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One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.
A $5B Pfizer buyout?
Pfizer
CEO
Albert Bourla
has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down. Rumor has it (or rather, the
Wall Street Journal
reported) that Pfizer
is in the final stages of acquiring
Global Blood Therapeutics
for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.
M&A Thursday
On the same day
Amgen
CEO
Bob Bradway
bellied up to the M&A table to scoop up the newly anointed commercial biotech
ChemoCentryx
and its recently approved rare disease drug
for $3.7 billion
out of the cash stockpile,
Gilead
engineered its own buyout to cushion its immune checkpoint pipeline. The
$405 million deal
for
MiroBio
adds an antibody discovery platform for potential treatments of inflammatory diseases.
Alnylam’s ATTR sweep
In a landmark win,
Alnylam
laid claim to a major success
in Phase III, with its RNAi drug
patisiran
hitting the primary endpoint in its APOLLO-B study for ATTR amyloidosis with cardiomyopathy. One of the most important pivotal trials to read out this year, the study results sent Alnylam’s shares soaring as it celebrates a topline hit with the 6-Minute Walk Test. And that sets the stage for a quick march to the FDA in search of a 2023 market launch.
Andrew Lo’s rare disease quest
A decade ago,
Andrew Lo
desperately sought out a therapy for his mother’s lung cancer that had developed resistance to existing drugs. What he learned in that process set him on a quest to change the way rare disease drugs are developed and paid for. Now, the MIT finance professor’s proposals are rippling through biotech and getting tested in the real world. Jared Whitlock’s profile
takes us deeper into his story
.
The search for male contraceptives
Years ago, Big Pharma abandoned male contraceptive development, putting to bed one clinical-stage hormonal contraceptive, laying off teams and evaporating a library of a couple of hundred possible targets. A new crop of startups has emerged to build up the field — despite a dearth of industry support — to launch multiple clinical trials in the coming years to convince funders and regulators that they can halt sperm from reaching the egg. And the overturning of Roe v. Wade is
shedding more light
on their quest, Kyle LaHucik reports.
PREMIUM
Regeneron plots I/O move
Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.
Regeneron
chief scientist
George Yancopoulos
and CEO
Len Schleifer
used the Q2 call to
spotlight their early success
with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody
REGN5678
in combination with their PD-1 checkpoint
Libtayo
, which is now fully theirs after regaining rights from
Sanofi
.
Granfluencers take up room in pharma
Cathy Chester’s
latest Instagram post is about her experience being pregnant while having multiple sclerosis — in 1992. Chester is one of the faces of a new generation of older social influencers building big audiences and communities online. Often called
Granfluencers or Boomfluencers
— the 55+ group of aging adults with major sway include fashionistas, relationship advice gurus, fitness buffs and much more — they’ve become health condition leading voices like Chester, Beth Bulik writes.
Q2 EARNINGS
“Chilling,” “onerous” and “historic mistake”: These were some of the words on tape as Big Pharma CEO took their turns during Q2 calls with analysts
blasting the Senate Democrats’ drug pricing reform
. According to them, enabling Medicare negotiations would stymie innovation — although some were willing to acknowledge that reform is needed.
As
Moderna
prepares two bivalent variant-specific Covid-19 boosters for delivery in the fall and looks into a potential monkeypox program, CEO
Stéphane Bancel
stressed on the Q2 call
that “now is not the time to slow down.” For now, the company expects public health authorities to be the key purchasers — although it’s also looking at potential private commercial markets.
Eli Lilly
had some
dreary Q2 numbers
to report. According to Lilly, that was due to both lower prices for some products — insulin was the standout — as well as a foreign exchange hit as a strong dollar bites and a drop of 13% on Covid-19 revenue. Looking ahead at drug pricing reforms, CEO
David Ricks
warns it could force his company to move away from small molecule research and focus on other areas.
Speaking with analysts after his shiny new acquisition,
Amgen
CEO
Bob Bradway
added his voice to the chorus of pharma CEOs lamenting the pending drug pricing legislation but didn’t linger for long. Rather, he wanted to talk about the
“exciting” additions
to the autoimmune/inflammatory pipeline and upcoming biosimilar launches.
Forget buyer’s remorse,
Pfizer
is likely feeling pretty good about its $11.6 billion
Biohaven
takeover deal following reports of a
57% sales boost
for migraine med
Nurtec
. Biohaven also reported in Q2 results that it’s cleared the necessary antitrust hurdles to move forward with the sale of its CGRP programs assets to Pfizer.
Bayer
CEO
Werner Baumann
highlighted
“strong operational performance”
while raising the full-year guidance. But before diving into the details, he summarized Bayer’s plan to settle a slate of ongoing litigation relating to the active ingredient of its weedkiller
Roundup
, expressing confidence that the major cases will soon be behind it.
With production finally up and running for its weight loss drug
Wegovy
,
Novo Nordisk
said it plans to
make all dose strengths available
in the US by the end of the year. However, CEO
Lars Fruergaard Jørgensen
also noted “a bit lower ramp-up versus planned” as it gets back on track following a shortage stemming from issues with a contract manufacturer.
Boehringer Ingelheim’s
pharma division sales led company earnings for the first half of 2022,
notching a sales increase of almost 12%
, with the diabetes brand
Jardiance
leading the way at €2.5 billion and idiopathic pulmonary fibrosis drug
Ofev
coming at €1.5 billion in the first half. Thanks to expansions into the cardiovascular space, Jardiance’s sales jumped by more than 74% compared to the first half of 2021 sales.
Gilead
CEO
Dan O’Day
uncorked some solid Q2 results
, touting a surge in
Yescarta
and
Trodelvy
sales and an uptick in demand for HIV med
Biktarvy
, despite sinking sales of the Covid-19 antiviral
Veklury
. Commenting on the $2.7 billion impairment charge they put on Trodelvy, execs said they took a “conservative approach” and will review the value later.
One of
Horizon Therapeutics’
top sellers isn’t performing as well as expected, CEO
Tim Walbert
revealed on his Q2 call
, leading the pharma company to switch up its strategy. Walbert told investors that getting the thyroid eye disease drug
Tepezza
and its representatives into ophthalmologists’ and endocrinologists’ offices is of utmost importance.
STARTUPS
Alexis Borisy
and
Ben Auspitz
want to be intelligent with their latest biotech, not “stupid.” That’s in the words of Borisy, the repeat biotech entrepreneur behind the likes of
Blueprint Medicines
and
EQRx
. The duo wants to bring together “intelligently designed” cancer drugs, hence their startup’s name:
IDRx
. With
$122 million in hand
, their first program will be a combo of two compounds from
Merck KGaA
and
Blueprint
.
Five years after forming and with more than $100 million from marquee backers, a biotech from
BeiGene
co-founder
Xiaodong Wang
is back with another whopping investment,
this time at $200 million
.
Sironax
said the new funds will bankroll studies of drugs for age-related degenerative diseases, including two RIPK1 inhibitors already in the clinic.
Looking to apply plant-based supply to the manufacturing of cell therapies, French biotech
Core Biogenesis
secured
$10.5 million in a Series A
to push its tech forward. The company uses camelina, otherwise known as wild flax traditionally used in gastronomy, to manufacture proteins from the seeds of the plant.
DEALS
Taking its next big step into the allogeneic CAR-T field,
Roche
is tying up alongside
Poseida Therapeutics
with $220 million in upfront and quick cash in a trademark oncology alliance that comes with a mother lode of milestones. The deal offers the pharma giant dibs on a slate of off-the-shelf CAR-Ts for hematologic malignancies, including a BCMA drug for multiple myeloma.
Meanwhile,
Genentech
is spinning its own deal to jump into fibrosis with a program from
Kiniksa
. Genentech
shelled out $80 million
in upfront cash and another $20 million in near-term payments to license Kiniksa’s
vixarelimab
, formerly known as
KPL-716
, and shepherd it into new clinical studies.
Sanofi
found a high-profile partner
in China to take two of its top cancer drug prospects through the clinic and onto the big Asian market:
Innovent
. Paris-based Sanofi spotlighted a deal with Innovent to acquire €300 million in the Chinese pharma’s shares, at a 20% markup, with an option on €300 million more at a later date. The drugs involved are an antibody-drug conjugate targeting CEACAM5 and a mid-stage IL-2 therapy.
Ipsen
continued its dealmaking ways to kick off the new month, shelling out a handsome
$45 million upfront
to
Marengo
Therapeutics
, a TCR upstart led by former
Merck KGaA
cancer chief
Zhen
Su
. The deal involves two experimental drugs out of Marengo’s bispecific antibody platform. And the payoff could be huge.
It took a couple of extra months to get all the regulatory sign-offs, but
CSL
said it’s lined up all the necessary approvals to get its $11.7 billion
Vifor
buyout done
. Once the M&A deal is complete, current Vifor commercial chief
Hervé Gisserot
will move up to the general manager’s role at the sub and report to CSL COO
Paul
McKenzie
.
Watertown, MA-based
Forma Therapeutics
has long made it clear that
olutasidenib
, its oral inhibitor of mutant isocitrate dehydrogenase 1, is a non-core program. So perhaps it’s little surprise that right as the FDA accepts its NDA, Forma’s licensing the drug to
Rigel Pharmaceuticals
in a
$235 million deal
.
Having turned to layoffs earlier this year to tighten its financial belt, microcap biotech
Avalo Therapeutics
added some much-needed cash to the bank. The Rockville, MD-based biotech is selling
AVTX-007
, the IL-18 antibody originally from
AstraZeneca’s
now-defunct
MedImmune
, to the UK’s
Apollo
Therapeutics
, for
$15 million upfront
and $74 million in milestones.
AbbVie
has got more work for
Sosei
Heptares
. A year and a half after breaking off a legacy
Allergan
pact involving a slate of Sosei neurology candidates, AbbVie
drew up a whole slew
of neuro targets it wants to direct Sosei’s G protein-coupled receptor expertise and structure-based drug design savviness toward. The heavily back-ended deal starts with a $40 million upfront.
R&D
Four years after promising early data in head and neck cancer drew
AstraZeneca
to a big-money deal with
Innate Pharma
around its next-generation checkpoint inhibitor
monalizumab
, disappointing Phase III results pushed AstraZeneca to shutter a study. The drug
flunked a futility interim analysis
. The partners, though, will keep testing it in lung cancer.
In the first few days of 2020,
Incyte
reported that its
JAK1 inhibitor failed
a Phase III study in first-line, acute graft vs host disease, triggering a stock meltdown. This time around, Incyte isn’t even completing a study of the drug, known as
itacitinib
, because efficacy data from part of a Phase II/III study give the biopharma no signs of hope for a pivotal success in treatment-naïve chronic GVHD.
While
Pfizer’s
$11.4 billion acquisition of
Array BioPharma
in the summer of 2019 was mainly focused on oncology, namely
Braftovi
and
Mektovi
, there were a few non-cancer assets, including a Phase III drug being tested in a rare cardiovascular disease. That late-stage trial
is now being axed
, alongside any further development of the oral small molecule, following an interim futility analysis.
Amgen
is
taking its foot off the pedal
just a few weeks after beginning a late-stage trial of a
Kyowa Kirin
drug for which it dished out $400 million last year in exchange for ex-Japan rights, pausing a Phase III trial to look at new doses. At the same time, it also swept a
BCMA BiTE out of the pipeline
in a cleanup, while dropping a PSMA candidate in favor of another.
While
Neurocrine Biosciences
continues to grow the sales of its tardive dyskinesia drug for patients who experience uncommon side effects from mental health drugs, it is
giving up on an essential tremor drug
that failed a Phase II study. Citing “negative” topline efficacy results, the company won’t study the indication any further — although an epilepsy study is ongoing.
As
Pieris Pharmaceuticals
favors an
AstraZeneca
-partnered program in asthma, and because the mid-stage study is taking longer than expected, the biotech is
deciding to end work
on a HER2 drug. Despite a couple of clinical partnerships, the biotech decided to stop testing
cinrebafusp alfa
(
PRS-343
) in gastric cancer.
Less than six months into his journey as CEO at
Voyager
,
Al Sandrock
is narrowing the focus
, concentrating on CNS diseases that were the hallmark of his time leading R&D at
Biogen
, including an emphasis on a familial form of ALS, Alzheimer’s disease and Parkinson’s disease. For the rest, the biotech will explore potential deals.
When you’ve got an alliance as hefty as the one
Arcus
and
Gilead
have, every update counts. That’s why the companies found analysts frowning on the latest disclosure around
quemliclustat
, their small molecule inhibitor of CD73, suggesting a triplet combo looked similar to chemotherapy alone and they will need to
wait for “more mature” survival data
. Analysts didn’t hide their disappointment.
In April,
Eliem Therapeutics’
lead candidate,
ETX-810
, failed a Phase II study for diabetic nerve pain, buckling the Seattle-based biotech’s stock by over half. Now, another shot with the drug — a second Phase II trial for a form of back pain —
also failed
. The company did not sugarcoat the news, saying it will drop the drug altogether.
Little
Kazia Therapeutics
hit a major hurdle developing the
Genentech
castoff paxalisib for glioblastoma. In a platform trial organized by the Global Coalition for Adaptive Research, the PI3K inhibitor
failed to meet pre-defined criteria
for continuing to a second stage — upending Kazia’s regulatory plans, especially in China.
Ipsen’s
grand plan to open up new markets for the cancer drug
Onivyde
hit a snag as its Phase III trial testing the therapy in small cell lung cancer
failed the primary endpoint
on overall survival, casting a shadow on its regulatory prospects. But Ipsen isn’t giving up on the drug, which it paid top dollar to license from
Merrimack
, and other trials are still ongoing.
The US-Danish biotech
Allarity Therapeutics
is having to pivot its pipeline strategy after the FDA
forced it to go back
to the drawing board for an oncology therapy. For the company, the agency’s request for a new dosing study means its former lead drug is no longer commercially viable. It will now refocus its strategy around combination therapies.
What happens if you try a second time and again don’t succeed?
Travere Therapeutics
will be asking itself that question after a second attempt to gun for accelerated approval
was rejected by the FDA
. The former
Martin Shkreli
biotech had attempted to push through its lead drug,
sparsentan
, to a speedy OK in a rare kidney disease, but regulators prefer the more methodical, full approval route.
Concert Pharmaceuticals
now has the final batch of Phase III data it needs to take its hair loss drug to the FDA. After selling off the bulk of its pipeline, the biotech unveiled topline results from its second pivotal trial of
CTP-543
in adult patients with moderate to severe alopecia areata suggesting the JAK1/JAK2 inhibitor
could reduce alopecia severity
.
Last week,
Otonomy
thought it was headed toward a Phase III trial in the first half of next year for its drug to reduce ringing and buzzing in the ear. But “unexpected” results showing its
OTO-313
did not beat placebo
in the condition known as tinnitus is forcing it to switch course, axing the program and shifting priorities to the only other clinical-stage asset in its pipeline.
PEOPLE
In the aftermath of a series of FDA clinical holds,
David Hung’s Nuvation Bio
decided to discontinue
development on one of its early-stage clinical programs that was the subject of the hold. The CDK inhibitor was linked to cases of inflammation in the eye. On top of this, Nuvation plans to lay off 30 employees, representing about 35% of its workforce.
Nearly two years after his arrest as part of a smuggling investigation,
Frank Zhang
is back in the game. Zhang, the founder and former CEO of
GenScript
Biotech
,
has been appointed
as a director of
Legend
Biotech
, the CAR-T specialist still majority owned by GenScript. Charges against Zhang were dropped earlier this year, when he also returned to a non-executive director role at GenScript.
Navigating the choppy biotech waters after raising a modest IPO last year,
Evaxion
Biotech
, a Danish startup that uses AI to develop personalized immuno-oncology therapies, is shaking up its C-suite.
Lars Staal Wegner
has decided to exit
as the company’s CEO.
Per
Norlén
, who has over 20 years in the industry, will take over as the new chief in six months.
CELL & GENE TX
The FDA
slapped a hold
on
Beam Therapeutics’
preclinical off-the-shelf CAR-T therapy, staving off its application to begin clinical trials in patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoma. Beam, a pioneer in base editing co-founded by
David
Liu
, has yet to provide any insight into the reason behind the hold.
Gene therapy biotech
MeiraGTx
is looking to get some quick cash and is putting up its manufacturing facilities to do it. In an unusual arrangement, the company clinched a loan with affiliates of
Perceptive Advisors
for up to $100 million
. The money should extend the company’s cash runway for the next two years and into Q4 of 2024.
David Hallal’s ElevateBio
is launching a new company
with Boston Children’s Hospital featuring research from
George
Daley
, the dean of Harvard Medical School. Other than the fact that they’re working on off-the-shelf cell therapies, Hallal is keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.
As the cell therapy field matures, two CDMOs
are coming together in a merger
to expand their reach.
Lykan
Bioscience
, based in Massachusetts, and
RoslinCT
, based in Edinburgh, UK, will become a single advanced therapies CDMO offering process development expertise as well as cGMP manufacturing for a broad range of autologous and allogeneic cell therapies.
FINANCING
As the former global brand leader of
Merck’s
antifungal business,
Francesco Maria Lavino
knows his facts: There are only three classes of antifungals. But
F2G
, the biotech where he’s now CEO, is confident that it can soon bring a fourth antifungal class to the market. And it’s
closed $70 million
in new financing to get there.
Amid a bear market, public companies have raced to investors primarily only after showing impressive clinical data or reaching other prominent milestones.
Arcutis Biotherapeutics
followed that path: Days after the FDA approved its psoriasis drug, the company looked to
raise $150 million
in a public offering.
The leaders of
Blue Water Vaccines
are joining the wave of blank check operators ditching plans to dock their boat on Wall Street. While the Blue Water duo of
Joseph Hernandez
and
Jon Garfield
was successful in getting their first SPAC to merge with a biotech, they have
decided to back out
of the SPAC market, following the suit of many others.
CORONAVIRUS
Regeneron
terminated four studies
of its monoclonal antibody combination, known as
REGEN-COV
, months after the FDA halted use of the drug for which the federal government had doled out billions of dollars. As the EUA was rolled back and a BLA review has gone beyond the extended decision date.
As Covid-19 cases mount once again and millions of people experience lingering symptoms months after diagnosis,
Axcella Therapeutics
wants to treat long Covid, but like others in the past, it
failed to meet the primary goal
of a mid-stage study. The biotech isn’t giving up on the pandemic disease’s long-term effects, though, and will attempt to persuade regulators in the US and UK with fatigue scores from the Phase IIa in discussions about a pivotal trial.
For as long as it’s existed,
Akebia
has always billed itself as a kidney disease specialist. But as it grapples with a costly FDA rejection of its lead anemia drug, the biotech is doing
whatever it can to stay afloat
— and that could mean holding onto the drug’s potential in treating acute respiratory distress syndrome even after failing a trial.
It was late last year when the biotech
GreenLight Biosciences
inked a deal with CDMO giant
Samsung Biologics
to manufacture its mRNA Covid-19 vaccine. Now that Samsung completed the first commercial-scale engineering run for GreenLight’s Covid-19 vaccine booster candidate, GreenLight
took the occasion to celebrate
and tout its mRNA platform.
PHARMA
Roche
is looking to score a class win in the hypercompetitive PD-(L)1 field. The pharma giant
put out word
that its subcutaneous version of
Tecentriq
looked equivalent to the IV in a pivotal pharmacokinetic study, putting the company on track to jump ahead with an easier-to-administer formulation that could prove distinctly attractive to patients.
A week after advocates called upon
ViiV Healthcare
to lower the price of its long-acting HIV injectable
Apretude
, the company struck a deal with the Medicines Patent Pool to make the drug
more accessible
in low- and middle-income countries. The licensing agreement will allow generic manufacturers in 90 countries to develop, manufacture and supply their own versions of Apretude, pending approval.
Marking some setbacks in its grand plans around the PD-1 cash cow,
Merck
reported
Keytruda
has missed two indications
— as a first-line therapy in combination with
Eisai’s Lenvima
for liver cancer, and also as a later-line treatment for metastatic prostate cancer. The drug brought in $5 billion in the last quarter.
Nearly a decade after
J&J’s Stelara
was approved to treat adults with psoriatic arthritis, the pharma giant is
expanding the label
to include the small percentage of children who suffer from the autoimmune disease. Because of a limited availability to pediatric PsA patients, regulators based their approval on safety and efficacy data extrapolated from multiple Phase III studies in adult and pediatric patients with plaque psoriasis and PsA.
LAW
Prosecutors
lost an appeal
to lengthen the sentences of two former
GSK
scientists who pleaded guilty to stealing trade secrets. While they sought to put the researchers behind bars for years, the court stuck with the original sentence because their new company never profited off the stolen information and prosecution didn’t prove they intended to harm GSK.
In a case brought by welfare-benefit plans, a federal appeals court ruled in
AbbVie’s
favor, upholding an Illinois court’s decision to dismiss allegations that the pharma giant created an unlawful “patent thicket” around its blockbuster drug
Humira
. “But what’s wrong with having lots of patents?” the judge
wrote in his opinion
.
Less than a week after Teva inked a $4.25 billion deal to settle opioid-related litigation in several states, many of the same states are now touting a similar deal with
AbbVie
. AbbVie’s
Allergan
unit agreed to pay
up to $2.37 billion
(including settlements already reached with individual states) to state and local governments affected by the opioid crisis.
Bausch Health
will continue litigating over
Xifaxan
, the antibiotic used to treat irritable bowel syndrome with diarrhea and one other condition, threatening to appeal all the way up to the US Court of Appeals for the Federal Circuit. Going up against
Norwich
— now part of generics maker
Alvogen
— Bausch and its
Salix
unit are looking to retain the patent.
MARKETINGRX
Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.
OptimizeRx
is hooking up with
Cooler Screens
media company to bring prescription drug advertising to refrigerator front doors at pharmacies including
Walgreens
,
CVS
and
Kroger
.
Add seniors’ advocate
AARP
to the list of groups
pushing hard
for proposed drug pricing legislation. The group’s most recent targeted TV ad campaign pushes congressional representatives to act. Its specific focus? “Put money back in the pockets of seniors” through the part of the bill that would allow Medicare to negotiate drug prices.
Bristol Myers Squibb’s
latest multiple sclerosis initiative is going to work — literally. Its
new “MS Work Space” program
targets employers with a suite of online education and advice to help them support patients with MS. Companies can use the website to tap the resources and can get even more help or information from BMS.
Biogen’s
short film about spinal muscular atrophy talks about the
behind-the-scenes care
given to SMA patients. The “Invisibles” work, created by
VMLY&R Health
Spain
, was launched earlier this summer to raise awareness about SMA in general as efforts to add newborn screening for SMA across Europe are increasing.
A new study from Biohaven and the American Migraine Foundation is linking migraine to mental health; Eyecare brand
Bausch
+ Lomb
is asking people to dance with their eyes in a new TikTok challenge for its
Lumify OTC
brand to treat eye redness; Kaiser Health and Politico disputed claims in a new political ad about drug pricing legislation; and other snippets await in this week’s
MarketingRx roundup
.
FDA+
Will a trio of new bosses at the FDA — a new agency commissioner, head of CDER and head of OPDP — lead to an increase in drug advertising enforcement? With few letters sent out so far, there’s just
not enough information to tell
, says one longtime FDA regulatory watchdog who doesn’t see the administration leaning one way or another yet.
Despite winning an approval back in 2016,
Acadia’s Nuplazid
has not had the easiest of paths in its journey to expand into new areas. It just
hit another roadblock
as the FDA rejected Acadia’s application to expand Nuplazid use into Alzheimer’s-related psychosis. In the rejection letter, the FDA also recommended that Acadia conduct an additional trial in ADP.
Four months ago, the FDA placed a clinical hold on
Celyad’s
CAR-T trial for colorectal cancer after two patients died during the study. Regulators
have now lifted the hold
, allowing the Belgian company’s trial to set sail once again. Celyad was testing its therapy in combination with
Merck’s Keytruda
and noted that both patients “presented with similar pulmonary findings.”
In a
new guidance
surrounding changes regarding disposable materials, the FDA stated that any changes to disposable materials used primarily in drug and biological product manufacturing, including at contract manufacturing sites, must “be available upon request during an FDA inspection.”
Move over,
Lucentis
: The FDA
approved the first interchangeable biosimilar
to
Roche’s
blockbuster anti-VEGF drug, namely
Coherus’
Cimerli
. The copycat version is expected to hit the market in October after getting the FDA’s thumbs-up in five retinal indications. Cimerli isn’t the first biosimilar to rival Roche’s eye drug — but it is the first to win interchangeable status, meaning it can be substituted at the pharmacy in some cases.
MANUFACTURING
Quite literally reaching for the stars to launch new manufacturing operations,
Eli Lilly
is partnering with a Florida-based space infrastructure manufacturer named
Redwire
to partner on
developing space technology
for drug manufacturing. The first step will be “to conduct critical testing during the initial flight missions” in low Earth orbit on its first experiments.
Thermo Fisher
completed a $76 million expansion
of one of its manufacturing facilities in New York, which specializes in dry powder media manufacturing. Part of a broader plan to beef up capabilities globally, it will extend its capabilities for materials used in vaccines and biologic therapy development and manufacturing.
While its name brings to mind sticky notes and packaging tape,
3M
does also manufacture a range of consumer and commercial products. It is now
planning to spin out
its healthcare products division into a separate publicly traded company, incorporating products used in the manufacturing of vaccines and recombinant proteins.
Fresh off an expansion a year ago, CDMO
Curia
is scaling up manufacturing
for a cannabinoid candidate from Australia’s
Incannex
Healthcare
. Curia is tasked with developing and producing a GMP-grade inhaled drug product for the treatment of concussion and traumatic brain injury . The company also tapped a new president in
Niall Condon
, as
Steve Lichter
retires.
German glassmaker
Schott
— which has been manufacturing glass for a wide range of uses for 138 years and has built up a robust healthcare division — will establish
a standalone company
specifically for its pharma business. As part of the carve-out, the pharma side will operate under the new name of
Schott Pharma AG & Co. KGaA
.
Societal CDMO
scored service contracts from three new customers;
Chime
Biologics
, which netted investor cash in 2021 for a 15x manufacturing expansion, received a commercial manufacturing license in China;
Teva
hit a supply snag with its popular ADHD drug
Adderall
; learn more in the
Manufacturing roundup
.
DON’T MISS
Rising monkeypox cases have put the US on high alert as it announces a
national health emergency
, which grants the government more power in its response. The news comes as
Bavarian Nordic
continues to fill orders for its
Jynneos
vaccine and other companies — including
Moderna
— consider jumping into the vaccine race.
Researchers spent close to a decade looking for signs that the failed Alzheimer’s drug
crenezumab
might work in a study that restricted itself to a group of families with a rare genetic mutation that left them susceptible to early-onset disease. While it failed,
AC
Immune
still put a
positive spin on the dataset
as it presents the numbers at a conference.
With the rising number of monkeypox cases, leading researchers at the CDC, FDA and NIH are
calling on a randomized clinical trial
to see if an approved smallpox drug is effective at treating monkeypox. No monkeypox treatments are approved in the US, so patients looking to get relief for their lesions and other symptoms must go through a set of hurdles to access a stockpile of drugs under an expanded access program.
Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen.
Kyrsten Sinema
(D-AZ) reportedly pledged her support — but the question is now
whether they can fit
it in before recess.