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There were days in the past few weeks where it’s felt really quiet on the news front — but then there are still enough important developments that we can’t bear to look away. See if you’ve missed anything this week. And if the Endpoints Weekly has been helpful for you, do spread the word.
Bluebird’s gene therapy takes off
The FDA
approved the first gene therapy
for a chronic condition —
bluebird bio’s
new
Zynteglo
(
beti-cel
) as a potentially curative treatment for those with transfusion-dependent thalassemia. The thumbs-up follows a unanimous adcomm vote, with outside experts pointing to extraordinary efficacy suggesting it can free patients of lifetime transfusions. It’s also one of the priciest of all time: bluebird said it will charge up to $2.8 million for the therapy. The biotech is learning from its experience in Europe, where it no longer markets Zynteglo due to financial issues.
Roche’s big China play
Roche
and
Genentech
are always on the hunt for deals, and they found their newest partner out of China. Roche
ponied up $60 million upfront
to get its hands on a prostate cancer drug candidate from
Jemincare
, promising up to $590 million in biobucks, plus royalties, down the line for the androgen receptor degrader. After spending years developing commercial and manufacturing ops along with a biotech incubator in Shanghai, Roche BD chief
James Sabry
says this new, first-time pact
signals more alliances ahead in China after watching the Asian biotech industry develop into a force to be reckoned with.
Merck bets on mRNA, again
Merck
went in deep on its collaboration with
Moderna
on new mRNA programs, and dropped them all over time. But it is coming in with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA by making RNA circular. The classic, validating Big Pharma deal
delivers $150 million in cash
to
Orna
Therapeutics
, plus a $3.5 billion smorgasbord of milestones. And to help fund this next step of the journey, Orna is simultaneously unveiling a $221 million B round, which features a $100 million Merck stake.
Drug pricing reforms, explained
President
Joe Biden
signed into law
historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition. So what’s actually in the bill that will affect drug prices and biopharma companies’ bottom lines? A lot, Endpoints FDA+ editor Zach Brennan writes.
PREMIUM
Better PhIII? At a fraction of the cost?
Martin Landray
— the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19 — knows what controversy in clinical drug development feels like, from first-hand experience. Now, after 20 years of mounting clinical trials, the Oxford professor is building on what he’s learned from RECOVERY and scores of drug studies to take on one of the most quixotic tasks in the industry: building a nonprofit organization that can take a drug and put it through its paces in large Phase III trials —
at just a tiny fraction
of the cost developers would normally spend on late-stage programs.
FINANCING
You can add a colorful Australian tycoon to the list of billionaires betting on biotech.
Andrew
“
Twiggy
”
Forrest
is making the leap after riding a mining venture to one of the biggest fortunes in Australia,
setting up a $250 million venture fund
called
Tenmile
after picking two biotechs for its portfolio: an MDMA psychotherapeutics outfit as well as a CAR-T biotech.
Senda Biosciences
will look a little different than it did two years ago when
Flagship Pioneering
unwrapped the bow on the venture, a merger of Senda and
Kintai
Therapeutics
. With a
$123 million Series C
, the biotech hopes to have a refined vision in the coming months as it turns off the lights on some of those programs out of Kintai and its original blueprint.
For the first time after teaming up,
Carlyle Group
and
Abingworth
are putting their combined powers to use, extending a custom,
$170 million financing deal
to
Opthea
— an Australian public company that’s in the middle of Phase III studies in wet age-related macular degeneration. Through
Launch
Therapeutics
, the investors will also lend clinical, regulatory and commercial expertise in exchange for future “success payments.”
Kymera
wasn’t looking to do a public raise. But a group of investors — with the lead fund deliberately leaving its name out of the public view — came in with an
unsolicited offer of $150 million
to fund its R&D work in protein degradation.
With sales of its first antibody-drug conjugate falling below expectations,
ADC Therapeutics
is taking on a
$175 million loan
and buying itself some time.
Owl Rock
and
Oak Tree
are providing the loan, which is mainly being used to repay convertible credit notes held by
Deerfield
— from a two-year-old deal designed to help ADC prepare for commercialization of
Zynlonta
.
A year and a half after rebranding,
Viridian Therapeutics
appears to have found a path forward. First, it reported initial data from its Phase I/II trial of thyroid eye disease — and the results, while only in one of three treatment arms, look promising thus far. Later in the day, Viridian followed up with a
public offering of $175 million
in both common and preferred stock.
Novartis
-partnered
Bluejay Therapeutics
closed $41 million
to fuel its search for a functional cure for hepatitis B infections. Its idea is to make HBsAg — viral protein-surface antigens — completely undetectable within six months of treatment using an antibody that targets such antigens, thereby restoring T cell and B cell function.
Planning for the long haul, mental health-focused biotech
atai Life Sciences
took a hard look at its sizable portfolio — and
decided to cut off parts of it
. On top of the “significant cost savings” it expects by stopping funding to certain programs and discovery efforts, atai is also pulling in new money in the form of a $175 million loan facility to extend its runway.
European Investment
Bank
, the lending arm of the European Union, is providing Poland’s
Ryvu Therapeutics
with
$22.3 million in debt financing
to fund its small molecule candidates through the discovery and preclinical phases and into clinical trials. The company is focused on oncology after out-licensing its inflammation programs to
Galapagos
in 2020.
R&D
Novartis
finally finished what it started with
canakinumab
, and the latest batch of data
is once again negative
. After steering the IL-1β drug straight to an FDA rejection as a heart drug, the Novartis team picked up on an unusual cancer signal — and has now followed it over their third successive cliff to a decisive Phase III flop.
Hit by a Phase III flop,
Sanofi
is
officially giving up
on its oral SERD — amcenestrant — which was once billed as a top late-stage prospect. In an interview with Endpoints, R&D chief
John Reed
noted “overall the class has rather underwhelmed.” Now comes the deep dive to see what went wrong, and Reed right now can’t say exactly what the problem is. But he has a theory.
Trodelvy
became the first TROP-2 directed ADC to show
statistically significant and “clinically meaningful”
results in overall survival in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemo,
Gilead
reported from a Phase III update — a surprise since the last update was less than stellar.
In the past few years, three new drugs for CKD have emerged on the market. However, these new drugs have yet to stop or reverse the disease itself, leaving researchers still searching for better, safer options. Scientists from
Mark Okusa’s
lab at the University of Virginia believe they may have
found a new target
by looking at a previously tried-and-failed pathway.
The CD47 field ran into another hurdle as
I-Mab
quietly disclosed that
AbbVie
is saying goodbye
to a Phase I study of the biotech’s drug, which was at the center of a $1 billion-plus deal. This Phase I tested a combo to treat acute myeloid leukemia and myelodysplastic syndrome. The news comes just weeks after AbbVie ended an exploratory trial of the antibody,
lemzoparlimab
.
Sales of
Lundbeck’s
CGRP inhibitor
Vyepti
, first approved in the US in 2020 and earlier this year in Europe, doubled to more than $50 million in the first half of 2022. But the up-and-coming migraine drug encountered a setback in its push to bring the drug to China as it
failed to beat out placebo
in a smaller Phase III trial based in Asia.
After a rare public rebuke from the FDA last year,
BrainStorm Cell Therapeutics
is headed back to the regulator
with what it claims is a “correction” to Phase III data for its ALS investigational therapy
NurOwn
. The drug didn’t pass the primary goal in the new analysis, either, but the biotech hopes a treatment difference on a secondary endpoint will make it look better this time.
Clene Nanomedicine
said its gold nanocrystal-based drug candidate, which failed an ALS trial last year,
was better than placebo
in a mid-stage study of patients with multiple sclerosis. But there are some big caveats to flag here — including the fact that it only passed muster on the primary endpoint after excluding a group of patients.
The second part of
Blueprint Medicines’
study on
Ayvakit
in non-advanced systemic mastocytosis — a rare disease in which a type of white blood cells known as mast cells builds up —
met all endpoints
, but the biopharma left key questions unanswered. While the biotech touted improvement in symptom scores, analysts wondered about the size of the difference.
On a roll,
AstraZeneca
and
Daiichi Sankyo
scored another trial win
with the HER2 ADC
Enhertu
. The Phase III trial, DESTINY-Breast02, tested the cancer drug versus physician’s choice in patients with HER2-positive metastatic breast cancer. And Enhertu beat out the other treatments in improving PFS as well as OS.
Looking to push its two top programs to the clinic,
Pyxis Oncology
is willing to throw other candidates to the wayside. In its words, the company is sharpening its short-term emphasis — on an anti-EDB ADC and an anti-Siglec-15 antibody — either
pausing or ceasing work
on three others.
DEALS
A little over two months after
Trodelvy
earned its first approval in China,
Gilead
is
making moves to regain
the drug’s rights in the country and the surrounding region.
Everest
Medicines
, which originally licensed the ADC from Immunomedics, will gain $280 million upfront for Trodelvy’s China rights and is on the hook for another $175 million.
After two years,
GSK
is punting a partnered program with
Ideaya
Biosciences
. The synthetic lethality-focused oncology player reported in its Q2 earnings that GSK
decided not to use its exclusive option
on Ideaya’s drug candidates targeting MAT2A, after taking a look at the preclinical and Phase I data package. Ideaya shares were slashed.
After a brief delay,
Bristol Myers Squibb
is finally about to close on its $4.1 billion
Turning Point
acquisition. A merger control clearance from the Federal Cartel Office of Germany allowed the drugmaker
to officially seal the deal
, which gives the pharma giant a rival to
Pfizer’s Xalkori
and
Roche’s Rozlytrek
in ROS1-positive non-small cell lung cancer.
GSK
landed a new first from UNICEF — the first-ever contract for malaria vaccines,
worth up to $170 million
for 18 million vaccine doses distributed over the next three years. The vaccine, known as
Mosquirix
or
RTS,S
, won WHO’s backing last October after a controversial start, but
UNICEF
said these doses will potentially save thousands of lives every year.
Bloomberg reported that digital health company
Babylon
is
considering a sale or new financing avenues
in the aftermath of a stock slump just quarters after going public via a SPAC. But according to Babylon, that’s gossip — it refuted the M&A rumors, twice, putting out statements two days in a row nixing the claims in the newswire report.
PEOPLE
Geoffrey Porges
has ended his two-decade run as a biotech analyst, as the former
SVB Securities
vice chair
began as CFO
of
Schrödinger
. Porges, who previously headed up vaccines marketing at
Merck
before the turn of the millennium, joins the 700-employee company as Schrödinger broadens its focus from a drug discovery shop to also building out an in-house pipeline.
As the CEO of
Pfizer
,
Albert Bourla
bet big on a new mRNA vaccine from
BioNTech
for Covid-19 — and won big. Now he can find out first-hand just how effective it is in blunting the impact of the virus. Pfizer put out a statement Monday saying that Bourla
had tested positive
for Covid-19, but is confident about a “speedy recovery” after getting four doses of his company’s vaccine and starting a course of
Paxlovid
.
As it slowly turns its attention to the biotech world,
Innovation
Endeavors
, the tech VC headed up by former Google CEO Eric
Schmidt
,
brought on
Joel Dudley
as partner. Most recently the CSO at
Tempus
Labs
, Dudley was also part of a team at
Mount Sinai
that conducted one of the studies investigating Theranos’ blood tests and found issues with the cholesterol readouts.
The success
AstraZeneca
and
Daiichi Sankyo
have enjoyed with
Enhertu
appear to be pushing a small rival to reconsider its clinical plans.
Ambrx Biopharma
, whose lead drug is an anti-HER2 ADC,
appointed
Kate Hermans
as interim CEO to replace
Feng
Tian
, a 17-year veteran of the company. She will oversee a strategic pipeline review until a permanent chief is found.
The clock is ticking for penny stock biotech
Clarus
Therapeutics
. With $19.2 million left in the bank and $40.5 million of senior notes payable, the company is
pulling out all the stops
to stay afloat — axing 40% of its workforce, including its CFO, and closing down R&D programs while it explores strategic alternatives. The reorg will keep the lights on until September 2022.
One of the first things “Pharma Bro”
Martin Shkreli
did after his release from jail was to create a new drug discovery platform and launch his own cryptocurrency. But he seems to be having a tough time managing his crypto ambitions. Shkreli apparently
sold off a huge share
of his own cryptocurrency, causing its value to plummet, according to Bloomberg reports.
After the untimely departure of then brand-new CFO
Jorge Gomez
— he was in the job for about one day — it has now
found a replacement
in
James Mock
, the soon-to-be former CFO at diagnostics and analytics company
PerkinElmer
.
David Meline
, who came out of retirement to fill the post temporarily, will officially leave.
Despite getting the all-clear from the FDA to restart a clinical trial,
Homology Medicines
is instead
pausing enrollment and dosing
of the gene therapy candidate to refocus on another program. Alongside the “prioritization” of its PKU clinical efforts, the biotech is also trimming its staff by about 10% across all departments.
AI
Sanofi
made clear its AI ambitions were real at the beginning of this year when it took its drug discovery collaboration with
Exscientia
to the next level. Seven months later, the AI blueprint is far from over. The French giant will pay
Atomwise
$20 million to kick off the hunt
for drugs against up to five targets, which are aimed at leading to the creation of new small molecules.
Bayer
and
Exscientia
are winding down
their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further. Having recently achieved a preclinical proof of concept milestone, Exscientia said it’s a natural point to end the work. Filings suggest it ultimately only collected a small fraction of the €240 million promised.
CORONAVIRUS
Moderna’s
bivalent vaccine booster — a 2-in-1 jab that targets both the original virus strain and Omicron —
secured its first-ever regulatory OK
in the UK. The approval was based on a Phase II/III study that suggested the new shot spurred better antibody response against Omicron than the original
Spikevax
.
Weeks after evidence emerged that current Omicron subvariants may be less susceptible to
AstraZeneca’s
prophylactic Covid-19 treatment
Evusheld
, the UK reportedly
decided against buying doses
for now. The UK’s Department of Health is taking issue with “insufficient data on the duration of protection offered, according to the BMJ. AstraZeneca calls it “disappointing news for immunocompromised patients.”
LAW
AstraZeneca
filed suit against
former VP and head of investor relations
Chris Sheldon
as he prepares to start a new job at
GSK
next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021. Sheldon worked at AstraZeneca for more than 18 years.
Alain
Bouaziz
, a 69-year-old French pharma exec,
pleaded guilty to lying
to the FDA in an attempt to gain control of Novartis’ weight loss drug, formerly marketed as
Sanorex
. While
Novartis
took the drug off the market years ago, Bouaziz sent letters to the FDA saying his company,
Hexim
, had purchased the NDA for Sanorex and got the NDA transferred.
GSK’s
first scheduled
Zantac
cancer trial w
as dismissed by the plaintiff
, the British pharma company said, while noting that it did not settle the claim and has not paid anything in exchange for the voluntary dismissal. But there are many more to go, with a hearing for a multi-district lawsuit set to kick off next month in Florida.
About a month after a Delaware court found certain
Xifaxan
patents invalid
— potentially opening the door for generic competition — a New Jersey court sided with
Bausch
in a separate patent feud with
Curia
. Xifaxan, an antibiotic, is one of Bausch’s top sellers.
PHARMA
ICER inched closer to a limited endorsement of two ALS drug candidates as the pricing watchdog’s Midwest CEPAC met to discuss clinical evidence on
Amylyx’s AMX0035
and
Mitsubishi Tanabe Pharma
America’s intravenous version of older ALS medicine edaravone. While clinical experts were divided as to the drugs’ efficacy, the panel
voted in favor
of their clinical effectiveness.
In view of widening health disparities in the South amid the Covid-19 pandemic,
Gilead
is doubling down and committing
another $4.5 million
to address structural barriers in Black communities to HIV testing, treatment and care in Atlanta, New Orleans and Baton Rouge, LA. The new initiative is a partnership with Morehouse School of Medicine and Xavier University of Louisiana’s pharmacy school.
The HHS says it will make available an
additional 1.8 million
intradermal doses of
Bavarian Nordic’s Jynneos
vaccine, although only states and other jurisdictions that have used up 90% of their current supplies can obtain the new doses. To boost supplies, Bavarian is tapping a contract manufacturer. The HHS will also deliver more doses of the antiviral
Tpoxx
.
Phil Gomez
, CEO of
Siga Technologies
(which makes the drug)
tells Endpoints in an interview
what people should expect in terms of accessing this treatment and when the clinical trial data are coming.
The
Bill & Melinda Gates Foundation
is already focused on the next pandemic. Doubling down a partnership with South Korea, it
pledged to collaborate
on projects such as a global health research fund, and work with other health organizations like CEPI to address disparities and advance programs in infectious diseases.
Irish drugmaker
Endo International
is entering into bankruptcy
as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US. Just after reaching a $450 million nationwide settlement, it filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with filings expected in other territories soon. Just two days later, it
lost a patent battle
on one of its top sellers.
As the ink dries on
CSL’s
$11.7 billion
Vifor
buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic. However, CEO
Paul Perreault
assured investors and analysts on the full-year call that the team has
left “no stone unturned”
when assessing options to grow plasma volumes. The company also spelled out positive results for its monoclonal antibody garadacimab in hereditary angioedema, a potential flagship molecule.
After initially delaying its filing of
Polivy
in diffuse large B-cell lymphoma,
Roche
says the
FDA accepted its sBLA
for the ADC. An approval would cover its use in tandem with
Rituxan
as well as
cyclophosphamide
,
doxorubicin
and
prednisone
(R-CHP).
MARKETINGRX
The Covid-19 pandemic and rush to vaccines spotlighted new names like
Spikevax
,
Comirnaty
and
Vaxzevria
. Now monkeypox drug and vaccine names are in the news — although both the leading vaccine
Jynneos
and the special use treatment
Tpoxx
have been around for years. When it comes to the brand names themselves, pharma brand powerhouse Brand Institute named both the
Bavarian Nordic
vaccine and
Siga’s
antiviral. Endpoints MarketingRx editor Beth Bulik
takes a look
.
Gilead Sciences
aired a six-part docuseries
about the real life impact of HIV in the South on CNN over the past few months, highlighting six different cities with different advocates, families, friends and communities covering Alabama, North Carolina, Virginia, Georgia, Tennessee and Mississippi. Individual episodes are being and screened at film festivals around the country.
Novo Nordisk
debuted its
first diversity and inclusion report
laying out its commitments — and progress — for employees, patients and external audiences. The highlights include more inclusive parental policies, travel and health benefits for employees seeking abortions, nine employee resource groups and specialized programs.
Next month at New York Fashion Week,
Genentech
will be hosting its
first-ever runway fashion show
to raise disability visibility, featuring models from the spinal muscular atrophy community. “Double Take” will be held Sept. 8, the day before the official New York event begins, with models walking and rolling across the stage wearing stylish and functional adaptive clothing.
Do you know the ABCs of CKD in T2D?
Bayer’s
first ad campaign
for
Kerendia
tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D). Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.
Genmab
often talks about its “knock-your-socks-off” antibodies — and now the term is
getting its own logo and corporate campaign
. The debut of the teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — comes on the heels of Genmab’s newly announced 2030 vision, which will see Genmab expand from oncology into other serious diseases.
A year ago,
miR Scientific
lit up La Fortaleza, the governor’s mansion in Puerto Rico, and other landmarks on the island in the color blue for Prostate Cancer Awareness Month. Next month, the company
is taking the campaign international
as it launches its prostate cancer diagnostic test, with plans to light up dozens of landmarks in New York, New Jersey, Chicago and Puerto Rico.
As the lyrics of his band’s 2019 pop-rock single suggest,
Joe Jonas
is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is
Merz’s
newest
celebrity brand partner
for its
Botox
rival
Xeomin
, as medical aesthetics brands target a younger audience.
After a splashy Super Bowl TV ad,
Hologic
is once again teaming up with celebrity spokesperson singer
Mary J. Blige
for a new campaign to encourage women to stay up to date on screenings;
Gilead
and
ViiV
pledged donations to raise monkeypox awareness;
Bristol Myers Squibb
is highlighting its employee cyclists in a countdown to its annual cancer cross-country cycle; and more snippets await in the
MarketingRx roundup
.
FDA+
Thanks to
recently released text messages
from FDA’s Freedom of Information Office, the spat between White House officials and former commission
Stephan Hahn
in the lead-up to the FDA’s issuance of its first Covid-19 vaccine EUA to Pfizer in Dec. 2020 is now in full view. Zach Brennan dives in.
Amid a general push to reform accelerated approvals at the FDA, researchers from Harvard, the University of Pennsylvania and the Brookings Institution
called for financial incentives
for companies to quickly complete their confirmatory trials. Payers should not pay the full price until it’s proven that the drug works, they argue. Others from the University of Zurich and Harvard, meanwhile, suggest that from 2007 to 2021, only about 39% of drugs making their way through the accelerated approval pathway, and another 38% were approved via the EU’s conditional marketing pathway,
“demonstrated ‘high therapeutic value.’”
After a nearly 365-day delay,
Axsome Therapeutics
secured its first drug approval
with an FDA green light for
Auvelity
as a treatment for adults with major depressive disorder. The rapid-acting NMDA receptor antagonist combines 45 mg of the cough suppressant
dextromethorphan
and 105 mg of the antidepressant bupropion in an extended-release tablet formulation.
Bayer’s
latest approval
for its popular IUD product
Mirena
covers prevention of pregnancy for up to eight years, extending its use by one year. Regulators based their decision on a Phase III extension trial showing Mirena maintained its efficacy of greater than 99% during years 6 through 8, while exhibiting no new or unexpected safety risks.
Four months after the FDA put two clinical trials from
Curis
on clinical hold in the wake of a patient death, one of the trials may now get back on track. The agency
lifted a partial clinical hold
of the company’s Phase I/II study of
emavusertib
in lymphoma, following a new data package that the biotech recently submitted.
In the latest chapter of the
Makena
saga, the voting questions for the drug’s withdrawal hearing
have been set
. First approved in 2011 under the accelerated approval pathway to reduce the risk of premature births, the drug flunked its confirmatory study, but still, its developer,
Covis
Pharma
, has refused to pull it from the market.
AstraZeneca
and
Merck’s
top-selling PARP inhibitor
Lynparza
is possibly on its way to reaching a broader group of prostate cancer patients. The FDA
granted a priority review
to Lynparza combination therapy for patients with metastatic castration-resistant prostate cancer, where it previously has a monotherapy approval for a genetically defined patient subgroup.
MANUFACTURING
Emergent BioSolutions
is facing a fresh set of manufacturing troubles as the FDA
issued a warning
to the company regarding its Baltimore site. The FDA letter pointed to deficiencies in the Emergent plant’s systems for cleaning and maintenance of equipment to prevent contamination of drug products.
After netting a massive $625 million round in June,
Resilience
is not sitting around and resting on its laurels. The
Bob Nelsen
-backed contract manufacturer
unveiled a new strategic collaboration
with the
Mayo Clinic
centered around manufacturing biotherapeutics for rare and complex conditions, with the focus on biologics including those based in cells, blood, enzymes, tissues, genes or genetically engineered cells.
Cipla
is the latest major Indian pharma manufacturer to
receive a Form 483
following an inspection from the US regulator. According to the FDA, the facility was not cleaned and maintained at correct intervals to prevent contamination that could alter the safety of drug products. The Form 483 also notes a lack of raw data.
Two drug manufacturers on opposite sides of the globe are facing the heat from the FDA over several quality control issues. India-based manufacturer
Sun Pharma
and
Revance
Therapeutics
, which makes a
Botox
rival,
both got hit with a Form 483
detailing various issues.
WuXi AppTec’s
contract research and manufacturing subsidiary
WuXi
STA
,
has broken ground
on a 190-acre manufacturing campus in Middletown, Delaware. Reportedly costing $510 million total, the site will be the CDMO’s second facility in the US, and it will create around 500 full-time jobs by 2026. The plan is to kick off operations in 2025.
The
Almac
Group
, a global contracting and manufacturing company for APIs and pharmaceuticals, is expanding its North American headquarters in the town of Souderton, PA, northwest of Philadelphia. The company is looking to
invest $65 million
into the facility with the plan being to increase the clinical capacity at the facility by 60%.
Samsung Biologics
and
AstraZeneca
are looking to work together on a $350 million contract manufacturing deal;
Societal CDMO
sold some of its land in Georgia; CDMO
AGC Biologics
formed a strategic partnership with
RoosterBio
, a supplier of human mesenchymal stem/stromal cells, around cell and exosome therapy manufacturing; get your weekly dose of manufacturing news briefs in the
Manufacturing roundup
.
DON’T MISS
What if a PI3K inhibitor somehow avoided the toxicities that have plagued the class? In a new paper, researchers from the University of Michigan describe a dual PI3K and MAPK inhibitor that
limited toxicities and extended survival time
in mice through what lead investigator
Brian Ross
called an “unanticipated” mechanism — going through the lymph nodes.
Most NIH-funded clinical trials with results due in 2019 and 2020
did not meet federal reporting requirements
, the HHS inspector general’s office said in a new audit. The report added that the NIH “did not have adequate procedures” to ensure that the results are submitted on time, took limited enforcement action against noncompliance and kept funding new research of people who did not turn in results on time.
A few weeks after announcing a reorganization and shutting down its only clinical trial,
Nordic Nanovector
decided to essentially call it quits. The Norwegian company revealed that it will
“explore strategic options,”
biotech codespeak for selling itself and/or its assets. The move will wrap up what’s been a 13-year journey since Nordic Nanovector’s 2009 founding.
Having started a protein design biotech with
David
Baker
,
Daniel-Adriano Silva
was in search of his next mission. He found it back in Baker’s lab at the University of Washington, where he reconnected with an old colleague now working on a biosensor technology. Their new company,
Monod
Bio
,
raised $25 million
in seed funding to bring it to market.