Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers
can visit their reader profile
to add Endpoints Weekly. New to Endpoints?
Sign up here
.
After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market.
We hope you can join him there
.
Some… positive? Alzheimer’s data
In a major surprise,
Eisai
and
Biogen’s
follow-up Alzheimer’s drug to the controversial
Aduhelm
passed a Phase III test looking at memory, problem-solving and other dementia metrics. One of the most-watched Alzheimer’s therapies in the clinic,
lecanemab
met all primary and secondary endpoints, giving the partners the confidence to ask for full approval early next year — right after the FDA is slated to make a decision on accelerated approval. While the results mark a milestone for the embattled amyloid beta hypothesis,
some experts also caution the effect is modest
. And the CMS
might just be the ultimate gatekeeper
for the drug’s future.
Amylyx OK spurs debate
For just the third time in its 116-year history, the FDA
approved a new treatment for ALS
. The thumbs-up to the drug, known as
Relyvrio
, in a massive win for patients and their families as well as
Amylyx
Pharmaceuticals
, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists. But the price of $158,000 per year — and the legal vagueness of the co-CEOs’ “pledge” to withdraw the drug if it fails a confirmatory study —
is drawing criticism from experts
.
Cancer trial bottleneck
As patients with life-threatening cancers seek to enroll in clinical trials for new therapies, trial operators across the US are struggling to staff their sites with adequate workforce to meet demand. Some academic researchers and industry leaders have billed it as a crisis, compounded by the influx of therapeutics entering the clinic and as the sheer amount of drug developers has skyrocketed in the past decade. The staffing shortages are intensifying even as the pandemic recedes, leaving cancer patients waiting, Kyle LaHucik
reports in his latest In Focus
.
Changes afoot for cell and gene therapy regulation
Housed within the FDA’s Center for Biologics Evaluation and Research, the once-tiny Office of Tissues and Advanced Therapies, which regulates all cell and gene therapy products, has been pummeled with a workload that now includes more than 3,000 active INDs. That punishing workload has translated into OTAT staff defections leading to a loss of experience. The office is ready to expand,
adding about 100 positions to its 300-strong team
, Zach Brennan reports. Days later, CBER followed up with the news that it will
retitle OTAT to the Office of Therapeutic Products
and elevate it to “Super Office” status, which will increase its review capabilities, and enhance its expertise on new cell and gene therapies. In a town hall, OTP
offered clarification on guidance and regulations
for manufacturers.
PREMIUM
Sanofi’s CRISPR bet
Like many of its Big Pharma brethren,
Sanofi
is on the hunt for the best, cutting-edge gene editing tech available. It ultimately settled on
Scribe Therapeutics’
CasX editing tech for their work on NK cells, in a
deal featuring a $25 million get-to-know-you upfront and a cool $1 billion
in biobuck milestones. The pact gives Sanofi a chance to jump on a platform that can be used to engineer their ex vivo NK cells, something they’ve focused on quite closely since the $358 million
Kiadis
buyout in late 2020.
FINANCING
Can a preclinical biotech with grand ambitions, a star scientific founder and enthusiastic backers with deep pockets fly a big IPO against the gale force headwinds we’ve seen this year?
David Liu’s Prime
Medicine
, which bills itself as a CRISPR 3.0 play, is going for it. Analysts say the
$100 million placeholder for Prime
is likely a stand-in for what may be a $200 million push.
Gate
Neurosciences
, well, came out of the gate in late August with a lineup of drugs, known as NMDA receptor modulators, for major depressive disorder and schizophrenia that it licensed from
AbbVie
. In an update, it disclosed that it
raised $25 million and unveiled more details
on two other licensing deals it struck with
Eli Lilly
and Northwestern University.
After its plans to go public on the HKEX fell through last year,
YishengBio
is taking the once-flashy SPAC route to get on Nasdaq. The vaccine maker, which will rename itself
YS Biopharma
,
will merge with Hong Kong-based
Summit Healthcare Acquisition Corp
. The transaction puts YS Biopharma at a pre-money equity valuation of $834 million.
Albireo
, a Boston biotech focused on liver disease, raised some quick cash by selling royalty rights to its sole FDA-approved drug. Canada-based investment firm
Sagard Holdings
shelled out $115 million
in exchange for tiered royalties on the sales of
Bylvay
, approved last year to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis.
STARTUPS
George Church’s Colossal Biosciences
has a somewhat lofty goal: revive the woolly mammoth. But it’s always thought that it could make other breakthroughs along the way. Now it’s spinning out a startup,
Form
Bio
,
armed with $30 million to develop
just one such project: an AI platform that is meant to make managing massive datasets — commonplace in biotech today — more user-friendly and less code-heavy.
Daniel Wiegand
and
Jonathan Rittichier
have been working on new ways to manufacture RNA in
George Church’s
lab for the past six years. They’re ready to take the wraps off
EnPlusOne
Biosciences
, a biotech built on their RNA synthesis platform
with $12 million in seed funding
. The enzyme-based method promises to overcome limitations of the chemical approach.
For Rett syndrome, like other neurological diseases, drug development has largely been a story of failure. To the founders of a new
Wyss Institute
spinout, a big part of that lies in the traditional drug development paradigm. So
Unravel Biosciences
will be pushing a new platform
that goes against the target-first model — using CRISPR-engineered tadpoles.
Bristol Myers
got the first TYK2 approval earlier in September.
Frazier’s
new biotech
Sudo Biosciences
hopes to get many more, and it’s
starting out with $37 million in Series A funding
. Sudo’s programs are focused on a specific part of TYK2 — the pseudokinase domain — with hopes of going after “some of the indications that are a little bit further back in the pipeline.”
The newest entrant into the antibody-drug conjugate space is coming in with two substantial backers and a secretive, old platform it’s looking to revitalize. The UK outfit is called
Pheon
Therapeutics
, and a Series A led by
Forbion
,
Atlas Venture
and
Brandon Capital
gives it $68 million to explore
multiple applications of its ADC tech.
Three young founders with medical and tech backgrounds
scored $6 million in seed funding
for an upstart that aims to tackle the communication gaps between research teams, starting with the world of biotech and eventually moving into other R&D-intense industries, like food manufacturing, battery and other fields. They named the venture
Kaleidoscope
.
CELL & GENE TX
Solid
Bio
, the developer of a gene therapy for Duchenne muscular dystrophy and now a struggling penny stock player, is merging with
AavantiBio
. The CEO of the younger outfit, which gutted its CMC group in a reorg earlier this year, will be in charge of the new ops. And some high-profile investors
are leading a $75 million raise
to add to the pool of cash.
San Francisco-based
ArsenalBio’s
designer T cells program is attracting the attention of some big players. After closing a deal with
Bristol Myers Squibb
last year, the biotech is back in the news with a brand new deal, this time
scoring $70 million upfront
from
Genentech
to share research ideas and develop targeted T cells for solid tumors.
The FDA’s Oncology Center of Excellence has a program, known as Real-Time Oncology Review (RTOR), that speeds up cancer drug approvals. Seizing the opportunity of commenting on a draft guidance on the program — which contains a footnote about cell and gene therapies —
Pfizer
expressed its support
for real-time reviews for such drugs.
Vertex
and
CRISPR Therapeutics
say they have wrapped up their lengthy talks with the FDA and gotten
regulators on board for a rolling review
of their CRISPR-based cell therapy for sickle cell disease and transfusion-dependent beta thalassemia beginning later this year — with the submission package due to be complete in the first quarter of 2023.
Two years after contending with an unexpected rejection,
BioMarin
is back with a refiled BLA
on its gene therapy for hemophilia A. The new
valrox
data package, which comes on the heels of a European approval, carries the long-term data that the FDA asked for and a promise for up to 15 years of follow-up to answer questions about durability.
The EMA is launching a new pilot program to help academic and other nonprofit researchers develop advanced therapy medicinal products, which include cell and gene therapies. For this pilot,
it will guide five participants
through the regulatory process with the aim to optimize the development of such products, starting from best practice principles for manufacturing to planning clinical development.
PHARMA
The battle over whether and how to reform the FDA’s accelerated approval pathway is heating up again with a new report from the HHS’ inspector general
reiterating concerns about delayed or slowed confirmatory trials
for accelerated approvals. It estimates that Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for 18 drugs with incomplete confirmatory trials that are past their original planned completion dates.
GSK
became the latest company to
voluntarily yank its PARP inhibitor
Zejula
as a treatment for ovarian cancer patients who are HRD-positive and have tried at least three prior chemotherapy treatments. The FDA’s adcomm is set to review the potential increased risk of death tied with the class, and the results could spell trouble for
Merck
,
AstraZeneca
and
Clovis
.
Is R&D spending linked to the final market price of a given drug? A group of researchers
tried and failed to find a link
, even as many companies claim that new therapies need to be priced high to recoup the cost of their development. But the research was limited by the few number of drugs with data available on company R&D investments.
UK regulators have a message for ADHD patients and their providers:
Take caution when switching
between long-acting forms of common meds such as
Novartis’
blockbuster
Ritalin
LA
and
Janssen’s Concerta
XL
. In a warning, they note that different formulations of methylphenidate may require varying dosing schedules and instructions.
Enalare
Therapeutics’
lead respiratory candidate earned the New Jersey-based biotech a deal with BARDA
worth up to $50.3 million
. The candidate is designed to stimulate breathing and is meant to be used in emergency cases when treating drug overdoses or respiratory depression post-surgery.
DEALS
As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma. Now
Novo Nordisk
is jumping on the bandwagon — and it is taking the target where it knows best: cardiometabolic diseases.
Paying $70 million upfront
, it will get rights to develop
Ventus Therapeutics’
lead NLRP3 drug and a slate of backups for diseases like NASH.
That big rumored
Merck
acquisition has yet to materialize, but
Seagen
is ready to do some dealmaking of its own. The ADC specialist is paying
LAVA
Therapeutics
, a Netherlands-based gamma delta T cell engager biotech,
$50 million upfront to grab
its EGFR-targeting drug candidate. The whole deal can add up to $700 million.
More than two and a half years after backing
PhaseBio
in developing a drug that can reverse a specific blood thinner, California-based
SFJ Pharmaceuticals
is demanding rights to the drug
, which was originally licensed from
AstraZeneca
. The dispute has to do with PhaseBio’s compliance with a “going concern condition,” and neither side is relenting.
Ever since disappointing late-stage data on its cancer drug tanked
Idera Pharmaceuticals’
stock last year (unhelped by an ill-fated collaboration with
AbbVie
), execs have been tightening the belt while searching for something — anything — that may dig the company out of its hole. They finally found it in private biotech
Aceragen
,
settling on an acquisition
that would turn it into a rare disease player.
China’s
Simcere
is looking to go international with its preclinical IL-2 mutant fusion protein, and
Almirall
is giving it a hand. The Spanish pharma
will pay $15 million upfront
to grab ex-China rights to the drug, and reserve $492 million for milestones. By activating T regulatory cells, the companies hope the drug can tackle autoimmune diseases.
It was only last year that the oral treatment
Tembexa
was approved by the FDA to treat smallpox, but the drug has already changed hands. After months of negotiations,
Emergent BioSolutions
paid $238 million in cash
to secure the global rights for Tembexa from the North Carolina-based biotech
Chimerix
. It’s also picking up a 10-year BARDA contract.
PEOPLE
Striving to scale new heights,
Moderna
CEO
Stéphane Bancel
made a bit more room
in the cockpit with a new executive role, promoting former chief technical operations and quality officer
Juan Andres
to president of strategic partnerships and enterprise expansion, and poaching
Jerh Collins
from
Novartis
to take his place.
Four years ago,
Emma Walmsley
recruited
Iain Mackay
from the banking world to become
GSK’s
CFO. Now that he’s helped oversee the spinoff of GSK’s consumer health unit, Walmsley
is turning to an industry veteran for his successor
.
Julie
Brown
, a veteran of
AstraZeneca
who recently switched lanes at
Burberry
, will be the first woman to take up this role at GSK.
To survive the current market conditions, Philadelphia-based
Context Therapeutics
resorted to cost-cutting, a hiring freeze and pipeline pruning
. The company, which develops treatments for breast and gynecological cancers, is hoping that the new measures will help it sustain itself until the end of Q1, 2024.
The drastic restructuring that
Exicure
undertook at the end of last year couldn’t save the biotech after all. Exicure — whose take on gene expression once drew the backing of
Bill Gates
and a slate of tech investors —
is going for another round
of layoffs, this time cutting 66% of the remaining staffers, while halting all R&D activities and looking to divest its entire pipeline. To help keep the lights on longer, an existing investor agreed to buy more shares for $5.4 million.
Mereo BioPharma’s
proxy fight with disgruntled shareholder
Rubric Capital Management
isn’t over. Amid a weekslong back-and-forth, the London biotech said Rubric
rejected its offer of two seats
on the board of directors, instead insisting that it be provided with four board seats. It’s previously called into question the qualifications of Rubric’s proposed members.
CORONAVIRUS
As the bivalent booster season kicks off in earnest, a new study from NYU researchers
identifies two cases of mutated coronavirus resistant
to
Gilead’s remdesivir
in immunocompromised individuals. “The combined effect of these mutations may limit the clinical efficacy of remdesivir,” the researchers wrote.
Beleaguered from a rocky couple of months in which European authorities recommended its non-mRNA Covid shot but its supply contract with the European Commission collapsed,
Valneva
says
it’s still in discussions
with a prospective partner to fund the development of a second-gen vaccine — leaving the program’s future still up in the air.
The WTO’s TRIPS Council is scheduled to debate in mid-October
whether to extend the IP waiver
for Covid-19 vaccines to therapeutics and diagnostics too. The US Chamber of Commerce, as well as industry groups BIO and EFPIA, expressed “strong opposition” to any expansion, with some arguing the vaccine waiver did little to begin with.
LAW
Looking to clear the legal deck,
Biogen
agreed to pay the US government and states a
whopping $900 million to settle seven-year-old allegations
that it submitted false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs. The whistleblower who started the case will take home almost $250 million.
Gilead
named two “kingpins” in its counterfeit drug lawsuit
for “leading and orchestrating” a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies. In newly unsealed court documents, they were accused of setting up and controlling a series of “fly-by-night” wholesalers to sell the counterfeit meds.
Handing
Viatris
its second loss in as many weeks, a federal appeals court
upheld
Merck’s
patent rights
related to the dihydrogen phosphate salt of
sitagliptin
— an active ingredient in the blockbuster diabetes drugs
Januvia
,
Janumet
and extended-release formulation
Janumet XR
— calling the generic maker’s claims “unpersuasive.”
J&J
filed a lawsuit against two of its former employees in March, alleging that they stole work at
Janssen
to create an HBV pipeline at
Aligos
Therapeutics
. The two startup co-founders
are now firing back
with not just a response on the disputed patent applications but their own countersuit claiming that Janssen made false promises to them.
R&D
Intercept Pharmaceuticals
ran into another big setback in its yearslong quest to win an approval for OCA in NASH, putting out word that its
Phase III REVERSE study failed the primary endpoint
of improving fibrosis for the liver disease. The biotech is banking on its other Phase III, which it says looks positive upon further analysis. But analysts aren’t optimistic.
Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated amyloidosis with cardiomyopathy,
Alnylam
is bolstering its package with new exploratory and subgroup data
before shipping it off to regulators later this year. It also revealed a bit more detail on a key miss.
Elsewhere in the ALS field, things are a bit more tepid.
Biohaven
disclosed that its drug
verdiperstat
failed its arm of a platform trial
led by Massachusetts General Hospital. It did not meet the primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks.
Axcella
Therapeutics
, with an empty bank account looming in the first quarter of next year and a recent setback in a mid-stage long Covid study,
is out with some upbeat interim data
on its NASH drug. The biotech isn’t yet saying how the drug performed on the primary endpoint, but the first batch of data, on liver stiffness, was enough to send shares up.
TCR²’s gavo-cel
survived a PhI test
, in which the majority of heavily pretreated cancer patients enrolled in the trial saw their target lesions reduce in size after receiving the T cell therapy, including six partial responses. Now the biotech’s diving head-first into PhII with the confirmed dose.
Weeks after rolling out its first psoriasis treatment,
Arcutis Biotherapeutics
is racking up more positive Phase III data
for a second formulation of an old
AstraZeneca
drug. The ARRECTOR trial tested roflumilast foam — which is nearly identical to the approved cream but designed for hair-bearing areas of the body — in patients with scalp and body psoriasis,
Aquestive
Therapeutics
, a New Jersey biotech specializing in drug delivery via oral film, is reporting new Phase II data suggesting its potential
EpiPen
replacement — which delivers a prodrug of
epinephrine
orally instead of through intramuscular injection —
performed in line with expectations
. It’s also setting a countdown to have it before the FDA by the end of 2023.
MARKETINGRX
When the Covid-19 pandemic began, consumer brands rushed to the TV airwaves to broadcast messages of solidarity and hope. But pharma and healthcare — the industries most closely tied to the actual public health crisis — kept mostly low profiles. The Covid-related ad boom began to wane though as 2020 turned into 2021, which opened the door for pharma companies and brands to return with their own messages. MarketingRx editor Beth Bulik
tracks the evolution
.
Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously,
a new patient report from
Phreesia
finds
, as few patients surveyed understand the longer-term health risks of constipation.
As
Sanofi
tests a new kind of drug for non-small cell lung cancer, it’s
prepping physicians for the potential biomarker
it’s tied to. The new campaign uses a colorful camouflaged moth to illustrate the idea of CEACAM5 — the target of Sanofi’s Phase III ADC
tusamitamab ravtansine
— hiding in plain sight.
The newest campaign for multiple sclerosis brand
Ocrevus
from
Roche’s Genentech
features the brand’s now-familiar two-finger peace sign
— symbolic of victory, peace and a nod to Ocrevus’ twice-yearly dosing schedule. But it’s looking to expand the reach to include new groups like Gen Z and Hispanic people living with MS.
Myovant Sciences’
new video series
featuring frank conversations among men who have prostate cancer is its first on a new storytelling platform that aims to educate, but also offer support and dispel stigma through real patients’ experiences. And the platform, in turn, is part of a broader campaign to look “beyond the pill” to address the other needs of patients.
Johnson & Johnson’s
consumer health company
has a new name, identity and purpose
.
Kenvue
is a combination of “ken” meaning knowledge and “vue” a homonym of view. The $15 billion consumer spinoff with household staple brands including
Neutrogena, Tylenol
,
Band-Aid
and a lineup of baby care products is set to become a separate publicly traded company by November 2023.
For the last four years,
Teva
has connected with Huntington’s disease patients through its Facebook page, Honestly HD. This year, the company
is hoping to reach a much broader audience
with a website full of resources and a new Twitter channel. Teva won approval five years ago for a treatment for Huntington’s-associated chorea, and the website focuses on that.
While hereditary angioedema is rare, treatment options for the condition have become much more common. So
BioCryst Pharmaceuticals
is taking a new angle in its recently launched
HAE awareness campaign encouraging patients to take control of their disease management, with a focus on “shared decision making” between patients and healthcare teams.
Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US — and that’s the message of
Tarsus Pharmaceuticals’
new awareness campaign
. The campaign debut comes just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.
AbbVie
is setting out to change beauty standards in aesthetics marketing — and to do so,
it’s teaming up with
Shutterstock
. The pharma giant’s
Allergan Aesthetics
unit announced the new partnership as part of its Driving Racial Equity in Aesthetic Medicine initiative, which features a report and a video series about diversity and representation in beauty and advertising.
In
this week’s MarketingRx roundup
you will find
Moderna’s
TV campaign encouraging Covid-19 vaccine boosters for the fall; the expansion of
Genentech’s
partnership with
Futurelab
to educate the next generation of STEM students in South San Francisco; A pledge of post-hurricane donation from
Gilead
to support people with HIV and at risk in Puerto Rico; and more.
FDA+
The FDA
is about to lose another top leader
with the departure of
Sally
Choe
, director of the Office of Generic Drugs. Her exit coincides with the transition from the second reauthorization of the Generic Drug User Fee Amendments to the third reauthorization. Choe has served in this role since February 2019.
With days left in the fiscal year, FDA-related policy riders approved in both House and Senate committees
appear dead
— at least for now, according to the text of a short-term government spending bill that will keep federal agencies open until late this year. But the absence of riders doesn’t mean Democrats are done fighting to add these regulatory reforms.
Sanofi
and
Regeneron
nabbed a fifth FDA approval
with
Dupixent
, making it the first approved treatment for prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch.
How do specifics around endorsements, mechanism of action and medication tracking in pharmaceutical ads impact consumers? That’s what the FDA’s Office of Prescription Drug Promotion
wants to find out
in three new studies. OPDP has proposed three research projects on direct-to-consumer marketing, adding to its roster of 13 ongoing projects.
Three years after paying a modest $20 million upfront to grab the late-stage rare disease drug leniolisib from
Novartis
,
Pharming
lined up a priority review at the FDA
. The drug belongs to the PI3Kẟ inhibitor class, which is best known for cancer applications. But Novartis helped Pharming complete the Phase II/III study that cemented its use in an immunodeficiency disease.
Avidity Biosciences
will have to wait to enroll new patients in a Phase I/II study of its antibody-siRNA conjugate therapy for myotonic dystrophy type 1, which weakens muscles and leads to respiratory and cardiac issues. The FDA
placed a partial hold
on its MARINA study as the company and one of its trial investigators look into a serious adverse event.
The EMA
is handing out a new recommendation
surrounding
J&J
and
AbbVie’s
cancer drug
Imbruvica
and some medicines containing
terlipressin
. Specifically, its safety committee stated that it has taken new measures to reduce the risk of respiratory failure and sepsis when medicines containing terlipressin are used to treat people with hepatorenal syndrome.
Roche’s Avastin
has attracted quite the crowd of biosimilars in recent years, and one more pharma company has elbowed its way in. Regulators
approved
Celltrion’s
biosimilar
Vegzelma
in six cancer types — with hepatocellular carcinoma conspicuously missing on the label. The drug is, however, the drug is a bit late to the party.
MANUFACTURING
As winter approaches, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind,
including generic drug manufacturers
. Medicines for Europe, a group that represents the generic industry on the continent, sent a letter to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.
Choosing to keep its card close to its chest,
Vor Biopharma
began manufacturing operations at an in-house facility
at its HQ in Cambridge, MA. Construction started last summer for the site, which will initially manufacture a clinical supply of its candidate
VCAR33allo
to support its IND, slated for the first half of next year. It also plans to transfer the production of another product.
Joining a long list of industry players making moves in Ireland,
Ipsen
unveiled the €52 million ($49.9 million) expansion
it made into its active pharmaceutical ingredient manufacturing facility in Blanchardstown, a small suburb of Dublin. The investment is aimed at boosting medicine and ingredient production in cancer and rare disease space.
The US government is
all set to buy $10.7 million worth of
Siga Technologies’
monkeypox oral antiviral. Of the total doses, $5.1 million worth of oral antivirals called
Tpoxx
(
tecovirimat
) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.
Two separate drug manufacturers
have been cited by US regulators
over several infractions including quality, cleaning and other issues. The warning letters went to Chinese API producer
Zhejiang Tianyu Pharmaceutical Co
and Germany-based OTC drug manufacturer
SystemKosmetik
, respectively.
Aceto
, a New York-based manufacturer of ingredients and raw materials, rebranded to
Actylis
after a buyout spree;
WuXi STA
is keeping up its momentum by opening another site in its manufacturing chain; Chinese CDMO
Asymchem
plans for a building project in
Jiangsu
Province
;
check out the Manufacturing roundup
to make sure you didn’t miss anything.
DON’T MISS
The US Senate
passed a bipartisan bill that would alter
a federal mandate for animal testing on new drugs, but stops short of removing animal testing entirely. Touted as a much-needed modernization of FDA’s rules, the bill’s co-sponsors have said they hope to stop needless suffering of animals.
Beginning this weekend, biopharma companies
can be charged rebates
for any new drug price increases rising faster than the rate of inflation. The new rebates are part of the newly signed Inflation Reduction Act, which introduces this new requirement that manufacturers pay rebates to Medicare for Part D drugs whose price increases exceed inflation, and in January 2023, the same will occur with Part B drugs.
Speaking of the Inflation Reduction Act, the White House’s Council of Economic Advisors argues in a blog post that the new cap on out-of-pocket costs for Medicare beneficiaries
could lead some of them to start cancer treatments
that they previously can’t afford.
New research funded by a European pharma industry group is looking to reinvigorate antimicrobial R&D with a system that’s similar to the priority review voucher systems in the US. As the need for novel antibiotics is urgent,
EFPIA
is calling for a system where developers of novel antibiotics
can win a voucher that can then be used to extend
the exclusivity of another drug for a period of time, or sold to another company, thereby paying for the antibiotic research.