
in
place,

[White
House
Cybersecurity
chief]
Anne
Neuberger
said.
“That’s
a
powerful
message.” 

The
FCC
is
poised
to
hold
meetings
next
month
to
address
whether
it
should
shore
up
its
cybersecurity
oversight
of
telecoms.
But
at
the
helm
of
those
conversations
will
be new
Trump
FCC
boss
Brendan
Carr
,
who
has never
stood
up
to
major
telecoms
on
any
issue
of
importance,
ever
.
And
the
looming Trump-court-backed
defeat
of
net
neutrality
 also
curtails
the
FCC’s
authority
on
cybersecurity
.

Again,
the
U.S.
Congress
has
repeatedly
proven
too
corrupt
to
pass
meaningful
telecom
reform.
Regulators
are
routinely
stocked
with
revolving
door
careerists
too
worried
about
their
next
career
move
to
stand
up
to
telecoms.
And
the
corrupt
U.S.
Supreme
Court just
neutered
what’s
left
of
regulatory
independence
,
ceding
most
reforms
to
a
Congress
too
corrupt
to
act.

The
Salt
Typhoon
hack
comes
after
years
and
years
of
officials
freaking
out
about
the
security
risks
of Chinese-made
Huawei
telecom
hardware
.
Though
when
the
worst
hack
in
U.S.
history
finally
arrived
it
was
courtesy
of
lax
domestic
oversight,
domestic
deregulation,
domestic
corruption,
domestic
laziness,
and
outdated
administrative
passwords.


Mindlessly
‘Deregulating’
U.S.
Telecom
Contributed
to
The
Worst
Hack
In
U.S.
History


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Criminal
Charges


Elon
Musk
Doesn’t
Like
Some
Headlines.
But
That
Doesn’t
Make
Them
Defamatory


‘Free
Speech
Absolutist’
Elon
Musk
Suspends
Critics
On
ExTwitter,
Asks
People
To
Be
Nicer

New Year, New Merger: Top U.K. Firm Announces Tie-Up With U.S. Firm – Above the Law

Biglaw
firms
across
the
globe
have
the
urge
to
merge,
and
in
the
wake
of
the

A&O
Shearman
merger
,
which
joined
U.K.
firm
Allen
&
Overy
and
U.S.
firm
Shearman
&
Sterling,
there’s
been
a

“heightened
level”
of
interest

in
U.K.
and
U.S.
combinations.
In
fact,
we’re
not
even
a
full
week
into
the
new
year,
and
a
U.K.
firm
has
already
announced
a
tie-up
with
a
U.S.
firm.

Earlier
this
week,
Clyde
and
Co.

a
firm
that
brought
in
$1,050,434,000
gross
revenue
in
2023,
putting
it
at
No.
8
on
the
UK
Top
50
and
No.
63
on
the
2024
Global
100

joined
with
Texas-based
insurance
boutique
Tillman
Batchelor.
After
having
lassoed
the
firm,
Clyde
and
Co.
will
now
have
its
first
office
in
the
Lone
Star
State,
and
seven
lawyers
in
Dallas.

Clyde
and
Co.
isn’t
done
expanding
its
footprint
in
the
U.S.
yet.
The

American
Lawyer

has
additional
details:

The
timing
was
right
for
the
combination,
[Eileen
King
Bower,
chair
of
Clyde
&
Co’s
North
American
board,]
said,
noting
that
the
firm’s
expansion
in
Dallas
plays
into
the
firm’s
strategy
of
growing
its
team
that
provides
services
to
insurance
clients.

With
19
offices
in
North
America,
including
15
in
the
U.S.
and
four
in
Canada,
the
firm
is
looking
to
expand
further
and
is
specifically
looking
at
launching
offices
in
Houston
and
in
Washington
State,
due
to
client
requests,
she
said.

“Our
aim
is
to
really
be
the
No.
1
provider
of
services
to
the
insurance
sector
in
North
America,”
she
said.

Congratulations
to
Clyde
and
Co.
on
its
latest
U.S.
merger,
and
best
of
luck
to
the
firm
in
its
quest
to
conquer
the
insurance
sector!


Clyde
&
Co
Announces
Combination
With
Dallas
Insurance
Boutique

[American
Lawyer]



Staci ZaretskyStaci
Zaretsky
 is
a
senior
editor
at
Above
the
Law,
where
she’s
worked
since
2011.
She’d
love
to
hear
from
you,
so
please
feel
free
to

email

her
with
any
tips,
questions,
comments,
or
critiques.
You
can
follow
her
on BlueskyX/Twitter,
and Threads, or
connect
with
her
on LinkedIn.

How Appealing Weekly Roundup – Above the Law

(Image
via
Getty)




Ed.
Note
:

A
weekly
roundup
of
just
a
few
items
from
Howard
Bashman’s

How
Appealing
blog
,
the
Web’s
first
blog
devoted
to
appellate
litigation.
Check
out
these
stories
and
more
at
How
Appealing.


“Banning
TikTok
Would
Violate
America’s
Free
Speech
Tradition;
It’s
up
to
the
Supreme
Court
whether
the
U.S.
will
join
China,
Afghanistan
and
other
authoritarian
countries
that
have
barred
their
citizens
from
using
the
popular
social
media
app”:
 Jacob
Mchangama
and
Jeff
Kosseff
have this
essay
 online
at
The
Wall
Street
Journal.


“US
Asks
Supreme
Court
to
Unblock
Corporate
Transparency
Act;
Supreme
Court
asked
to
stay
injunction
amid
appeal;
Corporate
disclosures
would
be
due
in
January”:
 Quinn
Wilson
of
Bloomberg
Law
has this
report
.


“Jamie
Raskin
Understands
That
Democrats
Need
to
Fight
the
Supreme
Court;
As
the
ranking
member
on
the
House
Judiciary
Committee,
the
outspoken
Court
critic
gets
to
set
the
agenda
for
his
fellow
Democrats
on
judiciary-related
issues

and
prepare
to
chair
the
committee
next
time
Democrats
control
the
House”:
 Molly
Coleman
has this
essay
 online
at
Balls
and
Strikes.


“Elon
Musk
Pay
Deal
Decision
Appealed
to
Delaware
High
Court;
Delaware
chancellor
blocked
$56
billion
pay
deal
last
January;
Florida
shareholders
appealed
decision
voiding
record
pay”:
 Gillian
R.
Brassil
of
Bloomberg
Law
has this
report
.


“The
huge
stakes
in
a
new
Supreme
Court
case
about
pornography;
Texas
asks
the
justices
to
abandon
longstanding
First
Amendment
protections
for
sexual
speech”:
 Ian
Millhiser
has this
essay
 online
at
Vox.


“Biden
Made
the
Judiciary
More
Diverse

but
Not
More
Liberal;
Judicial
nominees
largely
succeeded
other
like-minded
judges,
failing
to
offset
Trump’s
conservative
legal
inroads”:
 Jan
Wolfe
of
The
Wall
Street
Journal
has this
report
.

Top 25 Biglaw Firm Announces Milbank Match – But Only For Associates In Major Market Offices – Above the Law

Biglaw
firms
continue
to
spread
the
wealth
to
associates
across
the
country
after
a
successful
financial
year
by
announcing
matches
of
Milbank’s
generous

year-end
 and special
bonuses.
The
latest
law
firm
to
offer
big-money
bonuses
did
so
just
after
Christmas,
leaving
associates
excited
to
start
the
New
Year.

Holland
&
Knight

a
firm
that
brought
in
$1,849,319,000
gross
revenue
in
2023,
putting
it
at
No.
25
on
the
Am
Law
100

made
its
match
on
December
27,
but
only
for
some
associates
in
some
offices.
Here’s
the
firm’s
bonus
grid:

Holland Knight Bonus Grid 2024

Associates
in
Group
1
are
located
in
the
firm’s
more
regional
offices
(i.e.,
Birmingham,
Chattanooga,
Jacksonville,
Nashville,
Orlando,
Portland,
Richmond,
Tallahassee,
and
Tampa),
while
associates
in
Group
2
are
located
in
the
firm’s
major
market
offices
(i.e.,
Atlanta,
Austin,
Boston,
Century
City,
Charlotte,
Chicago,
Dallas,
Denver,
Fort
Lauderdale,
Houston,
Los
Angeles,
Miami,
New
York,
Newport
Beach,
Philadelphia,
San
Francisco,
Stamford,
Tysons,
Washington,
D.C.,
and
West
Palm
Beach).

On
top
of
its
Milbank
match,
H&K
will
also
award
additional
bonus
money
to
associates
whose
performance
was
“exceptional,”
based
on
billable
hours
and/or
originations.
Those
who
came
close
to
meeting
their
target
hours
(2,000)
but
didn’t
quite
get
there
will
be
considered
for
partial
bonuses.
Everyone
will
receive
their
bonuses
sometime
in
the
first
quarter
of
2025,
after
their
performance
evaluations.

Congratulations
to
all
associates
at
Holland
&
Knight!


(Flip
to
the
next
page
to
see
the
full
memo.)

Remember
everyone,
we
depend
on
your
tips
to
stay
on
top
of
compensation
updates,
so
when
your
firm
announces
or
matches,
please
text
us
(646-820-8477)
or email
us
 (subject
line:
“[Firm
Name]
Bonus/Matches”).
Please
include
the
memo
if
available.
You
can
take
a
photo
of
the
memo
and
send
it
via
text
or
email
if
you
don’t
want
to
forward
the
original
PDF
or
Word
file.

And
if
you’d
like
to
sign
up
for
ATL’s
Bonus
Alerts
(which
is
the
alert
list
we
also
use
for
salary
announcements),
please
scroll
down
and
enter
your
email
address
in
the
box
below
this
post.
If
you
previously
signed
up
for
the
bonus
alerts,
you
don’t
need
to
do
anything.
You’ll
receive
an
email
notification
within
minutes
of
each
bonus
announcement
that
we
publish.
Thanks
for
your
help!



Staci ZaretskyStaci
Zaretsky
 is
a
senior
editor
at
Above
the
Law,
where
she’s
worked
since
2011.
She’d
love
to
hear
from
you,
so
please
feel
free
to

email

her
with
any
tips,
questions,
comments,
or
critiques.
You
can
follow
her
on BlueskyX/Twitter,
and Threads, or
connect
with
her
on LinkedIn.


Bonus Time

Enter
your
email
address
to
sign
up
for
ATL’s

Bonus
&
Salary
Increase
Alerts
.


FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions – MedCity News

For
many
people,
the
end
of
the
year
is
a
mad
rush
to
wrap
things
up
before
the
holidays,
and
so
it
was
for
the
FDA.

Notable
regulatory
decisions
include
the
first
drug
approval
for
a
prevalent
chronic
condition
and
a
novel
regenerative
medicine
approach
to
help
trauma
patients.
In
one
case,
a
new
drug
approval
comes
as
its
developer
takes
on
a
new
identity
in
the
new
year.

Here’s
a
look
back
at
some
highlights
from
a
busy
regulatory
month:


Notable
Firsts


—The
prevalent
sleeping
disorder
obstructive
sleep
apnea
has
historically
been
managed
with
a
medical
device
that
helps
breathing.

Eli
Lilly’s
Zepbound
is
now
the
first
FDA-approved
drug
treatment
for
the
chronic
condition
.

Obesity
is
a
risk
factor
for
sleep
apnea
and
clinical
trial
results
showed
that
weight
reductions
from
treatment
with
Zepbound
were
accompanied
by
breathing
improvement.
Approval
in
obstructive
sleep
apnea
adds
another
potential
blockbuster
indication
for
a
metabolic
medication
that
has
fast
become
one
of
Lilly’s
top-selling
products.


—Patients
who
have
the
rare
inherited
metabolic
disorder
familial
chylomicronemia
syndrome
lack
the
ability
to
break
down
triglycerides,
a
type
of
fat
from
food.

The
only
way
to
avoid
potentially
fatal
complications
to
the
pancreas
is
by
maintaining
an
extremely
restrictive
diet.

Approval
of
Ionis
Pharmaceuticals’
olezarsen

gives
patients
a
therapeutic
option.
The
once-monthly
injected
genetic
medicine,
which
is
designed
to
block
the
body’s
production
of
a
liver
protein
that
regulates
triglyceride
metabolism,
will
be
marketed
under
the
brand
name
Tryngolza.
Ionis
previously
brought
drugs
through
late-stage
development
and
commercialization
under
partnerships
with
larger
companies.

Tryngolza
will
be
the
first
product
Ionis
commercializes
on
its
own
.


—When
trauma
to
an
arm
or
leg
requires
replacement
of
a
blood
vessel,
the
standard
treatment
is
grafting
a
vein
from
the
patient
or
implanting
a
synthetic
vein.
Now
there’s
a
new
regenerative
medicine
option.

Humacyte
won

FDA
approval
for
Symvess
,
a
bioengineered
blood
vessel
for
restoring
blood
flow
to
avoid
the
loss
of
a
limb
when
grafting
a
vein
from
the
patient
is
not
feasible.

Here’s
more
about
the
biotech’s
regenerative
technology
.


—Mesoblast’s
regulatory
approval
was
a
long
time
coming.
In
2020
and
2023,
the
FDA
turned
down
the
Australian
company’s
application
for
remestemcel,
an
allogeneic
cell
therapy
for
graft
versus
host
disease,
an
immune
response

that
develops
when
donor
T
cells
attack
the
recipient’s
cells
following
a
transplant
procedure.
Remestemcel,
brand
name
Ryoncil,
is
made
from
mesenchymal
stromal
cells
sourced
from
the
bone
marrow
of
healthy
donors.
The

product’s
approval

covers
acute
graft
versus
host
disease
that
is
refractory
to
treatment
with
steroids
in
patients
age
2
months
and
older.
It’s
the
first
affirmative
regulatory
decision
for
a
cell
therapy
made
from
mesenchymal
stromal
cells.


Approvals
in
Immunology


—Vtama,
an
Organon
drug

acquired
from
Roivant
Sciences
earlier
this
year
,
received
FDA
approval
as
a

treatment
for
atopic
dermatitis

in
adults
and
children
age
2
and
older.

The
drug
is
topical
cream
that
was

initially
approved
in
2022
as
a
treatment
for
plaque
psoriasis
.
Approval
in
atopic
dermatitis
brings
the
product
to
a
much
larger
dermatologic
indication,
albeit
one
served
by
many
branded
and
generic
medications.


—In
other
atopic
dermatitis
news,
Galderma
landed
FDA

approval
for
nemolizumab
,
brand
name
Nemluvio.

The
drug
is
an
antibody
designed
to
block
IL-31,
a
signaling
protein
associated
with
the
itch
and
inflammation
of
the
chronic
skin
disorder.
FDA
approval
of
Nemluvio
covers
use
of
the
drug
in
patients
age
12
and
older
who
have
moderate-to-severe
atopic
dermatitis.
It’s
the
second
approval
in
the
past
year
for
Nemluvio,
which
was
first
approved
over
the
summer
as
a
treatment
for
prurigo
nodularis.


Rare
Disease
Regulatory
Decisions


Neurocrine
Biosciences
received
approval
for
Crenessity
,
a
treatment
for
the
rare
inherited
hormone
disorder
congenital
adrenal
hyperplasia.

The
small
molecule
helps
bring
the
hormone
imbalance
back
to
more
normal
levels.
The
FDA
approved
a
pill
formulation
for
adults
and
an
oral
solution
for
pediatric
patients.
Analysts
project
Crenessity
could
achieve
blockbuster
sales,
pending
regulatory
approvals
in
other
countries.


—Novo
Nordisk
is
best
known
for
metabolic
medicines,
but
its
rare
disease
portfolio
is
getting
a
boost
with

FDA
approval
of
Alhemo
,
a
drug
that
reduces
bleeding
episodes
in
patients
with
either
hemophilia
A
or
B.

Alhemo,
known
in
development
as
concizumab,
is
an
antibody
designed
to
bind
to
TFPI,
preventing
that
protein
from
blocking
factor
Xa,
a
different
protein
that
plays
a
role
in
blood
clotting.
That’s
the
same
mechanism
of
action
as
Pfizer’s
Hympavzi,
which
won
its
FDA

approval
in
October
.

Both
drugs
are
subcutaneous
injections
that
provide
alternatives
to
intravenously
infused
hemophilia
therapies.
But
Pfizer’s
once-weekly
Hmypavzi
has
a
dosing
edge
over
Alhemo,
which
must
be
injected
once
daily.


—Vertex
Pharmaceuticals
is
adding
a
new
cystic
fibrosis
(CF)
drug
to
its
portfolio
with

FDA
approval
of
Alyftrek
,
which
combines
three
compounds
in
a
single
therapy.

Like
Vertex’s
other
CF
therapies,
Alyftrek
is
a
modulator
of
the
CFTR
a
protein
that
regulates
the
movement
of
chloride
ions
into
and
out
of
cells.

Alyftrek’s
approval
is
based
on
clinical
data
comparing
the
once-daily
therapy
to
Trikafta,
a
Vertex
triple
combination
drug
initially
approved
in
2019
as
a
twice-daily
CF
treatment.
Results
showed
Alyftrek
was
non-inferior
to
Trikafta
on
a
key
measure
of
lung
function
and
was
superior
in
reducing
sweat
chloride
levels,
which
is
a
surrogate
indicator
of
the
function
of
CFTR
proteins.
Besides
the
dosing
advantage,
Alyftrek
addresses
31
additional
mutations
that
are
not
addressable
by
other
CFTR
modulators.
The
Dec.
20
approval
of
Alyftrek
came
nearly
two
weeks
ahead
of
the
Jan.
2
target
date
for
a
regulatory
decision.


Developments
in
Cancer
Drugs


—The
FDA
awarded

accelerated
approval

to
Merus
Therapeutics
drug
zenacutuzumab
as
a
treatment
for
advanced
cases
of
two
types
of
cancer:
non-small
cell
lung
cancer
and
pancreatic
adenocarcinoma.

It’s
the
first
approval
for
a
drug
that
addresses
a
genetic
signature
called
an
NRG1
gene
fusion.
Netherlands-based
Merus
will
market
the
bispecific
antibody
under
the
brand
name
Bizengri.
In
a
deal
struck
days
prior
to
the
approval
announcement,
Partner
Therapeutics

licensed

U.S.
commercialization
rights
to
Bizengri.


—The
blockbuster
AstraZeneca
drug
Imfinzi

expanded
its
FDA-approved
uses

to
include
limited-stage
small
cell
lung
cancer
that
has
not
progressed
following
concurrent
platinum-based
chemotherapy
and
radiation
therapy.

The
checkpoint
inhibitor
was
first
approved
in
2017
for
bladder
cancer
and
added
extensive-stage
lung
cancer
as
a
new
indication
in
2020.
The
drug’s
latest
approval
is
based
on
Phase
3
results
showing
a
27%
reduction
in
the
risk
of
death
compared
to
a
placebo.

AstraZeneca
said

the
FDA
decision
makes
Imfinzi
the
first
immunotherapy
approved
for
limited-stage
small
cell
lung
cancer.


—Xcovery
Holdings
drug
ensartinib,
brand
name
Ensacove,
was

approved

to
treat
adults
with
advanced
cases
of
non-small
cell
lung
cancer
that
is
positive
for
ALK
mutations.

Patients
prescribed
the
once-daily
pill
must
not
have
previously
received
an
ALK
inhibitor.


—Pfizer
cancer
drug
Braftovi
landed

accelerated
approval

as
a
first-line
treatment
for
metastatic
colorectal
cancer
driven
by
the
BRAF
V600E
mutation.

The
approval
covers
use
of
the
drug
in
combination
with
Eli
Lilly’s
Erbitux
and
the
chemotherapy
regimen
referred
to
as
FOLFOX,
both
standard
colorectal
cancer
therapies.
Braftovi,
a
small
molecule
inhibitor
of
BRAF
V600E,
was

initially
approved
in
2018

for
advanced
cases
of
melanoma.
The
drug
came
from

Pfizer’s
2019
acquisition

of
Array
Biopharma.


—Tevimbra,
a
cancer
immunotherapy
developed
by
BeiGene,

received
FDA
approval

as
a
first-line
treatment
for
gastric
and
gastroesophageal
junction
cancers
when
used
in
combination
with
chemotherapy.

It’s
the
second
FDA
approval
for
the
checkpoint
inhibitor,
which
was

approved
last
March

for
treating
advanced
or
metastatic
esophageal
squamous
cell
carcinoma
after
prior
treatment
with
chemotherapy.

The
new
year
means
a

new
identity
for
BeiGene
.
The
cancer
drug
developer
is
changing
its
name
to
BeOne
Medicines.
Starting
Jan.
2,
the
company’s
stock
symbol
on
the
Nasdaq
will
be
“ONC.”


Rejections,
Warnings
&
More
Bad
News
in
Biotech


—Astellas
Pharma’s
bid
to
bring
patients
less-frequent
eye
injections
of
its
drug
Izervay
was

rejected

by
the
FDA.


Izervay,
approved
for
treating
geographic
atrophy
in
2023
,
is
administered
monthly
to
slow
progression
of
the
vision-loss
disorder.
Astellas
sought
approval
for
every-other-month
dosing
based
on
two-year
Phase
3
data.
According
to
Astellas,
no
safety
benefit/risk
issues
were
cited
but
the
FDA
took
issue
with
a
statistical
matter
related
to
labeling
language
proposed
by
the
company.
The
rejection
will
limit
Izervay’s
ability
to
compete
against

Apellis
Pharmaceuticals’
geographic
atrophy
drug
Syfovre,
which
is
approved
for
both
monthly
and
every-other-month
dosing
.


—In
other
Astellas
news,
the
label
for
menopause
drug
Veozah
now
sports
a

black
box
warning

for
the
risk
of
serious
liver
injury.

The
warning
follows
a
FDA
safety
communication
issued
in
September
after
a
postmarketing
report
of
a
patient
who
developed
signs
and
symptoms
of
liver
injury
after
taking
the
once-daily
pill
for
about
40
days.

Veozah
won
FDA
approval
in
2023
as
the
first
in
a
new
class
of
therapies
for
menopause
.


—Applied
Therapeutics
received
a
double
dose
of
bad
regulatory
news.
First
the

FDA
rejected
the
biotech’s
application
for
govorestat
,
a
drug
developed
as
a
treatment
for
the
rare
metabolic
disease
galactosemia.

According
to
Applied,
the
agency
cited
“deficiencies
in
the
clinical
application.”

Days
after
the
FDA
complete
response
letter,
the
FDA
sent
Applied
a

warning
letter.

The
trial
and
the
drug
are
redacted
in
the
public
version
of
the
letter,
but
in
a

regulatory
filing
,
Applied
acknowledged
the
FDA’s
concerns
are
about
the
govorestat
galactosemia
trial.
Applied
said
the
warning
letter
identified
issues
with
electronic
data
capture
and
a
dosing
error
in
the
dose-escalation
portion
of
the
study

both
of
which
the
company
believed
it
had
already
addressed
with
the
agency.
Applied
said
it
would
respond
to
the
FDA
warning
letter.


—Bad
news
keeps
stacking
up
for
Intercept
Pharmaceuticals
and
its
drug,
Ocaliva,
a
treatment
for
the
rare
liver
disease
primary
biliary
cholangitis
(PBC).

On
Dec.
12,
the
FDA

issued
a
safety
alert
,
warning
of
the
risk
of
serious
liver
injury
in
patients
without
advanced
liver
cirrhosis.
The
alert
came
one
month
after
the

FDA
turned
down

Intercept’s
application
seeking
full
approval
for
Ocaliva,
which
won
its
accelerated
approval
in
PBC
in
2016.
The
FDA’s
rejection
letter
for
the
drug
cited
safety
concerns.
When
Ocaliva
first
reached
the
market,
it
was
the
only
FDA-approved
second-line
treatment
for
PBC.
In
the
past
year,

drugs
from
Ipsen

and

Gilead
Sciences
have
each
won
accelerated
approvals
as
new
second-line
therapies

for
the
rare
disease.

Two
weeks
after
the
FDA
turned
down
full
approval
of
Ocaliva,
the
European
Commission

revoked

the
conditional
marketing
authorization
for
the
drug.
Advanz
Pharma
holds
rights
to
Ocaliva
in
Europe.
The
company
said
the
commission
decision
is
subject
to
an
ongoing
annulment
procedure
in
the
EU’s
General
Court
and
a
ruling
is
expected
in
2025.


—The
FDA

turned
down

Zealand
Pharma’s
glepaglutide
as
a
treatment
for
short
bowel
syndrome,
a
rare
disorder
that
develops
when
the
small
intestine
is
damaged
or
shortened,
making
it
difficult
for
the
organ
to
absorb
nutrients.

The
drug
is
a
long-acting
GLP-2
analog
intended
to
enhance
the
intestine’s
ability
to
absorb
nutrients,
reducing
patients’
dependence
on
intravenous
feeding.
According
to
Zealand,
the
FDA
said
the
application
needed
more
evidence
of
efficacy
and
safety.
The
company
said
it
would
discuss
the
letter
with
the
FDA
and
proceed
with
plans
to
seek
European
approval
in
2025.


—Lexicon
Pharmaceuticals
came
up
short
in
its
bid
to
expand
approval
of
its
drug,
sotagliflozin
(brand
name
Zynquista),
to
include
the
treatment
of
adults
with
type
1
diabetes
and
chronic
kidney
disease.

The
FDA’s

Dec.
20
rejection

of
the
drug
followed
a

negative
FDA
advisory
committee
vote

in
October.
The

FDA
approved
sotagliflozin
last
year
as
a
treatment
for
heart
failure
;
it’s
marketed
in
this
indication
under
the
brand
name
Inpefa.


—Johnson
&
Johnson
received
a

complete
response
letter

for
its
injectable
version
of
Rybrevant,
a
drug
that
treats
cancer
driven
by
EGFR
mutations.

Intravenously
infused
Rybrevant
was
approved
in
2021
as
a
treatment
for
non-small
cell
lung
cancer.
The
injectable
version
is
made
with
technology
from
Halozyme.
J&J
said
the
FDA
letter
flagged
manufacturing
issues
and
did
not
cite
any
concerns
about
the
new
formulation
or
its
safety
and
efficacy.


Photo:
Sarah
Silbiger,
Getty
Images