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Changes afoot at GSK
Two of
Hal Barron’s
big R&D bets at
GSK
came crashing down just a couple of months after his formal departure. On top of axing its 2019 cell therapy alliance with
Lyell
— which it paid $250 million upfront for — GSK
abandoned first-gen efforts with
Adaptimmune
as
Tony Wood
assumes full responsibility for the pipeline. In the spirit of cutting out subpar candidates, the pharma giant also
scrapped filing plans for
otilimab
in rheumatoid arthritis after receiving disappointing Phase III results. And did we mention that vaccine chief
Roger Connor
is heading out
?
Mixed vote for kidney drug
GSK
finds itself in a glass-half-full situation with
daprodustat
, its late-stage oral hypoxia-inducible factor-prolyl hydroxylase inhibitor. First, the FDA
raised serious questions
about the risk/benefit profile of the drug as a treatment for anemia due to chronic kidney diseases. Then a panel of external experts
voted differently
on two different patient populations, giving it a thumbs up to those on dialysis and thumbs down to those not dependent on dialysis.
Unanimous thumbs down
Over at the FDA’s oncology group, reviewers
flagged serious concerns
regarding the efficacy of
Y-mAbs Therapeutics’
potential pediatric neuroblastoma treatment. Part of the problem for the FDA is that the entire application for 131I-
omburtamab
is based on a small, single-arm trial. The ODAC agreed,
voting 16-0 against the drug’s approval
citing too many data confounders. Echoing the FDA’s internal review, the adcomm noted the external control group for Y-mAbs’ pivotal study was very different from the treatment group at baseline, making it hard to draw any conclusions.
The first victim of IRA?
Pharma execs are still talking about the ramifications they see for President
Biden’s
Inflation Reduction Act — which empowers Medicare to negotiate drug prices — in their Q3 earnings.
Alnylam
Pharmaceuticals
, the pharma market’s leader in RNAi therapies,
revealed it would scrap plans to launch
a Phase III trial for vutrisiran in the rare Stargardt disease and said it made the decision to avoid price negotiations.
Sanofi
CEO
Paul Hudson
said it will likely
“create significant uncertainties” and “artificially influence future R&D decisions,” although he also does predict an immediate impact.
Can RNA editing tool track cells, too?
It’s just been a few years since biotech startups publicized the potential of ADAR in editing RNA for therapeutic use, but researchers have already found a new use for it. A group of collaborators out of the Broad and MIT created a system known as RADARS — reprogrammable ADAR sensors — which can detect and control translation of selected proteins. According to the researchers, their new platform
has broad applications from studying cells
to tracking RNA therapies. https://endpts.com/broad-and-mit-scientists-repurpose-hot-rna-editing-tech-as-radar-with-uses-in-cancer-and-brain-research/
PREMIUM – As work halts, families behind gene therapy seek control
Families affected by the ultra-rare but deadly condition Leigh syndrome — formed the
Cure Mito Foundation
and raised $1 million to spark a gene therapy.
Taysha Gene Therapies
advanced the drug program. But in March, the biotech paused development, and when families tried to get venture investors to take over, Taysha asserted intellectual property rights in killing the plans. The situation raises tangled questions over how much say families should have after sparking research that’s later halted, as Jared Whitlock’s
In Focus story explores
.
Two notable drugs cross FDA finish line
It took years of sorting through failed trials to find the right dosing regimen, but
AstraZeneca
finally landed an approval
for its CTLA-4 inhibitor.
Imjudo
— better known as
tremelimumab
, or treme — is approved in combination with
Imfinzi
for a type of unresectable liver cancer, and the company says the pricing will be “comparable” to other combos in this space. Meanwhile,
J&J
scored accelerated approval for
Tecvayli
(
teclistamab
), a BCMA-directed bispecific antibody, looking to bring a new option for patients who’ve tried multiple treatments.
DEALS
A few weeks after balking at a buyout offer,
Myovant Sciences
managed to sweeten the deal.
Sumitomo
Pharma
, a majority owner of the biotech with a 52% stake,
is paying $1.7 billion to buy out
the remaining shareholders at $27 per share — up from its previous bid. The deal centered around Myovant’s two approved products, one for prostate cancer and the other to treat heavy menstrual bleeding associated with uterine fibroids and endometriosis.
https://endpts.com/sumitomo-clinches-myovant-buyout-after-upping-offer-to-2-9b/
Almost two years after
Agios
sold its oncology unit to French pharma
Servier
in a $1.8 billion deal, Agios is letting go of its last link to one of the old medicines it made its name on. It went ahead and
sold its rights to 5% royalties
on US net sales of Servier’s
Tibsovo
(
ivosidenib
) to
Sagard Healthcare Partners
for a one-time payment of $131.8 million.
The team at struggling
PhaseBio
is pulling out all the stops to stop development investor
SFJ Pharmaceuticals
from laying claims to its FDA-bound blood drug. The biotech
filed for Chapter 11 bankruptcy protection
, looking to set up a quick auction of the therapy to the highest bidder — and it’s lined up an unnamed pharma company to serve as a stalking horse bidder.
Syncona
is bringing a gene therapy player into its fold for a song. The UK life sciences investor
paid $23.5 million to buy out
Applied Genetic Technologies
Corporation
, also known as AGTC, which got started back in 1999 but still has no approved therapies. The hope is that will change, as Syncona helps push its lead candidate in X-linked retinitis pigmentosa into late-stage trials.
On the back of its Covid-19 success,
Moderna
is reportedly one step closer to securing a new deal for other serious infectious diseases. Bloomberg reported that the biotech
is nearing an agreement
with the US government to develop vaccines for Ebola and additional viruses considered to be threats.
R&D
Mitch Gold’s
plans to revive CD28 as a target and push the envelope on cell therapy 2.0 crashed into a fresh safety issue. A
second patient died from cardiogenic shock
after receiving one dose of
Alpine Immune Sciences’ davoceticept
plus
Keytruda
in a trial. Now Alpine will abandon the drug program and switch gears.
Two decades after the FDA first approved
fulvestrant
to treat a type of breast cancer,
AstraZeneca
spotlighted two new drugs that showed promise when added to or pitted against it. In separate trials involving different subsets of breast cancer patients, the oral SERD
camizestrant
and the AKT inhibitor
capivasertib
both spurred improvements
in progression-free survival.
Novartis
took another stride as it tries to break into a rare disease field that
AstraZeneca
subsidiary
Alexion
has dominated for years, reporting that its oral drug
iptacopan
bested anti-C5 therapies on increasing hemoglobin levels
in a Phase III trial for paroxysmal nocturnal hemoglobinuria patients, many of whom remain anemic despite current treatment.
Nuvalent
set out to show that by leveraging structure-based drug design and a bit of chemistry whiz out of its Harvard founder’s lab, it can hit well-known cancer targets in ways that no others can. First-in-human data suggest
its lead drug can indeed spur responses
in a group of ROS1-mutant non-small cell lung cancer patients who’ve exhausted options.
AstraZeneca
has been looking to give itself an edge against other rival treatments in eosinophilic indications, such as
GSK’s Nucala
, but an initial readout from a Phase III trial may now blunt that approach.
Fasenra
failed to alleviate difficulty swallowing
, one of the two dual-primary endpoints in eosinophilic esophagitis. It’s still analyzing the data.
In May,
Tricida
announced it was
stopping its Phase III trial
for the chronic kidney disease drug veverimer early due to “administrative reasons” — namely it didn’t have enough cash. Now that it’s wrapped up the study, Tricida reports the drug made virtually no difference in preventing death or severe disease compared to placebo.
Vaxcyte
, a scrappy California biotech with fewer than 150 employees,
says it’s ready to take on
Big Pharma’s heavy hitters in pneumococcal shots. Touting Phase I/II data showing its 24-valent vaccine was just as safe as
Pfizer’s
recently approved
Prevnar 20
— a 20-valent vaccine — the biotech also highlighted greater immune responses on multiple strains. It now plans to move into Phase III, with data expected in 2025 at the earliest.
While
J&J’s Janssen
previously reported that roughly 60% of moderate to severe ulcerative colitis patients responded to an IV formulation of
Tremfya
, the company’s now suggesting that a follow-on subcutaneous dose was able to boost response and bring the
total responder rate up to 80%
.
Patients with the rare disease NMOSD have attacks or relapses that may cause new onset of a range of symptoms or worsening of symptoms.
AstraZeneca
spelled out Phase III data showing that
Ultomiris
, a star drug from its
Alexion
group,
can stave off those attacks and drastically lower
the risk of relapse.
AstraZeneca
, through its rare disease group
Alexion
,
revealed data from the Phase III
open-label CHAMPION-NMOSD trial Thursday morning. In May, AstraZeneca reported the primary endpoint, which was time to first relapse, had been met in the trial.
Q3 EARNINGS
Buried in
Novartis’
third quarter report
were a few key indication drops
. First, Novartis is no longer planning to submit
tislelizumab
for FDA approval in first-line nasopharyngeal cancer or first-line non-small cell lung cancer alongside chemotherapy — marking two more US regulatory setbacks for the PD-1 inhibitor from
BeiGene
. In addition, it is dropping the liver transplant indication from its
iscalimab
program.
During
Novartis’
Q3 call, CEO
Vas Narasimhan
emphasized he’s “willing to be patient” as he
continues his mission to reshape Novartis
and makes final arrangements to spin off generics unit
Sandoz
. While he’s still looking for deals in the sub-$3 billion to $4 billion range and a “broad range of licensing opportunities,” he made clear he won’t jump for just anything.
One of the key programs that inspired
Sanofi’s
$2.5 billion buyout of
Synthorx
in late 2019 is now the subject of a $1.6 billion writedown. Sanofi
disclosed in its Q3 earnings
that it’s stopping Phase II platform trials for
SAR444245
, an IL-2 candidate that it had hoped would serve as a next-gen foundation of the oncology franchise. An early look at the data, it said, suggests efficacy that’s “lower than projected.” It’s going back to Phase I/II.
Does
Merck
have everything it needs for a successful pipeline? In short, no, CEO
Rob Davis
told investors and analysts during the company’s Q3 call. But he’s got his eye on
“a list of potential places to play”
when it comes to M&A. In typical pharma CEO fashion, he kept short on the details, vaguely admitting that “our urgency on business development has not changed.”
AbbVie’s
Q3 results and earnings call show a company bracing for what could be steep
Humira
losses with the coming of biosimilar competitors early next year, even as the rest of its immunology franchise outpaces initial expectations. It has signaled that it
expects about 45% erosion
of its megablockbuster Humira franchise in 2023.
Bristol Myers Squibb’s
Q3 numbers were down on the latest quarter, but execs are looking to stay the course, maintaining overall 2022 revenue guidance in light of generics eating away at the profits of megablockbuster
Revlimid
. And they’ve still got their eyes on BD opportunities as they look to grow the company.
Takeda
projected optimism in its first-half fiscal earnings call across its portfolio, announcing a
boost in peak sales estimates
for its already blockbuster IBD med
Entyvio
along with positive news on its dengue vaccine
Qdenga
and celiac disease pipeline. The positive outlook punctuated overall sales growth on first-half revenue of $13.6 billion, up 5.5%.
While
Biogen’s
Q3 revenue dipped by 10%
versus the prior year, the company focused its earnings call on two bright prospects — recently unveiled positive results for
lecanemab
, its anti-amyloid Alzheimer’s follow-up to
Aduhelm
, and its potential ALS drug tofersen. The FDA has until Jan. 6, 2023, to decide on lecanemab’s accelerated approval.
Despite rumors swirling around a potential buyout,
Seagen
is focusing on good news
for its key drugs while continuing to search for a more permanent CEO. That includes
Padcev
, with positive bladder cancer data at ESMO, and HER2 drug
Tukysa
, which execs say did well even as
Enhertu
entered the competitive space.
CORONAVIRUS
Looking back at the pandemic so far, it’s easy to spot the holes in the US clinical trial research infrastructure. To fix that, the White House’s Office of Science and Technology Policy, with a newly sworn-in director,
Arati
Prabhakar
,
announced plans to ensure
that coordinated and large-scale clinical trials “can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.”
Recent use of
Pfizer’s
blockbuster Covid-19 antiviral
Paxlovid
has declined sharply
since this summer, plunging by about half, according to federal data. But this decline, which comes amid a parallel drop in cases, means states now have more supplies ready to go for this winter. For its part, Pfizer said it’s focused on ensuring supply and monitoring resistance. The antiviral will become the first treatment
studied by the NIH for long Covid
as part of the NIH’s $1 billion RECOVER program, with researchers trying to figure out the cause of the condition and a way to treat it.The FDA is
changing up its marketing rules
for emergency use Covid treatments. Six drugmakers can now more broadly promote their Covid therapies, including
Pfizer’s Paxlovid
and
AstraZeneca’s
Evusheld
. However, that doesn’t mean the companies are ready to roll out new ads.
https://endpts.com/fda-loosens-marketing-rules-for-authorized-covid-drugs-but-will-it-move-the-needle/
CELL/GENE TX
Half a year after
Taysha Gene Therapies
laid off 35% of its staffers and paused the bulk of its R&D work — devastating the families behind them — the Dallas crew
secured a partner in
Astellas
— and about $50 million in cash — to support two main programs remaining in the pipeline. In exchange, Astellas will acquire 15% of the biotech plus an option to license the drugs, and
Paul Peter Tak’s
oncolytic virus startup,
Candel
Therapeutics
,
is jumping head-first into a new partnership
with
Carl June’s
lab at Penn to see if the herpes virus can boost the effectiveness of CAR-T therapies. The idea is to penetrate the tumor microenvironments that often keep drugs out, and pave the way for CAR-Ts to kill cancer cells.
Biopharma companies debating whether or not to start developing new gene therapies for neurodegenerative diseases — a historically difficult field to crack —
will now have more advice from the FDA
to help with preclinical testing and clinical trial design, among other topics. The final FDA guidance includes new clarifications on the recommendations regarding the use of tumor-forming cell lines, comparability studies and crossover designs for clinical trials.
LAW
Keen to protect its blockbusters,
Novartis
filed yet another federal court complaint
in an attempt to drive off
Entresto
generics.
Viatris
and
Mylan
are among Novartis’ latest targets, as well as
Alembic
Pharmaceuticals
,
Crystal
Pharmaceutical
,
MSN Pharmaceuticals
and
Nanjing Noratech Pharmaceutical
— which are all trying to bring Entresto generics onto the market.
Gilead’s
hoping for a swift end to its HIV patent battle with HHS,
filing for a summary judgment to dismiss
the case without a trial. Firing back at claims that
Truvada
and
Descovy
infringed on government-owned patents, the company said there are “critical holes in the government’s evidence,” and argued that the government lacks authority to sue.
More than 18 months after agreeing to pay $600 million to settle opioid marketing claims,
McKinsey
reached a settlement
with a number of school districts and local governments. The consulting firm, which worked with opioid makers such as
Purdue Pharma
on how to market their products, is still facing other claims.
PHARMA
Four months after the US Supreme Court handed down its Dobbs decision, overturning the right to an abortion, dozens of women across the pharma industry aren’t done fighting. A group dubbed the
Biotech Sisterhood
released a letter — signed by more than 200 biotech, pharma and investment execs —
calling for action to support reproductive rights
.
Regeneron
and
Bayer’s
blockbuster eye drug
Eylea
was given six months more protection from competition — now extending into the first half of 2024. The FDA granted the blockbuster VEGF inhibitor
an extension of pediatric exclusivity
, based on new data on retinopathy of prematurity, or ROP, in preterm infants.
Pharma’s lobbying expenses reached record heights last year — and according to the latest reports, the
industry is on track to top those numbers in 2022
. In the first three quarters, pharma companies spent a total of $281 million on lobbying, approaching last year’s total of $350 million. PhRMA was among the groups that saw a decent uptick in spending last quarter.
PEOPLE
Almost four years after
Genentech
first accused a former top scientist of stealing trade secrets, she is going to prison.
Xanthe Lam
and her husband,
Allen
Lam
, were both handed the same sentence of
six months imprisonment and $10,000 in fines
for their roles in an illicit scheme to benefit
Taiwan’s JHL Biotech
with confidential Genentech documents.
UK biotech
Mereo BioPharma
finally reached a truce
with its largest stockholder
Rubric Capital Management
after the investor fought for months to shake up its board and explore alternatives for its pipeline. It appears that Mereo has acquiesced to some of Rubric’s demands, placing four members on the board.
As it reviews plans for developing a plant-based vaccine for Covid-19,
Medicago’s
US subsidiary
Medicago USA
filed a WARN notice in North Carolina,
disclosing that 62 employees
at its manufacturing facility in Durham will be out of a job within two months.
Oncolytic viruses — viruses that can selectively replicate in cancer cells and kill them — have been steadily attracting investment and curiosity. However, for the most part, those candidates have not quite panned out to the extent their backers had hoped. But with former
Summit
CEO
Glyn Edwards
on board
,
VacV Biotherapeutics
claims it can actually meet that bar.
FINANCING
Recursion Pharmaceuticals
discreetly shut down work
on one of its clinical programs, tucking in a word in SEC filings that it will end development on
REC-3599
, a drug candidate for GM2 gangliosidosis. CEO
Chris Gibson
told Endpoints News that the move will help the company focus more on its oncology work. The news came at the same time as a $150 million private placement.
A year ago,
Alto Neuroscience
came into the game with a $32 million Series A and plans to launch three Phase IIa trials for several psychiatric disorders, including treatment-resistant depression and PTSD. Now the company, founded by Stanford neurologist
Amit
Etkin
,
has closed a $35 million Series B
to continue testing its biomarker-driven approach.
Days after giving the world a peek at data for its 24-valent pneumococcal vaccine,
Vaxcyte
raised a whopping $600 million
by selling 15 million shares in a public offering to take it forward in a space dominated by Big Pharma. On the other end of the spectrum,
Taysha
went for a stock sale that brought in $28 million to fund gene therapy programs still in the pipeline.
After securing an $80 million credit facility in the summer, California’s
Gritstone bio
is making another financial move as it lifts the cover on some vaccine trials. The PIPE financing is expected to net the biotech
around $45 million
to advance its vaccines, including the self-amplifying mRNA candidates against SARS-CoV-2 it just claimed a win on.
Diffusion Pharmaceuticals
is now
looking at all its options to keep itself going
, even if that means selling core company technology or even the company itself. With cash running low, the tiny Virginia biotech, which has been focused on oxygenation to treat hypoxia, says it will review possible strategic opportunities to enhance stockholder value.
The speed bump that little
PTC Therapeutics
ran into with its Huntington’s program didn’t stop
Blackstone
from sealing a deal to
invest $50 million in the company
and offer it up to $1 billion in loans. The debt will take a few different forms, but perhaps most significant is the $500 million the biotech can tap to “support business development opportunities” Blackstone agrees on.
STARTUPS
Lieping Chen
— the I/O researcher whose early work established the PD-1/PD-L1 as a cancer target — is
back with a new biotech
with a new take on getting T cells into unresponsive tumors. Specifically,
Normunity
boasts of a screening platform that will find proteins responsible for the locking mechanism keeping T cells out. It is launching out of stealth with a $65 million Series A.
Actuate
, a Texas biotech trying to treat various cancers, including refractory ones for pediatric patients, is on a winding financing journey, SEC filings reveal. Setting
out to raise $50 million
after bringing in less than expected in the last round, it’s secured at least $11 million from 30 investors so far. It also just announced three new members to its scientific advisory board.
MARKETINGRX
Whatever
Meta
and
Mark Zuckerberg
may have to say, the medical metaverse is already here, digital experts say. And that blending of real and virtual life in the medical metaverse is shaping the future of medicine and healthcare — even if the word itself proves a bit of a hard sell. So what does it mean for pharma marketers? Endpoints MarketingRx editor Beth Bulik
explores
.
Genentech
wants to do more than just shine a light on the health inequities faced by Black and brown people. Through a short one-minute film tracing the health system experiences of a Black woman from childhood through adulthood, its new “Question Reality” ad campaign hopes to center tough questions and
call out the systemic racism
fueling US health inequities.
Broadway actor
Tommy Brabcco
laid out his professional struggles
with asthma in a 10-minute video for
Sanofi
and
Regeneron’s Dupixent
“LungZone” campaign as a spokesperson for the medication he now uses, speaking about how he managed his condition before getting his asthma under control. He joins a group of five social influencers already working on the campaign that launched last year.
“Peeing in a cup sucks.” That’s the headline — and the uncomfortable truth — in one of
Aurinia Pharmaceuticals’
new campaign ads, a candid series speaking to lupus nephritis patients in a “candid and real” way and
encouraging them to prioritize doctor visits
. Because as it also points out in the same ad: “But kidney failure is way worse.”
A lot has changed in the world since
Bristol Myers Squibb
first introduced its campaign on cancer survivorship in 2019. However, BMS
is continuing to center personal experience
in its “Survivorship Today” campaign, featuring spokesman and actor
Sterling
K. Brown
often as an interviewer speaking with patients about what it’s like to live with cancer.
Cancer, specifically breast cancer, is the topic for Pfizer’s second season of its “Science Will Win” podcast;
Gilead’s Kite
signed on to sponsor national ‘Light the Night’ fundraisers for blood cancer patients; The Ad Council partnered with former drug dealers to raise awareness about
fentanyl
, including
naloxone
treatment; and more news can be found in the
MarketingRx roundup
.
FDA+
By the time
Gilead
bought out German biotech
Myr
and its hepatitis delta virus candidate for $1.7 billion, the drug already had an EU authorization and US approval seemed all but a done deal. But the FDA quashed those hopes with a
complete response letter
on
bulevirtide
over concerns about the “manufacture and delivery” of the drug.
When does a failed confirmatory trial evaluating overall survival not amount to a request from FDA to pull an accelerated approval for a cancer drug? That’s the situation right now for
Jazz Pharmaceuticals’
Zepzelca
, a second-line treatment for adults with metastatic small cell lung cancer. In
denying a petition to withdraw the drug
, the FDA made the point that the trial didn’t exactly cover what the approval was for.
Seres Therapeutics
is finally at the FDA’s doorstep with a microbiome candidate after years of ups and downs. And the FDA
granted priority review
to its BLA for
SER-109
in preventing recurrent C. difficile infection based on data readouts from two studies. An approval here would vault the biotech ahead of heavyweights and other microbiome players in this field.
Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns. The agency’s safety committee
issued new guidance recommending
that a group of JAK inhibitors used for chronic inflammatory disorders is only used in certain at-risk patients if no alternatives are available.
After setbacks and delays, the Swiss biotech
Santhera
says it has what it takes to steer its treatment for Duchenne muscular dystrophy past the FDA. Santhera, along with
ReveraGen
BioPharma
,
completed the rolling submission
for an NDA to US regulators and is seeking a priority review for vamorolone to treat Duchenne based on Phase IIb data.
In a new setback for Paris-based
Ipsen
, the
FDA is postponing an adcomm meeting
that was set for Oct. 31 to review new information on the company’s previously spurned potential treatment of patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder. A new meeting date has yet to be set and it remains to be seen whether this will delay its PDUFA deadline too.
MANUFACTURING
Only a few weeks after the FDA recognized a shortage of
Adderall
,
another crucial drug is in low supply
: the antibiotic
amoxicillin
. According to the American Society of Health System Pharmacists’ drug shortage list, three manufacturers are posting shortages of the oral version of the drug. The list includes
Hikma
Pharmaceuticals
,
Teva
and
Sandoz
.
Ireland has become a hot spot for major pharmaceutical manufacturing developments this year, and
Pfizer
might be the latest to get in on the action. The pharma giant is reportedly
planning to invest $987 million
on a manufacturing facility at its Grange Castle site in the Irish capital of Dublin.
As Pakistan faces a serious health crisis caused by major flooding,
GSK
is
drawing back on the production
of a common pain medicine in the country. In a letter to Pakistan’s stock exchange, the pharma explained that the price for
paracetamol
, the raw ingredient for its pain medication
Panadol
, is “debilitating” and continuing production would not be sustainable for the company.
As
Fujifilm Diosynth
continues its expansion drive in Europe, the company is also moving ahead with a major project in the Lone Star State. The company
broke ground on a $300 million
, 138,000-square-foot expansion at Fujifilm’s GMP manufacturing facility in College Station, TX, that makes vaccines and advanced therapies. It’s slated to open by 2024.
As part of its investment in manufacturing infrastructure in its home state of Indiana,
Eli Lilly
committed a total of $92.5 million
to
Purdue University
to establish a new pharmaceutical manufacturing scholarship program as well as renew strategic research collaborations between Purdue and Lilly.
With help from the local government, the CDMO
Curia
is
kicking off a $100 million expansion
in Albuquerque, NM. The project will see Curia install a new fill-finish manufacturing line for injectable medicines as well as other capabilities to make and distribute smaller-batch advanced therapies. The fill-finish line is expected to be up and running by 2025.
Nephron Pharmaceuticals’
contract manufacturing facility in South Carolina, which makes a saline solution to help replenish lost water and salt,
has been given a warning letter
from the FDA over several issues related to cross-contamination and other quality issues. According to regulators, the company failed to properly investigate why this happened.
Indian generics manufacturer
Aurobindo
is having to pull another product off the shelves. According to the FDA, the company’s US branch,
Aurobindo Pharma
USA
,
issued a voluntary recall
of two batches of the heart medication
Quinapril
. The recall was issued over a “Nitrosamine Drug Substance Related Impurity” above the proposed limit.
Only a month after the FDA inspected
Catalent’s
site in Indiana, a site in Europe similarly
received an inspection report from US regulators
, this time with nine observations. The Form 483 cites issues with air filters in aseptic areas, deficient changes to the HVAC system inside of the clean rooms used for filling, as well as equipment issues.
Generics giant
Jubilant
has one of its manufacturing sites under the FDA’s microscope. A 14-page Form 483 inspection report from late July and early August
revealed six major observations
at the Jubilant manufacturing site in the village of Sikanderpur Bhainswal in northern India, including that it had not reviewed failures in drug batches.
Dutch CDMO
Symeres
acquired
Exemplify
BioPharma
, a CRO that provides drug development services, formulation development and CMC services to customers; Meanwhile,
Cambrex
is planning several expansions in the Midwest; A French viral vector manufacturer will team up with a manufacturing service provider on cell and gene therapy offerings — get all the details in the
Manufacturing roundup
.
DON’T MISS
Even back in the day as the singer for
Chester
French
, a two-man indie pop group that sporadically flared into public sight,
DA Wallach
had a rep as someone who knew people. Those connections have earned him a place in the venture world as a “visionary young investor.” Now Wallach’s going to give it a go in biotech,
joining forces with longtime biopharma research vet
Tim Wright
to launch a new fund dubbed
Time BioVentures
, with $100 million to start.
Swiss billionaire
Hansjörg Wyss
made his largest donation yet to the institute at
Harvard University
that bears his name. His
$350 million gift
to the
Wyss Institute
for Biologically Inspired Engineering
brings the total donated to $731 million. It also comes as the institute plans to move to new headquarters and its biotech spinouts have been buzzing with activity.
Just a month after shipping out the initial batch of its homegrown nanoparticle Covid-19 vaccines, South Korea’s
SK bioscience
signed a deal with the Coalition for Epidemic Preparedness Innovations to try out a different technology platform: mRNA. CEPI is offering the company
up to $40 million for early development
of an mRNA vaccine platform, including two initial projects, with another $100 million on the line if it moves into late-stage trials.
Pacific Biosciences
, or
PacBio
for short, made its name in long-read DNA sequencing, filling in a niche market where typical short-read DNA sequencers, like the ones on which Illumina built its dominance, could not go. But now, PacBio
wants to take on
Illumina
directly, with plans to release a short-read sequencer known as
Onso
.
