The Trump administration will announce plans to change healthcare
regulations on Wednesday to loosen anti-kickback provisions that
restrict the kinds of outside services providers can refer patients to,
administration officials said.
President Donald Trump on Thursday will explain how the new rules
advance his broader healthcare agenda, which includes reducing
regulatory burdens and promoting innovative ways to reimburse healthcare
providers, in a speech in Minnesota, the officials said.
The plan will change how the Department of Health and Human Services
(HHS) enforces the Physician Self Referral Law, also known as the Stark
law, which penalizes healthcare providers for referring patients to
outside services that the provider could stand to benefit from
financially.
HHS will create exceptions for healthcare providers that enter into
agreements with other parties if they are aimed at cutting costs and
improving patient health, the officials said.
Trump issued an executive order last week that sought to woo seniors by strengthening the Medicare health program.
The order was the Republican president’s answer to Democrats like
Bernie Sanders, who is running to become the party’s nominee in the 2020
presidential election and is promoting the idea of Medicare for all
Americans.
New York City has sued more nearly two dozen online e-cigarette
retailers, accusing them of selling their products to underage New
Yorkers, the city announced Wednesday.
The lawsuit, filed Tuesday evening in Brooklyn federal court, targets
22 companies including Artison Vapor Franchise LLC, Eliquidstop.com and
Vapor 4 Life Holdings Inc. All of them are located outside New York.
The lawsuit accuses the companies of violating New York City law
prohibiting the sale of e-cigarettes to people under 21 by marketing to
underage consumers and failing to take adequate steps to verify their
ages.
It seeks an order requiring them to comply with the law, and money
damages “to compensate the city for the costs of abating the epidemic of
underage e-cigarette use in the city.”
“The kids of New York are the pride of our city, but to these
companies, they’re just a source of profit,” New York City Mayor Bill de
Blasio said in a statement. “Preying on minors and hooking them on a
potentially lethal, lifelong nicotine addiction is unconscionable.”
Artisan Vapor Franchise, Eliquidstop.com and Vapor 4 Life could not immediately be reached for comment.
There has been a regulatory crackdown on e-cigarettes and a growing
number of lawsuits by young adults and parents of teenagers against
leading e-cigarette company Juul Labs Inc and its parent company,
Marlboro maker Altria Group.
Most of the lawsuits say only that users became addicted to nicotine
as a result of using Juul, but some allege serious health consequences.
Some states, including New York, Michigan and Rhode Island, have
moved to restrict the sale of flavored e-cigarettes. Massachusetts has
gone further, instituting a four-month ban on all vaping products.
Last week, a New York judge blocked a state ban on most flavored
e-cigarettes from taking effect after an industry group sued to
challenge it, while a Massachusetts judge upheld that state’s ban. https://www.reuters.com/article/us-new-york-vaping-lawsuit/new-york-city-sues-online-e-cigarette-retailers-over-age-verification-idUSKBN1WO2IG
Researchers
at Duke University studied cartilage from the hip, knee and ankle and
discovered a pattern of regeneration when looking at proteins within the
cartilage. Credit: Alisa Weigandt for Duke Health
Contrary to popular belief, cartilage in human joints can repair
itself through a process similar to that used by creatures such as
salamanders and zebrafish to regenerate limbs, researchers at Duke
Health found.
Publishing online Oct. 9 in the journal Science Advances, the researchers identified a mechanism for cartilage repair that appears to be more robust in ankle joints
and less so in hips. The finding could potentially lead to treatments
for osteoarthritis, the most common joint disorder in the world.
“We believe that an understanding of this ‘salamander-like’
regenerative capacity in humans, and the critically missing components
of this regulatory circuit, could provide the foundation for new
approaches to repair joint tissues and possibly whole human limbs,” said
senior author Virginia Byers Kraus, M.D., Ph.D., a professor in the
departments of Medicine, Pathology and Orthopedic Surgery at Duke.
Kraus and colleagues, including lead author Ming-Feng Hsueh, Ph.D.,
devised a way to determine the age of proteins using internal molecular
clocks integral to amino acids, which convert one form to another with predictable regularity.
Newly created proteins in tissue have few or no amino acid
conversions; older proteins have many. Understanding this process
enabled the researchers to use sensitive mass spectrometry to identify
when key proteins in human cartilage, including collagens, were young, middle-aged or old.
They found that the age of cartilage largely depended on where it
resided in the body. Cartilage in ankles is young, it’s middle-aged in
the knee and old in the hips. This correlation between the age of human
cartilage and its location in the body aligns with how limb repair
occurs in certain animals, which more readily regenerate at the furthest
tips, including the ends of legs or tails.
The finding also helps explain why injuries to people’s knees and,
especially, hips take a long time to recover and often develop into
arthritis, while ankle injuries heal quicker and less often become
severely arthritic.
The researchers further learned that molecules called microRNA
regulate this process. Not surprisingly, these microRNAs are more active
in animals that are known for limb, fin or tail repair, including
salamanders, zebrafish, African fresh water fish and lizards.
These microRNAs are also found in humans—an evolutionary artifact
that provides the capability in humans for joint tissue repair. As in
animals, microRNA activity varies significantly by its location: it was
highest in ankles compared to knees and hips and higher in the top layer
of cartilage compared to deeper layers of cartilage.
“We were excited to learn that the regulators of regeneration in the
salamander limb appear to also be the controllers of joint tissue repair
in the human limb,” Hsueh said. “We call it our ‘inner salamander’
capacity.”
The researchers said microRNAs could be developed as medicines that might prevent, slow or reverse arthritis.
“We believe we could boost these regulators to fully regenerate
degenerated cartilage of an arthritic joint. If we can figure out what
regulators we are missing compared with salamanders, we might even be
able to add the missing components back and develop a way someday to
regenerate part or all of an injured human limb,” Kraus said. “We believe this is a fundamental mechanism of repair that could be applied to many tissues, not just cartilage.”
Medtronic’s (NYSE:MDT) voluntary recall
of its 6F Sherpa NX Active Coronary Guide Catheter is considered Class I
by the FDA, its highest level since the product issue could cause
serious injury or death.
Affected catheters have a risk of losing outer
material from a distal component which could result in the underlying
stainless steel braid wires being exposed after insertion, although the
company says it has not received any reports of patient injuries to
date. The company investigated the issue after receiving six complaints.
Vericel Corp VCEL 1.52%,
a commercial-stage company that specializes in advanced cell therapies
for treating patients with knee cartilage defects and severe burn
wounds, is investment-worthy, according to H.C. Wainwright.
The Analyst
Analyst Swayampakula Ramakanth initiated coverage of Vericel with a Buy rating and $19 price target.
The Thesis
Vericel is likely to see nearly a fivefold increase in sales from two of its innovative tissue-repairing cell therapies — MACI and Epicel — and NaxoBrid, a partnered product, Ramakanth said in a Wednesday initiation note. (See his track record here.)
The analyst estimates revenues from the three products will grow from $116 million in 2019 to $533 million by 2025.
MACI, a cell therapy approved for treating knee cartilage defects, is
a major growth driver for the company, with sales reaching $68 million
in 2018 despite an estimated market penetration of merely 3%, Ramakanth
said.
MACI has the potential to becomes the standard-of-care in the $5-billion cartilage repair market, he said.
MACI sales could rise from $91 million this year to $471 million in
2025, assuming an expanded commercial focus and expanded sales force,
the analyst said.
Vericel’s agreement with Mediwound Ltd MDWD 1.35% to market NaxoBrid in the U.S. could energize the former’s burn franchise sales, Ramakanth said.
The company’s burn care addressable market could increase from
Epicel’s current market of 1,500 per year to 5,000 burn patients per
year with NaxoBrid, he said.
NaxoBrid is being evaluated in a Phase 3 trial, with a commercial launch likely in the second quarter of 2021, the analyst said.
“We believe NexoBrid could aid in cross-selling Epicel and help the
burn franchise’s sales to grow to $62M in 2025 from $25M in 2019.” https://www.benzinga.com/analyst-ratings/analyst-color/19/10/14568293/vericel-analyst-projects-wound-care-product-sales-will-grow-fivefold-by-2025
Johnson & Johnson (JNJ.N)
shares were off more than 2% on Wednesday, a day after a U.S. jury said
it must pay $8 billion in punitive damages to a plaintiff in a case
involving its anti-psychotic drug Risperdal, a penalty the company and
others are confident will not stand.
The jury in a Philadelphia court awarded the $8 billion to a man who
previously won $680,000 over his claims that it failed to warn that
young men using Risperdal could grow breasts.
J&J called the sum “grossly disproportionate with the initial
compensatory award” and said it was confident it would be overturned.
The company has legal precedent on its side.
A 2003 U.S. Supreme Court decision found that “few awards exceeding a
single-digit ratio between punitive and compensatory damages, to a
significant degree, will satisfy due process.” By that measure, the
punitive damages should be more in the neighborhood of $6 million.
Gary Bradshaw, portfolio manager for the Hodges Blue Chip Equity
Income fund, said he expects the total damages that J&J will pay to
be “drastically reduced” on appeal.
“There’s certainly a cloud overhanging the stock, but what keeps me
owning J&J and not walking away is that they’ve got tremendous
earnings power,” Bradshaw said.
Bradshaw, a long-time holder of J&J shares, expects the company
to earn up to $10 per share in 2021, giving it a likely share price of
$170.
J&J shares were off 2.3% at $128.75 in Wednesday afternoon trading.
Among the clouds hanging over the U.S. healthcare conglomerate are
thousands of lawsuits involving Risperdal, baby powder, opioids, medical
devices and other products.
“Every pharmaceutical company needs to seriously consider if they
want to litigate to verdict in the present environment, but with the
settlement demands so incredibly high it’s not always clear what their
alternative is,” said Barry Thompson, a partner at Baker McKenzie law
firm who was not involved in the case.
J&J did not have an immediate comment on its legal strategy.
According to a recent filing, J&J faces some 13,400 lawsuits tied
to Risperdal, which allege the drug caused a condition called
gynecomastia in boys, in which breast tissue becomes enlarged.
Johnson & Johnson paid more than $2.2 billion in 2013 to resolve
civil and criminal investigations by the U.S. Department of Justice into
its marketing of Risperdal and other drugs.
Earlier this month, the company agreed to pay $20.4 million to settle
claims by two Ohio counties, avoiding a federal opioid trial.
An Oklahoma judge in August ordered J&J to pay $572.1 million to
that state for its part in fueling the opioid crisis by deceptively
marketing addictive painkillers, a sum that was substantially less than
investors had expected. https://www.reuters.com/article/us-johnson-johnson-risperdal/jj-shares-fall-but-8-billion-jury-award-likely-to-be-slashed-idUSKBN1WO1MW
Biotechnology start-up Ginkgo Bioworks said on Wednesday that it had
raised a $350 million fund to more easily invest in spinout ventures
that use its bio-engineering technology in a variety of industries that
are just starting to use cutting edge biology.
Dubbed the Ferment Fund, the investment vehicle will invest in two to
three companies a year, Ginkgo Chief Executive Officer Jason Kelly said
in an interview. Ginkgo hopes such investments will help increase the
use of its technology.
Ginkgo has used this strategy in the past. In 2017, it formed a joint venture with Bayer AG (BAYGn.DE)
to develop bacteria that can perform similar functions to fertilizers
without the associated pollution. Earlier this year, it launched Motif
Foodworks, a company developing animal-free food ingredients, with
investment from agricultural merchant Louis Dreyfus Co.
General Atlantic, Viking Global Investors, and Bill Gates’ investment firm Cascade Investment participated in the financing.
Ginkgo is one of the world’s largest privately held biotechnology
firms. It works to make biological engineering cheaper and more
accessible, particularly in fields where biotechnology is not yet
widespread, by serving as a platform that allows customers to bypass the
expensive overhead associated with doing their own scientific research.
This includes large corporations working in industries such as
agriculture, cosmetics, foods, and textiles, sectors where biotechnology
could have useful applications but where its use is in early stages.
“As computers got cheaper, a whole host of applications became
accessible. We think the same thing is true for biology” Kelly said.
“The big thing we’re tying to accomplish now is build an ecosystem for
people to build apps essentially for cells.”
The new fund follows a $290 million funding round the company
completed in September, which brought its total financing to $719
million and its valuation to $4 billion.
